Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT05099705

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
55 (estimated)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALAccess to a Family Service Navigator and Treatment Support SystemAn 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.

Timeline

Start date
2022-07-01
Primary completion
2026-04-30
Completion
2026-04-30
First posted
2021-10-29
Last updated
2025-03-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05099705. Inclusion in this directory is not an endorsement.