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Trial of Autism Parent Navigator Program (APN)

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autism Parent Navigators
Peer mentoring
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Family ConnectionsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Autism Parent Navigators Intervention

Peer mentoring

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weekly Count of Service Navigation Behaviors
Engagement with ASD-related Services
Parenting Scale (Arnold)
Parenting consistency, warmth
CES-Depression
Parent depression

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2020
Last Updated
July 5, 2022
Sponsor
Penn State University
Collaborators
University of South Carolina, Family Connections
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1. Study Identification

Unique Protocol Identification Number
NCT04744428
Brief Title
Trial of Autism Parent Navigator Program
Acronym
APN
Official Title
Test of an Innovative, Scalable Support Program for Parents With a Young Child Recently Diagnosed With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
University of South Carolina, Family Connections

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autism Parent Navigators Intervention
Arm Type
Experimental
Arm Description
Autism Parent Navigators Intervention is a manualized, in-home, peer support model for parents with a young child recently diagnosed with ASD.
Arm Title
Peer mentoring
Arm Type
Active Comparator
Arm Description
Peer mentors will offer an equivalent number of in-home or telephone visits for families, providing non-manualized peer support.
Intervention Type
Behavioral
Intervention Name(s)
Autism Parent Navigators
Intervention Description
The Autism Parent Navigator program consists of six sessions delivered to parents in the home, supporting adjustment to ASD, accessing services, and coparenting support.
Intervention Type
Behavioral
Intervention Name(s)
Peer mentoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weekly Count of Service Navigation Behaviors
Description
Engagement with ASD-related Services
Time Frame
12 month
Title
Parenting Scale (Arnold)
Description
Parenting consistency, warmth
Time Frame
12 month
Title
CES-Depression
Description
Parent depression
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Coparenting Relationship Scale (Feinberg, Brown, & Kan, 2012)
Description
Coparenting Support
Time Frame
12 month
Title
Family Empowerment Scale - FES
Description
Parent Efficacy regarding Service Access
Time Frame
12 month
Title
PDD-BI
Description
Challenging Child Behaviors: Aggression, Non-compliance
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Hostetler, PhD
Phone
8144043166
Email
mxh14@psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Feinberg, PhD
Email
mef11@psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Feinberg, PhD
Organizational Affiliation
Penn State
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Connections
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Holbert

12. IPD Sharing Statement

Plan to Share IPD
No

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Trial of Autism Parent Navigator Program

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