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Let's Know!2: intervento incentrato sulla lingua per bambini a rischio di difficoltà di comprensione (LK!2)

29 settembre 2026 aggiornato da: Tiffany P. Hogan, PhD, CCC-SLP, FASHA, MGH Institute of Health Professions

Tradurre la ricerca nella pratica scolastica tramite un intervento di comprensione incentrato sulla lingua in piccoli gruppi

In the proposed project, the investigators will conduct a multisite randomized controlled trial (RCT) to determine the efficacy of Let's Know!2, a small-group, language focused comprehension intervention, on children's lower- and higher-level language skills and comprehension skills in the short- and long-term (Specific Aims 1 and 2). The investigators will also explore whether intervention effects are moderated by dosage, initial language skill, developmental language disorder (DLD) status, word reading skill, nonverbal IQ, and family socioeconomic status (Specific Aim 3).

Children who have low language skills and are thus at risk for reading comprehension difficulties will participate in the study. Children will be randomly assigned to receive Let's Know! in small groups at their respective schools or to a business-as-usual control condition. The investigators will measure children's language and comprehension skills at the beginning and end of Grade 1 as well as in Grade 2 and Grade 3. The investigators hypothesize that children who experience Let's Know! will end Grade 1 with higher language skills than children in the control condition and that this will translate into better listening and reading comprehension skills as these children matriculate through elementary school.

Panoramica dello studio

Descrizione dettagliata

Parents of children enrolled in Grade 1 at partnering schools will receive consent materials and those who provide consent will complete a brief background/demographic survey about their child. For children whose parents provide informed consent, research staff will (a) ask their educator to confirm basic English proficiency and lack of profound disabilities or behavior issues that severely impair classroom functioning, (b) seek the child's assent to project activities, and (c) administer a language screener in a quiet location at their respective school, either in a small group of other consented children or one-on-one. In order to qualify as eligible for the intervention phase of the study, consented children must: (1) be enrolled in Grade 1 (per educator or parent report) (2) score at or below the empirically derived cut-score on the OWL screener (obtained via direct testing), (3) exhibit at least basic skills in speaking and understanding English (per educator report), (4) not exhibit behavioral difficulties sufficiently severe to prevent participation in the intervention (per educator report), (5) not have a severe disability that would prevent participation in the intervention (per educator report), (6) assent to study activities. Children who meet all eligibility criteria, including scoring below our cutoff on the language screener, will be categorized as potentially eligible for enrollment in the intervention phase of the study. In order to enroll children within a particular school, the investigators must identify a minimum of 6 eligible participants in that school. The investigators will cap the child participants per school at a maximum of 20 in cohort 1 and 10 in cohorts 2 & 3 to allow for later analysis of nested data (children nested within schools; the investigators need 40 schools for appropriate statistical power). Children who are identified as potentially eligible but who attend schools with fewer than 6 total eligible participants, or who consent to the study but have not yet been screened by the time the investigators identify 20 eligible participants in cohort 1 and 10 in cohorts 2 & 3 will be excluded from further participation. In schools in which the investigators have more than the allotted potentially eligible children, the investigators will randomly select the cohort-specific number to enroll in the intervention phase of the study. Children enrolled in the intervention phase of the study will be randomly assigned to receive the Let's Know! intervention or to a business-as-usual control condition. Random assignment will be conducted by Dr. Flemming at KUMC, who will be uninvolved in recruitment, screening, and pretest activities. Prior to intervention start, all enrolled children will complete pretest assessments to measure the lower-level and higher-level language skills targeted by the Let's Know! intervention, comprehension skills, and other abilities (i.e., covariates and moderators for addressing Aim 3). All direct child assessments are listed in Table 1 above. All child direct assessments (screening, pretest, curriculum-aligned measures, posttest, follow-up) will be administered by trained research staff in quiet locations at children's respective schools; alternative arrangements to conduct assessments in the PIs' research laboratories or community locations (e.g., public library) will be made as necessary (e.g., if a child moves into a new, non-partnering school). All but the language screener and Gates-MacGinitie Tests of Reading will be administered individually, with the two exceptions administered to small groups or 1:1, dependent on scheduling. Screening and assessment sessions may be audio or video recorded to allow for accurate scoring and analysis. Following pretest assessments and assignment to conditions, research staff will provide the Let's Know! intervention to small groups of 3 to 5 children allocated to the intervention condition at their respective schools. The Let's Know! intervention provides instruction in the domains of text structure, integration, word knowledge, and grammar; as such, it targets key lower-level (vocabulary) and higher-level (e.g., story grammar, comprehension monitoring, inferencing) language skills to support listening and reading comprehension. The intervention features manualized, soft-scripted lessons that will be provided in small groups of 3-5 children 4 times a week for 25-30 minutes. The lessons are organized into four instructional units that are delivered over 22 weeks. All four instructional units emphasize repeated readings and explorations of commercial texts, with two units comprising narrative books and two comprising expository books. All intervention lessons will be videotaped for purposes of monitoring implementation and coding fidelity. If an individual child misses a session, this will be documented and the session will not be made up. If an entire group misses a session (e.g., due to a field trip/school assembly), the interventionist will wait and deliver that lesson during the next scheduled session (e.g., one group may miss Animals 12 due to a Tuesday assembly; the interventionist teaches Animals 12 at the regularly scheduled Wednesday session and proceeds from there). Children in the control condition will participate in study assessments as noted above but will not experience the Let's Know! intervention. They will receive business-as-usual classroom instruction and supports within their schools. That is, the child's family and school will provide instruction and support for children in the control condition as they typically would for any child not enrolled in the study. The investigators will document the interventions received by children in both the intervention and control conditions.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

241

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02192
        • MGH Institute of Health Professions
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210
        • The Ohio State University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 5 anni a 12 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Parental consent to participate in the research;
  • Enrollment in Grade 1;
  • Scores below the 30th percentile on the OWL Language Screener
  • Basic English proficiency as reported by parents/teachers

Exclusion Criteria:

  • Unable to speak or understand English at a basic level, as reported by parents/teachers;
  • Profound disability that severely impairs classroom participation, as reported by teachers;
  • Serious behavior issue that severely impairs classroom participation, as reported by teachers.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention

Participants receive the Let's Know! intervention in small groups as provided by research staff

Let's Know!2 is an 22-week intervention spanning 1 school year. Each week features 4, 20-30 minute lessons targeting lower-level and higher-level language skills. Within units, instructors and children progress through specific types of lessons to meet language-focused learning objectives. LK!2 was adapted from the original Let's Know! curriculum (LARRC, 2016). The adaption from LK! to LK! made lessons appropriate for small groups of Grade 1 students with low language skills. Adaptations focused on (1) simplification of language input, (2) increased scaffolding, (3) attention to distributed practice, (4) materials to support diversity and inclusion, and (5) enhanced interventionist training. LK!2 comprised 76 20-30 min lessons across four units (fiction, animals, earth materials, folktales) as implemented by trained research staff (i.e., interventionists).

Altri nomi:
  • Sappiamo! intervento in piccoli gruppi o di livello 2
Nessun intervento: Business-As-Usual

Participants continue to receive only their typical classroom instruction (i.e., no small groups)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment unit 1 (fiction) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Lasso di tempo: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment

The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 1 (fiction) and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.

approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
Treatment unit 2 (animals) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Lasso di tempo: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment

The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 2 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.

approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
Treatment unit 3 (earth materials) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Lasso di tempo: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment

The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 3 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.

approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
Treatment unit 4 (folktales) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Lasso di tempo: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment

The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses change in children's definitional knowledge of the 8 vocabulary words taught in unit 4 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible per CAM.

approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
Change in vocabulary knowledge as assessed by the LARRC Target Word Knowledge
Lasso di tempo: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Change in vocabulary knowledge as assessed by the Language and Reading Research Consortium (LARRC) Target Word Knowledge measures which assesses definitional knowledge of a sampling of words taught across the 4 treatment units, in addition to several words not taught in the intervention.

right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in breadth of vocabulary as assessed by the Peabody Picture Vocabulary Test 5th Edition (PPVT-5)
Lasso di tempo: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Change in the breadth of vocabulary will be assessed by the Peabody Picture Vocabulary Test 5th Edition (PPVT-5), a standardized measure of the number of words that a child should know compared to a nationwide sample of age-matched peers. Children point to one picture out of four that best represents a word spoken by the examiner.

right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Treatment unit 1 (fiction) comprehension monitoring as assessed by the LARRC Unit 1 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Lasso di tempo: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment

The Language and Reading Research Consortium (LARRC) Unit 1 (fiction) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.

approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
Treatment unit 2 (animals) comprehension monitoring as assessed by the LARRC Unit 2 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Lasso di tempo: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment

The Language and Reading Research Consortium (LARRC) Unit 2 (animals) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.

approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
Treatment unit 3 (earth materials) comprehension monitoring as assessed by the LARRC Unit 3 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Lasso di tempo: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment

The Language and Reading Research Consortium (LARRC) Unit 3 (earth materials) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.

approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
Treatment unit 4 (folktales) comprehension monitoring as assessed by the LARRC Unit 4 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Lasso di tempo: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment

The Language and Reading Research Consortium (LARRC) Unit 4 (folktales) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.

approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
Change in child's ability to monitoring comprehension, as assessed by the LARRC Comprehension Monitoring Test
Lasso di tempo: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Change in comprehension monitoring as assessed by the Language and Reading Research Consortium (LARRC) Comprehension Monitoring Test, which assesses child's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown from the strategies learned across all 4 treatment units.

right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Treatment unit 1 (fiction) knowledge of text structures as assessed by the LARRC Unit 1 Text Structure Curriculum-Aligned Measure (CAM)
Lasso di tempo: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment

The Language and Reading Research Consortium (LARRC) Unit 1 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to a story and answer questions about the stories' structure, such as characters, settings, problem, and resolution.

approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
Treatment unit 2 (animals) knowledge of text structures as assessed by the LARRC Unit 2 Text Structure Curriculum-Aligned Measure (CAM)
Lasso di tempo: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment

The Language and Reading Research Consortium (LARRC) Unit 2 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to an expository text passage and answer questions about the passage, such as main idea and important details.

approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
Treatment unit 3 (earth materials) knowledge of text structures as assessed by the LARRC Unit 3 Text Structure Curriculum-Aligned Measure (CAM)
Lasso di tempo: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment

The Language and Reading Research Consortium (LARRC) Unit 3 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to an expository text passage and answer questions about the passage, such as main idea and important details.

approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
Treatment unit 4 (folktales) knowledge of text structures as assessed by the LARRC Unit 1 Text Structure Curriculum-Aligned Measure (CAM)
Lasso di tempo: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment

The Language and Reading Research Consortium (LARRC) Unit 4 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to a story and answer questions about the stories' structure, such as characters, settings, problem, and resolution.

approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
Change in child's ability to use their knowledge to fill in the gaps in short stories, as assessed by the LARRC Inference Task
Lasso di tempo: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Change in child's ability to use their knowledge to fill in the gaps in short stories, as assessed by the Language and Reading Research Consortium (LARRC) Inference Task, which assesses child's ability to answer questions about short stories they have heard presented by the examiner.

right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in story retelling abilities, as assessed by the CUBED Narrative Retell measure
Lasso di tempo: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Change in child's ability to accurately and completely retell a story as assessed by the CUBED Narrative Retell measure. The examiner tells the child a story using pictures and the child retells the story back to the examiner.

right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in ability to understand stories, as assessed by the Test of Narrative Language
Lasso di tempo: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Change in the child's ability to understand stories, as assessed by the Test of Narrative Language. The examiner tells the child stories and asks the child questions about those stories.

right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in a child's ability to comprehend short passages read aloud to them, as assessed by the LARRC Listening Comprehension Measure
Lasso di tempo: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Change in a child's ability to comprehend short passages read aloud to them, as assessed by the LARRC Listening Comprehension Measure, which requires a child to listen to two short stories and answer questions about those stories

right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in a child's ability to comprehend short passages they read, as assessed by the LARRC Reading Comprehension Measure
Lasso di tempo: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Change in a child's ability to comprehend short passages they read, as assessed by the LARRC Listening Comprehension Measure, which requires a child to read two short stories and answer questions about those stories

right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in reading comprehension, as assessed by the norm-referenced Gates-McGinitie Reading Test
Lasso di tempo: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Change in child's ability to comprehend short passages that the child reads to themselves, as assessed by their ability to answer questions about those passages using the norm-referenced Gates-McGinitie Reading Test

right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Nonverbal intelligence as assessed by the Kaufman Brief Intelligence Test - Second Edition nonverbal intelligence (matrices) subtest
Lasso di tempo: right before intervention starts

The nonverbal intelligence (matrices) subtest of the Kaufman Brief Intelligence Test - Second Edition measures children's ability to to solve new problems, perceive relationships and complete visual analogies without taxing language skills. The matrices subtest requires the child to point to the picture that would complete a picture or abstract design. Nonverbal intelligence will be tested as a moderator of treatment effects in analyses.

right before intervention starts
Change in timed word and nonword reading, as assessed by the Test of Word Reading Efficiency - Second Edition
Lasso di tempo: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Change in timed word and nonword reading accuracy will be assessed by asking children to read as many words and then nonwords as possible in 45 seconds each, as measured by the Test of Word Reading Efficiency - Second Edition. Timed word and nonword reading will be tested as a moderator of treatment effects in the analyses as well as a distal treatment outcome.

right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Language comprehension skills, as assessed by the OWL Language Screener
Lasso di tempo: right before intervention starts

Language comprehension skills are assessed by the The OWL Language Screener, which requires children to point to the one picture out of four pictures that best represents a sentence.This measure will be tested as a moderator of treatment effects in analyses as well as the measure to determine if the child has language weaknesses to qualify for treatment.

right before intervention starts
Academic performance will be assessed by the Massachusetts or Ohio State Assessments of Reading
Lasso di tempo: 2 years after intervention ends

Children's academic reading performance will be assessed by the Massachusetts or Ohio State Reading Assessments to examine distal treatment outcomes on state assessments of reading

2 years after intervention ends

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Tiffany P Hogan, PhD, MGH Institute of Health Professions

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2021

Completamento primario (Effettivo)

30 giugno 2026

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

10 settembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

12 novembre 2021

Primo Inserito (Effettivo)

24 novembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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