APN: Trial of Autism Parent Navigator Program

Sponsor
Penn State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04744428
Collaborator
University of South Carolina (Other), Family Connections (Other)
360
1
2
51.2
7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Autism Parent Navigators
  • Behavioral: Peer mentoring
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Test of an Innovative, Scalable Support Program for Parents With a Young Child Recently Diagnosed With Autism Spectrum Disorder
Actual Study Start Date :
Mar 25, 2021
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Weekly Count of Service Navigation Behaviors [12 month]

    Engagement with ASD-related Services

  2. Parenting Scale (Arnold) [12 month]

    Parenting consistency, warmth

  3. CES-Depression [12 month]

    Parent depression

Secondary Outcome Measures

  1. Coparenting Relationship Scale (Feinberg, Brown, & Kan, 2012) [12 month]

    Coparenting Support

  2. Family Empowerment Scale - FES [12 month]

    Parent Efficacy regarding Service Access

  3. PDD-BI [12 month]

    Challenging Child Behaviors: Aggression, Non-compliance

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Family Connections Columbia South Carolina United States 29204

Sponsors and Collaborators

  • Penn State University
  • University of South Carolina
  • Family Connections

Investigators

  • Principal Investigator: Mark Feinberg, PhD, Penn State

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark Feinberg, Research Professor, Feinberg, Mark, Ph.D.
ClinicalTrials.gov Identifier:
NCT04744428
Other Study ID Numbers:
  • APN-RT01
First Posted:
Feb 9, 2021
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022