Autism Doula Program Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-18

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Translating Peer-to-Peer Support Into a Clinical Setting

NCT04313283

Development Delay Neurodevelopmental Disorders Autism

COMPLETED NA

Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder

NCT01340092

Autistic Disorder

COMPLETED NA

Testing Scalable Caregiver Interventions for Autism

NCT07259044

Autism Spectrum Disorder Autism ASD

NOT_YET_RECRUITING NA

Social and Communication Outcomes for Young Children With Autism

NCT00953095

Autism Spectrum Disorder

COMPLETED NA

A Coping Effectiveness Training Intervention for Caregivers of Children With Autism Spectrum: A Feasibility Study

NCT01168284

Autism Spectrum Disorders

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health Equity Autism Spectrum Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

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).

Group Type EXPERIMENTAL

Autism Doula

Intervention Type OTHER

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).

Control group

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.

Group Type ACTIVE_COMPARATOR

DDBP Family Navigation

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.

Minimum Eligible Age

18 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No