Improving Quality of Life for African American Female Adolescents With Lupus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lupus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Educational comparison group

Group Type ACTIVE_COMPARATOR

Educational training

Intervention Type BEHAVIORAL

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

2

Group receiving coping intervention designed to enhance coping and psychological adjustment

Group Type EXPERIMENTAL

Coping skills and cognitive restructuring techniques

Intervention Type BEHAVIORAL

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.

3

Comparison control group with no active intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Educational training

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

Intervention Type BEHAVIORAL

Other Intervention Names

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HELP - Health Education for Lupus Patients

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No