NCT07016009

Thrive Person-Centered Planning Program for Young Adults With Fetal Alcohol Spectrum Disorders

Randomized Controlled Trial of the Thrive Person-Centered Planning Program for Young Adults With FASD

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

This study is testing a new program called Thrive. The Thrive program was developed for young adults with fetal alcohol spectrum disorders (FASD). Thrive uses a person-centered planning approach, which means it focuses on what is most important to the young adult with FASD. The young adult invites people that support them to help them make plans to meet their goals. 60 young adults with FASD will participate in this study. Half of the young adults will try out the Thrive program immediately. The other half will be on a waitlist and will get to start the program about 8 months later. Everyone completes online surveys at three times during the study. They do surveys at the beginning of the study, after 4 months, and after 8 months. The goal of the study is to test if the Thrive program helps young adults meet their goals and get support when they need it.

Detailed description

This type 1 hybrid effectiveness-implementation trial proposes a 2-arm parallel pilot RCT design. A total of 60 young adults with FASD will be randomly assigned into the (1) Thrive intervention or the (2) waitlist comparison group using a 50:50 allocation ratio. As this is a type 1 hybrid trial, measurement emphasizes effectiveness outcomes, with collection of some implementation outcomes/process to inform planning of subsequent larger scale community trials. Consistent with the pilot RCT design, analysis will focus on determining feasibility of the intervention, trial procedures and measurement, and intervention process. This information will optimize success of the planned R01 larger-scale RCT.

Conditions

• Fetal Alcohol Spectrum Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Thrive Program	Thrive is a person-centered planning intervention that is based on self-determination theory and integrates elements of social network interventions. The proposed Thrive intervention has four phases: 1) Strengths \& Network Assessment, 2) Network Engagement, 3) Goal Setting \& Planning, and 4) Plan Implementation \& Monitoring. It involves about 10-13 sessions and is delivered by a trained facilitator over Zoom.

Timeline

• Start date: 2026-03-30
• Primary completion: 2028-08-31
• Completion: 2028-08-31
• First posted: 2025-06-11
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States