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Clinical Trials/NCT05099705
NCT05099705
Completed
N/A

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

Vanderbilt University2 sites in 1 country52 target enrollmentJuly 1, 2022

Overview

Phase
N/A
Intervention
Access to a Family Service Navigator and Treatment Support System
Conditions
Autism Spectrum Disorder
Sponsor
Vanderbilt University
Enrollment
52
Locations
2
Primary Endpoint
Change in Advocacy at 9 months
Status
Completed
Last Updated
10 days ago

Overview

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.

Detailed 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).

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
April 16, 2026
Last Updated
10 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meghan Burke

Professor

Vanderbilt University

Eligibility Criteria

Inclusion 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.

Arms & Interventions

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.

Intervention: Access to a Family Service Navigator and 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).

Outcomes

Primary Outcomes

Change in Advocacy at 9 months

Time Frame: At the pre-survey and at the nine-month survey

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.

Change in Service Delivery Outcomes

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

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.

Change in Skills at 9 months

Time Frame: At the pre-survey and at the nine-month survey

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.

Change in Parenting self-efficacy at 9 months

Time Frame: At the pre-survey and at the nine-month survey

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.

Change in Adaptive and maladaptive behavior at 9 months

Time Frame: At the pre-survey and at the nine-month survey

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.

Change in Social responsiveness at 9 months

Time Frame: At the pre-survey and at the nine-month survey

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.

Change in Empowerment at 9 months

Time Frame: At the pre-survey and at the nine-month survey

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.

Change in Knowledge at 9 months

Time Frame: At the pre-survey and at the nine-month survey

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.

Study Sites (2)

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