Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- To determine whether the CATCH-IT 2-R depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to AMPE.
研究概览
简要总结
In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the CATCH-IT primary care/Internet based depression prevention intervention against Attention Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an intermediate to high risk group of adolescents aged 13-17. We plan to (a) identify high risk adolescents based on elevated scores on the PHQ-A, a screening measure of depressive symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into either the CATCH-IT or the AMPE group; (c) assess outcomes at 2, 8, 12, 18, and 24 months post intake on measures of depressive symptoms, depressive diagnoses, other mental disorders, and on measures of role impairment in education, quality of life, attainment of educational milestones, and family functioning; and (d) conduct exploratory analyses to examine the effectiveness of this intervention program, moderators of protection, and potential ethnic and cultural differences in intervention response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth ages 13 through
- •Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression46 (CES-D) scale (score >/= 16) and have at least two core symptoms of Major Depression on the Patient Health Questionnaire, Adolescents.
- •Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse.
排除标准
- •Current DSM-IV diagnosis (Kiddie Schedule of Affective Disorders) of Major Depressive Disorder, current therapy for depression, or be taking antidepressants (e.g., SSRIs, TCAs, MAOIs, bupropion, nefazodone, mirtazapine, venlafaxine).
- •Current CES-D score >35
- •DSM-IV diagnosis of schizophrenia (current or past) or bipolar affective disorder
- •Current serious medical illness that causes significant disability or dysfunction
- •Significant reading impairment (a minimum sixth-grade reading level based on parental report), mental retardation, or developmental disabilities
- •Serious imminent suicidal risk (as determined by endorsement of current suicidality on CES-D or in KSADS interview) or other conditions that may require immediate psychiatric hospitalization
- •Psychotic features or disorders, or currently be receiving psychotropic medication
- •Extreme, current drug/alcohol abuse (greater than or equal to 2 on the CRAFFT).
结局指标
主要结局
To determine whether the CATCH-IT 2-R depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to AMPE.
时间窗: 49-60 months from beginning of trial
次要结局
- To determine if participants in the CATCH-IT 2-R group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared with the AMPE group.(49-60 months from beginning of the trial)
- To determine if participants in the CATCH-IT 2-R program report lower perceived educational impairment, greater quality of life, greater health-related quality of life, and lower incidence of other mental disorders (anxiety, substance/alcohol use).(49-60 months from beginning of trial)
- To determine for whom (moderators) and how (mediators) the CATCH-IT 2-R program works in this population.(49-60 months from beginning of trial)