NCT04744428

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Mar 2021Jun 2026

First Submitted

Initial submission to the registry

April 9, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

April 9, 2020

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Weekly Count of Service Navigation Behaviors

    Engagement with ASD-related Services

    12 month

  • Parenting Scale (Arnold)

    Parenting consistency, warmth

    12 month

  • CES-Depression

    Parent depression

    12 month

Secondary Outcomes (3)

  • Coparenting Relationship Scale (Feinberg, Brown, & Kan, 2012)

    12 month

  • Family Empowerment Scale - FES

    12 month

  • PDD-BI

    12 month

Study Arms (2)

Autism Parent Navigators Intervention

EXPERIMENTAL

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

Peer mentoring

ACTIVE COMPARATOR

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

Behavioral: Peer mentoring

Interventions

The Autism Parent Navigator program consists of six sessions delivered to parents in the home, supporting adjustment to ASD, accessing services, and coparenting support.

Autism Parent Navigators Intervention
Peer mentoringBEHAVIORAL

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.

Peer mentoring

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC

Columbia, South Carolina, 29204, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mark Feinberg, PhD

    Penn State

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

April 9, 2020

First Posted

February 9, 2021

Study Start

March 25, 2021

Primary Completion

March 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations