LupusPhase 2NCT00068874
Improving Quality of Life for African American Female Adolescents With Lupus
A Phase 2 study testing Coping skills and cognitive restructuring techniques and Educational training in people with Lupus, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will evaluate a program designed to help African American adolescents with lupus (systemic lupus erythematosus or SLE) cope with the disease. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Lupus
- What is being tested?
- Coping skills and cognitive restructuring techniques and Educational training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of systemic lupus erythematosus (SLE)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald T. Brown, PhD
Philadelphia, Pennsylvania, 19140
About this study
Official title: Predictors of Adaptation and a Cognitive Behavioral Intervention for African American Adolescents With Lupus
This study will evaluate a program designed to help African American adolescents with lupus (systemic lupus erythematosus or SLE) cope with the disease.
Read the 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.
- Conditions
- Lupus
- Being tested
- Coping skills and cognitive restructuring techniques, Educational training
- Keywords
- African American, Adolescent, Coping, Adjustment, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping skills and cognitive restructuring techniquesBehavioural
Also called HELP - Health Education for Lupus Patients
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.
Educational trainingBehavioural
Participants will attend five study visits that will include disease-appropriate education materials.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Educational comparison group Receives: Behavioral: Educational training |
| 2 | Experimental | Group receiving coping intervention designed to enhance coping and psychological adjustment Receives: Behavioral: Coping skills and cognitive restructuring techniques |
| 3 | No intervention | Comparison control group with no active intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BASC scores (measures of general adjustment)
Measured: 4 years
BASS Scores
Measured: 4 years
SPPA scores (perception of physical appearance and social
Measured: 4 years
competence)
Measured: 4 years
Peds-QL 4.0 and 3.0 (quality of life assessments)
Measured: 4 years
Psychological Adjustment
Measured: 4 years
BASC Scores
Measured: 4 years
Secondary outcomes (1)
SLEDAI (measure of disease status)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study startApr 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LupusStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- Ronald T. Brown, PhD, Principal investigator, Department of Public Health - Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068874
- Sponsor's protocol ID
- P60AR049459
- Other IDs
- P60AR049459, NIAMS-094
- Status last verified
- May 2018
- First submitted
- 10 Sep 2003
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Adaptation and a Cognitive Behavioral Intervention for African American Adolescents With Lupus
- ClinicalTrials.gov ID
- NCT00068874
- Acronym / sponsor ID
- P60AR049459
- Conditions
- Lupus
- Keywords
- African American, Adolescent, Coping, Adjustment, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Apr 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 11 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Educational trainingEducational comparison group |
| 2 | Experimental | Behavioral: Coping skills and cognitive restructuring techniquesGroup receiving coping intervention designed to enhance coping and psychological adjustment |
| 3 | No intervention | –Comparison control group with no active intervention |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Diagnosis of systemic lupus erythematosus (SLE)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping skills and cognitive restructuring techniquesAlso: HELP - Health Education for Lupus PatientsThis 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. | Behavioural | 2 |
| Educational trainingParticipants will attend five study visits that will include disease-appropriate education materials. | Behavioural | 1 |
Primary outcome
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
1 secondary outcome
SLEDAI (measure of disease status)
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald T. Brown, PhD principal investigator
Department of Public Health - Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coping skills and cognitive restructuring techniques and Educational training in people with Lupus, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BASC scores (measures of general adjustment) (time frame: 4 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.