Trial of Autism Parent Navigator Program

Autism Spectrum Disorder Clinical Trial

— APN  

Official title:

Test of an Innovative, Scalable Support Program for Parents With a Young Child Recently Diagnosed With Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744428
• Other study ID #: APN-RT01
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: November 2023
• Source: Penn State University
• Contact: Michelle Hostetler, PhD
• Phone: 8144043166
• Email: mxh14[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Parents of children who have been newly diagnosed with Autism Spectrum Disorder (ASD).

• The child will be age 2-6 years and been diagnosed with ASD in the past four months.

• The child is the first child in the family to be diagnosed with ASD.

• Parents are not already involved in a parent mentoring relationship.

• Parents are currently involved in a couple relationship, including same-sex partners, dating couples, adoptive parents and step-parent families.

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Autism Parent Navigators
The Autism Parent Navigator program consists of six sessions delivered to parents in the home, supporting adjustment to ASD, accessing services, and coparenting support.
• Peer mentoring
Six in-home or telephone sessions, depending on family uptake, providing non-manualized general support as usual from parent peer mentors regarding adjustment to ASD.

Locations

Country	Name	City	State
United States	Family Connections	Columbia	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Penn State University	Family Connections, University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly Count of Service Navigation Behaviors	Engagement with ASD-related Services	12 month
Primary	Parenting Scale (Arnold)	Parenting consistency, warmth	12 month
Primary	CES-Depression	Parent depression	12 month
Secondary	Coparenting Relationship Scale (Feinberg, Brown, & Kan, 2012)	Coparenting Support	12 month
Secondary	Family Empowerment Scale - FES	Parent Efficacy regarding Service Access	12 month
Secondary	PDD-BI	Challenging Child Behaviors: Aggression, Non-compliance	12 month