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NCT Number: NCT07748780

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

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Communication Mental Disorders Neurodevelopmental Disorders Social Emotional Development Delays

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

<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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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.

  2. Change in Brief Observation of Social Communication Change-Minimally Verbal Total Score

    Time frame: 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.

  3. Change in Frequency of Child Challenging Behavior During Caregiver-Child Routines

    Time frame: 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.

  4. Change in Child Behavior Checklist for Ages 1.5-5 Externalizing Problems Raw Score

    Time frame: 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.

  5. Change in Devereux Early Childhood Assessment for Infants and Toddlers Total Protective Factors T-Score

    Time frame: 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.

Other outcomes

  1. Provider Coaching Fidelity Percentage

    Time frame: 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.

  2. Caregiver-Rated Intervention Acceptability Mean Score

    Time frame: 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.

  3. Caregiver-Rated Intervention Feasibility Mean Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gospel Y Kim, Ph.D.

CONTACT

[email protected]

16263296989

Sponsors and collaborators

Lead sponsor

Baylor University

Other

Registry information

Acronym: BALANCED

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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