NCT07748780Not yet recruiting
Testing a Blended Social-Communication and Social-Emotional Intervention for Autistic Toddlers
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 13 Sept 2025
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Baylor University
- Diseases
- Autism
- NCT number
- NCT07748780
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Sept 2026 to the primary completion date, 30 Sept 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not currently eligible for or receiving Part C services.
- Previously participated in pilot testing of the blended intervention.
- \<Caregiver Participant\>
Other illness
- Has a co-occurring medical condition (e.g., uncontrolled seizures, significant sensory or motor impairment) that would prevent participation in caregiver-child interaction sessions.
Other
- 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.
Who the study is looking for
- 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.
- 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).
Criteria the registry did not label
- \<Child Participant\>
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.