Improving Quality of Life for African American Female Adolescents With Lupus

NCT00068874 | Completed Phase 2 DMC

• 2 other identifiers: P60AR049459NIAMS-094
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus

Keywords

African American; Adolescent; Coping; Adjustment; Quality of Life

Outcome Measures

Primary Outcomes (7)

• BASC scores (measures of general adjustment)

  4 years

• BASS Scores

  4 years

• SPPA scores (perception of physical appearance and social

  4 years

• competence)

  4 years

• Peds-QL 4.0 and 3.0 (quality of life assessments)

  4 years

• Psychological Adjustment

  4 years

• BASC Scores

  4 years

Secondary Outcomes (1)

• SLEDAI (measure of disease status)

  4 years

Study Arms (3)

1

ACTIVE COMPARATOR

Educational comparison group

Behavioral: Educational training

2

EXPERIMENTAL

Group receiving coping intervention designed to enhance coping and psychological adjustment

Behavioral: Coping skills and cognitive restructuring techniques

3

NO INTERVENTION

Comparison control group with no active intervention

Interventions

Coping skills and cognitive restructuring techniques 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.

Also known as: HELP - Health Education for Lupus Patients

2

Educational training BEHAVIORAL

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

1

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of systemic lupus erythematosus (SLE)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Ronald T. Brown, PhD

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Interventions

Coping Skills; Training Support

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Financial Support; Economics; Health Care Economics and Organizations

Study Officials

• Ronald T. Brown, PhD

  Department of Public Health - Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: April 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

US (1)