Juvenile Arthritis Clinical Trial
Official title:
Jointstrong Intervention for Juvenile Arthritis
This study is a randomized wait-list controlled trial with repeated measures. There will be two groups: (1) standard medical care (wait-list control), and (2) standard medical care plus the adjunctive Jointstrong pain coping skills CD-ROM program (treatment). The study will have four phases: Pre-intervention Baseline (2 weeks); Intervention (4 weeks); immediate post-intervention follow up (2 weeks); and 12-week post-intervention follow up (2 weeks). The purpose of this study is to determine if using a CD-ROM program for juvenile arthritis can help children learn how to improve their symptoms on their own and reduce the frequency of symptoms.
If your child is eligible and decides to participate in this study, this participation will
last approximately eight weeks. Please refer to the table at the end of this consent form.
Your child's participation in this study will involve the completion of daily questionnaires
during a one-week baseline period and a one-week follow-up period. These questionnaires will
contain various questions about your child's arthritis and his/her ability to do various
activities. The questionnaires will take approximately 15-30 minutes each week to complete.
Your child will be randomly assigned to complete one of two CD-ROM programs. One of the
CD-ROM programs is a "control" program that contains educational information about arthritis
and medical treatments and the other is the "treatment" program and contains the same
educational information as the control program plus information on behavioral strategies for
controlling symptoms of arthritis. Your child's participation in this study will involve
working through one of these CD-ROM programs over a one-month period. Your child will also
continue to receive medical treatment from the rheumatologist treating your child for
arthritis. The CD-ROM programs involve working through developmentally appropriate lessons
on the nature of arthritis and how to treat it. The CD-ROM programs are divided into weekly
"modules" and are designed to be completed within four weeks. Lessons take an average of 15
minutes to complete (plus "homework"), and there is an average of 4 lessons to complete each
week.
Your participation in this study will involve the completion of questionnaires and helping
your child understand any parts of the study that he or she does not understand.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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