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

NCT07016009 | Recruiting

• 1 other identifier: STUDY00010579
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fetal Alcohol Spectrum Disorders

Keywords

fetal alcohol spectrum disorders; person-centered planning

Outcome Measures

Primary Outcomes (6)

• Change from Baseline in Goal Setting Capacity Scale Total Score

  The Goal Setting Capacity Scale is an 8 item scale that measures an individual's agency and capacity to set clear goals. Items are rated on a 5 point Likert scale from 1 Completely Disagree to 5 Completely Agree. Item scores are summed to produce a total score (range 8-40), with higher scores indicating greater goal setting capacity. The outcome measure is the change in total score from baseline to follow up for each participant, calculated as follow up score minus baseline score.

  Baseline through approximately 10 months

• Change from Baseline in Patient Measure of Collaborative Goal Setting Total Score

  The Patient Measure of Collaborative Goal Setting is a 37 item scale measuring the extent to which participants report collaborative goal setting across domains including listening and learning from each other, sharing ideas, caring relationship, agreement on a measurable objective, and support for goal achievement. Items are rated on a Likert scale from 1 "completely disagree" to 5 "completely agree." Items are aggregated to produce a total score (range 37 to 185), with higher scores indicating greater perceived collaborative goal setting. The outcome measure is the change in total score from baseline to follow up for each participant, calculated as follow up score minus baseline score.

  Baseline through approximately 10 months

• Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Autonomy Subscale Score

  The Basic Psychological Need Satisfaction and Frustration Scale is a 24 item scale assessing psychological need satisfaction and frustration in the domains of autonomy, competence, and relatedness. Items are rated on a 5 point Likert scale from 1 Not at all true to 5 Completely true. The autonomy subscale has 8 items with a range of 8 to 40. Higher scores indicate greater autonomy need satisfaction. This outcome measure is the change from baseline in the autonomy subscale score for each participant, calculated as follow up score minus baseline score.

  Baseline through approximately 10 months

• Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Competence Subscale Score

  The Basic Psychological Need Satisfaction and Frustration Scale is a 24 item scale assessing psychological need satisfaction and frustration in the domains of autonomy, competence, and relatedness. Items are rated on a 5 point Likert scale from 1 Not at all true to 5 Completely true. The competence subscale has 8 items with scores ranging from 8 to 40. Higher scores indicate greater competence need satisfaction. This outcome measure is the change from baseline in the competence subscale score for each participant, calculated as follow up score minus baseline score.

  Baseline through approximately 10 months

• Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Relatedness Subscale Score

  The Basic Psychological Need Satisfaction and Frustration Scale is a 24 item scale assessing psychological need satisfaction and frustration in the domains of autonomy, competence, and relatedness. Items are rated on a 5 point Likert scale from 1 Not at all true to 5 Completely true. The relatedness subscale has 8 items with scores ranging from 8 to 40. Higher scores indicate greater relatedness need satisfaction. This outcome measure is the change from baseline in the relatedness subscale score for each participant, calculated as follow up score minus baseline score.

  Baseline through approximately 10 months

• Change from Baseline in Personal Well being Index Total Score

  The Personal Well being Index Intellectual Disability Version is an 8 item measure of subjective well being and quality of life. Items assess material, physical, mental, and general well being using a 5 point pictorial scale. Item scores are summed to generate a total score (range 8 to 40), with higher scores indicating better perceived well being. The outcome measure is the change in total score from baseline to follow up for each participant, calculated as follow up score minus baseline score.

  Baseline through approximately 10 months

Secondary Outcomes (5)

• Change from Baseline in Youth Participation in Planning Scale Participation/Voice Subscale Score

  Baseline through approximately 10 months

• Change from Baseline in Youth Participation in Planning Scale Preparation to Participate Subscale Score

  Baseline through approximately 10 months

• Change from Baseline in Youth Participation in Planning Scale Accountability Subscale Score

  Baseline through approximately 10 months

• Goal Attainment Scaling Rating at Follow up

  Follow up assessments after goal setting through approximately 10 months

• Change from Baseline in Theoretical Framework of Acceptability Total Score

  Post intervention assessments through approximately 10 months

Study Arms (4)

Immediate Start Individual Format

EXPERIMENTAL

Participants receive psychoeducation immediately followed by individual goal setting, planning, and implementation sessions.

Behavioral: Thrive Program

Immediate Start Group Format

EXPERIMENTAL

Participants receive psychoeducation immediately followed by group based goal setting sessions involving their social support network.

Behavioral: Thrive Program

Delayed Start Individual Format

EXPERIMENTAL

Participants complete a delay period prior to receiving psychoeducation followed by individual goal setting, planning, and implementation sessions.

Behavioral: Thrive Program

Delayed Start Group Format

EXPERIMENTAL

Participants complete a delay period prior to receiving psychoeducation followed by group based goal setting sessions involving their social support network.

Behavioral: Thrive Program

Interventions

Thrive Program BEHAVIORAL

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.

Delayed Start Group Format; Delayed Start Individual Format; Immediate Start Group Format; Immediate Start Individual Format

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14608, United States

RECRUITING

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Christie Petrenko, Ph.D.

CONTACT

585-275-2991; christie_petrenko@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 11, 2025
• Study Start: April 14, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)