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临床试验/NCT00068874
NCT00068874已完成2 期

Predictors of Adaptation and a Cognitive Behavioral Intervention for African American Adolescents With Lupus

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2004年4月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
2
主要终点
BASC Scores

研究概览

简要总结

This study will evaluate a program designed to help African American adolescents with lupus (systemic lupus erythematosus or SLE) cope with the disease.

详细描述

SLE is the most common autoimmune connective tissue disease of childhood, affecting 5,000 to 10,000 children; the prevalence is higher among African American children and approximately 80% of sufferers are female. SLE is multisystemic in onset and has no known cure. Children with chronic illness have at least a two-fold increased risk for adjustment problems relative to their healthy peers. This risk is heightened among adolescents, who are at greater risk for psychopathology than are younger children. The diagnosis of a chronic medical condition during adolescence presents unique stressors, particularly for adolescents with lupus, who must endure bodily changes, including dermatological problems, hair loss, and changes in appearance due to medical therapies. Psychosocial processes, including methods of coping, expectations, and family functioning, are believed to mediate the influence of disease severity. This study will evaluate the effectiveness of a cognitive-based intervention to improve the quality of life of adolescents with SLE.

Participants in this study will be randomly assigned to either the cognitive-based intervention, a lupus education program, or a control group. Participants in the intervention group will have five study visits over 5 months. The first three visits are biweekly, 45-minute sessions during which the adolescent will be taught coping skills and cognitive restructuring techniques. The coping skills training will include training in relaxation, distraction, and problem-solving skills. The cognitive restructuring techniques will assist adolescents in using more accurate and adaptive cognitive responses. Caregivers will join the adolescent at the end of each training session to gain familiarity with the content reviewed in each session. The remaining two study visits are booster sessions during which the intervention material will be reviewed.

Participants in the education program will also have five study visits. Study visits will include disease-appropriate education materials. Caregivers will not be included in the education program. Participants will be assessed at study entry and Months 6, 9, and 12. Assessments will include questionnaires designed to measure disease severity, pain intensity, methods of coping, expectations of efficacy, social support, and adjustment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of systemic lupus erythematosus (SLE)

排除标准

  • Severe depression with suicidal thoughts
  • Delirium, dementia, or cognitive impairment (e.g., Mini Mental Status Examination 24 or less)
  • Severe intellectual impairment
  • Terminal illness with a life expectancy of less than 1 year

研究组 & 干预措施

1

Active Comparator

Educational comparison group

干预措施: Educational training (Behavioral)

2

Experimental

Group receiving coping intervention designed to enhance coping and psychological adjustment

干预措施: Coping skills and cognitive restructuring techniques (Behavioral)

3

No Intervention

Comparison control group with no active intervention

结局指标

主要结局

BASC Scores

时间窗: 4 years

BASS Scores

时间窗: 4 years

competence)

时间窗: 4 years

BASC scores (measures of general adjustment)

时间窗: 4 years

SPPA scores (perception of physical appearance and social

时间窗: 4 years

Peds-QL 4.0 and 3.0 (quality of life assessments)

时间窗: 4 years

Psychological Adjustment

时间窗: 4 years

次要结局

  • SLEDAI (measure of disease status)(4 years)

研究者

申办方类型
Other

研究点 (2)

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