Randomized Controlled Trial of the Thrive Person-Centered Planning Program for Young Adults With FASD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in Goal Setting Capacity Scale Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Does not have access to the internet or data plan allowing video conferencing
- •Is not able to listen or speak in English
研究组 & 干预措施
Immediate Start Individual Format
Participants receive psychoeducation immediately followed by individual goal setting, planning, and implementation sessions.
干预措施: Thrive Program (Behavioral)
Immediate Start Group Format
Participants receive psychoeducation immediately followed by group based goal setting sessions involving their social support network.
干预措施: Thrive Program (Behavioral)
Delayed Start Individual Format
Participants complete a delay period prior to receiving psychoeducation followed by individual goal setting, planning, and implementation sessions.
干预措施: Thrive Program (Behavioral)
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.
干预措施: Thrive Program (Behavioral)
结局指标
主要结局
Change from Baseline in Goal Setting Capacity Scale Total Score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Group mean differences on Personal Well-being Index
时间窗: Baseline to 8 months
Participants will complete the Personal Well-being Index (PWI) at all time-points. The PWI is a brief measure of quality of life. The 8-item measure asks how people feel about their material, physical, mental, and general well-being. The Intellectual Disability Version uses more concrete item wording and a 5-point visual scale. Ratings are summed and higher scores reflect better perceived well-being. An effect size of 0.2 is small, 0.5 is medium, and 0.8 is large.
Group mean differences on Basic Psychological Need Satisfaction and Frustration Scale
时间窗: Baseline to 8 months
Participants will complete the Basic Psychological Need Satisfaction and Frustration Scale (BPNSF) at all timepoints. The BPNSF is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5 point visual scale. Higher scores reflect greater need satisfaction.
Group mean differences on Medical Outcomes Study: Social Support Survey
时间窗: Baseline to 8 months
Participants will complete the Medical Outcomes Study: Social Support Survey (MOS-SSS) at all time-points. The MOS-SSS is a 19-item measure of perceived availability of social support including emotional, informational, tangible, positive social interaction, and affectionate sources of support. Higher scores reflect higher levels of perceived support.
次要结局
- Change from Baseline in Youth Participation in Planning Scale Subscale 1 Score(Baseline through approximately 10 months)
- Change from Baseline in Youth Participation in Planning Scale Subscale 2 Score(Baseline through approximately 10 months)
- Change from Baseline in Youth Participation in Planning Scale Subscale 3 Score(Baseline through approximately 10 months)
- Goal Attainment Scaling Rating at Follow up(Follow up assessments after goal setting through approximately 10 months)
- Change from Baseline in Theoretical Framework of Acceptability Total Score(Post intervention assessments through approximately 10 months)
- Change from Baseline in Youth Participation in Planning Scale Participation/Voice Subscale Score(Baseline through approximately 10 months)
- Change from Baseline in Youth Participation in Planning Scale Preparation to Participate Subscale Score(Baseline through approximately 10 months)
- Change from Baseline in Youth Participation in Planning Scale Accountability Subscale Score(Baseline through approximately 10 months)
研究者
Christie Petrenko
Research Associate Professor
University of Rochester