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NCT Number: NCT07016009

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

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14608, United States

Location status: Recruiting

Location contact

Christie Petrenko, Ph.D.

CONTACT

[email protected]

5852752991 ext. 241

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from Baseline in Goal Setting Capacity Scale Total Score

    Time frame: Baseline through approximately 10 months

    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.

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

    Time frame: Baseline through approximately 10 months

    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.

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

    Time frame: Baseline through approximately 10 months

    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.

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

    Time frame: Baseline through approximately 10 months

    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.

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

    Time frame: Baseline through approximately 10 months

    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.

  6. Change from Baseline in Personal Well being Index Total Score

    Time frame: Baseline through approximately 10 months

    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.

Secondary outcomes

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

    Time frame: Baseline through approximately 10 months

    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.

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

    Time frame: Baseline through approximately 10 months

    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.

  3. Change from Baseline in Youth Participation in Planning Scale Accountability Subscale Score

    Time frame: Baseline through approximately 10 months

    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.

  4. Goal Attainment Scaling Rating at Follow up

    Time frame: Follow up assessments after goal setting through approximately 10 months

    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.

  5. Change from Baseline in Theoretical Framework of Acceptability Total Score

    Time frame: Post intervention assessments through approximately 10 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christie Petrenko, Ph.D.

CONTACT

[email protected]

585-275-2991 ext. 241

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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