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

Sponsor
Baylor University
Study ID
NCT07748780
Status
Not Yet Recruiting

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Conditions

  • Autism
  • Social Emotional Development Delays

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 6, 2026
Start date
Sep 1, 2026
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.
  • No Intervention: 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.

Primary Outcome Measure

Change in Child Behavior Checklist for Ages 1.5-5 Internalizing Problems T-Score [ Time Frame: Baseline, 12 weeks (post-intervention), and 3-month follow-up. ]

Central Contacts

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