- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00068874
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Ronald T. Brown, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Educational comparison group
|
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
|
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 Names:
|
No Intervention: 3
Comparison control group with no active intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BASC scores (measures of general adjustment)
Time Frame: 4 years
|
4 years
|
BASS Scores
Time Frame: 4 years
|
4 years
|
SPPA scores (perception of physical appearance and social
Time Frame: 4 years
|
4 years
|
competence)
Time Frame: 4 years
|
4 years
|
Peds-QL 4.0 and 3.0 (quality of life assessments)
Time Frame: 4 years
|
4 years
|
Psychological Adjustment
Time Frame: 4 years
|
4 years
|
BASC Scores
Time Frame: 4 years
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SLEDAI (measure of disease status)
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ronald T. Brown, PhD, Department of Public Health - Temple University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P60AR049459 (U.S. NIH Grant/Contract)
- NIAMS-094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lupus
-
AmgenTerminatedSystemic Lupus Erythematosus | Cutaneous Lupus | Lupus | Discoid LupusUnited States
-
BiogenRecruitingSubacute Cutaneous Lupus Erythematosus | Chronic Cutaneous Lupus ErythematosusUnited States, Italy, Korea, Republic of, Taiwan, Argentina, Chile, Spain, Canada, Serbia, France, Germany, Japan, Brazil, United Kingdom, Puerto Rico, Bulgaria, Portugal, Switzerland, Philippines, Saudi Arabia, Sweden, Mexico, Poland, Hunga... and more
-
BiogenEnrolling by invitationSubacute Cutaneous Lupus Erythematosus | Chronic Cutaneous Lupus ErythematosusSpain, United States, Sweden
-
Florida Academic Dermatology CentersUnknownDiscoid Lupus Erythematosus (DLE)United States
-
Bristol-Myers SquibbRecruitingLupus Erythematosus, Discoid | Lupus Erythematosus, Subacute CutaneousUnited States, Mexico, Russian Federation, Australia, Argentina, Poland, France, Germany, Taiwan
-
SanofiCompletedCutaneous Lupus Erythematosus-Systemic Lupus ErythematosusJapan
-
AmgenCompleted
-
LEO PharmaTerminatedDiscoid Lupus ErythematosusUnited States, France, Germany, Denmark
-
University of RochesterIncyte CorporationCompletedDiscoid Lupus ErythematosusUnited States
-
Massachusetts General HospitalNovartisWithdrawnDiscoid Lupus ErythematosusUnited States
Clinical Trials on Educational training
-
Barcelonabeta Brain Research Center, Pasqual Maragall...Fundacion SARquavitaeCompletedDementia | Alzheimer's DiseaseSpain
-
University of IbadanRecruitingUrinary Tract Infections | Urinary Tract Infection Lower AcuteNigeria
-
University Hospital of FerraraUniversity of PadovaRecruitingMedication Adherence | Aging | Fall | Multidisciplinary Communication | Hospital DischargeItaly
-
Azienda Ospedaliero-Universitaria di ParmaCompleted
-
University of Texas Southwestern Medical CenterThe Hospital for Sick ChildrenCompletedColonoscopy | Education, MedicalUnited States
-
Mersin UniversityCompleted
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedGestational Diabetes | Gestational Diabetes Mellitus in PregnancyUnited States
-
The Cleveland ClinicNational Institutes of Health (NIH)CompletedAging | Alzheimer's DiseaseUnited States
-
Taipei Medical UniversityNot yet recruiting
-
Northwestern UniversityCompletedMelanoma | Nevi | Skin MolesUnited States