| NCT ID | NCT06896942 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Health Equity |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-01-18 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 52 participants in total. It began in 2025-01-18 with a primary completion date of 2025-03-31.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: caregivers of children who are 18 months to five years and recently diagnosed with autism. Caregivers must identify as Black and be over the age of 18 and identify their children as Black.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06896942 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 71 Months, studying Health Equity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06896942 currently recruiting?
Yes, NCT06896942 is actively recruiting participants. Contact the research team at teresa.smith@cchmc.org for enrollment information.
Where is the NCT06896942 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06896942 clinical trial?
NCT06896942 is sponsored by Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 52 participants.