Clinical trial NCT06896942: Autism Doula Program Evaluation
Official title: EVALUATION OF A COMMUNITY DRIVEN, EQUITABLE INTERVENTION FOR BLACK CHILDREN WITH AUTISM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Equity
Autism Spectrum Disorder
Keywords: health equity
autism spectrum disorder
family navigation
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2025-03-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot study will obtain and compare data from the intervention group (i.e., families receiving Autism Doula services) and the control group (i.e., families receiving care as usual including DDBP Family Navigation) to examine the acceptability, feasibility, and preliminary effectiveness of an Autism Doula program.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The current project aims to evaluate a community driven, equitable intervention for Black children with autism. Specifically, we will assess the feasibility and acceptability of the Autism Doula program to enhance culturally responsive care and services for Black children newly diagnosed with autism and their families. The Autism Doula intervention will be measured in several ways, including number of families who complete the Autism Doula intervention, Autism Doula sessions successfully completed, content delivered as intended, and the satisfaction of the families involved in the intervention group. Additionally, preliminary effectiveness will be assessed by comparing the intervention group (i.e., families who receive Autism Doula services) to the experiences of families who receive care as usual including DDBP Family Navigation. Specifically, we will examine caregiver perceived stress levels, caregiver self-efficacy, and initiation of recommended next steps/services. We hypothesize that families receiving Autism Doula services will report high satisfaction with the program and that the program will be determined to be feasible and effective. Should results reveal acceptability, feasibility, and preliminary effectiveness of the Autism Doula intervention, additional funding will be sought out in collaboration with the Division of Developmental and Behavioral Pediatrics (DDBP) at CCHMC to expand the program. Aligned with the hospital wide initiative of incorporating family navigation into clinical care, DDBP leadership has made it a priority to provide culturally-response family navigation, similar to the Autism Doula program.

Eligibility criteria: 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.

Primary outcomes:
measure: Autism Doula field notes
timeFrame: from enrollment to end of doula program at 3 months
measure: Satisfaction Survey
timeFrame: end of the autism doula program at 3 months after enrollment
measure: Chart Review Form:
timeFrame: end of the autism doula program at 3 months after enrollment
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: at study enrollment until after autism doula intervention (3 months)
measure: Early Intervention (EI) Parent Self Efficacy Scale
timeFrame: at study enrollment until after autism doula intervention (3 months)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
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