Clinical trial NCT07016009: Thrive Person-Centered Planning Program for Young Adults With Fetal Alcohol Spectrum Disorders
Official title: Randomized Controlled Trial of the Thrive Person-Centered Planning Program for Young Adults With FASD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Keywords: fetal alcohol spectrum disorders
person-centered planning
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Young adult between the ages of 18 and 25
* Lives in the United States
* Has a diagnosis of fetal alcohol spectrum disorder or confirmed prenatal alcohol exposure

Exclusion Criteria:

* Does not have access to the internet or data plan allowing video conferencing
* Is not able to listen or speak in English

Primary outcomes:
measure: Group mean differences on Personal Well-being Index
timeFrame: Baseline to 8 months
measure: Group mean differences on Basic Psychological Need Satisfaction and Frustration Scale
timeFrame: Baseline to 8 months
measure: Group mean differences on Medical Outcomes Study: Social Support Survey
timeFrame: Baseline to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: