Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06896942

Conditions

Health Equity

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Not accepted

Interventions

Autism Doula

DDBP Family Navigation

Study Details

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.

Conditions

Health Equity

Autism Spectrum Disorder

Study ID

NCT06896942

Start date

Jan 18, 2025

Status verified date

Mar, 2025

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Group

Autism 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 group

The 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.

Interventions

Autism Doula

The 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

A 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.

Primary outcome measure

  • Autism Doula field notes [ Time Frame: from enrollment to end of doula program at 3 months ]
  • Satisfaction Survey [ Time Frame: end of the autism doula program at 3 months after enrollment ]
  • Chart Review Form: [ Time Frame: end of the autism doula program at 3 months after enrollment ]

Central Contacts and Locations

Central contacts

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45209

Contacts

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Mar 26, 2025

Last verified

Mar, 2025

Keywords

  • health equity
  • autism spectrum disorder
  • family navigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-03-26.