Empower EI: Srovnání přístupů časné intervence ke zlepšení komunikace u batolat s vývojovými opožděními
Empower EI: Porovnání přístupů rané intervence ke zlepšení komunikace u batolat s vývojovými opožděními
This study is testing three ways to deliver Early Intervention (EI) services for toddlers with developmental disabilities (DD).
Children enrolled in EI speech therapy will receive one of three approaches:
- Therapist Delivered EI: For 28 weeks, the child's speech therapist will work directly with the child to support their communication.
- Caregiver Coaching EI: For 28 weeks, the child's speech therapist will coach the caregiver on how to support their child's communication.
- Combined EI Approach + Parent-Led Education Program: For 14 weeks, the caregiver will take part in a parent-led education program while the speech therapist works directly with the child to support their communication. During the next 14 weeks, the speech therapist will coach the caregiver on how to support their child's communication.
The goal of this study is to identify which approaches are most effective so that all families can benefit fully from EI services.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
High-quality Early Intervention (EI) during the first three years of life, a period of heightened neuroplasticity, is critical to improving outcomes for children with developmental disabilities (DD). There are two EI approaches that may be effective for supporting child communication and improving family outcomes: 1) caregiver coaching, in which the EI therapist teaches the caregiver strategies to help their child's communication, and 2) caregiver psychoeducation, in which a peer mentor teaches the caregiver about skills and resources that are helpful in supporting their child and family.
The aim of the current clinical trial is to determine which EI approaches are most effective, for which families, and why they are effective. This clinical trial also aims to investigate how therapists are delivering the interventions and to characterize the acceptability and feasibility of these interventions for use in real-world settings.
A total of 1,269 toddlers (approximately equal numbers of Black, Latine, and white children) will be enrolled across community-based EI sites. Families will be directly recruited from participating EI therapists' existing caseloads. Caregiver-child dyads will be randomly assigned to one of three groups:
- Therapist Delivered EI: For 28 weeks, the child's speech therapist will work directly with the child to support their communication.
- Caregiver Coaching EI: For 28 weeks, the child's speech therapist will coach the caregiver on how to support their child's communication.
- Combined EI Approach + Parents Taking Action: For 14 weeks, the caregiver will take part in a parent-led education program (Parents Taking Action) while the speech therapist works directly with the child to support their communication. During the next 14 weeks, the speech therapist will coach the caregiver on how to support their child's communication.
Outcomes will assess both caregiver and child domains, including caregiver use of responsive strategies, caregiver capacity to support the child's needs, and child social communication. The study will also examine moderators (e.g., race) and mediators (e.g., caregiver use of responsive strategies) to identify for whom and why each approach is most effective.
A process evaluation will assess implementation fidelity (quality, dosage, adaptations) and explore how fidelity influences effectiveness outcomes. Feasibility, acceptability, and appropriateness of each approach will be evaluated through surveys and interviews with caregivers and EI therapists.
This study is among the first large-scale comparative effectiveness trials of early intervention approaches conducted in real-world EI settings. Findings will inform EI practices and guide caregivers, therapists, and policymakers in selecting interventions that best meet the needs and preferences of diverse families.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Laura Sudec, Masters
- Telefonní číslo: 1-847-491-3183
- E-mail: laura.sudec@northwestern.edu
Studijní místa
-
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Illinois
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Evanston, Illinois, Spojené státy, 60201
- Nábor
- Northwestern University
-
Vrchní vyšetřovatel:
- Megan Roberts, PhD
-
Kontakt:
- Laura Sudec, Masters
- E-mail: laura.sudec@northwestern.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Child Inclusion Criteria:
- At least 12 months old
- Functional communication skills at an age equivalent of at least 6 months
- At least 7 months of Early Intervention (EI) service eligibility remaining
- Enrolled in the Illinois EI system and is new to the speech-language pathologist's (SLP's) caseload (i.e., no prior EI speech-language therapy experience with the SLP)
- Plans to receive one hour of speech-language therapy per week in the home or in a private space outside of the home
Child Exclusion Criteria:
- Exposed to a language other than English or Spanish more than 10% of the time
Caregiver Inclusion Criteria:
- The child's parent, legal guardian, or other family member
- Self-identifies as Black, Latine (Hispanic), or white
- Available to participate in weekly EI sessions and study assessments
Caregiver Exclusion Criteria
- Younger than 18 years old at enrollment
- Uses a language other than English or Spanish during their interactions with the child more than 10% of the time
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Aktivní komparátor: Therapist-Delivered Early Intervention Approach
For 28 weeks, this arm will receive the therapist-delivered early intervention approach. |
The therapist-delivered early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will use responsive strategies directly with the child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention. The SLP will not coach the caregiver during the sessions. |
|
Experimentální: Caregiver Coaching Early Intervention Approach
For 28 weeks, this arm will receive the caregiver coaching early intervention approach. |
The caregiver-coaching early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will coach the caregiver to use responsive strategies with their child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention. |
|
Experimentální: Combined Early Intervention Approach + Parents Taking Action
For the first 14 weeks, this arm will receive the therapist-delivered early intervention as well as Parents Taking Action. For the following 14 weeks, this arm will receive the caregiver coaching early intervention approach. |
The therapist-delivered early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will use responsive strategies directly with the child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention. The SLP will not coach the caregiver during the sessions. The caregiver-coaching early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will coach the caregiver to use responsive strategies with their child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention. Parents Taking Action (PTA) will be delivered during weekly, one-hour virtual sessions with the caregiver, separate from the child's early intervention (EI) sessions. PTA is a psychoeducation program implemented by a peer mentor (i.e., a culturally-matched caregiver of a child with a developmental disability). During the sessions, the peer mentor will provide information and guidance on a range of topics (e.g., child development, early intervention systems, special education rights/resources, and advocacy) following a structured curriculum. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Responsive Strategy Use (RSU) Rating Scale
Časové okno: Week 14, Week 28
|
The Responsive Strategy Use (RSU) Rating Scale will be used to measure caregivers' use of responsive strategies during a naturalistic, caregiver-child interaction. Items on the RSU Rating Scale are rated on a 4-point Likert Scale (0 = Rarely/Never, 3 = Consistently) and averaged to yield the RSU Total Score (Min = 0, Max = 3), with higher scores reflecting a higher frequency of responsive strategy use. |
Week 14, Week 28
|
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Family Outcomes Survey - Revised
Časové okno: Week 14, Week 28
|
The Family Outcomes Survey-Revised is a 24-item informant-report questionnaire that assesses caregivers' understanding, confidence, and ability to support their child's needs. The Family Outcomes Total Score (Min = 24, Max = 120) reflects the caregiver's capacity to support their child's needs, with higher scores indicating greater capacity. |
Week 14, Week 28
|
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Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)
Časové okno: Week 28
|
The Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP) is a structured, norm-referenced, observational measure of child communication. The assessment is scored for 20 items across 7 domains (i.e., Emotion and Eye Gaze, Communication, Gestures, Sounds, Words, Understanding, Object Use). The weighted raw scores for each of the 7 domains are grouped into 3 clusters (social, speech, and symbolic) and combined into a total raw score (min = 0; max = 113). Higher scores indicate better skills. |
Week 28
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Session Attendance
Časové okno: Week 1 to Week 28
|
Session attendance will be documented in weekly session logs completed by interventionists and summarized as the percentage of planned intervention sessions attended by each family (Min = 0%, Max = 100%). |
Week 1 to Week 28
|
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Intervention Fidelity Checklist
Časové okno: Week 1 to Week 28
|
The Intervention Fidelity Checklist is a rating scale assessing adherence to the intervention protocol. Items on the checklist correspond to the core elements of the respective intervention protocol and are scored based on specific behavioral criteria. The Intervention Fidelity Checklist will be scored on a randomly selected 20% of intervention sessions per participant. Scores will be averaged across sessions to yield an average intervention quality score (Min = 0, Max = 100), with higher scores indicating higher intervention quality. |
Week 1 to Week 28
|
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Framework for Reporting Adaptations and Modifications (FRAME)
Časové okno: Week 1 to Week 28
|
The Framework for Reporting Adaptations and Modifications (FRAME) will be used to document intervention adaptations. Adaptations will be documented through intervention session logs and direct observations of intervention sessions. These data will yield the total number of adaptations (Min = 0, Max = NA). |
Week 1 to Week 28
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Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Early Intervention Program Satisfaction Scale
Časové okno: Week 14, Week 28
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An adapted version of the Early Intervention Program Satisfaction Scale, a caregiver-report questionnaire, will be used to assess caregiver satisfaction. This survey includes 6 items rated on a 5-point Likert (1 = Very Dissatisfied, 5 = Very Satisfied). The Total Score (Min = 6, Max = 30) reflects caregivers' overall satisfaction with the intervention, with higher scores representing greater satisfaction. |
Week 14, Week 28
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Megan Roberts, PhD, Northwestern University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- BPS-2024C1-38924
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
De-identified individual participant data (IPD) that underlie the results reported in any publication arising from this trial will be made publicly available via the Dryad repository. The shared dataset will include all variables necessary to reproduce the published findings, including treatment assignment, participant demographics, baseline characteristics, and outcome measures. All data will be de-identified in accordance with HIPAA standards and institutional policies to protect participant confidentiality.
Data will be uploaded to Dryad after publication of the primary results, and will be freely accessible to qualified researchers without restriction. A corresponding DOI will be provided in publications to facilitate data access and citation.
Časový rámec sdílení IPD
Data will be uploaded to the Dryad data repository on November 1st, 2030 and remain there indefinitely.
Kritéria přístupu pro sdílení IPD
De-identified individual participant data (IPD) and supporting documentation (e.g., data dictionaries, survey instruments, codebooks) will be publicly available to any researcher or member of the public. All data will be uploaded to the Dryad Digital Repository, where users can freely access and download the datasets. No special request or application will be required to access the IPD. The data will be shared in a de-identified format to protect participant privacy, and users will be able to access the IPD along with associated documentation necessary to understand and use the data for secondary analyses or replication studies.
Typ podpůrných informací pro sdílení IPD
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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