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NCT06896942 · ClinicalTrials.gov registry record · NA
Autism Doula Program Evaluation
A NA study of Autism Spectrum Disorder and Health Equity, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT06896942: Recruiting NA study of Autism Spectrum Disorder and Health Equity, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT06896942 is a NA study of Autism Spectrum Disorder and Health Equity that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 52 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06896942, a NA study of Autism Spectrum Disorder and Health Equity, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study 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 ch
Primary Outcome
The Autism Doula will have an electronic field note in REDCap that includes the date of contact with family, contact method, and a checklist of intervention content delivered (e.g., assistance with scheduling therapy, contacting early intervention, providing social support). To ensure confidentiality of participants, this REDCap project will be separate from the REDCap project for study measures.
Conditions Studied
Interventions
- OTHER Autism Doula
- OTHER DDBP Family Navigation
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2025-01-18 |
| Est. Completion | 2025-08-31 |
| Phase | NA |
What NCT06896942 shows while recruiting
NCT06896942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Autism Doula is the first listed.
NCT06896942 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06896942 about?
NCT06896942 is a clinical study titled "Autism Doula Program Evaluation". 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...
What is the current status of trial NCT06896942?
This trial is currently recruiting. It is a NA study. The enrollment target is 52 participants. The study started on 2025-01-18. Estimated completion is 2025-08-31.
What conditions does trial NCT06896942 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Health Equity.
What interventions are being tested in trial NCT06896942?
The interventions under investigation include: Autism Doula (OTHER), DDBP Family Navigation (OTHER).
Who is sponsoring clinical trial NCT06896942?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06896942 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06896942's enrollment target sits among peer trials
52 140th of 224 higher than 85 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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