胎儿酒精谱系疾病的年轻人以人为本的以人为本的计划计划
2026年4月25日 更新者：Christie Petrenko、University of Rochester
FASD的年轻人以人为本的以人为中心的计划计划的随机对照试验
这项研究正在测试一个名为Thrive的新程序。
该计划是针对患有胎儿酒精谱系障碍（FASD）的年轻人开发的。
Thrive采用以人为本的计划方法，这意味着它专注于对FASD年轻人最重要的事情。
年轻的成年人邀请支持他们帮助他们制定计划以实现目标的人们。
在这项研究中，我们将包括60名患有FASD的年轻人。
一半的年轻人将立即尝试繁荣计划。
另一半将在候补名单上，并将在大约8个月后开始启动该程序。
在研究期间，每个人都完成了三次在线调查。
他们在研究开始时，4个月和8个月后进行调查。
我们想知道繁荣计划是否可以帮助年轻人实现目标并在需要时获得支持。
研究概览
详细说明
此类型1的混合有效性实施试验提出了2臂并行试验RCT设计。
共有60名具有FASD的年轻人将随机分配到（1）繁发展干预措施中，或使用50:50的分配比例（2）候补名单比较组。
由于这是一项1型混合试验，测量值强调有效性结果，并收集了一些实施结果/过程，以告知随后大规模社区试验的规划。
与试点RCT设计一致，分析将重点侧重于确定干预，试验程序和测量以及干预过程的可行性。
该信息将优化计划的R01大规模RCT的成功。
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Christie Petrenko, Ph.D.
- 电话号码：241 585-275-2991
- 邮箱：christie_petrenko@urmc.rochester.edu
学习地点
-
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New York
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Rochester、New York、美国、14608
- 招聘中
- University of Rochester
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接触：
- Christie Petrenko, Ph.D.
- 电话号码：241 5852752991
- 邮箱：christie_petrenko@urmc.rochester.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
纳入标准：
- 18至25岁的年轻人
- 生活在美国
- 患有胎儿酒精谱系障碍或确认的产前酒精暴露
排除标准：
- 无法访问Internet或数据计划，允许视频会议
- 无法听或说英语
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：立即开始个人格式
参与者立即接受心理教育，随后进行个人目标设定、规划和实施环节。
|
Thrive是一种以人为中心的规划干预，分阶段实施，包括识别、心理教育、目标设定和实施。
该计划通过Zoom进行，大约12到15个会话。
参与者可以立即或在延迟后接受干预，并以个人形式或涉及他们社交网络的团体形式完成目标设定。
|
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实验性的：立即开始组格式
参与者在接受心理教育后，立即参与基于小组的目标设定会议，这些会议涉及他们的社会支持网络。
|
Thrive是一种以人为中心的规划干预，分阶段实施，包括识别、心理教育、目标设定和实施。
该计划通过Zoom进行，大约12到15个会话。
参与者可以立即或在延迟后接受干预，并以个人形式或涉及他们社交网络的团体形式完成目标设定。
|
|
实验性的：延迟启动个体格式
参与者在接受心理教育前需完成一段延迟期，随后进行个人目标设定、计划制定及实施阶段。
|
Thrive是一种以人为中心的规划干预，分阶段实施，包括识别、心理教育、目标设定和实施。
该计划通过Zoom进行，大约12到15个会话。
参与者可以立即或在延迟后接受干预，并以个人形式或涉及他们社交网络的团体形式完成目标设定。
|
|
实验性的：延迟启动组格式
参与者在接受心理教育之前完成一个延迟期，随后是与他们的社会支持网络一起进行的基于团体的目标设定会议。
|
Thrive是一种以人为中心的规划干预，分阶段实施，包括识别、心理教育、目标设定和实施。
该计划通过Zoom进行，大约12到15个会话。
参与者可以立即或在延迟后接受干预，并以个人形式或涉及他们社交网络的团体形式完成目标设定。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Goal Setting Capacity Scale Total Score
大体时间：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.
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Baseline through approximately 10 months
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Change from Baseline in Patient Measure of Collaborative Goal Setting Total Score
大体时间：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.
|
Baseline through approximately 10 months
|
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Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Autonomy Subscale Score
大体时间：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.
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Baseline through approximately 10 months
|
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Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Competence Subscale Score
大体时间：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.
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Baseline through approximately 10 months
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Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Relatedness Subscale Score
大体时间：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.
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Baseline through approximately 10 months
|
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Change from Baseline in Personal Well being Index Total Score
大体时间：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.
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Baseline through approximately 10 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Youth Participation in Planning Scale Participation/Voice Subscale Score
大体时间：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.
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Baseline through approximately 10 months
|
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Change from Baseline in Youth Participation in Planning Scale Preparation to Participate Subscale Score
大体时间：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.
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Baseline through approximately 10 months
|
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Change from Baseline in Youth Participation in Planning Scale Accountability Subscale Score
大体时间：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.
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Baseline through approximately 10 months
|
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Goal Attainment Scaling Rating at Follow up
大体时间：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.
|
Follow up assessments after goal setting through approximately 10 months
|
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Change from Baseline in Theoretical Framework of Acceptability Total Score
大体时间：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.
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Post intervention assessments through approximately 10 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月14日
初级完成 (估计的)
2028年8月31日
研究完成 (估计的)
2028年8月31日
研究注册日期
首次提交
2025年6月2日
首先提交符合 QC 标准的
2025年6月2日
首次发布 (实际的)
2025年6月11日
研究记录更新
最后更新发布 (实际的)
2026年4月30日
上次提交的符合 QC 标准的更新
2026年4月25日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.