Autism Doula Program Evaluation
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Study ID
- NCT06896942
- Status
- Recruiting
Conditions
- Autism Spectrum Disorder
- Health Equity
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Months - 71 Months
- Healthy Volunteers
- Not accepted
Interventions
- Autism Doula — OTHERThe Autism Doula provides caregiver support, navigation with next steps for their child, connects families to resources and the Black autism community, and coordinates services to help alleviate caregiver stress (e.g., cleaning, cooking, respite care).
- DDBP Family Navigation — OTHERA one-time consult with a DDBP family navigator via telehealth to come up with an action plan for next steps for the patient's care.
Study Details
Background: Findings from a group level assessment with caregivers of Black children with autism revealed barriers to equitable care and services (e.g., a lack of cultural representation among their child's care team, caregiver stress, stigma, and uncertainty about services needed). The Autism Doula program was identified by the community to address the aforementioned barriers and provide culturally matched family navigation and social-emotional support while also acknowledging the unique experiences and values of caregivers of Black children with autism. Impact: The current project aims to assess the acceptability, feasibility, and preliminary effectiveness of the Autism Doula program and promote equitable care for Black children with autism and their families. Methods: Fifty-six Black families of children 18 months to five years of age who recently received a new diagnosis of autism spectrum disorder from CCHMC will be recruited to the current study. Twenty-six families will be randomly assigned to either the control group (i.e., care as usual including DDBP Family Navigation) or the intervention group (i.e., Autism Doula services). Feasibility and acceptability data will be gathered, including satisfaction of both groups, how many families approached agree to be in the study, how many sessions with the doula were successfully completed, and was the intervention content delivered as intended. Additionally, preliminary effectiveness will be evaluated by examining completion of recommended next steps, caregivers' perceived stress, and self-efficacy. Implications: Data from this project will provide evidence that the Autism Doula program is feasible, acceptable, and effective, ultimately demonstrating it as an equitable care approach for Black children with autism and their families. Future Directions: Findings from this pilot project will highlight the need for growth of the Autism Doula program to promote culturally competent care and health equity for Black children with autism and their families.
Key Dates
- Start date
- Jan 18, 2025
- Status verified
- Mar 2025
- Primary completion
- Mar 31, 2025
- Completion
- Aug 31, 2025
Study Design
- Enrollment
- 52 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Intervention GroupAutism doula care includes providing caregivers with culturally-responsive support, helping them navigating next steps for their child's care, connecting them with the Black autism community, and providing services to alleviate caregiver stress (e.g., cooking, cleaning, respite care).
- Active Comparator: Control groupThe control group will receive care as usual and a referral to DDBP family navigation, which is usually a one time telehealth appointment to plan next steps for their child's care.
Primary Outcome Measure
Autism Doula field notes [ Time Frame: from enrollment to end of doula program at 3 months ]
Central Contacts
- Teresa Smith, PhD6143137432
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45209 |
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