This R21 pilot study is a randomized controlled trial (RCT) of an innovative educational and behavioral web-based adherence promotion program for parents of children with juvenile arthritis (JA). It will allow us to systematically develop the intervention and to collect sufficient pilot data to justify a suitably large randomized clinical trial. The proposed study addresses behavioral and biopsychosocial research priorities of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), specifically """"""""studies on non- pharmacological interventions and combined interventions, including development and testing of individual, group, and technology-based interventions to enhance self-management and improve health-related behaviors"""""""" .Nonadherence to medical regimens poses a significant threat to the health and quality of life of children and adolescents with chronic pediatric diseases . Children with JA and their parents are usually asked to adhere consistently and over a long period of time to a variety of therapeutic regimens, most notably, medications, therapeutic exercises, and splinting of joints. Many of these regimens may have delayed beneficial effects and in the short term may cause unwanted side effects, such as gastrointestinal irritation and pain. The need for consistent adherence over a long period of time, delayed beneficial effects, and negative side effects have all been predictive factors of greater adherence problems in pediatric chronic diseases . The primary aim of this proposal is to develop and pilot test """"""""Adherence-Strong for JA"""""""", a program designed to help parents enhance their children's adherence to medical regimens for JA, including medications, therapeutic exercise, and splinting of joints. After developing and testing the program with 4 to 6 parents, we will conduct a pilot study wherein 64 parents of children with JA will be randomly assigned to the Adherence-strong program or a wait-list control. Measures of adherence (electronic monitoring and parent ratings) and quality of life will be obtained at baseline, immediate post-treatment and 3-month follow-up. Hypotheses are that children whose parents receive the Adherence-strong program will demonstrate higher adherence and quality of life compared to children whose parents were assigned to the wait-list control group. If this pilot study is successful, a larger multi-site R01 RCT will be proposed to further validate the Adherence-strong program.
This R21 pilot study is a randomized controlled trial (RCT) of an innovative educational and behavioral web- based adherence promotion program for parents of children with juvenile arthritis (JA). It will allow us to systematically develop the intervention and to collect sufficient pilot data to justify a suitably large randomized clinical trial.