Autism Doula Program Evaluation

NCT06896942 | Recruiting

• 2 other identifiers: 2024-0473UL1TR001425
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Equity; Autism Spectrum Disorder

Keywords

health equity; autism spectrum disorder; family navigation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  end of the autism doula program at 3 months after enrollment

Secondary Outcomes (2)

• Perceived Stress Scale (PSS)

  at study enrollment until after autism doula intervention (3 months)

• Early Intervention (EI) Parent Self Efficacy Scale

  at study enrollment until after autism doula intervention (3 months)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Autism Doula 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).

Intervention Group

DDBP Family Navigation 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.

Control group

Eligibility Criteria

• Age: 18 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45209, United States

RECRUITING

Related Publications (7)

• Hoagwood KE, Cavaleri MA, Serene Olin S, Burns BJ, Slaton E, Gruttadaro D, Hughes R. Family support in children's mental health: a review and synthesis. Clin Child Fam Psychol Rev. 2010 Mar;13(1):1-45. doi: 10.1007/s10567-009-0060-5.

  PMID: 20012893 BACKGROUND

• Ogunwole SM, Bennett WL, Williams AN, Bower KM. Community-Based Doulas and COVID-19: Addressing Structural and Institutional Barriers to Maternal Health Equity. Perspect Sex Reprod Health. 2020 Dec;52(4):199-204. doi: 10.1363/psrh.12169. Epub 2021 Jan 5. No abstract available.

  PMID: 33399272 BACKGROUND

• Castelin S, Okorodudu J, Smith T. Partnering With a Purpose: Promoting Equity and Justice for Black Children With Autism Spectrum Disorder. J Dev Behav Pediatr. 2024 Jul-Aug 01;45(4):e302-e308. doi: 10.1097/DBP.0000000000001276. Epub 2024 Jul 17.

  PMID: 39023854 BACKGROUND

• Smith KA, Gehricke JG, Iadarola S, Wolfe A, Kuhlthau KA. Disparities in Service Use Among Children With Autism: A Systematic Review. Pediatrics. 2020 Apr;145(Suppl 1):S35-S46. doi: 10.1542/peds.2019-1895G.

  PMID: 32238530 BACKGROUND

• Shaw KA, Bilder DA, McArthur D, Williams AR, Amoakohene E, Bakian AV, Durkin MS, Fitzgerald RT, Furnier SM, Hughes MM, Pas ET, Salinas A, Warren Z, Williams S, Esler A, Grzybowski A, Ladd-Acosta CM, Patrick M, Zahorodny W, Green KK, Hall-Lande J, Lopez M, Mancilla KC, Nguyen RHN, Pierce K, Schwenk YD, Shenouda J, Sidwell K, Vehorn A, DiRienzo M, Gutierrez J, Hallas L, Hudson A, Spivey MH, Pettygrove S, Washington A, Maenner MJ. Early Identification of Autism Spectrum Disorder Among Children Aged 4 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2020. MMWR Surveill Summ. 2023 Mar 24;72(1):1-15. doi: 10.15585/mmwr.ss7201a1.

  PMID: 36952289 BACKGROUND

• Fisher AP, Lynch JD, Jacquez FM, Mitchell MJ, Kamimura-Nishimura KI, Wade SL. A systematic review examining caregivers' of color experiences with the diagnostic process of autism spectrum disorder. Autism. 2023 May;27(4):876-889. doi: 10.1177/13623613221128171. Epub 2022 Nov 2.

  PMID: 36321366 BACKGROUND

• Magana S, Parish SL, Son E. Have Racial and Ethnic Disparities in the Quality of Health Care Relationships Changed for Children With Developmental Disabilities and ASD? Am J Intellect Dev Disabil. 2015 Nov;120(6):504-13. doi: 10.1352/1944-7558-120.6.504.

  PMID: 26505871 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Teresa Smith, PhD

CONTACT

6143137432; teresa.smith@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: January 18, 2025
• Primary Completion: March 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: De-identified data will be made available to all those who inquire.

Locations

US (1)