Testing a Blended Social-Communication and Social-Emotional Intervention for Autistic Toddlers (BALANCED)
Autistic toddlers often need support to develop both social-communication and social-emotional skills. Social communication (such as making requests or sharing attention) is usually addressed in early intervention, but social-emotional needs (such as expressing feelings or learning to cope with frustration) are often overlooked. Both are important for children's development and for preventing challenging behaviors.
This study is testing a blended intervention designed to support both areas at the same time. The program combines Project ImPACT, a caregiver-mediated social communication intervention, with universal practices from the Pyramid Model, a national framework for promoting young children's social-emotional development.
Caregivers of autistic toddlers will be coached by early intervention providers to use strategies during everyday routines and play. The study will enroll 40 caregiver-toddler pairs, randomly assigning them to one of four study conditions. Families assigned to the waitlist control group will receive the intervention after a delay.
The goal is to understand whether this blended approach improves toddlers' communication and emotional development, and whether caregivers find it helpful and practical in daily life. Because many states and early intervention systems already use the Pyramid Model, this study could provide a way to make those programs more inclusive of autistic children and their families.
Przegląd badań
Status
Szczegółowy opis
Supporting social communication in autistic children is essential, but their social-emotional needs are often overlooked even though both are critical for early development and for preventing challenging behavior. National efforts such as the Pyramid Model aim to promote social-emotional skills for all young children, yet autistic children are often excluded in practice.
This community-partnered study, shaped by autistic voices and family input, addresses that gap by testing a blended intervention that integrates:
Project ImPACT, an evidence-based intervention to support social communication, and Pyramid Model universal practices, strategies that promote social-emotional development.
The study will use a randomized controlled trial with a waitlist control group to evaluate outcomes for 40 caregiver-toddler dyads. Families will be assigned to one of four conditions. Early intervention providers will coach caregivers to embed strategies into daily routines, helping children learn in natural settings.
With nearly 40 states having adopted the Pyramid Model, this study offers a timely opportunity to collaborate with Part C early intervention programs to strengthen their focus on both social communication and social-emotional skills. By supporting integration across these developmental domains, the project aims to enhance the quality and inclusivity of early intervention services for autistic toddlers and their families.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Gospel Y Kim, Ph.D.
- Numer telefonu: 16263296989
- E-mail: gospel_kim@baylor.edu
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
<Child Participant>
Inclusion Criteria:
- Under 36 months of age at enrollment.
- Has a clinical diagnosis of autism.
- Is currently receiving services through Part C Early Intervention (EI).
- Able to participate in natural caregiver-child routines and play activities.
Exclusion Criteria:
- Has a co-occurring medical condition (e.g., uncontrolled seizures, significant sensory or motor impairment) that would prevent participation in caregiver-child interaction sessions.
- Not currently eligible for or receiving Part C services.
- Previously participated in pilot testing of the blended intervention.
<Caregiver Participant>
Inclusion Criteria:
- At least one primary caregiver is available and willing to participate in weekly coaching sessions for 12 weeks.
- Caregiver agrees to participate in baseline, post-intervention, and follow-up assessments.
- Caregiver consents to allow video recording of some sessions for fidelity monitoring and research purposes.
- Caregiver has sufficient English proficiency to engage in intervention and assessment procedures (Spanish adaptation to follow in future phases).
Exclusion Criteria
- Unable to commit to the 12-week intervention schedule or 3-month follow-up.
- Does not consent to video recording required for fidelity monitoring.
- Insufficient English proficiency for participation in intervention sessions at this time.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Blended Intervention (Project ImPACT + Pyramid Model)
Caregiver-toddler dyads will receive a blended intervention that integrates Project ImPACT strategies to support social communication with Pyramid Model universal practices to promote social-emotional development.
Early intervention providers will coach caregivers during weekly sessions across 12 weeks, focusing on embedding strategies into daily routines and play.
|
A caregiver-mediated intervention that integrates Project ImPACT strategies for social communication with Pyramid Model universal practices to promote social-emotional development.
Early intervention providers will coach caregivers across 12 weekly sessions to embed blended strategies into daily routines and play.
|
|
Aktywny komparator: Project ImPACT Only
Caregiver-toddler dyads will receive Project ImPACT, a parent-mediated intervention that targets social communication skills such as language, joint attention, and reciprocity.
Early intervention providers will coach caregivers during weekly sessions across 12 weeks, focusing on embedding Project ImPACT strategies into daily routines.
|
An evidence-based parent-mediated intervention designed to improve social communication, language, and reciprocity in young autistic children.
Early intervention providers will coach caregivers in Project ImPACT strategies across 12 weekly sessions, focusing on embedding practices into natural routines.
|
|
Aktywny komparator: Pyramid Model Only
Caregiver-toddler dyads will receive Pyramid Model universal practices (Tier 1), which promote nurturing relationships, supportive environments, and emotional literacy.
Early intervention providers will coach caregivers during weekly sessions across 12 weeks, helping families embed these social-emotional promotion strategies into daily routines.
|
A framework for promoting social-emotional development and preventing challenging behaviors through universal practices (Tier 1).
Providers will coach caregivers across 12 weekly sessions to embed practices such as nurturing relationships, supportive environments, and emotional literacy into daily routines.
|
|
Brak interwencji: Waitlist Control (Usual Care)
Caregiver-toddler dyads will continue receiving their usual early intervention services during the 12-week study period.
Following post-intervention data collection, families assigned to this arm will be offered the blended intervention.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Child Behavior Checklist for Ages 1.5-5 Internalizing Problems T-Score
Ramy czasowe: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
|
The Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5) is a caregiver-report measure of child emotional and behavioral problems.
The Internalizing Problems raw score is calculated by summing relevant items from the Emotionally Reactive, Anxious/Depressed, Somatic Complaints, and Withdrawn syndrome scales.
Scores range from 0 to 72, with higher scores indicating greater internalizing behavior problems and therefore a worse outcome.
|
Baseline, 12 weeks (post-intervention), and 3-month follow-up.
|
|
Change in Brief Observation of Social Communication Change-Minimally Verbal Total Score
Ramy czasowe: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
|
Social communication and related autism characteristics will be measured using the Brief Observation of Social Communication Change-Minimally Verbal version (BOSCC-MV), coded from recorded caregiver-child interactions.
The total score ranges from 0 to 75, with higher scores indicating greater social-communication and autism-related impairment and therefore a worse outcome.
|
Baseline, 12 weeks (post-intervention), and 3-month follow-up.
|
|
Change in Frequency of Child Challenging Behavior During Caregiver-Child Routines
Ramy czasowe: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
|
Trained observers will code the frequency of operationally defined child challenging behaviors during recorded caregiver-child routines.
The reported value will be the number of challenging behavior episodes observed during each session.
The minimum possible value is 0 episodes; there is no fixed maximum.
Higher values indicate more frequent challenging behavior and therefore a worse outcome.
|
Baseline, 12 weeks (post-intervention), and 3-month follow-up.
|
|
Change in Child Behavior Checklist for Ages 1.5-5 Externalizing Problems Raw Score
Ramy czasowe: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
|
The Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5) is a caregiver-report measure of child emotional and behavioral problems.
The Externalizing Problems raw score is calculated by summing relevant items from the Attention Problems and Aggressive Behavior syndrome scales.
Scores range from 0 to 48, with higher scores indicating greater externalizing behavior problems and therefore a worse outcome.
|
Baseline, 12 weeks (post-intervention), and 3-month follow-up.
|
|
Change in Devereux Early Childhood Assessment for Infants and Toddlers Total Protective Factors T-Score
Ramy czasowe: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
|
Caregiver-reported social-emotional competence will be measured using the Devereux Early Childhood Assessment for Infants and Toddlers (DECA-I/T).
The age-appropriate Infant Form (DECA-I; ages 1 month to 18 months) or Toddler Form (DECA-T; ages 18 months to 36 months) will be administered.
The Total Protective Factors T-score summarizes initiative and attachment/relationships for infants and initiative, attachment/relationships, and self-regulation for toddlers.
T-scores range from 28 to 72, with higher scores indicating greater social-emotional competence and therefore a better outcome.
|
Baseline, 12 weeks (post-intervention), and 3-month follow-up.
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Provider Coaching Fidelity Percentage
Ramy czasowe: During the 12-week intervention period, with sessions sampled across the intervention.
|
Provider adherence to the coaching procedures will be assessed from recorded coaching sessions using a study-developed provider coaching fidelity rubric.
The fidelity score is calculated as the percentage of applicable coaching components implemented correctly.
Scores range from 0% to 100%, with higher percentages indicating greater provider coaching fidelity and therefore a better outcome.
Approximately 33% of recorded coaching sessions will be randomly selected for fidelity coding.
|
During the 12-week intervention period, with sessions sampled across the intervention.
|
|
Caregiver-Rated Intervention Acceptability Mean Score
Ramy czasowe: 12 weeks (post-intervention).
|
Caregiver perceptions of intervention acceptability and usefulness will be measured using a study-developed social validity survey.
The acceptability score is calculated as the mean of the acceptability items, each rated from 1 to 5. Mean scores range from 1 to 5, with higher scores indicating greater intervention acceptability and therefore a better outcome.
|
12 weeks (post-intervention).
|
|
Caregiver-Rated Intervention Feasibility Mean Score
Ramy czasowe: 12 weeks (post-intervention).
|
Caregiver perceptions of intervention feasibility will be measured using a study-developed social validity survey.
The feasibility score is calculated as the mean of the feasibility items, each rated from 1 to 5. Mean scores range from 1 to 5, with higher scores indicating greater perceived feasibility and therefore a better outcome.
|
12 weeks (post-intervention).
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2343845-1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .