Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention on Moderate Depressive Symptoms in Low-Income Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-8 Adolescent
研究概览
简要总结
This study evaluates the effectiveness of a novel depression self-management intervention in adolescents with depression.
详细描述
Half of participants will receive a traditional depression self-management intervention, while the other half will receive the novel depression self-management intervention. In an exploratory, pilot 2-group randomized controlled trial (RCT), 16 adolescents were followed over 6 months. Data were collected at baseline, 3 months, and 6 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lives in the Cleveland metro area
- •Ages 14-17 years old
- •Reports moderate depressive symptoms
- •Able to read, speak, and understand the English language
排除标准
- •Current suicide risk
- •Diagnosis with bipolar disorder, schizophrenia, or a personality disorder
- •Severe behavioral problems that preclude group participation (as reported by parent)
- •Family plans to move from the region within 6 months
研究组 & 干预措施
Depression Management
8 weekly group sessions
干预措施: Depression Management (Behavioral)
Trust-building Self-management Together
8 weekly group sessions
干预措施: Trust-building Self-management Together (Behavioral)
结局指标
主要结局
Patient Health Questionnaire-8 Adolescent
时间窗: 3 months and 6 months post baseline
The Patient Health Questionnaire-8 (PHQ-8) Adolescent has 8 items scored on a 4 point Likert scale summed for a total score ranging from 0-24. Higher scores indicate greater levels of depressive symptoms with a score of 10 indicating a moderate level of depressive symptoms. The population mean = 5.6 (SD = 1.0).
次要结局
- Appointment Keeping(3 and 6 months post baseline)
- Stress Management(3 and 6 months post baseline)
- Medication Adherence(3 and 6 months post baseline)
- Adolescent Sleep Hygiene Scale(3 and 6 months post baseline)
- Youth Quality of Life Scale(3 and 6 months post baseline)
研究者
Heather K. Hardin, PhD, RN
Assistant Professor
Case Western Reserve University