Clinical trial NCT05099705: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Mental Health Services
Keywords: Autism
Navigator
Services
Children
Low-resource
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: Change in Knowledge at 9 months
timeFrame: At the pre-survey and at the nine-month survey
measure: Change in Skills at 9 months
timeFrame: At the pre-survey and at the nine-month survey
measure: Change in Advocacy at 9 months
timeFrame: At the pre-survey and at the nine-month survey
measure: Change in Empowerment at 9 months
timeFrame: At the pre-survey and at the nine-month survey
measure: Change in Parenting self-efficacy at 9 months
timeFrame: At the pre-survey and at the nine-month survey
measure: Change in Service Delivery Outcomes
timeFrame: At the pre-survey and at the three-month, six-month, and nine-month survey
measure: Change in Adaptive and maladaptive behavior at 9 months
timeFrame: At the pre-survey and at the nine-month survey
measure: Change in Social responsiveness at 9 months
timeFrame: At the pre-survey and at the nine-month survey
Secondary outcomes:
Other outcomes:
Locations:
city: Champaign
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: Vanderbilt University
name: Meghan Burke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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
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.
citation: Maas, C.J. and J.P. Hox, Sufficient sample sizes for multilevel modeling. Methodology, 2005. 1: p. 86- 92.