Examining the Psychosocial Effects of Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The 14-Item Resiliency Scale (RS-14)
研究概览
简要总结
This is a prospective study that will examine psychosocial improvements among CF adolescents and caregivers going through the Stress Management and Resiliency Training - Relaxation Response Resiliency Program (SMART-3RP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Unable to benefit from the program due to cognitive, psychiatric or other reasons based on the opinion of the group leader
- •Unable or unwilling to sign the informed consent documents
结局指标
主要结局
The 14-Item Resiliency Scale (RS-14)
时间窗: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The RS-14 measures stress coping ability in the face of adversity.
Quality of Life (WHOQOL-BREF)
时间窗: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The WHOQOL-BREF comprises of 26 items which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
次要结局
- Satisfaction with Life (SWL)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Patient Health Questionnaire (PHQ) - caregivers only(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Child and Adolescent Mindfulness Measure (CAMM) - patients only(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- The Gratitude Questionnaire (GQ-6)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Measure of Current Status (MOCS-A)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Patient Health Questionnaire for Adolescents (PHQ-A) - patients only(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Generalized Anxiety Disorder 7-item (GAD-7)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Cognitive and Affective Mindfulness Scale (CAMS) - caregivers only(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Interpersonal Reactivity Index (IRI)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Perceived Stress Scale (PSS-10)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Distress Analogue Scales(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Medical Outcomes Study (MOS) Social Support Survey(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Life Orientation Test (LOT) Optimism Scale(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- Rosenberg Self Esteem Scale (RES)(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
- The Body Image Quality of Life Inventory (BIQLI) - patients only(Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32))
研究者
John W. Denninger, MD, PhD
Principal Investigator
Massachusetts General Hospital