Prevention of Depression in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 3
- 主要终点
- Rating on Children's Global Assessment Scale
研究概览
简要总结
This study will compare Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), IPT-AST plus parent involvement (Enhanced IPT-AST), and Usual Care for the prevention of adolescent depression.
详细描述
Depression is a serious medical illness that is difficult to diagnose and treat, especially in children and adolescents. Signs of depression in children may include the following behaviors: pretending to be sick; refusing to go to school; clinging to a parent; or worrying that a parent may die. Older children may sulk, behave inappropriately at school, act in a negative or grouchy manner, or feel misunderstood. Because normal behaviors vary from one childhood stage to another, it can be difficult to determine whether a child is going through a temporary "phase" or is suffering from depression. This study will compare IPT-AST, Enhanced IPT-AST, and Usual Care for the prevention of adolescent depression.
Participation in this single-blind study will last approximately 21 months. Participants will be randomly assigned to receive either IPT-AST, Enhanced IPT-AST, or Usual Care for 12 weeks. IPT-AST is a school-based group intervention program that focuses on prevention, psychoeducation, and interpersonal skill-building. Enhanced IPT-AST will entail IPT-AST plus three parent-adolescent sessions. Usual Care will consist of standard treatments and will not include IPT-AST. Study visits will occur before and during the intervention at baseline and Weeks 6 and 12. Follow-up visits will occur 6, 12, and 18 months post-intervention. Study visit assessments will include depression symptoms, anxiety symptoms, psychiatric diagnoses, overall functioning, social adjustment, parent-child conflict, perceived support from parents and peers, and service utilization.
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
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between grades 7 and 10 in school
- •Score of at least 16 on the Center for Epidemiologic Studies Short Depression Scale (CES-D)
- •Currently experiencing at least 2 symptoms on the K-SADS depression section, one of which is either depressed mood, irritability, or an inability to feel pleasure during normal activities
- •Score of at least 61 on the Children's Global Assessment Scale (CGAS), indicating mild to moderate impairment
- •English-speaking
排除标准
- •Score of 15 or less on the CES-D scale
- •Currently experiencing fewer than 2 depression symptoms on the K-SADS or 2 or more symptoms on the K-SADS with no report of depressed mood, irritability, or anhedonia
- •Attempted suicide or self-mutilation in the year prior to study entry
- •Current active suicidal ideation and/or history of a clinically significant suicidal behavior (i.e., with intent to die and high medical lethality) or repeated patterns of self-injurious behavior
- •Current major depressive disorder or dysthymia as determined by K-SADS
- •Current DSM-IV diagnosis of psychosis, substance abuse or dependence, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, or conduct disorder as determined by K-SADS
- •Score of 60 or less on the CGAS, indicating substantial functional impairment
结局指标
主要结局
Rating on Children's Global Assessment Scale
时间窗: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Depression diagnoses on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnostic instrument
时间窗: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Score on the Center for Epidemiologic Studies Depression Scale
时间窗: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
次要结局
- Score on the Conflict Behavior Questionnaire(Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups)
- Score on the Social Adjustment Scale(Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups)
- Score on the Perceived Social Support scale(Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups)