Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility defined in the 18-25 year old cancer patient group as a completion rate of greater than or equal to 60 percent among those approached to enter the study.
研究概览
简要总结
Background:
- An interview called the Schedule for Affective Disorders and Schizophrenia for School Age Children Present and Lifetime version (K-SADS-PL) is used to identify mental health problems among children and younger teens. Both the child and a parent are asked questions about the child s behaviors and symptoms that might indicate such problems. Researchers want to see if the K-SADS-PL can help identify mental health problems in young adults (ages 18 to 25). Two groups of young adults, including healthy volunteers and people with cancer, and their parents will participate in this study.
Objectives:
- To see if the K-SADS-PL interview used for children and teens can also be used for young adults.
- To see whether information provided by parents will affect the rate of mental health problems found.
Eligibility:
- Individuals aged 18-25 years who have cancer and are participating in research studies at the National Institutes of Health.
- Healthy volunteers aged 18-25 years.
- A parent of a young adult who is participating in this study.
Design:
- This study requires one study visit that includes an interview and self-report questionnaires. It will take about 1 to 3 hours. A follow-up phone call or visit will also be required.
- Young adult participants will be given the K-SADS-PL interview and four questionnaires that ask about mood, anxiety, distress, parental contact, and development during childhood. The K-SADS-PL interview will be video recorded or audio recorded.
- Parents will also be given the K-SADS-PL interview. This interview can be done in person or by phone, and will also be recorded.
- No treatment will be provided as part of this study.
详细描述
Objective:
The goal of this pilot project is to describe the feasibility of using the Schedule for Affective Disorders and Schizophreni\a for School Age Children Present and Lifetime Version (K-SADS-PL) to screen and evaluate older adolescents and young adults (ages 18-25) for mood and anxiety disorders. An additional aim is to describe the contribution of the parent interview portion of the instrument for this age group. Two groups of 18-25 year old participants will be enrolled: healthy volunteers and patients with cancer. The information gained in this pilot study will inform the design of future intervention studies that target mood and anxiety disorders among pediatric oncology patients.
Primary aim:
Aim 1: Feasibility - Describe the feasibility of using the K-SADS-PL interview to screen and evaluate for mood and anxiety disorders among two groups of 18 25 year olds (healthy volunteers and patients with cancer) and their parents.
Hypothesis 1: The K-SADS-PL interview is feasible to use in the two groups of 18 25 year olds; the feasibility of completing the parent portion of the K-SADS-PL will be better among parents of cancer participants compared to parents of healthy volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility defined in the 18-25 year old cancer patient group as a completion rate of greater than or equal to 60 percent among those approached to enter the study.
时间窗: 2 years
Feasibility in parents is greater than or equal to 80 percent completion rate of the parent portion of the K-SADS-PL interview.
时间窗: 2 years
次要结局
- Frequency of positive (threshold or subthreshold) KSADS-PL summary ratings in both groups of participants.(2 years)
- 2x2 tables and kappa statistics that describe agreement between participant responses and summary ratings.(2 years)