Family Management of Type 1 Diabetes in Children
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized controlled trial to test whether a clinic-integrated, low
      intensity, multi-component behavioral intervention is effective in preventing the
      deterioration in glycemic control, treatment adherence, and quality of life that commonly
      occur during late childhood and early adolescence in youth with type 1 diabetes. The study
      will also examine mechanisms and processes that influence the effectiveness of family
      management of diabetes during this developmental period.
    

Detailed description: 
      The purpose of this study is to test the effectiveness of a practical, low-cost,
      low-intensity behavioral intervention that can be integrated directly into diabetes clinic
      routines. The goal of the intervention is to prevent the deterioration in glycemic control,
      treatment adherence, and quality of life that often occur during the transition to
      adolescence in families of youth with type 1 diabetes. Four-hundred and eighty families (120
      from each of the four sites) will be randomly assigned by the coordinating center to
      intervention or standard care conditions. Standard care will be the multidisciplinary
      management of type 1 diabetes as currently practiced at the clinical sites. Randomization
      will be stratified by main versus recent-onset subgroup, age, and for the main subgroup,
      baseline glycosylated hemoglobin level. Families will remain in their respective experimental
      conditions for 24 months. A trained health advisor will be responsible for interactions with
      parents and patients prior to each diabetes clinic visit (preparation phase), at the time of
      the diabetes clinic visit (consolidation phase) and by phone, e-mail, etc. after the clinic
      visit (follow-up phase). Using educational modules developed for the study, families will be
      engaged in problem identification and solving activities to foster improved disease
      management capabilities and improved parent-youth communication around and sharing of
      responsibility for diabetes management. Families will be assessed at home three times and in
      the clinic four times over the course of the study. Measures include parent, child, and
      family characteristics that may affect intervention effectiveness, targeted mediators, family
      interaction, management practices, and glycosylated hemoglobin (HbA1c). Primary outcomes are
      diabetes management adherence and metabolic control; secondary outcomes are quality of life,
      health status, and psychosocial status.
    

Intervention name(s): family diabetes management intervention
Intervention type(s): Behavioral
Intervention description(s): a clinic-integrated, low intensity, multi-component behavioral intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetes Mellitus, Insulin-Dependent; Diabetes Mellitus, Juvenile-Onset; IDDM; Type 1 Diabetes Mellitus