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Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-03-26
52
Participants Needed
1
Research Sites
21 weeks
Total Duration
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 childs 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
Autism Doula Program Evaluation
T
Teresa Smith, PhD
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Children's Hospital Medical Center, Cincinnati
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Autism Doula Program | Family Navigation (Telehealth Consult) |
|---|---|---|
| What it is | A culturally informed support model where an Autism Doula provides Black caregivers with ongoing practical help, navigation guidance, connections to advocacy and resources, and coordination of services to reduce caregiver stress after a child's autism diagnosis. | A single telehealth session with a family navigator, during which caregivers receive an action plan and guidance about next steps for their child's care. |
| Role in the trial | Intervention arm. Caregivers receive ongoing support, resource navigation, and community connections for 3 months. | Comparator arm. Caregivers receive a single session providing guidance and an action plan but do not receive ongoing support. |
| Primary use | To provide extended, culturally specific support, help with service navigation, and practical aid for Black caregivers during the early period following their child's autism diagnosis. | To offer an actionable care plan and brief guidance after diagnosis through a single family navigation telehealth session. |
| How it is given or performed | Caregivers receive continuing support over three months through direct interactions, practical service coordination (e.g., help with household tasks, care coordination, connecting with resources/communities), and stress relief activities. | A one-time telehealth session where the navigator and caregiver develop an action plan for next care steps. |
| Evidence status | No results are yet available from this randomized trial. Systematic review evidence suggests that culturally tailored, ongoing caregiver support may help address service barriers and improve engagement, especially for Black families facing disparities after autism diagnosis. | Trial data are not available yet. Family navigation programs are broadly used to help caregivers with care planning, but evidence of direct benefit for Black families after autism diagnosis remains limited and gaps in service access persist. |
| Important limitations | This trial is ongoing with no published outcomes. Evidence for the effectiveness of autism-focused doula programs specifically for Black families is emerging but not yet established. Additional studies are needed to determine lasting benefits and scalability. | Current one-time navigation sessions may not provide the ongoing support some families need. Recent reviews highlight persistent service gaps, limited engagement, and unmet needs for families of color after autism diagnosis. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) for eligibility assessment
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
