Testing a Family Service Navigator Program for Low-resourced Families of Young Children With Autism Spectrum Disorder

NCT05099705 | Completed DMC

• 1 other identifier: University of Illinois
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and test a family navigator training and an app (a technology-based treatment support system) for low-resourced families of young children (aged 3-5) with autism. The hypothesis is that the navigator training and treatment support system will help enable navigators to support families of young children with autism in accessing needed services.

Conditions

Autism Spectrum Disorder; Mental Health Services

Keywords

Autism; Navigator; Services; Children; Low-resource

Outcome Measures

Primary Outcomes (8)

• Change in Knowledge at 9 months

  Called the Autism Knowledge Scale, a multi-item measure examining knowledge of autism services. There are 24 items with higher scores indicating more knowledge. Scale ranges from 0-24.

  At the pre-survey and at the nine-month survey

• Change in Skills at 9 months

  Called the Comfort with Advocacy Scale, A multi-item measure examining skills to identify, access, and receive services. There are 12 items with higher scores indicating greater advocacy. Scale ranges from 0 to 60.

  At the pre-survey and at the nine-month survey

• Change in Advocacy at 9 months

  Called the Advocacy Skills Scale, a multi-item measure examining the frequency of advocacy activities. There are nine items with higher scores indicating greater advocacy. Scale ranges from 9 to 45.

  At the pre-survey and at the nine-month survey

• Change in Empowerment at 9 months

  Called the Family Empowerment Scale, aa multi-item measure examining empowerment in family, services, and community/political environments. There are 34 items with higher scores indicating greater empowerment. Scale ranges from 0 to 136.

  At the pre-survey and at the nine-month survey

• Change in Parenting self-efficacy at 9 months

  Called the Self-Efficacy scale, a multi-item measure examining competence in parenting. There are nine items with higher scores indicating greater self-efficacy. Scale ranges from 0 to 36.

  At the pre-survey and at the nine-month survey

• Change in Service Delivery Outcomes

  Called the adapted service measure scale, access to the type, number, and quality of services and unmet service needs. There are over 20 services with higher scores indicating needing greater services. Scale ranges from 0 to 20.

  At the pre-survey and at the three-month, six-month, and nine-month survey

• Change in Adaptive and maladaptive behavior at 9 months

  Called the Vineland Adaptive Behavior Scale, a multi-item measure examining adaptive and maladaptive behavior. There are 100 items with higher scores indicating greater adaptive behavior. Scale ranges from 0 to 100.

  At the pre-survey and at the nine-month survey

• Change in Social responsiveness at 9 months

  Called the Social Responsiveness Scale, a multi-item measure to examine social responsiveness. There are sixty items with higher scores indicating greater social responsiveness. Scale ranges from 0 to 180.

  At the pre-survey and at the nine-month survey

Study Arms (2)

Intervention Group (Access to an FSN/TSS)

EXPERIMENTAL

40 participants will be randomly assigned to the intervention group (i.e., to receive an FSN and have access to the TSS). The FSN may meet with the participant at least twice and provide navigation support.

Behavioral: Access to a Family Service Navigator and Treatment Support System

Control Group (Access to Information, training and referral)

NO INTERVENTION

15 participants will be randomly assigned to the non-personalized comparison group (i.e., information, training, and referral).

Interventions

Access to a Family Service Navigator and Treatment Support System BEHAVIORAL

An RCT will be conducted. 40 participants will be randomly assigned to the intervention group and 15 participants to the non-personalized comparison group (i.e., information, training, and referral). The intervention group will have access to a navigator and the treatment support system.

Intervention Group (Access to an FSN/TSS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Be a parent who is in some way from a low-resourced community,
• Be the parent a child with autism between the ages of 3-5,
• Be age 18 or older,
• Want assistance with navigating service delivery systems,
• Be English speaking or Spanish-speaking,
• Be able to provide informed consent,
• Own a phone which can use the treatment support system (or be provided a phone from the Public Assistance Office or from the grant)
• Agree to participate in the navigator training and become an navigator,
• Be a parent who is in some way from a low-resourced community,
• Be the parent a child with autism who is older than 5,
• Be age 18 or older, Be English speaking,
• Be able to provide informed consent,
• Own a phone which can use the treatment support system (or be provided a phone from the Public Assistance Office or from the grant)

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Champaign, Illinois, 61820, United States

Location

Related Publications (3)

• Magana, S., et al., Use of promotoras de salud in interventions with Latino families of children with IDD. International Review of Research in Developmental Disabilities, 2014. 47: p. 39-75

  BACKGROUND

• Burke, M.M. and S.E. Goldman, Special education advocacy among culturally and linguistically diverse families Journal of Research in Special Educational Needs 2018. 1: p. 3-14.

  BACKGROUND

• Maas, C.J. and J.P. Hox, Sufficient sample sizes for multilevel modeling. Methodology, 2005. 1: p. 86- 92.

  BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Meghan Burke, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Later in the project, a randomized controlled trial will be conducted. 40 participants will be in the intervention group and 15 participants will be in the non-personalized comparison group (i.e., information, training, and referral). Families will complete pre/post measures related to: intervention targets (except the ability to facilitate knowledge), service delivery outcomes, adaptive and maladaptive behavior, and autism symptoms. Information will also be collected via the treatment support system; such information will include the type and frequency of communication between the navigator and the family. Individual interviews will be collected with the navigator supervisor and the 20 navigators to identify barriers to the navigator model for low-resourced families.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 29, 2021
• Study Start: July 1, 2022
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 7/2022-4/2025

Locations

US (1)