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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
University of Rochester
Rochester, New York, United States
Group mean differences on Personal Well-being Index
Participants will complete the Personal Well-being Index (PWI) at all time-points. The PWI is a brief measure of quality of life. The 8-item measure asks how people feel about their material, physical, mental, and general well-being. The Intellectual Disability Version uses more concrete item wording and a 5-point visual scale. Ratings are summed and higher scores reflect better perceived well-being. An effect size of 0.2 is small, 0.5 is medium, and 0.8 is large.
Time frame: Baseline to 8 months
Group mean differences on Basic Psychological Need Satisfaction and Frustration Scale
Participants will complete the Basic Psychological Need Satisfaction and Frustration Scale (BPNSF) at all timepoints. The BPNSF is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5 point visual scale. Higher scores reflect greater need satisfaction.
Time frame: Baseline to 8 months
Group mean differences on Medical Outcomes Study: Social Support Survey
Participants will complete the Medical Outcomes Study: Social Support Survey (MOS-SSS) at all time-points. The MOS-SSS is a 19-item measure of perceived availability of social support including emotional, informational, tangible, positive social interaction, and affectionate sources of support. Higher scores reflect higher levels of perceived support.
Time frame: Baseline to 8 months
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