Behavior Therapy for Families of Diabetic Adolescents
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to
      work together effectively to solve problems and resolve disagreements in order to achieve
      acceptable diabetic control and treatment adherence. Many studies show that problematic
      family communication, insufficient parental involvement in care and parent-adolescent
      conflict are associated with poor adherence and poor diabetic control. This study tests a
      family communication and problem solving intervention by randomizing families of adolescent
      with type 1 diabetes to 6 months' treatment either with the experimental intervention,
      continuation in standard medical care for diabetes, or participation in a multifamily
      educational support group. Families are then followed for an additional 12 months to examine
      the longer-term effects of the interventions on the targeted diabetes outcomes.
    

Detailed description: 
      Adolescents with Type 1 diabetes mellitus often struggle to maintain adequate treatment
      adherence and diabetic control, leading to preventable hospitalizations and emergency room
      visits. Numerous cross-sectional and prospective studies show that family communication and
      conflict resolution skills are important influences on adolescents' diabetic control,
      treatment adherence and psychological adjustment. Empirical validation of psychological
      interventions targeting these processes could reduce excess health care costs and risks of
      diabetic complications. In the parent grant, we showed that Behavioral Family Systems Therapy
      (BFST; Robin & Foster, 1989) yielded improvements in family communication skills and
      parent-adolescent relationships, but it had weaker and less durable effects on treatment
      adherence and diabetic control. In this competing continuation application, we have relied on
      extensive preliminary data, our clinical experience with BFST and the results of others'
      investigations to formulate refinements to BFST that are designed to maximize its impact on
      diabetes treatment adherence and metabolic control. These include required targeting of
      behavioral barriers to adherence and diabetic control for every family, lengthening treatment
      from 3 to 6 months, and incorporation of several treatment components that were shown to be
      effective in other studies. We propose a randomized, controlled trial of this refined BFST
      intervention compared with standard medical therapy or participation in a diabetes
      educational support group on measures of: family communication, parent-adolescent
      relationships, adolescent psychological adjustment, treatment adherence, diabetic control and
      health care use. We will analyze predictors of treatment outcome and evaluate the clinical
      significance, social validity and maintenance of treatment effects over 6month and 12-month
      follow-up intervals. The results could influence the clinical practice of diabetes management
      and health care policy regarding adolescents with diabetes and other chronic diseases.
    

Intervention name(s): Behavioral Family Systems Therapy for Diabetes
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus; adolescence; adherence; glycemic control; adaptation; communication