Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention (NCT07471594) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention
40 participantsStarted 2026-04
Plain-language summary
Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes). The Part C system is ideally situated to provide family-based intervention to children aged birth to three. However, Part C EI providers receive little training in ASD or the challenges characterizing ASD in toddlerhood, most notably emotion regulation. This study introduces Parent Training for emotion regulation for autistic toddlers into the Part C EI system, determines its feasibility and preliminary efficacy in this setting, and assesses what family, provider, and system-level factors may facilitate the uptake of parent training in the Part C EI system.
Who can participate
Age range
12 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The following is a list of inclusion and exclusion criteria by participant group across all three research aims.
Inclusion Criteria for All Participants:
* Able to provide written and informed consent;
* Both sexes and all racial and ethnic origins;
* English fluency (necessary for informed consent and measure completion)
Inclusion Criteria for Providers:
* Is between 18 and 75 years of age
* Holds a contract with or formally employed by BabyNet
* Provides services within BabyNet at least one half-hour per week
* Provides therapeutic services within BabyNet to at least one child 12-36 months who is 1) at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI, and 2) has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
Exclusion Criteria for Providers:
* Not contracted or employed by BabyNet
* Provides services less than one half-hour per week
* Does not provide services to a child 12-36 months of age at high-likelihood for ASD and with elevated emotion dysregulation (based on the POSI and the EDI-YC)
Inclusion Criteria for Caregiver in Caregiver-Child Dyad:
* Is between 18 and 75 years of age
* Is the legal guardian of the participating child
* Child is receiving services within BabyNet at least one half-hour per week - Caregiver participates or is present for BabyNet services
Exclusion Criteria for Caregiver in Caregiver-Child Dyad:
* Not betw…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parent Training Treatment Acceptability
Timeframe: 8 weeks after the start of intervention (1-3 weeks post intervention)