Improving Quality of Life for African American Female Adolescents With Lupus

Phase 2

Completed

• Conditions: Lupus
• Interventions: Behavioral: Educational training; Behavioral: Coping skills and cognitive restructuring techniques

• Registration Number: NCT00068874
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2003-09-10
• Study First Submitted QC: 2003-09-10
• Study First Posted: 2003-09-11
• Study Start: 2004-04
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Educational training	Educational comparison group
2	Coping skills and cognitive restructuring techniques	Group receiving coping intervention designed to enhance coping and psychological adjustment

Primary Outcome Measures

Name	Time	Method
BASS Scores	4 years
competence)	4 years
BASC Scores	4 years
BASC scores (measures of general adjustment)	4 years
SPPA scores (perception of physical appearance and social	4 years
Peds-QL 4.0 and 3.0 (quality of life assessments)	4 years
Psychological Adjustment	4 years

Secondary Outcome Measures

Name	Time	Method
SLEDAI (measure of disease status)	4 years

Trial Locations

Locations (1)

Ronald T. Brown, PhD; 🇺🇸 Philadelphia, Pennsylvania, United States