Lupus Clinical Trial
Official title:
Predictors of Adaptation and a Cognitive Behavioral Intervention for African American Adolescents With Lupus
This study will evaluate a program designed to help African American adolescents with lupus (systemic lupus erythematosus or SLE) cope with the disease.
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.
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