Autism Parent Navigators for Autism

(APN Trial)

Recruiting at 1 trial location

Overseen By Michelle Hostetler, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

360 Participants Needed

Trial Summary

What is the purpose of this trial?

To address the dual needs of parents for support in navigating Autistic Spectrum Disorder (ASD) services and maintaining positive family functioning, the investigators propose to test Autism Parent Navigators (APN), an innovative in-home, peer support model for parents with a young child recently diagnosed with ASD.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Autism Parent Navigators for Autism?

Research shows that programs like Autism Parent Navigators can help parents of children with autism better understand and access services, improve their knowledge about autism services, and feel more empowered to advocate for their children. These programs have been found to be particularly beneficial for families with fewer resources, helping them navigate complex systems to get the support they need. ^{1 2 3 4 5}

Is the Autism Parent Navigators program safe for participants?

There is limited information on the safety of the Autism Parent Navigators program, but a study on interventions for young autistic children found that adverse events (physical or psychological distress) were rarely reported. It is recommended that researchers improve reporting on adverse events to better inform families. ^{5 6 7 8 9}

How is the Autism Parent Navigators treatment different from other autism treatments?

The Autism Parent Navigators treatment is unique because it focuses on helping parents navigate complex systems to access autism services, rather than directly treating the child. This approach empowers parents by improving their knowledge and advocacy skills, which can lead to better outcomes for their children. ^{1 2 3 10 11}

Research Team

Mark Feinberg, PhD

Principal Investigator

Penn State

Eligibility Criteria

This trial is for parents with a child aged 2-6 who has been diagnosed with Autism Spectrum Disorder (ASD) within the last four months. The child should be the first in the family to have this diagnosis, and parents must not already be in a mentoring program. Parents can be in any form of couple relationship.

Inclusion Criteria

My child has recently been diagnosed with Autism Spectrum Disorder.

My child is the first in our family diagnosed with autism.

Both parents in the household are in a committed relationship, regardless of their gender or marital status. This includes dating couples, adoptive parents, and step-parent families.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive in-home or telephone peer support through the Autism Parent Navigators Intervention

12 months

Regular in-home or telephone visits

Follow-up

Participants are monitored for family empowerment, coparenting support, parenting consistency, and engagement with ASD-related services

12 months

Treatment Details

Interventions

• Autism Parent Navigators
• Peer mentoring

Trial Overview The study is testing an 'Autism Parent Navigators' program where peer mentors provide in-home support to help parents navigate ASD services and maintain positive family dynamics after their young child's recent ASD diagnosis.

Participant Groups

Group I: Autism Parent Navigators Intervention Experimental Treatment 1 Intervention

Autism Parent Navigators Intervention is a manualized, in-home, peer support model for parents with a young child recently diagnosed with ASD.

Group II: Peer mentoring Active Control 1 Intervention

Peer mentors will offer an equivalent number of in-home or telephone visits for families, providing non-manualized peer support.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

University of South Carolina

Collaborator

Trials

233

Recruited

122,000+

Family Connections

Collaborator

Trials

1

Recruited

360+

Findings from Research

The SPANS program effectively improved the knowledge of 19 low-resourced parents about autism services, enhancing their ability to advocate for themselves and others.

The program showed high attendance and acceptability, indicating that it is a feasible and well-received approach to training navigators for families facing challenges in accessing services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the Effectiveness and Feasibility of a Family Navigator Program for Parents of Children With Autism. Burke, MM., Cheung, WC., Kim, J.[2023]

Family navigation (FN) services for families of children with autism spectrum disorder (ASD) showed improvements in parent activation and reduced caregiver strain among 260 parents, indicating potential efficacy in supporting families.

However, the effectiveness of FN services varied significantly based on how they were implemented, including factors like timing and type of services, suggesting that tailored approaches may be necessary for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Families' Experiences With Family Navigation Services in the Autism Treatment Network. Crossman, MK., Lindly, OJ., Chan, J., et al.[2020]

Parents of children with Medicaid who received early access to an Autism Patient Navigator (APN) found the assessment significantly more useful, indicating that the APN may enhance the support for families navigating autism services.

Children with early access to the APN were more successful in scheduling and completing appointments for necessary services, suggesting that timely support can improve access to care for children diagnosed with autism spectrum disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Autism Navigator on Access to Services. Roth, BM., Kralovic, S., Roizen, NJ., et al.[2019]

This study is testing the effectiveness of Patient Navigation (PN) as a strategy to improve access to evidence-based services for children with autism spectrum disorder (ASD), involving 250 families across multiple clinics in the northeastern U.S.

The trial aims to measure how PN affects the time it takes for families to receive a diagnosis and access recommended services compared to conventional care management, potentially revealing important insights into reducing disparities in care for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder. Broder-Fingert, S., Walls, M., Augustyn, M., et al.[2021]

The study identified five high-priority areas where Family Navigation for children with autism spectrum disorder could fail, including setting up community services and initial family meetings, based on expert evaluations from a mixed-methods approach involving 9 experts.

The most critical failure was found in 'setting up community-based services,' while 'attending testing appointments' was rated as the most severe potential failure, highlighting the need for targeted strategies to improve implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed-methods process evaluation of Family Navigation implementation for autism spectrum disorder. Broder-Fingert, S., Qin, S., Goupil, J., et al.[2020]

Out of 150 studies on non-medication interventions for young autistic children, only 11 reported any adverse events, highlighting a significant gap in safety reporting in this area of research.

Among the studies that did report on participant withdrawal, 10 identified reasons that could be classified as adverse events, suggesting that researchers need to improve their methods for tracking and reporting these occurrences to better inform families and professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. Bottema-Beutel, K., Crowley, S., Sandbank, M., et al.[2023]

In a pilot study involving 40 families, the pediatric developmental passport significantly improved service contact rates for families of children with autism spectrum disorder (ASD), with 95% of the intervention group reaching out to services compared to 70% in the control group.

The passport was particularly effective in community clinics, where it helped 90% of families contact services, compared to only 40% in the control group, highlighting its potential to enhance service navigation in settings with limited specialist availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Access to Developmental Services for Children with Autism Spectrum Disorder: The Pediatric Developmental Passport Pilot Randomized Trial. Young, E., Aiyadurai, R., Jegathesan, T., et al.[2021]

The Family-Centered Autism Navigation semi-structured interview guide was developed to help family navigators prioritize caregiver concerns and create a shared navigation plan after a child's autism diagnosis, based on insights from 42 brief interviews and expert feedback.

This guide aims to enhance caregiver knowledge and skills in navigating services, ultimately improving access to care and supporting families in managing their child's autism spectrum disorder effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and utility of the Family-Centered Autism Navigation interview. Pizur-Barnekow, K., Lang, AC., Barger, B.[2021]

Modifications to the family navigation (FN) strategy significantly improved recruitment for the study, with a reduction in the number of families refusing or being excluded from participation (from 19.5% to 4.8% and 43.6% to 0%, respectively).

In the second pilot RCT, families were more likely to complete the diagnostic assessment and reported greater satisfaction with clinical care, with FN showing a continued benefit over usual care in increasing the likelihood of completing assessments (hazard ratio of 2.57).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Family Navigation for Children With Autism: A Comparison of Two Pilot Randomized Controlled Trials. Feinberg, E., Kuhn, J., Eilenberg, JS., et al.[2022]

References

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

Understanding the Effectiveness and Feasibility of a Family Navigator Program for Parents of Children With Autism. [2023]

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

Families' Experiences With Family Navigation Services in the Autism Treatment Network. [2020]

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

Impact of Autism Navigator on Access to Services. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A mixed-methods process evaluation of Family Navigation implementation for autism spectrum disorder. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Dasl(n)e: the challenge of developing a regional database for autism spectrum disorder. [2019]

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

Adverse event reporting in intervention research for young autistic children. [2023]

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

Increasing Access to Developmental Services for Children with Autism Spectrum Disorder: The Pediatric Developmental Passport Pilot Randomized Trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Developmental regression and autism reported to the Vaccine Adverse Event Reporting System. [2007]

10. England pubmed.ncbi.nlm.nih.gov

Development and utility of the Family-Centered Autism Navigation interview. [2021]

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

Improving Family Navigation for Children With Autism: A Comparison of Two Pilot Randomized Controlled Trials. [2022]