Actively Recruiting

Phase Not Applicable
Age: 18Months - 71Months
All Genders
ID06896942

Evaluation of a Community-Driven, Equitable Autism Doula Program for Black Children with Autism Spectrum Disorder

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

52

Participants Needed

1

Research Sites

21 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

Researchers are evaluating a community-driven intervention designed to support Black children newly diagnosed with autism spectrum disorder and their families. The study aims to assess the Autism Doula program, which was developed to address barriers to equitable care such as lack of cultural representation, caregiver stress, stigma, and uncertainty about needed services. This program offers culturally matched family navigation and social-emotional support to improve care experiences and promote health equity. The study randomly assigns 56 Black families with children aged 18 months to five years to either the intervention group receiving Autism Doula services or a control group receiving usual care including a one-time telehealth consultation with DDBP Family Navigation. The Autism Doula provides culturally responsive support, helps caregivers navigate next steps for their child's care, connects families with the Black autism community, and offers services to alleviate caregiver stress such as cooking, cleaning, and respite care. The study period includes three months of program participation. Participants will be monitored through Autism Doula field notes, satisfaction surveys, and medical chart reviews at the end of the three-month program. Researchers will assess feasibility and acceptability by measuring satisfaction, session completion, and intervention delivery fidelity. They will also evaluate preliminary effectiveness by comparing caregiver perceived stress levels, self-efficacy, and completion of recommended next steps between the two groups. The total study duration for each participant is three months after enrollment.

CONDITIONS

Brief Title

Autism Doula Program Evaluation

Who Can Participate

Age: 18Months - 71Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregivers of children aged 18 months to five years
  • Children must have a recent diagnosis of autism spectrum disorder
  • Caregivers must identify as Black or African American
  • Caregivers must be over 18 years old
  • Children must be identified as Black or African American
Not Eligible

You will not qualify if you...

  • None explicitly stated in the eligibility criteria provided in the source data

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for eligibility assessment

Treatment

Duration - 3 months

Participants in the intervention group receive Autism Doula care which includes culturally-responsive support, navigation for next steps in their child's care, connection to the Black autism community, and services to alleviate caregiver stress. Participants in the control group receive care as usual and a one-time telehealth consult with a DDBP family navigator to plan next steps.

Multiple Autism Doula sessions depending on family needs; 1 telehealth consult for control group

Follow-up

Duration - At 3 months after enrollment

Participants complete satisfaction surveys and assessments of caregiver stress and self-efficacy after the Autism Doula program ends.

1 visit to complete satisfaction survey and outcome assessments

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

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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Published Research Related To This Trial

Community-Based Doulas and COVID-19: Addressing Structural and Institutional Barriers to Maternal Health Equity.

S Michelle Ogunwole, Wendy L Bennett, Andrea N Williams...

https://pubmed.ncbi.nlm.nih.gov/33399272

Early Identification of Autism Spectrum Disorder Among Children Aged 4 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2020.

Kelly A Shaw, Deborah A Bilder, Dedria McArthur...

https://pubmed.ncbi.nlm.nih.gov/36952289

A systematic review examining caregivers' of color experiences with the diagnostic process of autism spectrum disorder.

Allison P Fisher, James D Lynch, Farrah M Jacquez...

https://pubmed.ncbi.nlm.nih.gov/36321366

Have Racial and Ethnic Disparities in the Quality of Health Care Relationships Changed for Children With Developmental Disabilities and ASD?

Sandra Magaña, Susan L Parish, Esther Son

https://pubmed.ncbi.nlm.nih.gov/26505871