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

Randomized Controlled Trial of the Thrive Person-Centered Planning Program for Young Adults With FASD

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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Alcohol Spectrum Disorders
• Intervention / Treatment: Behavioral: Thrive Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christie Petrenko, Ph.D.; Phone Number: 241 585-275-2991; Email: christie_petrenko@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14608
      • Recruiting
      • University of Rochester
      • Contact: Christie Petrenko, Ph.D.; Phone Number: 241 5852752991; Email: christie_petrenko@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Start Individual Format; Participants receive psychoeducation immediately followed by individual goal setting, planning, and implementation sessions.	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.
Experimental: Immediate Start Group Format; Participants receive psychoeducation immediately followed by group based goal setting sessions involving their social support network.	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.
Experimental: Delayed Start Individual Format; Participants complete a delay period prior to receiving psychoeducation followed by individual goal setting, planning, and implementation sessions.	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.
Experimental: Delayed Start Group Format; Participants complete a delay period prior to receiving psychoeducation followed by group based goal setting sessions involving their social support network.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Youth Participation in Planning Scale Participation/Voice Subscale Score	The Youth Participation in Planning Scale is a 16 item measure assessing participants' perceptions of meaningful participation in planning. Items are rated on a 5 point Likert scale from 1 Never or almost never to 5 Always or almost always. Several items were adapted to reference the participant's support network and involvement in goal setting. The Participation/Voice subscale has 8 items with scores ranging from 8 to 40. Higher scores indicate greater perceived participation in planning. This outcome measure is the change from baseline in Participation/Voice subscale score for each participant, calculated as follow up score minus baseline score.	Baseline through approximately 10 months
Change from Baseline in Youth Participation in Planning Scale Preparation to Participate Subscale Score	The Youth Participation in Planning Scale is a 16 item measure assessing participants' perceptions of meaningful participation in planning. Items are rated on a 5 point Likert scale from 1 Never or almost never to 5 Always or almost always. Several items were adapted to reference the participant's support network and involvement in goal setting. The Preparation to Participate subscale has 4 items with scores ranging from 4 to 20. Higher scores indicate greater perceived participation in planning. This outcome measure is the change from baseline in Preparation to Participate subscale score for each participant, calculated as follow up score minus baseline score.	Baseline through approximately 10 months
Change from Baseline in Youth Participation in Planning Scale Accountability Subscale Score	The Youth Participation in Planning Scale is a 16 item measure assessing participants' perceptions of meaningful participation in planning. Items are rated on a 5 point Likert scale from 1 Never or almost never to 5 Always or almost always. Several items were adapted to reference the participant's support network and involvement in goal setting. The Accountability scale consists of 4 items with scores ranging from 4 to 20. Higher scores indicate greater perceived participation in planning. This outcome measure is the change from baseline in Accountability subscale score for each participant, calculated as follow up score minus baseline score.	Baseline through approximately 10 months
Goal Attainment Scaling Rating at Follow up	Participants establish formal goals as part of the Thrive intervention. Personalized Goal Attainment Scaling is used to assess attainment of these goals on a 5 point scale with benchmarks for less than expected to more than expected goal attainment. The rating is entered at follow up visits after goal setting. Scores range from 1 to 5. Higher ratings indicate greater goal attainment.	Follow up assessments after goal setting through approximately 10 months
Change from Baseline in Theoretical Framework of Acceptability Total Score	Theoretical Framework of Acceptability is an 8 item measure assessing intervention acceptability. Each item is rated on a scale from 1 to 5, with scaling anchors varying by item. Item scores are aggregated to produce a total score (range 8 to 40), with higher scores indicating greater acceptability of the intervention. The outcome measure is the change from baseline to follow up for each participant, calculated as follow up score minus baseline score.	Post intervention assessments through approximately 10 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: June 2, 2025
• First Submitted That Met QC Criteria: June 2, 2025
• First Posted (Actual): June 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: fetal alcohol spectrum disorders; person-centered planning
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Fetal Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcohol-Induced Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fetal Alcohol Spectrum Disorders
• Other Study ID Numbers: STUDY00010579; 1R61AA030780 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No