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Recruiting Not applicable NCT07016009

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

No applicable phase (e.g. observational)
Conditions: Fetal Alcohol Spectrum Disorders

Sponsor: University of Rochester

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Overview
This study evaluates the Thrive person centered planning program for young adults with fetal alcohol spectrum disorders. Participants are randomized to either an immediate start or delayed start group for the psychoeducation phase. Following this phase, participants are randomized again to receive the intervention in either an individual or group based format. Participants complete repeated online assessments at multiple timepoints over approximately 10 months to evaluate whether the program improves goal setting, social support, and quality of life.
Description
This study is a randomized, multi stage trial with two sequential randomization timepoints. At baseline, participants are randomized to either an immediate start psychoeducation group or a delayed start group. After completion of the psychoeducation phase, participants undergo a second randomization to receive the intervention in either an individual or group based goal setting format. This results in four study arms representing combinations of intervention timing and delivery format. Participants complete repeated assessments at multiple timepoints over approximately 10 months to evaluate effectiveness, goal setting format differences, and maintenance of outcomes.
Who can participate
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
Interventions
Thrive Program
BEHAVIORAL
Locations 1
United States (1)
University of Rochester
Rochester , New York
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
25 Years
Healthy volunteers
No
Start date
14.04.2026
Completion date
31.08.2028
Registry ID
NCT07016009
Source
clinicaltrials.gov
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