Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068874
Status:
COMPLETED
Last Update Posted:
2018-05-09
First Post:
2003-09-10
Brief Title:
Improving Quality of Life for African American Female Adolescents With Lupus
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Predictors of Adaptation and a Cognitive Behavioral Intervention for African American Adolescents With Lupus
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate a program designed to help African American adolescents with lupus systemic lupus erythematosus or SLE cope with the disease
Detailed Description:
SLE is the most common autoimmune connective tissue disease of childhood affecting 5000 to 10000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-094 | US NIH GrantContract | None | httpsreporternihgovquickSearchP60AR049459 |
| P60AR049459 | NIH | None | None |