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

NCT07748780 | Not Yet Recruiting DMC

• 1 other identifier: 2343845-1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autism; Social Emotional Development Delays

Keywords

Autism; Social Communication; Social Emotional; Early Intervention; Project ImPACT; Pyramid Model; Community-Partnered Research

Outcome Measures

Primary Outcomes (5)

• Change in Child Behavior Checklist for Ages 1.5-5 Internalizing Problems T-Score

  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score is calculated by summing relevant items from the Emotionally Reactive, Anxious/Depressed, Somatic Complaints, and Withdrawn syndrome scales.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

  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

  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

  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

  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.

Other Outcomes (3)

• Provider Coaching Fidelity Percentage

  During the 12-week intervention period, with sessions sampled across the intervention.

• Caregiver-Rated Intervention Acceptability Mean Score

  12 weeks (post-intervention).

• Caregiver-Rated Intervention Feasibility Mean Score

  12 weeks (post-intervention).

Study Arms (4)

Blended Intervention (Project ImPACT + Pyramid Model)

EXPERIMENTAL

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.

Behavioral: Blended Intervention (Project ImPACT + Pyramid Model)

Project ImPACT Only

ACTIVE COMPARATOR

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.

Behavioral: Project ImPACT

Pyramid Model Only

ACTIVE COMPARATOR

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.

Behavioral: Pyramid Model Universal Practices

Waitlist Control (Usual Care)

NO INTERVENTION

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.

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.

Blended Intervention (Project ImPACT + Pyramid Model)

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.

Project ImPACT Only

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.

Pyramid Model Only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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\>
• 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).
• 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.

Sponsors & Collaborators

• Baylor University: lead

MeSH Terms

Conditions

Autistic Disorder; Communication

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Central Study Contacts

Gospel Y Kim, Ph.D.

CONTACT

16263296989; gospel_kim@baylor.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to one of four arms: (1) blended intervention (Project ImPACT + Pyramid Model practices), (2) Project ImPACT only, (3) Pyramid Model only, or (4) waitlist control. Randomization occurs at the provider level to reduce contamination, with each provider assigned to two caregiver-toddler dyads.

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 6, 2026

Record last verified: 2025-09