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

Trial Summary

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 data supports the effectiveness of the Autism Doula treatment for autism?

The 'Skippu-Mama' program, which is a peer support program for mothers of children with autism, showed improvements in quality of life and reduced parental stress, suggesting that support-focused interventions can positively impact families dealing with autism. Additionally, the TEACCH-based home program intervention demonstrated significant developmental improvements in young children with autism, indicating that structured home-based support can be effective. ^{1 2 3 4 5}

Is the Autism Doula Program safe for humans?

The studies reviewed did not specifically evaluate the Autism Doula Program, but they did examine other treatments for autism. For example, bone marrow mononuclear cell transplantation combined with educational intervention showed no severe adverse events, and acupuncture was generally well-tolerated. However, more rigorous studies are needed to confirm the safety of these treatments. ^{6 7 8 9 10}

How does the Autism Doula treatment differ from other autism treatments?

The Autism Doula treatment is unique because it involves trained professionals providing continuous support, similar to how doulas assist during childbirth, but tailored for individuals with autism. This approach focuses on offering personalized, culturally appropriate care and promoting informed decision-making, which is different from traditional medical or behavioral therapies for autism. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Remembering parents in parent-mediated early intervention: An approach to examining impact on parents and families. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a home program intervention for young children with autism. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pilot study of a parent training program for young children with autism: the PLAY Project Home Consultation program. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Developing the "Skippu-Mama" program for mothers of children with autism spectrum disorder. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Parent Coaching in Early Intervention for Autism Spectrum Disorder: A Brief Report. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Outpatient Procedural Sedation of Patients With Autism Spectrum Disorders for Magnetic Resonance Imaging of the Brain Using Propofol. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Outcomes of bone marrow mononuclear cell transplantation combined with interventional education for autism spectrum disorder. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Taxonomy of Reported Harms in Pediatric Autism Spectrum Disorder Screening: Provider and Parent Perspectives. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for treatment of autism spectrum disorders. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Autism Spectrum Disorder: When There is no Cure, There are Countless of Treatments. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Current Resources for Evidence-Based Practice, July 2020. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Birth Companions: Teaching Nursing Students to Become Doulas. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Doula Care: A Review of Outcomes and Impact on Birth Experience. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Birth equity on the front lines: Impact of a community-based doula program in Brooklyn, NY. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

Doulas as community health workers: lessons learned from a volunteer program. [2020]