Clinical trial NCT00068874: Improving Quality of Life for African American Female Adolescents With Lupus
Official title: Predictors of Adaptation and a Cognitive Behavioral Intervention for African American Adolescents With Lupus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus
Keywords: African American
Adolescent
Coping
Adjustment
Quality of Life
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2003-09-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus (SLE)

Exclusion Criteria:

* 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

Primary outcomes:
measure: BASC scores (measures of general adjustment)
timeFrame: 4 years
measure: BASS Scores
timeFrame: 4 years
measure: SPPA scores (perception of physical appearance and social
timeFrame: 4 years
measure: competence)
timeFrame: 4 years
measure: Peds-QL 4.0 and 3.0 (quality of life assessments)
timeFrame: 4 years
measure: Psychological Adjustment
timeFrame: 4 years
measure: BASC Scores
timeFrame: 4 years
Secondary outcomes:
measure: SLEDAI (measure of disease status)
timeFrame: 4 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Ronald T. Brown, PhD
state: Pennsylvania
Study officials:
affiliation: Department of Public Health - Temple University
name: Ronald T. Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: