NCT07471594 Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention
| NCT ID | NCT07471594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Carolina |
| Condition | Autism |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-03-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 between 18 and 75 years of age * Not the legal guardian of the child * Not able to be present for BabyNet services Inclusion Criteria for Children in Caregiver-Child Dyad: * Is between 12 and 36 months of age * Is enrolled in BabyNet services at least one half-hour per week * Is considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI * Has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index. Exclusion Criteria for Children in Caregiver-Child Dyad: * Is not between 12 and 36 months of age * Is not receiving services in BabyNet at least one half-hour per week * Is not considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI * Does not have elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
Contact & Investigator
Sarah R Edmunds, PhD
PRINCIPAL INVESTIGATOR
University of South Carolina
Frequently Asked Questions
Who can join the NCT07471594 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 36 Months, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07471594 currently recruiting?
Yes, NCT07471594 is actively recruiting participants. Contact the research team at sredmunds@sc.edu for enrollment information.
Where is the NCT07471594 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT07471594 clinical trial?
NCT07471594 is sponsored by University of South Carolina. The principal investigator is Sarah R Edmunds, PhD at University of South Carolina. The trial plans to enroll 40 participants.