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临床试验/NCT03733548
NCT03733548已完成不适用

Improving Emotion Regulation in Adolescents With ADHD

Virginia Commonwealth University4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
4
主要终点
Change in Emotion Dysregulation

研究概览

简要总结

The purpose of our study is to examine the impact of a program that provides emotion regulation skills for adolescents aged 11-16 with Attention-Deficit/Hyperactivity Disorder (ADHD) and poor emotion regulation. The program is called RELAX (Regulating Emotions Like An eXpert). RELAX is an experimental intervention that may equip adolescents with emotion regulation and conflict management skills and includes parent involvement to help parents support adolescents' use of these skills.

详细描述

Regulating Emotions Like An eXpert (RELAX) consists of 8 weekly 90-minute group sessions and 1 booster session 8 weeks after the completion of the RELAX intervention. The first 60 minutes of each group involve separate parent and adolescent groups. Adolescents (ages 11-16) attend an emotion regulation and conflict management skills group, while parents attend a group focused on how to support utilization of these skills in adolescents at home and school through use of modeling their own emotion regulation skills and use of supportive emotion socialization practices. For the final 30 minutes of the session, parents and adolescents combine and complete a collaborative activity and skill rehearsal homework is discussed for the week. Homework will be discussed at the beginning of the separate group meetings the following week. The primary overall goal of the RELAX intervention is to assist adolescents and parents in traveling down the Path of RELAXation by working on the three C's (communication, coping, and conflict management skills). A multimethod assessment of emotional, social, and family functioning will be assessed pre- and post-intervention and at an 8 week follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Regulating Emotions Like An eXpert (RELAX)

Experimental

Families at the Virginia Commonwealth University Center for Psychological Services and Development or Clark-Hill Institute for Positive Youth Development

干预措施: RELAX (Behavioral)

结局指标

主要结局

Change in Emotion Dysregulation

时间窗: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)

Parent and adolescent-reported emotion regulation on the Difficulties in Emotion Regulation Scale (DERS; Bunford et al., 2018; Kaufman et al., 2016). Total score is out of 180 (5 point Likert for each of 36 items). Higher scores indicate more difficulties with emotion regulation. RSA will be assessed with an EKG: three electrodes will be placed in a bipolar configuration on the left and right rib cage and the sternum. RSA is a measure of heart rate variability based on the respiratory cycle and is an indicator of vagal regulation (Berntson, Cacioppo, \& Quigley, 1997). Decreases in RSA, or RSA withdrawal, correspond to increased heart-rate and arousal; whereas, increases in RSA, or RSA augmentation, correspond to decreased arousal.

Change in Family Conflict

时间窗: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)

Parent and adolescent-reported family conflict as measured by the Conflict Behavior Questionnaire (CBQ). The CBQ consists of 20 true-false questions, with higher scores indicating more conflict between parents and their children.

次要结局

  • Emotion Reactivity Predicting Treatment Outcomes(Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention))
  • Change in Emotion Socialization Predicting Treatment Outcomes(Baseline, Post-Intervention (Completion of 8 week intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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