Family Management of Childhood Diabetes Study
Condition: Diabetes; Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the effectiveness of a practical, low-cost, problem-solving method
      called WE CAN that can be taught to families at diabetes clinics. The goal is to see if this
      teaching and support can help with controlling the level of blood sugar in children with type
      1 diabetes as they approach adolescence. Attention would go to young people's completion of
      tasks necessary to manage diabetes, quality of life, and psychological adjustments, plus the
      role of the family in these situations. Type 1 diabetes mellitus, accounting for less than
      10% of the disease cases, is marked by the inability of the pancreas to secrete insulin.
      People who have it must consistently manage their disease. Successful disease management for
      children depends on the family's adaptation to treatment demands. Yet maintaining acceptable
      blood sugar control becomes more difficult for adolescents, owing to changes in the body
      during that period of life. Also, early adolescence is a vital time in people's development
      of health outcomes. The title WE CAN is a way to remember the steps of the problem-solving
      method:

        -  Work together to set goals

        -  Explore barriers and solutions

        -  Choose the best solutions

        -  Act on your plan

        -  Note the results

      Children who have reached age 9 but are not yet 14.5 years who have had type 1 diabetes for
      at least 1 year and who have had at least two visits to diabetes clinics at one of four
      clinical sites may be eligible for this study. A total of 120 children will participate in
      clinic visits once every 3 months.

      Participants and their families will attend diabetes clinic visits once every 3 months. They
      will be assigned to one of two groups: standard care or WE CAN. Those in the WE CAN group
      will have visits about 15 to 45 minutes longer than those involved in the standard care
      group. All participants will have two home visits: at the beginning and at 6 months. There
      will also be telephone interviews, about 20 minutes long, once every 3 months with the
      children and their parents. Medical data will be collected during each visit to the clinic,
      including blood samples. A health advisor will work with the families. Questionnaires given
      to parents and children separately will measure diabetes-related family conflict, parent
      child sharing of responsibilities for the disease, attitudes and emotions about diabetes, and
      impact of the disease on the child's life. Also, parents and children together will take part
      in a 10-minute discussion of a diabetes-related issue that has caused friction among family
      members. They will discuss the problem, come up with possible solutions, and to try to decide
      on a solution within 10 minutes. Family discussions will be videotaped at the first home
      visit and at the 6-month home visit.

      Families in both groups will receive more detailed monitoring of family diabetes management
      than is usually the case. Those in the WE CAN group may be able to control diabetes more
      effectively during the child's early adolescence, though that result is not guaranteed. If
      the family guidance and support provided by the WE CAN health advisor is effective, children
      in that group may have better results in blood sugar than they would if they did not
      participate in the study. Each family member completing the first and 6-month visits and
      completing each telephone interview will receive payment for participating.
    

Detailed description: 
      This protocol describes 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.
    

Intervention name(s): Blood testing
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: Adherence; Education; Problem Solving; Motivation; Locus of Responsibility