Testing a Blended Social-Communication and Social-Emotional Intervention for Autistic Toddlers

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Blended Intervention (Project ImPACT + Pyramid Model)
  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.
• Поведенческое Project ImPACT
  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.
• Поведенческое Pyramid Model Universal Practices
  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.

Первичные конечные точки

• Change in Child Behavior Checklist for Ages 1.5-5 Internalizing Problems T-Score [Срок оценки: Baseline, 12 weeks (post-intervention), and 3-month follow-up.]
• Change in Brief Observation of Social Communication Change-Minimally Verbal Total Score [Срок оценки: Baseline, 12 weeks (post-intervention), and 3-month follow-up.]
• Change in Frequency of Child Challenging Behavior During Caregiver-Child Routines [Срок оценки: Baseline, 12 weeks (post-intervention), and 3-month follow-up.]
• Change in Child Behavior Checklist for Ages 1.5-5 Externalizing Problems Raw Score [Срок оценки: 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 [Срок оценки: Baseline, 12 weeks (post-intervention), and 3-month follow-up.]

Критерии участия

<Child Participant>

Критерии включения

• 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.

Критерии исключения

• 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>

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07748780 · 2343845-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗