Recruiting

Thrive Program

Sponsor:

University of Rochester

Code:

NCT07016009

Conditions

Fetal Alcohol Spectrum Disorders

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

Thrive Program

Study Details

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

Study ID

NCT07016009

Start date

Apr 14, 2026

Status verified date

Apr, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate Start Individual Format

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

experimental: Immediate Start Group Format

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

experimental: Delayed Start Individual Format

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

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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Christie Petrenko, Ph.D.

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

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14608

Contacts

Christie Petrenko, Ph.D.

5852752991christie_petrenko@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • fetal alcohol spectrum disorders
  • person-centered planning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-04-30.