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

NCT ID: NCT05099705

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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The purpose of this project is to determine whether access to a family service navigator/treatment support system improves outcomes among families of young children (aged 3-5) from low-resourced communities. Pilot work includes interviews and pre/post surveys. Then, a randomized controlled trial will be conducted by randomly assigning families to navigators/treatment support systems or the non-personalized comparison condition (information, training, and referral services). Three-month, six-month, and nine-month follow-up survey data will be collected. Each of the 20 navigators will support two families. Intervention families will have access to the navigator and the treatment support system, which includes a dashboard showing their child's service needs, resources, and a platform to facilitate and document communication between navigators and families. The treatment support system will also allow the navigator supervisor to ensure fidelity of the navigators' support to the family. The statistician will randomize 55 families who meet the inclusionary criteria to each condition--40 individuals will receive navigator/treatment support system (intervention group) and 15 individuals will receive information, training, and referrals (comparison group).

Conditions

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Autism Spectrum Disorder Mental Health Services

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Group (Access to an FSN/TSS)

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.

Group Type EXPERIMENTAL

Access to a Family Service Navigator and Treatment Support System

Intervention Type 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.

Control Group (Access to Information, training and referral)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Access to a Family Service Navigator and Treatment Support System

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Meghan Burke

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meghan Burke, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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University of Illinois at Urbana-Champaign

Champaign, Illinois, United States

Site Status

Countries

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United States

References

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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

Reference Type 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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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University of Illinois

Identifier Type: -

Identifier Source: org_study_id

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