Actively Recruiting

Phase Not Applicable
Age: 18Months - 71Months
All Genders
NCT06896942

Autism Doula Program Evaluation

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-03-26

52

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

N

National Center for Advancing Translational Sciences (NCATS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Autism Doula Program Evaluation

Who Can Participate

Age: 18Months - 71Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45209

Actively Recruiting

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Research Team

T

Teresa Smith, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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