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临床试验/NCT03781037
NCT03781037已完成不适用

Targeting Burdensomeness Among Clinic Referred Youth

Florida International University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire

研究概览

简要总结

This study will develop and pilot test a novel intervention module targeting perceived burdensomeness toward others in 30 clinic referred youths who experience anxiety or depression and elevated levels of burdensomeness. All participants will be assigned to receive the intervention in this open trial.

详细描述

Suicidal ideation is prevalent and impairing in youth, with approximately 15% of high school students reporting seriously considering a suicide attempt and making a specific plan for suicide in the past 12 months. Substantial evidence documents perceived burdensomeness towards others, or the belief that one is a burden or drain on others, as a risk factor for suicide ideation in youth. This evidence highlights the potential promise of perceived burdensomeness as a novel intervention target to prevent suicide ideation in youth. The current study will develop and preliminary evaluate a novel, brief behavioral treatment module targeting perceived burdensomeness in youth that can be embedded within existing psychosocial treatments. The study will use an open trial design. The first aim of this proposal is to develop a novel, brief psychosocial intervention module (the GIVE module) targeting perceived burdensomeness towards others that can be embedded within existing CBT protocols for youth internalizing problems. The second aim is to collect data relevant to client satisfaction and reductions in perceived burdensomeness. Participants will be N=30 clinic-referred youth ages 10 to 17 years with anxiety or depressive disorders in a university-based research clinic, who display elevated levels of perceived burdensomeness. In the context on ongoing CBT for anxiety or depression, participants will complete the GIVE module at sessions 6 and 7 of the CBT protocol. It is hypothesized that perceived burdensomeness will be significantly lower after the GIVE module is administered, and that client satisfaction will be high. Data collected in this study will provide the foundation for a subsequent randomized controlled trial of the GIVE module.

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
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of an anxiety disorder, persistent depressive disorder, or major depressive disorder
  • Score > 4 on the youth self-report Interpersonal Needs Questionnaire- Perceived Burdensomeness Scale

排除标准

  • Clinical diagnosis of a Psychotic Disorder, Autism Spectrum Disorder or Intellectual Disability
  • Show high risk of imminent self-injurious behaviors
  • Be involved currently in another behavioral treatment
  • Not live with a primary caregiver who is legally able to give consent for the youth's participation
  • Be a victim of previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Children and Families.

结局指标

主要结局

6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire

时间窗: post-intervention (within one week of completing the GIVE Module)

Youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 6 and 42. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).

次要结局

  • 10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory(post-intervention (within one week of completing the GIVE Module))
  • 41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders(post-intervention (within one week of completing the GIVE Module))
  • 10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory(post-intervention (within one week of completing the GIVE Module))
  • 41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders(post-intervention (within one week of completing the GIVE Module))
  • 28-item Youth-rated Children's Depression Inventory - 2(post-intervention (within one week of completing the GIVE Module))
  • 17-item Parent Rated Children's Depression Inventory - 2(post-intervention (within one week of completing the GIVE Module))
  • 8-item Youth Rated Client Satisfaction Questionnaire(post-intervention (within one week of completing the GIVE Module))
  • 8-item Parent Rated Client Satisfaction Questionnaire(post-intervention (within one week of completing the GIVE Module))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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