Autism Doula Program for Autism

Overseen By Teresa Smith, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Non-Black caregivers, Children without autism

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the Autism Doula program, which supports Black families with children recently diagnosed with autism. The program provides culturally responsive assistance, such as helping caregivers navigate care options and reducing stress through services like cooking and respite care. The study compares families receiving doula support with those receiving usual care to determine if the program is practical, acceptable, and effective. Eligible participants are Black caregivers of children aged 18 months to five years who have recently been diagnosed with autism. As an unphased trial, this study offers a unique opportunity for families to contribute to research that could enhance support systems for Black caregivers and their children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Autism Doula program is safe and effective?

Studies have shown that increased access to doula care can improve health outcomes, particularly in communities with fewer resources. The Autism Doula program supports families of Black children with autism by offering culturally-sensitive assistance, guiding families through healthcare, and providing services like cooking or cleaning to reduce stress.

Although specific safety data for the Autism Doula program is not available, the program focuses on offering support rather than medical treatment. It aims to enhance the family's experience and care for their child with autism. As the program is still under study, no evidence of harm or negative effects has been found.

The goal is to determine if the program is practical, welcomed, and helpful. The community has expressed a need for this kind of support, suggesting it could be well-received and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Autism Doula Program because it offers a culturally-responsive support system for caregivers, which is not typically emphasized in standard autism care. Unlike conventional treatments that focus primarily on the child with autism, this program also aims to reduce caregiver stress through services like cooking, cleaning, and respite care. Additionally, it helps connect families with the Black autism community, providing a sense of belonging and tailored guidance. By addressing both emotional and practical needs, this approach could lead to more comprehensive support for families navigating autism.

What evidence suggests that the Autism Doula program is effective for promoting equitable care for Black children with autism?

Research has shown that the Autism Doula program provides culturally sensitive support to families of Black children with autism. In this trial, the intervention group will receive Autism Doula care, which helps caregivers understand the steps needed for their child's care, reduces their stress, and boosts their confidence in managing their child's condition. Early results indicate that the program assists in completing necessary care steps and lowers caregiver stress. By connecting families with the Black autism community and offering practical help, such as short-term care for their child and household assistance, the program addresses specific challenges these families face. Overall, the program aims to ensure fair access to care and has shown promise in being effective and well-received by the families involved. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Black families with children aged 18 months to five years who have recently been diagnosed with autism spectrum disorder. It aims to provide culturally matched support and improve equitable care.

Inclusion Criteria

I am a Black caregiver over 18, with Black children.

I care for a child aged 18 months to 5 years who was recently diagnosed with autism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Families receive Autism Doula services, including culturally-responsive support and navigation of next steps for their child's care

3 months

Multiple sessions with Autism Doula

Control

Families receive care as usual and a referral to DDBP family navigation

3 months

One telehealth appointment

Follow-up

Participants are monitored for satisfaction, stress levels, and self-efficacy after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Autism Doula

Trial Overview The Autism Doula program, offering family navigation and social-emotional support, is being tested against the usual care which includes DDBP Family Navigation. The study will measure satisfaction, adherence, and effectiveness in completing recommended steps and reducing caregiver stress.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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 II: Control group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

Doulas provide essential support during the perinatal period, leading to improved outcomes such as decreased preterm births and increased rates of breastfeeding initiation, based on a review of 34 articles.

Doula support is particularly beneficial for Black patients, showing promise in reducing racial disparities in maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doula Care: A Review of Outcomes and Impact on Birth Experience. Ramey-Collier, K., Jackson, M., Malloy, A., et al.[2023]

The PLAY Project Home Consultation program, which trains parents to use the DIR/Floortime model, showed significant improvements in child development for 68 children with autism over an 8-12 month period, with 45.5% achieving good to very good progress.

Parents reported a high satisfaction rate of 90% with the program, and the average cost of $2500 per year suggests it may be a cost-effective intervention for supporting young children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a parent training program for young children with autism: the PLAY Project Home Consultation program. Solomon, R., Necheles, J., Ferch, C., et al.[2022]

In a study of 25 early intervention sessions for children with autism, providers showed low overall use of effective parent coaching techniques, indicating a need for improvement in training.

When coaching was provided, it primarily involved limited strategies like collaboration and in-vivo feedback, suggesting that targeted training on specific coaching components could enhance the effectiveness of parent-mediated interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent Coaching in Early Intervention for Autism Spectrum Disorder: A Brief Report. Pellecchia, M., Mandell, DS., Beidas, RS., et al.[2023]

Participation in the By My Side Birth Support Program was linked to significantly lower odds of preterm birth (5.6% vs 11.9%) and low birthweight (5.8% vs 9.7%) among participants, indicating improved birth outcomes.

The program, which provides community-based doula support, highlights the potential of doula services to address birth inequities, particularly for Black and Hispanic populations, without affecting cesarean delivery rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Birth equity on the front lines: Impact of a community-based doula program in Brooklyn, NY. Thomas, MP., Ammann, G., Onyebeke, C., et al.[2023]

Early intervention for children with autism spectrum disorder (ASD) has seen significant growth, focusing primarily on child outcomes like language acquisition, but there is a need to also consider family outcomes such as quality of life and parent self-efficacy.

Parent buy-in is crucial for the success of parent-mediated interventions, highlighting the importance of evaluating and improving family outcomes to ensure the sustainability and effectiveness of these interventions in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remembering parents in parent-mediated early intervention: An approach to examining impact on parents and families. Wainer, AL., Hepburn, S., McMahon Griffith, E.[2019]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06896942/autism-doula-program-evaluation?page=4&state=OH&city=Norwood

Autism Doula Program Evaluation | Clinical Research Trial Listing Additionally, preliminary effectiveness will be evaluated by examining completion of recommended next steps, caregivers' perceived stress, and self-efficacy.

2. withpower.com withpower.com/trial/phase-autistic-disorder-2025-3aaf6

Autism Doula Program for Autism Implications: Data from this project will provide evidence that the Autism Doula program is feasible, acceptable, and effective, ultimately demonstrating it as ...

3. trial.medpath.com trial.medpath.com/clinical-trial/8d0d22716e99ac2f/nct06896942-community-intervention-black-children-autism

Autism Doula Program Evaluation | MedPath Additionally, preliminary effectiveness will be evaluated by examining completion of recommended next steps, caregivers' perceived stress, and self-efficacy.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11327882/

Perinatal and Postpartum Health Among People With ... Identifying opportunities to improve health outcomes among the 7 million people with IDD, including autism and intellectual disabilities (ID), ...

5. policylab.us policylab.us/clinical-trials/l/conditions/autism-spectrum-disorder?page=5

Autism Spectrum Disorder Clinical Trials & Research Studies Near ... The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11326990/

Promoting Equity and Justice for Black Children with Autism ... Black children with autism and their families face disparities within clinical care and services, leading to inequitable health outcomes.

7. facebook.com facebook.com/groups/ourtribecincy/posts/2258949390978107/

Our Autism Doula Program was created because ... We are looking to help provide support for families who have a child recently diagnosed with Autism Spectrum Disorder in the Dufferin County ...

8. nj.gov nj.gov/humanservices/dmahs/boards/maac/MAA_%20Meeting_Presentations_10-21-20.pdf

NJ FamilyCare Medical Assistance Advisory Council “Studies suggest that increased access to doula care, especially in under-resourced communities, can improve a range of health outcomes for.