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Improving Quality of Life for African American Female Adolescents With Lupus

This study has been completed.
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00068874
First received: September 10, 2003
Last updated: April 8, 2009
Last verified: April 2009

September 10, 2003
April 8, 2009
April 2004
April 2007   (final data collection date for primary outcome measure)
  • BASC scores (measures of general adjustment) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • BASS Scores [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • SPPA scores (perception of physical appearance and social [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • competence) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Peds-QL 4.0 and 3.0 (quality of life assessments) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Psychological Adjustment [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • BASC Scores [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00068874 on ClinicalTrials.gov Archive Site
SLEDAI (measure of disease status) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Improving Quality of Life for African American Female Adolescents With Lupus
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Lupus
  • Behavioral: Coping skills and cognitive restructuring techniques
    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.
    Other Name: HELP - Health Education for Lupus Patients
  • Behavioral: Educational training
    Participants will attend five study visits that will include disease-appropriate education materials.
  • Active Comparator: 1
    Educational comparison group
    Intervention: Behavioral: Educational training
  • Experimental: 2
    Group receiving coping intervention designed to enhance coping and psychological adjustment
    Intervention: Behavioral: Coping skills and cognitive restructuring techniques
  • No Intervention: 3
    Comparison control group with no active intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Female
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068874
P60 AR049459, NIAMS-094
Yes
Ronald T. Brown, Ph.D., ABPP, Temple University, Department of Public Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Not Provided
Principal Investigator: Ronald T. Brown, PhD Department of Public Health - Temple University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP