针对儿童自伤性思维和行为（SITBs）的情绪调节和执行功能干预措施试点试验
2026年7月27日 更新者：University of Colorado, Denver
针对儿童自伤与自杀相关行为（SITBs）的情绪调节与执行功能干预的概念验证试验
本研究旨在为具有自伤想法和行为（SITBs）的青春期前儿童（7-12岁）开发和测试一种门诊干预措施。
研究主要试图回答以下问题：
- 与常规治疗（TAU）相比，新型干预措施是否能更好地促进家庭参与治疗？
- 新型干预措施是否具有可行性、可接受性和适用性？
- 与常规治疗相比，新型干预措施是否能在SITBs、心理健康症状和治疗目标方面带来更多改善？
具有SITBs的青春期前儿童参与者及其家庭将被随机分配接受新型干预或常规治疗，后者将包括研究治疗师通常用于具有SITBs的青春期前儿童的典型干预措施。参与者将：
- 完成初始基线评估，以确定资格并评估SITBs、心理健康症状、执行功能和情绪调节能力
- 参与约每周一次的门诊干预，持续约3-4个月
- 在治疗中期、治疗后和3个月随访时完成额外评估
- 参与访谈，分享他们对干预措施的看法
研究概览
详细说明
在研究的第一阶段（目标1），研究人员将通过使用系统开发和调整干预措施的框架（Wingood等人，2008年；Bartholomew等人，1998年）的逐步过程，迭代设计针对青春期前自伤行为的干预措施。设计过程将融入以用户为中心的设计方法，多部门专家和最终用户（即治疗师和家庭）将参与设计过程，以最大化干预措施的传播和实施潜力。在研究的第二阶段（目标2和3），研究人员将对52名7-12岁的青春期前儿童进行干预的试点随机对照试验（RCT），以常规治疗（TAU）作为对照。目标2将评估干预措施和研究程序的参与度（主要结果）、可行性、可接受性和实施结果。目标3将收集初步证据，探索自伤行为干预措施在减少自伤行为和激活目标机制（执行功能和情绪调节）方面相对于常规治疗的优越性。
在第一阶段，研究人员将使用混合方法和以用户为中心的设计原则，迭代开发青春期前自伤行为干预措施。通过需求评估，研究人员将采用探索性顺序定性→定量混合方法设计，其中对治疗师的定性访谈将指导开发定量调查，评估治疗师在治疗青春期前自伤行为患者时的需求和经验。治疗师评估的结果将与青春期前儿童和照顾者的定性访谈结果整合，进一步为干预措施核心功能和具体组成部分的初步决策提供信息。在采用并行混合方法的预测试阶段，治疗师和青春期前儿童/家庭将参与出声思考设计会议，提供关于干预措施粗略原型的定量和定性反馈。然后，将生成干预措施的初稿，并由专家小组审查，形成干预措施的第二稿以及治疗师培训和咨询程序。对9名青春期前儿童进行的单臂试点可行性试验（ADAPT-ITT步骤8，第1部分）将为干预措施、治疗师培训和试验程序的调整提供信息。
第二阶段将涉及培训治疗师使用干预措施，采用在试点试验中完善的程序材料，随后对52名青春期前儿童进行以常规治疗为对照条件的随机对照试验（ADAPT-ITT步骤8，第2部分）。该试验将具备检测条件间参与度差异（主要结果）并确定可行性和可接受性的统计效力，同时评估初步疗效结果和执行功能变化机制。
研究类型
介入性
注册 (估计的)
52
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。
学习地点
-
-
Colorado
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Aurora、Colorado、美国、80045
- Children's Hospital Colorado
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接触：
- Sarah Kennedy, PhD
- 电话号码：303-724-6458
- 邮箱：sarah.kennedy@cuanschutz.edu
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首席研究员：
- Sarah M Kennedy, 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
入选标准：
- 年龄在7-12岁之间
- 至少有一名看护人/法定监护人能够参与（允许多名）
- 在过去一个月内至少经历过一次自伤相关行为（SITBs）
- 能够每周亲自或通过远程医疗参加会话
- 能够亲自参加基线和12周评估
- 预估言语智商为70或更高
排除标准
- 症状影响参与评估/治疗的能力（例如，精神病）
- 预估言语智商<70或先前诊断为智力发育障碍
- 需要住院精神科稳定或高强度干预以防止住院
- 活跃的物质使用
- 国家监护对象
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：非随机化
- 介入模型：顺序分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：青春期前自伤自杀行为干预
针对执行功能、情绪调节及其他SITB风险因素的青春期前SITBs实验性干预
|
与终端用户及专家共同开发，针对青春期前儿童情绪调节、执行功能及其他自伤/自杀相关行为风险因素的实验性干预方案
|
|
有源比较器：常规治疗（TAU）
门诊心理健康治疗师提供的常规治疗
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门诊治疗师根据其临床判断，为有自伤与自杀相关行为（SITBs）的青春期前儿童提供的典型干预措施
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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 |
|---|---|---|
|
Feasibility of recruitment
大体时间：Calculated at enrollment
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% recruitment targets met (benchmark = 52 preadolescents enrolled within 13 months)
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Calculated at enrollment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Suicidal Ideation Intensity
大体时间：From enrollment to 3-month follow-up at 20 weeks
|
Measured using the Columbia Suicide and Self Injury Severity Rating Scale (C-SSRS; Posner et al., 2011), a brief interview that consists of sections that assess: suicidal ideation, ideation intensity, and suicidal behavior.
The C-SSRS has strong convergent validity, sensitivity to change, predictive and incremental validity, and good internal consistency.
|
From enrollment to 3-month follow-up at 20 weeks
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Feasibility of Retention
大体时间：From enrollment to the end of treatment at 8 weeks
|
% participants completing treatment (benchmark =≥ 80% participants considered treatment completers)
|
From enrollment to the end of treatment at 8 weeks
|
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Perceived Appropriateness of Intervention
大体时间：From enrollment to the end of treatment at 8 weeks
|
The Intervention Appropriateness Measure (IAM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists.
The IAM is a 4-item measure assessing the extent to which stakeholders believe an intervention or to be appropriate.
Items are rated from 1 ("completely disagree") to 5 ("completely agree"), with higher scores indicating greater appropriateness.
The appropriateness benchmark for all reporters is set at a mean score of 4 or greater.
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From enrollment to the end of treatment at 8 weeks
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Perceived Feasibility of Intervention
大体时间：From enrollment to the end of treatment at 8 weeks
|
The Feasibility of Intervention Measure (FIM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists.
The FIM is a 4-item measures assessing the extent to which stakeholders believe an intervention to be feasible.
Items are rated from 1 ("completely disagree") to 5 ("completely agree"), with higher scores indicating greater feasibility.
The feasibility benchmark for all reporters is set at a mean score of 4 or greater.
|
From enrollment to the end of treatment at 8 weeks
|
|
Perceived acceptability of intervention
大体时间：From enrollment to the end of treatment at 8 weeks
|
The Acceptability of Intervention Measure (AIM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists.
The AIM is a 4-item measure assessing the extent to which stakeholders believe an intervention to be acceptable.
Items are rated from 1 ("completely disagree") to 5 ("completely agree"), with higher scores indicating greater acceptability.
The acceptability benchmark for all reporters is set at a mean score of 4 or greater.
|
From enrollment to the end of treatment at 8 weeks
|
|
Treatment Engagement
大体时间：From enrollment to post-treatment at 8 weeks
|
Number of treatment sessions completed at post-treatment, compared to prescribed or recommended number of sessions
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From enrollment to post-treatment at 8 weeks
|
|
Readmission/Admission Rates
大体时间：From enrollment to 3-month follow-up at 8 weeks
|
Readmission/admission rates to the psychiatric ED or inpatient psychiatric hospitalization will be evaluated via caregiver report on the Brief form of the Services Assessment for Children and Adolescents (SACA; Horwitz et al., 2001), which will be supplemented with chart review.
|
From enrollment to 3-month follow-up at 8 weeks
|
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Feasibility of Measurement
大体时间：From enrollment to follow-up at 20 weeks
|
% participants at each timepoint completing measures (target = ≥ 80% at each timepoint).
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From enrollment to follow-up at 20 weeks
|
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Non-Suicidal Self-Injury
大体时间：From enrollment to 3-month follow-up at 20 weeks
|
Measured using an adapted version of the Self-Injurious Thoughts and Behaviors Interview (SITBI)-Short Form, Thoughts of NSSI and NSSI subscales (Nock et al., 2007), which assesses history and characteristics of NSSI thoughts and behaviors.
First instance of engagement in NSSI after beginning treatment will be the outcome of most interest, but other outcomes assessed by the interview (e.g., frequency of NSSI thoughts) may be examined as well if rates of NSSI are very low.
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From enrollment to 3-month follow-up at 20 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Anxiety Symptoms
大体时间：From enrollment to 3-month follow-up at 20 weeks
|
We will measure anxiety using the Revised Child Anxiety and Depression Scale (RCADS)-Short Version (Ebesutani et al., 2012; 2017), which is a 25-item measure of depression and anxiety symptoms that includes both parent-and self-report measures.
Both versions are rated on a 5-point Likert scale, with higher scores indicating greater frequency of anxiety symptoms.
Anxiety items are summed to yield a raw score, which is then converted to a t-score.
The measure has good psychometric properties and treatment sensitivity (Ebesutani et al., 2012; 2017).
|
From enrollment to 3-month follow-up at 20 weeks
|
|
Depression Symptoms
大体时间：From enrollment to 3-month follow-up at 20 weeks
|
We will measure depression using the Revised Child Anxiety and Depression Scale (RCADS)-Short Version (Ebesutani et al., 2012; 2017), which is a 25-item measure of depression and anxiety symptoms that includes both parent-and self-report measures.
Both versions are rated on a 5-point Likert scale, with higher scores indicating greater frequency of depression symptoms.
Depression items are summed to yield a total raw score, which is then converted to a t-score.
The measure has good psychometric properties and treatment sensitivity (Ebesutani et al., 2012; 2017).
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From enrollment to 3-month follow-up at 20 weeks
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Disruptive Behavior Symptoms
大体时间：From enrollment to 3-month follow-up at 20 weeks
|
We will measure disruptive behaviors using the Disruptive Behavior Disorders Scale (DBRS)-Parent Version (Fosco et al., 2023), a 45-item rating scale used to assess symptoms of inattention, hyperactivity-impulsivity, and oppositional defiant behavior among school-aged children.
Items are rated on a 4-point scale, with higher scores indicating greater severity of symptoms.
|
From enrollment to 3-month follow-up at 20 weeks
|
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Emotion Dysregulation--Reactivity
大体时间：From enrollment to 3-month follow-up at 20 weeks
|
Measured using the Emotion Dysregulation Inventory-Reactivity Short Form (EDI-R; Mazefsky et al., 2018; 2021), which includes a 7-item, caregiver report measure of emotional reactivity.
Items are rated on a 5-point Likert scale, with higher scores indicating greater emotional reactivity.
|
From enrollment to 3-month follow-up at 20 weeks
|
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Emotion Dysregulation--Dysphoria
大体时间：From enrollment to 3-month follow-up at 20 weeks
|
Measured using the Emotion Dysregulation Inventory-Dysphoria Short Form (EDI-D; Mazefsky et al., 2018; 2021), which is a 6-item, caregiver report measure of dysphoria in youth.
Items are rated on a 5-point Likert scale, with higher scores indicating greater dysphoria.
|
From enrollment to 3-month follow-up at 20 weeks
|
|
Caregiver Report of Preadolescent Executive Functioning
大体时间：From enrollment to 3-month follow-up at 20 weeks
|
The Brief Rating Inventory of Executive Function 2nd Edition (BRIEF 2) --Parent Form (Gioia et al., 2015) is 63-item questionnaire with eight clinical scales designed to assess everyday behaviors associated with seven domains of EF.
These scales are combined to form two broader indices (Behavioral Regulation and Metacognition) and a Global Executive Composite score.
Items are rated on a 4-point scale, and sum scores for each scale and index are converted to t-scores, with higher t-scores indicating greater difficulties with executive functioning.
The measure has strong psychometric properties, discriminates between typically developing and clinical populations, and is sensitive to change.
|
From enrollment to 3-month follow-up at 20 weeks
|
|
Behavioral Assessment of Executive Functioning and Distress Tolerance
大体时间：From enrollment through post-treatment at 8 weeks
|
Executive Function Challenge Task (EFCT; Kenworthy et al., 2014, 2020) is a "hot" measure of EF that uses a standardized protocol to assess flexibility and planning during several activities with an examiner that change rules or modalities.
The EFCT has precise behavioral markers to guide scoring on a three-point scale and yields flexibility and planning raw scores that range from 0 to 8. The EFCT has good psychometric properties and demonstrated moderate associations with parent-reported EF and treatment-specific sensitivity to change (Kenworth et al., 2014; 2020).
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From enrollment through post-treatment at 8 weeks
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Task-Based Assessment of Executive Functioning
大体时间：From enrollment to the end of treatment at 8 weeks
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NIH toolbox Dimensional Change Card Sort test (DCCS; Kavanaugh et al., 2020; Zelazo et al., 2013). is a standard, lab-based, computerized task for assessing cognitive flexibility, will be administered as a computerized measure of EF.
The DCCS has been validated in youth, does not demonstrate practice effects, and has excellent convergent validity.
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From enrollment to the end of treatment at 8 weeks
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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 (估计的)
2026年12月1日
初级完成 (估计的)
2028年5月1日
研究完成 (估计的)
2028年5月1日
研究注册日期
首次提交
2025年12月1日
首先提交符合 QC 标准的
2025年12月11日
首次发布 (实际的)
2025年12月15日
研究记录更新
最后更新发布 (实际的)
2026年7月29日
上次提交的符合 QC 标准的更新
2026年7月27日
最后验证
2026年7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.