An interventional study of Autism Doula and DDBP Family Navigation in Health Equity and Autism Spectrum Disorder, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 18 Months to 71 Months. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Supportive care
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.
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's planned enrollment of 52 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
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Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
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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.
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).
Other: Autism Doula
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.
Other: DDBP Family Navigation
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).
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.
Autism Doula field notes
The Autism Doula will have an electronic field note in REDCap that includes the date of contact with family, contact method, and a checklist of intervention content delivered (e.g., assistance with scheduling therapy, contacting early intervention, providing social support). To ensure confidentiality of participants, this REDCap project will be separate from the REDCap project for study measures.
Time frame: from enrollment to end of doula program at 3 months
Satisfaction Survey
This survey will be given following completion of the Autism Doula program or at three months for the control group. This survey will have two versions, one for the Autism Doula program and one for DDBP Family Navigation, and was adapted from the Patient Satisfaction with Logistical Aspects of Navigation Scale (PSN-L). Questions will be asked on a Likert Scale from 1 (strongly disagree) to 5 (strongly agree) and include their satisfaction with the services they received from the Autism Doula. The items are summed for a total score and higher scores indicate higher satisfaction. There will also be a comment section for open-ended feedback.
Time frame: end of the autism doula program at 3 months after enrollment
Chart Review Form:
The Chart Review form was developed by research staff and will be used to obtain relevant information pertaining to the completion of recommended next steps, including the following: speech therapy, occupational therapy, Applied Behavior Analysis, Early Intervention services, establishing care with a developmental pediatrician, and behavior therapy. This form will be completed by research staff three months after study enrolment for the control group and after completion of the Autism Doula program for the intervention group (i.e., three months).
Time frame: end of the autism doula program at 3 months after enrollment
Perceived Stress Scale (PSS)
The PSS measures perceptions of stress according to how uncontrollable, unpredictable, and overloaded participants view their lives. This 14 item self-report test measures stress from ongoing life circumstances, from anticipating future events, and reactions to specific events. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. The manual for the PSS reports findings supporting the reliability and validity of this measure. This survey will be administered at study enrollment and again three months later for the control group and after completion of the Autism Doula program for the intervention group (i.e., three months).
Time frame: at study enrollment until after autism doula intervention (3 months)
Early Intervention (EI) Parent Self Efficacy Scale
This scale is a 16-item scale used to assess EI related competence beliefs of parents of children with disabilities. The manual for this scale reports findings supporting the reliability and validity of this measure. This survey will be administered at study enrollment and again six months later for the control group and after completion of the Autism Doula program for the intervention group.
Time frame: at study enrollment until after autism doula intervention (3 months)
Plan to share: Yes — all collected IPD, all IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Children's Hospital Medical Center, Cincinnati