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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05099705
• Other study ID #: University of Illinois
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Vanderbilt University
• Contact: Meghan Burke, PhD
• Phone: 615-585-1420
• Email: meghan.burke[@]vanderbilt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Mental Health Services

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Champaign	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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