An interventional study of Blended Intervention (Project ImPACT + Pyramid Model) and Project ImPACT in Autism and Social Emotional Development Delays, sponsored by Baylor University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Baylor University · Not applicable, Interventional, and Treatment
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.
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 40 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Baylor University is the lead sponsor of 42 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
\<Child Participant>
Inclusion Criteria:
Exclusion Criteria:
\<Caregiver Participant>
Inclusion Criteria:
Exclusion Criteria
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)
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
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
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Provider Coaching Fidelity Percentage
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.
Time frame: During the 12-week intervention period, with sessions sampled across the intervention.
Caregiver-Rated Intervention Acceptability Mean Score
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.
Time frame: 12 weeks (post-intervention).
Caregiver-Rated Intervention Feasibility Mean Score
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.
Time frame: 12 weeks (post-intervention).
No study locations are listed for this record.
Plan to share: Undecided — The research team has not yet determined whether de-identified individual participant data (IPD) will be shared. Decisions will depend on IRB guidance, funding agency requirements, and feasibility of preparing anonymized datasets while maintaining participant confidentiality.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Baylor University