NCT06896942 · Children's Hospital Medical Center, Cincinnati
Autism Doula Program Evaluation
What this study is about
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).
View original scientific description
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.
Interventions
OTHER
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).
OTHER
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 measures
Autism Doula field notes
Time frame: from enrollment to end of doula program at 3 months
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.
Satisfaction Survey
Time frame: end of the autism doula program at 3 months after enrollment
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.
Chart Review Form:
Time frame: end of the autism doula program at 3 months after enrollment
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Cincinnati, Ohio
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 26, 2025 · Source of record for eligibility and locations