Family-centered parent training for autistic toddlers in early intervention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study adds a parent-training approach for emotion regulation to Part C early intervention services for toddlers aged birth to three with autism. It will test feasibility and preliminary efficacy of delivering the intervention through providers who are already serving families in the BabyNet system. The study also examines factors at the family, provider, and system levels that might influence uptake and real-world use of the training. Outcomes will inform how to integrate evidence-based parent strategies into routine early intervention, with attention to accessibility and practicality in community settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of South Carolina
  Columbia, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Sarah R Edmunds, PhD — University of South Carolina
• Study coordinator: Sarah R Edmunds, PhD
• Email: sredmunds@sc.edu
• Phone: (803) 386-1150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.