Improving Quality of Life for African American Female Adolescents With Lupus
Condition: Lupus
Study type: Interventional
Phase: Phase 2

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

Detailed description: 
      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.
    

Intervention name(s): Coping skills and cognitive restructuring techniques; Educational training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This is a cognitive psychoeducational program designed to enhance coping and adaptation to SLE. Participants will attend 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.; Participants will attend five study visits that will include disease-appropriate education materials.
Other intervention name(s): HELP - Health Education for Lupus Patients
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: African American; Adolescent; Coping; Adjustment; Quality of Life