Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,142
- 试验地点
- 14
- 主要终点
- Major Depressive Episode (major and sub-threshold)
研究概览
简要总结
The purpose of this randomized multiple-site clinical study is to determine whether a revised CATCH-IT (Internet-based depression prevention program) is more effective than a general health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). It is hypothesized that teens in CATCH-IT will exhibit lower levels of depressed mood and/or maintain lower depressive scores over 2 years long-term follow up as compared to teens in Health Education group.
详细描述
Additional aims and hypothesis are provided below:
-Aim 1: To determine whether the CATCH-IT depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to HEALTH EDUCATION.
Hypothesis 1: Compared to youth in the HEALTH EDUCATION condition, youth assigned to CATCH-IT will have a lower hazard ratio of major depressive episodes and non-affective disorder episodes over 2 years.
-Aim 2: To determine if participants in the CATCH-IT group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared to the HEALTH EDUCATION group.
Hypothesis 2: Compared to youth in the HEALTH EDUCATION condition, youth in the CATCH-IT program will demonstrate a steeper slope of improved symptoms and fewer depressed days over 2 years.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents:
- •(A) Youth ages 13 through 18 who are English speaking. (B) Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression (CES-D) scale (score >/= 16). (C) Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse. Youth presenting in partial remission from a major depressive episode at Baseline will be rescreened after 2 months utilizing the phone screen to ensure episode is fully remitted prior to randomization or access to study intervention. Those who do not fully remit after two months will be excluded.
- •*Parent of eligible adolescents
- •Physicians (PCP) or NP:
- •*Physician in any of the study sites
- •Healthcare Professionals:
- •*Primary care practice for a minimum of 6 months
排除标准
- •Adolescents:
- •Current DSM-IV diagnosis 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 suicide 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).
- •Ineligible child
- •Non-English speaking
- •Physicians:
- •Healthcare Professionals:
研究组 & 干预措施
CATCH-IT
200 randomized teens 13-18 year old (inclusive) will be enrolled into the online program that contains 14 modules focused various therapeutic techniques, a booster session of 6 modules at the end of the online program and three 15 minute visits with their primary care doctor to discuss the benefits and disadvantages of the program.
Parents will also be invited to participant in a partnering online program involving 4 modules online and 1 optional module. They will be asked to then participate in three 15 minute interviews with a member of the study team to discuss the benefits and disadvantages of the program.
干预措施: CATCH-IT (Behavioral)
Health Education
200 randomized teens, ages 13-18 year old (inclusive) receiving an online program with 14 modules that focus on general health education, depression, diet, exercise, hygiene and safety.
Parents will also be invited to participate in an online program with 4 modules that also focus on general health education.
结局指标
主要结局
Major Depressive Episode (major and sub-threshold)
时间窗: 0, 2, 6, 12, 18 and 24 months
Kiddie Schedule of Affective Disorders Scale (KSADS) used to evaluate for current and past depressive episode at each time point (interval between time points). Occurrence of first depressive episode was determined by the Depression Symptom Rating (DSR). We considered a score indicating at least sub-threshold major depression (a DSR of ≥3+) to be a depressive episode. DSR 4 and above and 5 alone will also be assessed.
次要结局
- Vulnerability Factors(0, 2, 6, 12, 18, 24 months)
- Depressed mood(0, 2, 6, 12, 24 months)
- Quality of Life, educational impairment and other mental disorder symptoms or episodes(0, 2, 6, 12, 18, 24 months)
研究者
Benjamin Van Voorhees, MD, MPH
Associate Professor of Medicine, Chief, Section of General Pediatrics and Adolescent Medicine, TIKES Center Director
University of Illinois at Chicago