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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Does not have access to the internet or data plan allowing video conferencing

Is not able to listen or speak in English

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Immediate Start Individual FormatExperimental treatment 1 intervention
Group B: Immediate Start Group FormatExperimental treatment 1 intervention
Group C: Delayed Start Individual FormatExperimental treatment 1 intervention
Group D: Delayed Start Group FormatExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline through approximately 10 months
2

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.

Time frame
Baseline through approximately 10 months
3

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.

Time frame
Baseline through approximately 10 months
4

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.

Time frame
Baseline through approximately 10 months

Secondary outcomes

1

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.

Time frame
Baseline through approximately 10 months
2

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.

Time frame
Baseline through approximately 10 months
3

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.

Time frame
Baseline through approximately 10 months
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator