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

Primary Purpose

Autism Spectrum Disorder, Mental Health Services

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Access to a Family Service Navigator and Treatment Support System

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder focused on measuring Autism, Navigator, Services, Children, Low-resource

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Illinois at Urbana-ChampaignRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group (Access to an FSN/TSS)

Control Group (Access to Information, training and referral)

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05099705

First Posted

October 4, 2021

Last Updated

October 27, 2022

Sponsor

University of Illinois at Urbana-Champaign

1. Study Identification

Unique Protocol Identification Number

NCT05099705

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder, Mental Health Services

Keywords

Autism, Navigator, Services, Children, Low-resource

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group (Access to an FSN/TSS)

Arm Type

Experimental

Arm Description

Arm Title

Control Group (Access to Information, training and referral)

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Access to a Family Service Navigator and Treatment Support System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Knowledge at 9 months

Description

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.

Time Frame

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

Title

Change in Skills at 9 months

Description

Time Frame

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

Title

Change in Advocacy at 9 months

Description

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.

Time Frame

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

Title

Change in Empowerment at 9 months

Description

Time Frame

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

Title

Change in Parenting self-efficacy at 9 months

Description

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.

Time Frame

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

Title

Change in Service Delivery Outcomes

Description

Time Frame

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

Title

Change in Adaptive and maladaptive behavior at 9 months

Description

Time Frame

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

Title

Change in Social responsiveness at 9 months

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meghan Burke, PhD

Phone

217-300-1266

meghanbm@illinois.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine Cheung, PhD

Phone

4123276783

wcheung3@illinois.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meghan Burke, PhD

Organizational Affiliation

University of Illinois at Urbana-Champaign

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Illinois at Urbana-Champaign

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meghan M Burke

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Sharing of data generated by this project will be an important part of the proposed activities of this research and will be carried out in several ways. All research resources developed in this project will be made readily available to the scientific community for non-profit research purposes. The main mechanism for the transfer of information will take the form of peer-reviewed publications and presentations/posters at scientific conferences. Information is collected from participants upon enrollment will be generated to a Global Unique Identifier. Annual reports with de-identified information will be presented to National Institute of Mental Health annually and more often upon request. By the completion of the project, all data will be de-identified and relevant documentation to facilitate data sharing will be available.

IPD Sharing Time Frame

7/2022-12/2023

Citations:

Citation

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

Results Reference

background

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

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

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