Thrive Person-Centered Planning Program for Young Adults With Fetal Alcohol Spectrum Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thrive Program.
- Who it may be relevant to
- Registry conditions: Fetal Alcohol Spectrum Disorders. Basic parameters: 18 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial of the Thrive Person-Centered Planning Program for Young Adults With FASD
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.
Detailed 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.
Interventions
- Behavioral Thrive Program
Thrive is a person centered planning intervention delivered in stages including identification, psychoeducation, goal setting, and implementation. The program is delivered via Zoom over approximately 12 to 15 sessions. Participants may receive the intervention immediately or after a delay and complete goal setting in either an individual format or a group format involving their social network.
Primary outcome measures
- Change from Baseline in Goal Setting Capacity Scale Total Score [Time frame: Baseline through approximately 10 months]
- Change from Baseline in Patient Measure of Collaborative Goal Setting Total Score [Time frame: Baseline through approximately 10 months]
- Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Autonomy Subscale Score [Time frame: Baseline through approximately 10 months]
- Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Competence Subscale Score [Time frame: Baseline through approximately 10 months]
- Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Relatedness Subscale Score [Time frame: Baseline through approximately 10 months]
- Change from Baseline in Personal Well being Index Total Score [Time frame: Baseline through approximately 10 months]
Secondary outcome measures (5)
- Change from Baseline in Youth Participation in Planning Scale Participation/Voice Subscale Score [Time frame: Baseline through approximately 10 months]
- Change from Baseline in Youth Participation in Planning Scale Preparation to Participate Subscale Score [Time frame: Baseline through approximately 10 months]
- Change from Baseline in Youth Participation in Planning Scale Accountability Subscale Score [Time frame: Baseline through approximately 10 months]
- Goal Attainment Scaling Rating at Follow up [Time frame: Follow up assessments after goal setting through approximately 10 months]
- Change from Baseline in Theoretical Framework of Acceptability Total Score [Time frame: Post intervention assessments through approximately 10 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Rochester — Rochester
Identifiers
NCT: NCT07016009 · STUDY00010579