Improving Quality of Life for African American Female Adolescents With Lupus

Lupus Clinical Trial

Official title:

Predictors of Adaptation and a Cognitive Behavioral Intervention for African American Adolescents With Lupus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068874
• Other study ID #: P60AR049459
• Secondary ID: P60AR049459NIAMS
• Status: Completed
• Phase: Phase 2
• Start date: April 2004
• Est. completion date: April 2007

Study information

• Verified date: May 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus

Intervention

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.
• Educational training
Participants will attend five study visits that will include disease-appropriate education materials.

Locations

Country	Name	City	State
United States	Ronald T. Brown, PhD	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BASC scores (measures of general adjustment)		4 years
Primary	BASS Scores		4 years
Primary	SPPA scores (perception of physical appearance and social		4 years
Primary	competence)		4 years
Primary	Peds-QL 4.0 and 3.0 (quality of life assessments)		4 years
Primary	Psychological Adjustment		4 years
Primary	BASC Scores		4 years
Secondary	SLEDAI (measure of disease status)		4 years