Improving Quality of Life for African American Female Adolescents With Lupus
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|ClinicalTrials.gov Identifier: NCT00068874|
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : April 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|Lupus||Behavioral: Coping skills and cognitive restructuring techniques Behavioral: Educational training||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Predictors of Adaptation and a Cognitive Behavioral Intervention for African American Adolescents With Lupus|
|Study Start Date :||April 2004|
|Primary Completion Date :||April 2007|
|Study Completion Date :||April 2007|
Active Comparator: 1
Educational comparison group
Behavioral: Educational training
Participants will attend five study visits that will include disease-appropriate education materials.
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
- BASC scores (measures of general adjustment) [ Time Frame: 4 years ]
- BASS Scores [ Time Frame: 4 years ]
- SPPA scores (perception of physical appearance and social [ Time Frame: 4 years ]
- competence) [ Time Frame: 4 years ]
- Peds-QL 4.0 and 3.0 (quality of life assessments) [ Time Frame: 4 years ]
- Psychological Adjustment [ Time Frame: 4 years ]
- BASC Scores [ Time Frame: 4 years ]
- SLEDAI (measure of disease status) [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068874
|United States, Pennsylvania|
|Ronald T. Brown, PhD|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Ronald T. Brown, PhD||Department of Public Health - Temple University|