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临床试验/NCT01220635
NCT01220635已完成不适用

Prevention of Depression Within Salient Adolescent Contexts

Seattle Children's Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Moods and Feelings Questionnaire (MFQ; child and parent version)

研究概览

简要总结

This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.

详细描述

This study involve two parts: Part 1 entailed screening 7th and 8th graders from 4 public middle schools to identify students who may be showing moderate signs of stress. Students who score at the designated cutoff on a depression symptoms measure received a brief check-in to determine eligibility for the follow up randomized trial (Part 2). An "indicated" sample of 120 adolescents in the 7th and 8th grade and their caregivers were randomly assigned to a brief, Individual Support Program (ISP) comparison group or a Skills Group Program. Research interviews were conducted at multiple timepoints with students and caregivers, and teacher questionnaires were used to examine changes in outcome measures. Following completion of the intervention, all participants were followed for 12-months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 7th and 8th grade students at 4 participating middle schools
  • Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%)
  • No imminent plans to move or change to non-participating school
  • At minimum 6th grade language skills
  • Agree to participate in random assignment and research interviews
  • One Parent/caregiver willing to complete research interviews

排除标准

  • Student with past or current Major Depressive Disorder (MDD) or Probable MDD
  • Students with parents who do not speak English or Spanish
  • Students in concurrent treatment
  • Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member
  • Parent not willing to complete research interviews

结局指标

主要结局

Moods and Feelings Questionnaire (MFQ; child and parent version)

时间窗: up to 1 year

Depressive symptoms of the child are assessed on the MFQ. Youth completed the MFQ at all 4 timepoints, parent ratings of students symptoms were collected at baseline, post-intervention, and 12 month follow up.

次要结局

  • Parent-Child Communication (PCC; child and parent version)(up to 1 year)
  • Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)(up to 1 year)
  • Health Enhancing Behavior Index (HEBI)(up to 1 year)
  • Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)(up to 1 year)
  • Service Use Interview (Service for Children and Adolescence Parent Interview-modified)(up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolyn McCarty

Principal Investigator

Seattle Children's Hospital

研究点 (2)

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