Rheumatologic Conditions (JRA,Lupus)Phase 2NCT00359775
Coping Skills Training (CST) for Children With Chronic Health Conditions
A Phase 2 study testing Coping Skills Training in people with Rheumatologic Conditions (JRA,Lupus) and Epilepsy, run by Children's Hospital and Health System Foundation, Wisconsin at 1 site in United States.
Trial summary
Purpose of the study The purpose of this study is to pilot an adapted Coping Skills Training (CST) intervention for feasibility and preliminary efficacy with a sample of children 8 to 12 years of age and their parents. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Rheumatologic Conditions (JRA,Lupus), Epilepsy, Spina Bifida
- What is being tested?
- Coping Skills Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jan 2012
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children ages 8 to 12 with no known severe cognitive delays,
- Who are English speaking,
- With one of the three target conditions; and
- Have at least one parent willing to participate.
Who cannot join
- Children with cognitive delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
About this study
Official title: Coping Skills Training (CST) for Children With Chronic Health Conditions: An Extension From Children With Diabetes to Children With Rheumatologic Conditions, Epilepsy, Spina Bifida, and Asthma
Purpose of the study The purpose of this study is to pilot an adapted Coping Skills Training (CST) intervention for feasibility and preliminary efficacy with a sample of children 8 to 12 years of age and their parents. The participants in this study at Children's Hospital of Wisconsin are dealing with one of three chronic health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma).
Research Questions/Study Aims
Read more
The research questions addressed in the full study are:
- What is the impact of CST on child depression, QOL, health motivation, attitude toward illness, and self-management efficacy?
- What is the impact of CST on parent depression, perception of child's quality of life, perception of impact of CHC on family, and family conflict?
Read the detailed description
Many children with chronic health conditions (CHC) are at increased risk for poor adaptation such as psychosocial problems, behavioral disturbances, and decreased quality of life (QOL). Their parents face economic, social and emotional challenges. In addition, management of the CHC and the involvement of the child in that management can severely challenge both child and parent. Effective coping has been shown to moderate the negative impact of CHC. This study is a pilot study to evaluate the feasibility and preliminary efficacy of adapting a Coping Skills Training (CST) intervention developed for children with diabetes. The CST intervention will be adapted for an integrated sample of school-aged children 8 to 12 years of age with four health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma). The study will be a randomized clinical trial with a wait-list control group. Each arm will consist of 25 families. CST is a 6-session group intervention based on cognitive behavioral and learning theory. The impact of CST on both outcomes (child: depression, QOL; parent: depression, Child QOL, CHC impact on family) and protective factors (child: health motivation, attitude, self-management efficacy; parent: family conflict) will be measured.
- Conditions
- Rheumatologic Conditions (JRA,Lupus), Epilepsy, Spina Bifida, Asthma
- Being tested
- Coping Skills Training
- Keywords
- Coping, psychosocial, Quality of Life, problem solving
- Medical subject headings
- Epilepsy, Spinal Dysraphism, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Skills TrainingBehavioural
6 session behavioral program
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Depression measured by Child Depression Inventory (CDI)
Measured: ongoing
Parent Depression measured by Beck Depression inventory (BDI)
Measured: ongoing
Quality of life measured by Child Health Questionnaire
Measured: ongoing
Impact on Family measured by the Impact of Family Scale.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatologic Conditions (JRA,Lupus)Studies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital and Health System Foundation, Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Principal investigator, Betsy Roth-Wojcicki, Children's Hospital and Health System Foundation, Wisconsin
- Investigators
- Betsy Roth-Wojcicki, MS, CPNP, Principal investigator, Medical College of Wisconsin/Children's Hospital of WisconsinKathleen Sawin, DNS, CPNP,, Principal investigator, University of Wisconsin Milwaukee/Children's Hopsital of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359775
- Sponsor's protocol ID
- CHW 06/32,GC 95
- Other IDs
- UWM # 06-02-208
- Status last verified
- Feb 2012
- First submitted
- 31 Jul 2006
- Last updated
- 20 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping Skills Training (CST) for Children With Chronic Health Conditions: An Extension From Children With Diabetes to Children With Rheumatologic Conditions, Epilepsy, Spina Bifida, and Asthma
- ClinicalTrials.gov ID
- NCT00359775
- Acronym / sponsor ID
- CHW 06/32,GC 95
- Conditions
- Rheumatologic Conditions (JRA,Lupus), Epilepsy, Spina Bifida, Asthma
- Keywords
- Coping, psychosocial, Quality of Life, problem solving
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Children's Hospital and Health System Foundation, WisconsinUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- Jul 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Aug 2006 (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.
Purpose of the study The purpose of this study is to pilot an adapted Coping Skills Training (CST) intervention for feasibility and preliminary efficacy with a sample of children 8 to 12 years of age and their parents. The participants in this study at Children's Hospital of Wisconsin are dealing with one of three chronic health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma).
Research Questions/Study Aims
The research questions addressed in the full study are:
- What is the impact of CST on child depression, QOL, health motivation, attitude toward illness, and self-management efficacy?
- What is the impact of CST on parent depression, perception of child's quality of life, perception of impact of CHC on family, and family conflict?
Detailed description
Many children with chronic health conditions (CHC) are at increased risk for poor adaptation such as psychosocial problems, behavioral disturbances, and decreased quality of life (QOL). Their parents face economic, social and emotional challenges. In addition, management of the CHC and the involvement of the child in that management can severely challenge both child and parent. Effective coping has been shown to moderate the negative impact of CHC. This study is a pilot study to evaluate the feasibility and preliminary efficacy of adapting a Coping Skills Training (CST) intervention developed for children with diabetes. The CST intervention will be adapted for an integrated sample of school-aged children 8 to 12 years of age with four health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma). The study will be a randomized clinical trial with a wait-list control group. Each arm will consist of 25 families. CST is a 6-session group intervention based on cognitive behavioral and learning theory. The impact of CST on both outcomes (child: depression, QOL; parent: depression, Child QOL, CHC impact on family) and protective factors (child: health motivation, attitude, self-management efficacy; parent: family conflict) will be measured.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female children ages 8 to 12 with no known severe cognitive delays,
- Who are English speaking,
- With one of the three target conditions; and
- Have at least one parent willing to participate.
Key exclusion criteria (1 listed)
- Children with cognitive delay
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 Training6 session behavioral program | Behavioural | – |
Primary outcome
Child Depression measured by Child Depression Inventory (CDI)
Time frame: ongoing
Parent Depression measured by Beck Depression inventory (BDI)
Time frame: ongoing
Quality of life measured by Child Health Questionnaire
Time frame: ongoing
Impact on Family measured by the Impact of Family Scale.
Time frame: ongoing
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 20 Feb 2012.
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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.
Betsy Roth-Wojcicki, MS, CPNP principal investigator
Medical College of Wisconsin/Children's Hospital of Wisconsin
Kathleen Sawin, DNS, CPNP, principal investigator
University of Wisconsin Milwaukee/Children's Hopsital of Wisconsin
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 Training in people with Rheumatologic Conditions (JRA,Lupus) and Epilepsy, run by Children's Hospital and Health System Foundation, Wisconsin 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 4 inclusion and 1 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 20 Feb 2012. 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?
Child Depression measured by Child Depression Inventory (CDI) (time frame: ongoing). The study lists 4 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 20 Feb 2012.