Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation (RT-PWS)
2026年8月31日 更新者：Walker McKinney、Children's Mercy Hospital Kansas City
Adapting a Group Intervention for Emotion Dysregulation in Prader-Willi Syndrome
The goal of this study is to help teens with Prader-Willi Syndrome (PWS) and their families learn practical strategies for managing issues like irritability, meltdowns, and anxiety. The main objective of the study is:
To adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in Prader-Willi Syndrome (PWS) that will improve psychosocial outcomes for youth with PWS.
研究概览
详细说明
Up to ten children with Prader-Willi Syndrome (PWS) ages 13 to 17.5 years and their caregivers will be enrolled in the study. This study is being done to develop and test a behavior therapy to help teenagers with PWS calm their emotions. Participants will complete assessments at five time points:
Screening (T1); Week 0: Baseline visit (T2); Week 5: Post Active Treatment (T3); Week 10: 5 week follow-up (T4); and Week 15: 10 week follow-up (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.
研究类型
介入性
注册 (估计的)
10
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：Grayson Manley, RN
- 电话号码：816-816-6967
- 邮箱：gmanley@cmh.edu
学习地点
-
-
Missouri
-
Kansas City、Missouri、美国、64108
- 招聘中
- Children's Mercy
-
接触：
- Grayson Manley, RN
- 电话号码：816-816-6967
- 邮箱：gmanley@cmh.edu
-
接触：
- Walker McKinney, PhD
- 电话号码：816-234-3656
- 邮箱：wsmckinney@cmh.edu
-
首席研究员：
- Walker McKinney, PhD
-
-
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
- 孩子
接受健康志愿者
不
描述
Child Participant Inclusion Criteria:
- Ages 13-17.5 years
- Confirmed genetic diagnosis of Prader-Willi Syndrome
- Fluent in spoken English
- Adolescent's use of flexible phrase speech or greater
- Meeting clinically significant emotional dysregulation criteria
- Willing to participate in weekly 90-minute group sessions
- Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable
- Parent, guardian, or legally authorized representative must provide written permission on behalf of the participant
Child Participant Exclusion Criteria:
- Initiation of new psychosocial intervention within 30 days prior to first day of treatment
- Presence of physical aggression in the adolescent directed towards a peer outside the home that resulted in injury within 30 days prior to screening
- Presence of comorbid major neuropsychiatric illness warranting other treatment approaches
- Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Caregiver Inclusion Criteria:
- Age ≥ 18 years
- Lives and cares for their child with PWS for > 50% of the year
- Fluent in spoken English
- Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly
Caregiver Exclusion Criteria:
-Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Teens with Prader-Willi Syndrome and their caregiver
Participants will receive Regulating Together - the emotion dysregulation intervention
|
Regulating Together is the original curriculum developed for autistic youth that uses evidence-based therapeutic strategies including relaxation techniques, parent management training, and mindfulness to help regulate emotions.
This study will adapt the original Regulating Together curriculum to focus on behavioral interventions to treat emotion dysregulation in Prader-Willi Syndrome.
|
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 |
|---|---|---|
|
Emotion Dysregulation Inventory - Reactivity
大体时间：From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
The Emotion Dysregulation Inventory consists of two subscales.
We will use the Reactivity subscale which captures poorly regulated negative emotional responses and a dysphoria subscale characterized by increased negative affect and lack of motivation.
Minimum raw score: 0; Maximum raw score: 96; Higher scores reflect higher emotional reactivity.
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Caregiver and Adolescent Readiness and Satisfaction Surveys
大体时间：From enrollment to end of follow up at 15 weeks
|
We will assess acceptability as reflected in the average caregiver and adolescent satisfaction rating measured using two study-specific measures.
Caregivers will complete the Caregiver Readiness and Satisfaction Survey (CRS) and adolescents will complete the Adolescent Readiness and Satisfaction Survey (ARS).
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From enrollment to end of follow up at 15 weeks
|
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Clinician Global Impressions - Improvement (CGI-I)
大体时间：From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
A trained, independent clinician will rate the CGI at T3 and T5.
The CGI-I provides a qualitative measure of treatment response through a rating from 1=very much improved to 7=very much worse.
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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Emotion Regulation Skills Test
大体时间：From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)
大体时间：From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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Caregiver-report measures to measure change in internalizing symptoms.
For both measures: minimum raw value: 13; maximum raw value: 65; higher scores reflect greater anxiety/depression
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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Aberrant Behavior Checklist, 2nd Edition (ABC-2)
大体时间：From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
Irritability subscale; a caregiver-report measures to measure change in irritability and related challenging behaviors.
Minimum score: 0; Maximum score: 45; higher scores reflect greater irritability
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Parenting Stress Index, 4th Edition, Short Form
大体时间：From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
A caregiver-report questionnaire measuring the magnitude of stress in the parent-child system.
Minimum score: 36; Maximum score: 180; Higher scores reflect greater parental stress
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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。
调查人员
- 首席研究员：Walker McKinney, PhD、Children's Mercy
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (估计的)
2027年1月1日
初级完成 (估计的)
2027年9月1日
研究完成 (估计的)
2027年11月1日
研究注册日期
首次提交
2026年5月19日
首先提交符合 QC 标准的
2026年5月19日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年9月2日
上次提交的符合 QC 标准的更新
2026年8月31日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00004042
- 1568503 (其他赠款/资助编号：Foundation for Prader-Willi Research)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Risk for participant identification due to small sample and narrow geographic area
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.