Testing a Blended Social-Communication and Social-Emotional Intervention for Autistic Toddlers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBaylor University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
At least one primary caregiver is available and willing to participate in weekly coaching sessions for 12 weeks.
Trial design
Design model
Parallel
Treatments tested in this trial
Blended Intervention (Project ImPACT + Pyramid Model)
BehavioralA 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
BehavioralAn 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
BehavioralA 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.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Blended Intervention (Project ImPACT + Pyramid Model)Experimental treatment 1 intervention
Group B: Project ImPACT OnlyActive comparator 1 intervention
Group C: Pyramid Model OnlyActive comparator 1 intervention
Group D: Waitlist Control (Usual Care)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
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.2
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).3
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).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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