- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07915115
Computer-Assisted Vocabulary Intervention for Spanish-English Bilingual Children With Developmental Language Disorder (CABVI)
A Randomized Controlled Trial of Computer-Assisted Bilingual Vocabulary Intervention in Emergent Bilinguals With Developmental Language Disorder
This study will examine whether computer-assisted vocabulary instruction in Spanish and English helps young bilingual children with developmental language disorder learn and use vocabulary. It will include 120 Spanish-English bilingual children in kindergarten or first grade. Eighty children with developmental language disorder will be assigned by chance to bilingual computer-assisted vocabulary instruction, English-only computer-assisted vocabulary instruction, or usual English-language school services. Forty children with typical language development will receive bilingual instruction without random assignment, providing a developmental comparison.
The program teaches 36 vocabulary concepts through 24 small-group sessions, ordinarily over about six weeks. School-calendar disruptions may extend the schedule. Vocabulary will be assessed in both languages before intervention, immediately afterward, and approximately six weeks after the final session. The primary outcomes are naming and defining the taught concepts in each language.
The implementation component anticipates 15 unique school speech-language pathologists or appropriately supervised speech-language pathology assistants across five project years, with a planning target of approximately 3 new clinicians per year. Annual recruitment may vary with eligible caseloads. This component examines delivery fidelity, feasibility, clinician confidence, usability and satisfaction. Teacher and parent feedback about children's vocabulary use, communication confidence and engagement will also be collected after intervention and at follow-up where feasible.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The awarded CABVI R01 addresses three aims. Aim 1 compares bilingual CABVI, English-only CABVI and usual English-language school services among Spanish-English emergent bilingual children with developmental language disorder. Aim 2 compares vocabulary growth among children with and without developmental language disorder receiving bilingual CABVI. Aim 3 examines implementation fidelity, feasibility, clinician confidence, usability and satisfaction.
The child sample includes 80 children with developmental language disorder randomized approximately 1:1:1 after baseline assessment, using blocked allocation stratified by speech-language pathologist or interventionist, and 40 typically developing children receiving bilingual CABVI without randomization. Children remain in their assigned condition.
CABVI uses fixed groups of three to five children and six instructional units, each containing four sequential sessions. The 24 sessions ordinarily take about six weeks, with four sessions completed within seven days. Each session includes approximately 45 minutes of instruction within a 60-minute school scheduling block for transitions and breaks. School-calendar disruptions may extend the calendar while preserving the planned sessions and sequence. Individual absences do not lead to individual makeup sessions or transfers; whole-group cancellations may be rescheduled for the same group.
Both CABVI conditions teach the same 36 concepts through shared reading, receptive and expressive vocabulary activities, movement and songs, and supported conversations. Bilingual CABVI uses Spanish in Sessions 1 and 3 of each unit and English in Sessions 2 and 4. English-only CABVI uses English throughout. Qualified school clinicians or appropriately trained and supervised study clinicians provide adult oversight. Usual-care services have no CABVI-matched research dose; weekly logs document actual frequency, duration, content and attendance. Required school and individualized education program services continue independently of participation.
Outcome assessments occur before intervention and allocation, during the school week after the final intervention session, and approximately six weeks after that session. English and Spanish are assessed on different days. The first assessment language is counterbalanced across children independently of intervention allocation, and each child's assigned order is preserved across timepoints. Both vocabulary blocks in the assigned first language precede the other language's blocks. Within each language, generalization, Naming and incidental expressive tasks precede Definition, Elaboration, target receptive and incidental receptive tasks. Narrative retells may be scheduled separately. All participant assessments and intervention procedures take place at participating schools. Masked assessors do not test children whose intervention they delivered or supervised and do not receive condition-revealing records. Compatible modules may be combined and visits divided for school scheduling, fatigue or willingness while preserving sequence and timing; no teaching or corrective feedback is provided during testing.
The four primary outcomes are binary Naming and Definition scores for the 36 directly taught concepts, separately in Spanish and English. Elaboration is a secondary picture-supported measure scoring 0-3 new distinct accurate target-related ideas per concept beyond all information in its preceding Definition exchange. Additional pre-specified outcomes include contextualized expressive generalization, target receptive recognition, exploratory expressive and receptive knowledge of 15 selected incidental concepts, and narrative mean length of utterance in words and number of different word roots, reported separately for Spanish- and English-elicited retells. The outcome plan combines the awarded R01 core with later prespecified measures selected for this study.
The implementation component anticipates 15 unique school-based SLPs or appropriately supervised SLPAs across five project years, targeting approximately 3 new clinicians per year with variation by eligible DLD caseloads. Each adult participates during one project year. Adult participants are distinct from hired research personnel and student clinicians and are not automatically randomized with the children. Data include independent fidelity observations, session completion and burden records, pre/post confidence, and post-implementation usability, satisfaction and feedback. Teacher and parent ratings address perceived child vocabulary use, communication confidence and engagement after intervention and at six-week follow-up where feasible. Analyses distinguish the randomized DLD comparison, the developmental comparison within bilingual CABVI, and implementation outcomes.
The same fixed assessment pictures are reused at pretest, immediate posttest and six-week follow-up. They differ from intervention pictures; they are not previously unseen at every assessment. The 15 incidental concepts are tiny, enormous, curious, bright, together, carefully, help, inside, clap, drag, last, whole, again, on and remember. They occur in instructional stories, elaborations, routines or directions outside the 36 direct targets. These are exploratory researcher-developed measures; psychometric validation of this exact assessment is not claimed. Independently score a planned 20% of outcomes and narrative transcripts where adequate permitted source records support it, retaining original ratings and adjudication.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Jean F Rivera Perez, PhD, CCC-SLP
- Numero di telefono: 817-257-4075
- Email: j.riveraperez@tcu.edu
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Child participants:
- Age 5 years or older and enrolled in kindergarten or first grade at an authorized participating study site.
- Spanish-English emergent bilingual with regular Spanish exposure at home, including Spanish-primary or balanced bilingual homes, documented by parent questionnaire.
- Primary Test of Nonverbal Intelligence score of at least 70.
- Passes pure-tone hearing screening at 25 dB HL at 1000, 2000 and 4000 Hz.
- Names fewer than 12 of the 36 intervention target concepts before allocation, using the item-level bilingual conceptual union across complete Spanish and English Naming administrations. Count a concept once when an accepted label is produced in either language; 0-11 known concepts meets this vocabulary criterion, while 12-36 does not. Incomplete or unresolved administrations remain pending.
- Comprehensive age-appropriate bilingual assessment and converging clinical information support classification as developmental language disorder or typical language development.
- Children in the DLD cohort have at least one relevant language/vocabulary individualized education program goal; other goals are permitted.
- Written parent permission and the applicable child-assent process.
Adult clinician participants:
- At least 18 years old.
- School-based English-monolingual or English-dominant speech-language pathologist, or appropriately supervised speech-language pathology assistant, authorized to provide the assigned school services.
- Caseload includes eligible Spanish-English children with developmental language disorder and relevant language/vocabulary individualized education program goals.
- Written adult consent before adult research screening or questionnaires.
- Participation during one project year only.
Exclusion Criteria:
- Does not meet the inclusion criteria for the respective child or adult cohort.
- Comprehensive assessment does not support classification in the intended child study group.
- Adult clinician has participated in an earlier project year.
Declining optional audio/video recording does not itself exclude participation.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Bilingual CABVI in children with DLD
Spanish-English bilingual children with developmental language disorder are randomized to bilingual CABVI. The computer-assisted behavioral vocabulary program teaches 36 concepts in 24 small-group sessions, ordinarily over about six weeks. Each session includes approximately 45 minutes of instruction within a 60-minute school block. Sessions 1 and 3 of each unit are in Spanish; Sessions 2 and 4 are in English. School-calendar disruptions may extend the schedule while preserving the planned sequence. |
Behavioral vocabulary intervention using the CABVI app with trained adult oversight in fixed groups of three to five children. Twenty-four planned sessions teach 36 concepts across six units. Each session includes approximately 45 minutes of instruction within a 60-minute school block. Spanish is used in Sessions 1 and 3 of each unit and English in Sessions 2 and 4. Activities include shared reading, receptive and expressive vocabulary practice, songs and movement, and supported conversations. Four sessions ordinarily occur within seven days, for about six weeks total; school-calendar disruptions may extend the schedule while preserving session sequence. |
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Comparatore attivo: English-only CABVI in children with DLD
Spanish-English bilingual children with developmental language disorder are randomized to English-only CABVI. This condition uses the same computer-assisted behavioral vocabulary content, 36 concepts, 24-session sequence, small-group format, and planned dose as bilingual CABVI, with all instruction delivered in English. Sessions include approximately 45 minutes of instruction within a 60-minute school block, ordinarily over about six weeks, with school-calendar extensions as needed. |
Computer-assisted behavioral vocabulary intervention using the same 36 concepts, instructional content, 24-session sequence, fixed groups of three to five children, and planned dose as bilingual CABVI. All instruction is delivered in English. Sessions include approximately 45 minutes of instruction within a 60-minute school block, ordinarily four sessions within seven days over about six weeks. School-calendar disruptions may extend the schedule while preserving session sequence. Trained adults oversee the shared reading, receptive and expressive vocabulary activities, songs and movement, and supported conversations. |
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Comparatore attivo: Usual English-language school services in children with DLD
Spanish-English bilingual children with developmental language disorder are randomized to their usual English-language school services. A CABVI-matched research dose is not imposed. Weekly logs document actual service frequency, duration, content, and attendance. Required educational and individualized education program services continue independently of study participation. |
Usual English-language school services without a CABVI-matched research dose. Weekly logs document actual service frequency, duration, content, and attendance. Required educational and individualized education program services continue independently of study participation. |
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Sperimentale: Bilingual CABVI in typically developing children
Forty Spanish-English bilingual children with typical language development receive bilingual CABVI without randomization, providing a developmental comparison. They receive the same 36-concept, 24-session program and planned dose as the bilingual CABVI group with developmental language disorder. Sessions 1 and 3 of each unit are in Spanish; Sessions 2 and 4 are in English. Delivery is ordinarily completed over about six weeks, with school-calendar extensions as needed. |
Behavioral vocabulary intervention using the CABVI app with trained adult oversight in fixed groups of three to five children. Twenty-four planned sessions teach 36 concepts across six units. Each session includes approximately 45 minutes of instruction within a 60-minute school block. Spanish is used in Sessions 1 and 3 of each unit and English in Sessions 2 and 4. Activities include shared reading, receptive and expressive vocabulary practice, songs and movement, and supported conversations. Four sessions ordinarily occur within seven days, for about six weeks total; school-calendar disruptions may extend the schedule while preserving session sequence. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Target vocabulary Naming in Spanish
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Researcher-developed picture Naming task for 36 directly taught concepts in Spanish. Images differ from intervention pictures and are reused across assessment timepoints. After any clearly other-language-only initial response, regardless of accuracy, give one fixed reminder to answer in Spanish, without translation or answer cues. An accepted requested-language label initially or after that reminder earns 1; incorrect, absent or other-language-only responses earn 0. Mixed responses containing an accepted requested-language label need no reminder. Record initial response, reminder and subsequent response separately; retain other-language conceptual knowledge separately. Complete-inventory total: 0-36; higher scores indicate greater requested-language Naming knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Target vocabulary Definition in Spanish
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Researcher-developed Definition task for 36 directly taught concepts in Spanish, without a picture. Supply the label and allow up to THREE TOTAL fixed neutral prompts: the initial meaning question and up to two neutral rephrasings. Continue only when no clearly accurate requested-language attribute, function or description has emerged and the child remains willing. Once binary credit is clear, stop extra prompting but let the child finish all volunteered information. No answer cues or correctness feedback. Accurate attribute, function or description: 1; incorrect, irrelevant, label-only or absent response after valid administration: 0. Preserve all prompts and responses for scoring and Elaboration exclusions. Complete-inventory total: 0-36; higher scores indicate greater semantic knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Target vocabulary Naming in English
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Researcher-developed picture Naming task for 36 directly taught concepts in English. Images differ from intervention pictures and are reused across assessment timepoints. After any clearly other-language-only initial response, regardless of accuracy, give one fixed reminder to answer in English, without translation or answer cues. An accepted requested-language label initially or after that reminder earns 1; incorrect, absent or other-language-only responses earn 0. Mixed responses containing an accepted requested-language label need no reminder. Record initial response, reminder and subsequent response separately; retain other-language conceptual knowledge separately. Complete-inventory total: 0-36; higher scores indicate greater requested-language Naming knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Target vocabulary Definition in English
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Researcher-developed Definition task for 36 directly taught concepts in English, without a picture. Supply the label and allow up to THREE TOTAL fixed neutral prompts: the initial meaning question and up to two neutral rephrasings. Continue only when no clearly accurate requested-language attribute, function or description has emerged and the child remains willing. Once binary credit is clear, stop extra prompting but let the child finish all volunteered information. No answer cues or correctness feedback. Accurate attribute, function or description: 1; incorrect, irrelevant, label-only or absent response after valid administration: 0. Preserve all prompts and responses for scoring and Elaboration exclusions. Complete-inventory total: 0-36; higher scores indicate greater semantic knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Target vocabulary Elaboration in Spanish
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Researcher-developed picture-supported Elaboration task for 36 directly taught concepts in Spanish. After the Definition block, show the fixed concept picture and ask for something ELSE about the word, with up to two neutral continuations. Score 0-3 distinct accurate target-relevant ideas not expressed anywhere in that item's preceding Definition exchange, including volunteered details. Exclude every earlier Definition fact, repeated idea, unrelated scene detail and target-label repetition alone. Accurate knowledge beyond the picture may count. Preserve Definition evidence and each newly credited idea; record other-language contributions separately. Images are reused across timepoints and differ from intervention images. Complete-inventory total: 0-108; higher scores indicate more additional information with picture support. Record actual denominators; refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Target vocabulary Elaboration in English
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Researcher-developed picture-supported Elaboration task for 36 directly taught concepts in English. After the Definition block, show the fixed concept picture and ask for something ELSE about the word, with up to two neutral continuations. Score 0-3 distinct accurate target-relevant ideas not expressed anywhere in that item's preceding Definition exchange, including volunteered details. Exclude every earlier Definition fact, repeated idea, unrelated scene detail and target-label repetition alone. Accurate knowledge beyond the picture may count. Preserve Definition evidence and each newly credited idea; record other-language contributions separately. Images are reused across timepoints and differ from intervention images. Complete-inventory total: 0-108; higher scores indicate more additional information with picture support. Record actual denominators; refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Contextualized expressive generalization in Spanish
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Researcher-developed task in Spanish using six scenes, one per unit, each depicting six target concepts in contexts different from intervention scenes. The SAME scenes are reused at pretest, posttest and follow-up; they are not previously unseen at every assessment. Administer first within each language, before Naming, target-label supply or receptive tasks. Per concept: 2 for spontaneous accurate requested-language target use; 1 for accurate use only after a logged permitted nonlexical continuation; 0 for absent or inaccurate use during valid administration. No target labels, pointing cues or teaching. Preserve initial and prompted responses separately. Complete-inventory total: 0-72 across 36 concepts; higher scores indicate more contextualized target use. Report languages separately, actual denominators and source limitations. Refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Target receptive recognition in Spanish
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Researcher-developed receptive task in Spanish assessing 36 directly taught concepts. The examiner supplies the target label and presents a fixed four-image array. The first independent choice receives 1 point if correct and 0 if incorrect or no choice; no retries or corrective feedback are given. The complete-inventory raw total ranges from 0 to 36, with higher scores indicating greater receptive recognition. Actual item denominators and reasons for nonadministration are recorded; nonadministered items are missing, not zero. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Incidental expressive vocabulary in Spanish
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Exploratory researcher-developed expressive task in Spanish for the 15 selected incidental concepts encountered in instructional stories, elaborations, routines or directions outside the 36 directly taught targets. Fixed image/scene prompts do not supply or define the tested word. An appropriate requested-language selected word, phrase or accepted inflection earns 1; an incorrect or absent selected form after valid administration earns 0. Accurate paraphrases and other-language knowledge are retained separately as supplemental conceptual evidence, without replacing the word-production score. The same inventory, pictures, prompts and response keys are used across timepoints. Complete-inventory total: 0-15; higher scores indicate greater selected-word expressive knowledge. Report actual denominators; refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Incidental receptive vocabulary in Spanish
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Exploratory researcher-developed receptive task in Spanish for the same 15 selected incidental concepts encountered in instructional stories, elaborations, routines or directions outside the 36 directly taught targets. After expressive tasks, supply the target label and show a fixed four-image array. Score the first deliberate independent choice: 1 correct; 0 incorrect or no choice after valid administration. No teaching, corrective feedback or child retries. Correct documented recording/motor errors with an audit trail. Use the same inventory, pictures, positions and response keys across timepoints. Complete-inventory total: 0-15; higher scores indicate greater receptive knowledge. Expressive and receptive scores remain separate. Report actual denominators; refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Contextualized expressive generalization in English
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Researcher-developed task in English using six scenes, one per unit, each depicting six target concepts in contexts different from intervention scenes. The SAME scenes are reused at pretest, posttest and follow-up; they are not previously unseen at every assessment. Administer first within each language, before Naming, target-label supply or receptive tasks. Per concept: 2 for spontaneous accurate requested-language target use; 1 for accurate use only after a logged permitted nonlexical continuation; 0 for absent or inaccurate use during valid administration. No target labels, pointing cues or teaching. Preserve initial and prompted responses separately. Complete-inventory total: 0-72 across 36 concepts; higher scores indicate more contextualized target use. Report languages separately, actual denominators and source limitations. Refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Target receptive recognition in English
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Researcher-developed receptive task in English assessing 36 directly taught concepts. The examiner supplies the target label and presents a fixed four-image array. The first independent choice receives 1 point if correct and 0 if incorrect or no choice; no retries or corrective feedback are given. The complete-inventory raw total ranges from 0 to 36, with higher scores indicating greater receptive recognition. Actual item denominators and reasons for nonadministration are recorded; nonadministered items are missing, not zero. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Incidental expressive vocabulary in English
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Exploratory researcher-developed expressive task in English for the 15 selected incidental concepts encountered in instructional stories, elaborations, routines or directions outside the 36 directly taught targets. Fixed image/scene prompts do not supply or define the tested word. An appropriate requested-language selected word, phrase or accepted inflection earns 1; an incorrect or absent selected form after valid administration earns 0. Accurate paraphrases and other-language knowledge are retained separately as supplemental conceptual evidence, without replacing the word-production score. The same inventory, pictures, prompts and response keys are used across timepoints. Complete-inventory total: 0-15; higher scores indicate greater selected-word expressive knowledge. Report actual denominators; refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Incidental receptive vocabulary in English
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Exploratory researcher-developed receptive task in English for the same 15 selected incidental concepts encountered in instructional stories, elaborations, routines or directions outside the 36 directly taught targets. After expressive tasks, supply the target label and show a fixed four-image array. Score the first deliberate independent choice: 1 correct; 0 incorrect or no choice after valid administration. No teaching, corrective feedback or child retries. Correct documented recording/motor errors with an audit trail. Use the same inventory, pictures, positions and response keys across timepoints. Complete-inventory total: 0-15; higher scores indicate greater receptive knowledge. Expressive and receptive scores remain separate. Report actual denominators; refused, unadministered and uninterpretable items remain missing. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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CABVI implementation fidelity
Lasso di tempo: During independently sampled sessions across the 24-session CABVI intervention, ordinarily about 6 weeks; school-calendar extensions are documented.
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Observed session-level fidelity on the 10-criterion CABVI Fidelity Checklist, completed by a trained reviewer who did not deliver the session. Criteria are rated Y (delivered as planned), N (not delivered as planned), NO (not observable), or NA (not applicable). Fidelity is 100 x Y/(Y + N), ranging from 0% to 100%; higher percentages indicate greater delivery as planned. NO and NA are excluded from the denominator and reported separately; a zero denominator is not estimable. Observation method and denominator are reported. Independent review covers at least 20% of completed sessions per therapy group, rounded up (at least 5 of 24). Provider self-checks are separate and excluded from independent fidelity scores. No passing cutoff is assumed. |
During independently sampled sessions across the 24-session CABVI intervention, ordinarily about 6 weeks; school-calendar extensions are documented.
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Clinician confidence ratings for assigned vocabulary and research activities
Lasso di tempo: Before implementation and at the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Six researcher-developed items (C1-C6) assess confidence in supporting bilingual vocabulary within professional role; assigned activities when child and clinician languages differ; use of assigned materials and technology within the instructional plan; accurate clinical and research records; responding to breaks or unwillingness; and recognizing and obtaining needed help. Each item is rated separately: 1 Not at all confident, 2 Slightly, 3 Moderately, 4 Very, 5 Extremely confident. Higher ratings indicate greater confidence. The same items are given before and after implementation. For usual-care clinicians, assigned activities mean usual care and study documentation. Not applicable and Declined are recorded separately from numeric ratings. Item-level responses are retained; no summed or mean composite is specified. |
Before implementation and at the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Clinician-reported implementation experience and satisfaction
Lasso di tempo: At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Ten researcher-developed items (I1-I10) from the post-implementation clinician questionnaire assess preparation by training, clarity of instructions/materials, fit with the agreed school schedule, manageable documentation time, protection of required IEP services, access to help, child engagement, comfort with privacy/assent procedures, acceptability for children served, and overall satisfaction with study participation. Each item is rated separately: 1 Strongly disagree, 2 Disagree, 3 Neither agree nor disagree, 4 Agree, 5 Strongly agree. Higher ratings indicate greater agreement with the favorable statements. All participating clinicians may respond. Not applicable and Declined are recorded separately from numeric ratings. Item-level responses are retained; no summed or mean composite is specified. CABVI app items A1-A4 are reported separately. |
At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Clinician-reported CABVI app usability and acceptability
Lasso di tempo: At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Four researcher-developed items (A1-A4) from the CABVI app block of the same post-implementation clinician questionnaire, completed only by CABVI providers, assess whether app audio models helped support assigned Spanish-language activities; usefulness of clinician controls and captions; manageability of technical interruptions with approved procedures and support; and willingness to consider future use if available and institutionally approved. Each item is rated separately: 1 Strongly disagree, 2 Disagree, 3 Neither agree nor disagree, 4 Agree, 5 Strongly agree. Higher ratings indicate greater agreement. Usual-care clinicians skip this block and are not asked to use or review CABVI. Not applicable and Declined are recorded separately. Item-level responses are retained; no summed or mean composite is specified. |
At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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CABVI provider self-reported Spanish word or phrase learning
Lasso di tempo: At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Researcher-developed item A5 asks CABVI providers whether they learned Spanish words or phrases while using CABVI. Responses are Yes, No, Unsure, Not applicable, or Declined and are retained as separate categorical responses; there is no numerical scale or total score. An optional nonidentifying general example may accompany the response. Usual-care clinicians skip this CABVI-only block. This is clinician self-report, not an objective Spanish proficiency test. |
At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Clinician-reported extra research time per week during implementation
Lasso di tempo: At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Researcher-developed item W1 asks all adult clinician participants to report the approximate extra time per week spent on research activities during implementation, excluding ordinary school therapy. Responses are recorded in minutes per week. Higher numeric values indicate greater reported research time. Unsure and Declined responses are recorded separately from numeric time and are not scored as zero. The form specifies no upper numerical bound. This is a retrospective report of weekly research time, not a sum of ordinary therapy minutes or a daily time log. |
At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Clinician-reported research workload compared with expectations
Lasso di tempo: At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Researcher-developed item W2 asks all adult clinician participants how the extra research workload compared with what they expected. Ordered response categories are Much less, Somewhat less, About the same, Somewhat more, and Much more. Declined is recorded separately. Responses are retained as categories rather than an invented numerical total. Categories toward Much more indicate greater workload relative to expectations. Optional nonidentifying comments about the time required are collected separately. |
At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year.
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Teacher and parent feedback on perceived child communication changes
Lasso di tempo: After intervention and at approximately six weeks after the final intervention session, where feasible.
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Brief researcher-developed parent and teacher questionnaires assess perceived changes in the child's vocabulary use, communication confidence and engagement. The planned questionnaires use five-point item ratings and open-ended comments, with no CABVI-specific wording to reduce response bias. Ratings are summarized descriptively by item and respondent group; comments are thematically coded. No combined total is specified. This feedback is distinct from baseline language-background questionnaires. |
After intervention and at approximately six weeks after the final intervention session, where feasible.
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Narrative mean length of utterance in words: Spanish-elicited retell
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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MLUw is calculated from the whole available Spanish-elicited Frog story retell using SALT bilingual modified C-unit segmentation and fixed transcription rules. SALT-counted non-maze words in complete, intelligible verbal units are divided by the number of eligible units. Scores are expressed as words per unit, with no fixed maximum; higher values indicate longer average utterances. Intelligible code switches are marked and retained. Eligible-unit counts, sample length and transcription limitations are recorded. English-elicited and Spanish-elicited results remain separate. When no adequately transcribed eligible units are available, the score is missing with a documented reason, not zero. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Narrative number of different word roots: Spanish-elicited retell
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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NDW counts distinct word roots among non-maze words in complete, intelligible verbal units from the whole available Spanish-elicited Frog story retell, using fixed SALT bilingual transcription and root-coding rules. Intelligible code switches are marked and retained. Higher counts indicate more distinct roots observed; counts depend on sample length and are not length-independent diversity scores. NTW and eligible-unit counts are retained for interpretation. The maximum is the sample's included total-word count. Language results remain separate. An unscorable or absent sample is missing with its reason, not zero. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Narrative mean length of utterance in words: English-elicited retell
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
|
MLUw is calculated from the whole available English-elicited Frog story retell using SALT bilingual modified C-unit segmentation and fixed transcription rules. SALT-counted non-maze words in complete, intelligible verbal units are divided by the number of eligible units. Scores are expressed as words per unit, with no fixed maximum; higher values indicate longer average utterances. Intelligible code switches are marked and retained. Eligible-unit counts, sample length and transcription limitations are recorded. English-elicited and Spanish-elicited results remain separate. When no adequately transcribed eligible units are available, the score is missing with a documented reason, not zero. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
|
|
Narrative number of different word roots: English-elicited retell
Lasso di tempo: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
|
NDW counts distinct word roots among non-maze words in complete, intelligible verbal units from the whole available English-elicited Frog story retell, using fixed SALT bilingual transcription and root-coding rules. Intelligible code switches are marked and retained. Higher counts indicate more distinct roots observed; counts depend on sample length and are not length-independent diversity scores. NTW and eligible-unit counts are retained for interpretation. The maximum is the sample's included total-word count. Language results remain separate. An unscorable or absent sample is missing with its reason, not zero. |
Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jean F Rivera Perez, PhD, Texas Christian University
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB#2026-128
- 1R01DC023613-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
De-identified child participant data will be shared, including standardized assessment results, proximal assessment task results, intervention outcomes, and demographic information, with study documentation and analytic code. Data will be deposited in a controlled-access generalist repository participating in the NIH Generalist Repository Ecosystem Initiative. Supporting materials include the study protocol, data collection forms, manuals, and study-created assessments. Direct identifiers, the linkage key, and audio/video recordings will not be shared. Indirect identifiers will be reviewed to reduce re-identification risk. Sharing will follow the approved consent, data-sharing agreement, and institutional requirements.
Periodo di condivisione IPD
Data associated with the three main aims will be available when the corresponding articles are accepted for publication; final manuscripts are planned for submission by project Year 5. Scientific data supporting publications will be available by publication, and other generated scientific data will be shared no later than the end of the award. Protocols and intervention manuals are planned to be publicly available by Year 5. Repository retention will be at least five years.
Criteri di accesso alla condivisione IPD
Access is limited to health or social-science research approved by the requesting institution's IRB or equivalent body. Requesters must enter a data-sharing agreement committing to research-only use, no attempts to identify participants, appropriate data security, and destruction or return of data after analyses are completed. A data-sharing agreement application is planned for the project and investigators' professional websites in or after project Year 5. Data will be accessed through the selected controlled-access repository.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .