Trial of Autism Parent Navigator Program (APN)

November 14, 2023 updated by: Mark Feinberg, Penn State University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michelle Hostetler, PhD
  • Phone Number: 8144043166
  • Email: mxh14@psu.edu

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Recruiting
        • Family Connections
        • Contact:
          • Amy Holbert

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autism Parent Navigators Intervention
Autism Parent Navigators Intervention is a manualized, in-home, peer support model for parents with a young child recently diagnosed with ASD.
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.
Active Comparator: Peer mentoring
Peer mentors will offer an equivalent number of in-home or telephone visits for families, providing non-manualized peer support.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly Count of Service Navigation Behaviors
Time Frame: 12 month
Engagement with ASD-related Services
12 month
Parenting Scale (Arnold)
Time Frame: 12 month
Parenting consistency, warmth
12 month
CES-Depression
Time Frame: 12 month
Parent depression
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coparenting Relationship Scale (Feinberg, Brown, & Kan, 2012)
Time Frame: 12 month
Coparenting Support
12 month
Family Empowerment Scale - FES
Time Frame: 12 month
Parent Efficacy regarding Service Access
12 month
PDD-BI
Time Frame: 12 month
Challenging Child Behaviors: Aggression, Non-compliance
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

University of South Carolina
Family Connections

Investigators

  • Principal Investigator: Mark Feinberg, PhD, Penn State

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APN-RT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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