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

Vanderbilt University

Status: Active, not recruiting

Conditions: Autism Spectrum Disorder; Mental Health Services

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05099705

University of Illinois

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For the families in the clinical trial, there are the following inclusion and exclusion criteria:

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)

Exclusion criteria:

-Individuals who do not meet all inclusion criteria are by definition excluded.

For the navigators in the clinical trial, they must meet inclusion and exclusion criteria:

Inclusion Criteria:

• 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)

Exclusion criteria:

-Individuals who do not meet all inclusion criteria are by definition excluded.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Intervention Group (Access to an FSN/TSS)

Experimental group

Description:

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.

Treatment:

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

Control Group (Access to Information, training and referral)

No Intervention group

Description:

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