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
  Purpose

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


Condition Intervention Phase
Lupus
Behavioral: Coping skills and cognitive restructuring techniques
Behavioral: Educational training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Predictors of Adaptation and a Cognitive Behavioral Intervention for African American Adolescents With Lupus

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • SLEDAI (measure of disease status) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Educational comparison group
Behavioral: Educational training
Participants will attend five study visits that will include disease-appropriate education materials.
Experimental: 2
Group receiving coping intervention designed to enhance coping and psychological adjustment
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
No Intervention: 3
Comparison control group with no active intervention

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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068874

Locations
United States, Pennsylvania
Ronald T. Brown, PhD
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Investigators
Principal Investigator: Ronald T. Brown, PhD Department of Public Health - Temple University
  More Information

No publications provided

Responsible Party: Ronald T. Brown, Ph.D., ABPP, Temple University, Department of Public Health
ClinicalTrials.gov Identifier: NCT00068874     History of Changes
Other Study ID Numbers: P60 AR049459, NIAMS-094
Study First Received: September 10, 2003
Last Updated: April 8, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
African American
Adolescent
Coping
Adjustment
Quality of Life

ClinicalTrials.gov processed this record on April 15, 2014