Fetal Alcohol Spectrum DisordersNCT07016009
Thrive Person-Centered Planning Program for Young Adults With Fetal Alcohol Spectrum Disorders
A study testing Thrive Program in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Thrive Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Does not have access to the internet or data plan allowing video conferencing
- Is not able to listen or speak in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14608
Christie Petrenko, Ph.D., 5852752991 ext. 241, christie_petrenko@urmc.rochester.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Thrive Program
- Keywords
- fetal alcohol spectrum disorders, person-centered planning
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrive ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Start Individual Format | Experimental | Participants receive psychoeducation immediately followed by individual goal setting, planning, and implementation sessions. Receives: Behavioral: Thrive Program |
| Immediate Start Group Format | Experimental | Participants receive psychoeducation immediately followed by group based goal setting sessions involving their social support network. Receives: 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. Receives: 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. Receives: Behavioral: Thrive Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through approximately 10 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post intervention assessments through approximately 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start14 Apr 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Christie Petrenko, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016009
- Sponsor's protocol ID
- STUDY00010579
- Status last verified
- Apr 2026
- First submitted
- 2 Jun 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Thrive Person-Centered Planning Program for Young Adults With FASD
- ClinicalTrials.gov ID
- NCT07016009
- Acronym / sponsor ID
- STUDY00010579
- Conditions
- Fetal Alcohol Spectrum Disorders
- Keywords
- fetal alcohol spectrum disorders, person-centered planning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immediate Start Individual Format | Experimental | Behavioral: Thrive ProgramParticipants receive psychoeducation immediately followed by individual goal setting, planning, and implementation sessions. |
| Immediate Start Group Format | Experimental | Behavioral: Thrive ProgramParticipants receive psychoeducation immediately followed by group based goal setting sessions involving their social support network. |
| Delayed Start Individual Format | Experimental | Behavioral: Thrive ProgramParticipants complete a delay period prior to receiving psychoeducation followed by individual goal setting, planning, and implementation sessions. |
| Delayed Start Group Format | Experimental | Behavioral: Thrive ProgramParticipants complete a delay period prior to receiving psychoeducation followed by group based goal setting sessions involving their social support network. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Does not have access to the internet or data plan allowing video conferencing
- Is not able to listen or speak in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrive ProgramThrive 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. | Behavioural | Delayed Start Group Format, Delayed Start Individual Format, Immediate Start Group Format, Immediate Start Individual Format |
Primary outcome
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.
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.
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.
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.
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrive Program in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christie Petrenko, Ph.D. (585-275-2991 ext. 241, christie_petrenko@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Goal Setting Capacity Scale Total Score (time frame: Baseline through approximately 10 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.