Behavioral Family Systems Therapy (BFST) for Teens With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Childhood Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Pediatric Obesity
Study type: Interventional

Summary: 
      This is a randomized, controlled pilot trial of Behavioral Family Systems Therapy for Teens
      with Type 2 Diabetes (BFST-DM2), an individual psychological intervention tailored to meet
      the needs of teens with type 2 diabetes. It is hypothesized that this behavioral family
      intervention will be feasible to implement with teens with type 2 diabetes and will have
      positive effects on treatment adherence, health outcomes like weight status and metabolic
      control, and psychological outcomes.
    

Detailed description: 
      The incidence of type 2 diabetes mellitus (DM2) in youth is increasing dramatically with the
      rise in obesity in the U.S. and worldwide. DM2 in youth, as with adults, is clearly linked to
      modifiable risk factors such as obesity, sedentary lifestyle, and poor diet. Youth with DM2
      are at increased risk for medical complications such as cardiovascular disease, retinopathy,
      and neuropathy, as well as psychological problems such as depression, anxiety, poor
      self-esteem, eating disorders, and poor coping and problem solving. Although there are
      studies demonstrating that family-based lifestyle and psychological interventions are
      successful in reducing obesity in youth and in improving metabolic control and adherence in
      youth with type 1 diabetes mellitus (DM1), very little has been published on potential
      lifestyle or psychological treatments for youth with DM2. Studies have shown that Behavioral
      Family Systems Therapy (BFST) has been effective in improving metabolic control, adherence,
      family communication, and problem solving in youth with DM1. This intervention could be
      effective in treating youth with DM2, as many of the skills necessary for good metabolic
      control, health outcomes, treatment adherence, and psychological adjustment are similar in
      both populations. This application proposes a randomized, controlled pilot trial of BFST-DM2,
      an individual psychological intervention tailored to meet the needs of teens with DM2. BFST
      will be adapted to make this intervention more feasible and relevant with minority and
      low-income populations and also to focus on weight management, exercise, and nutrition. The
      BFST-DM2 intervention includes 12 (90-minute) sessions over 6 months. Areas targeted for
      improvement will include metabolic control, weight/body mass index, treatment adherence,
      family lifestyle choices (activity, diet), family communication, and problem solving. One of
      the main aims of this pilot study is to gather exploratory information on the effectiveness
      of the BFST-DM2 intervention on measures of health outcomes, medical adherence, lifestyle
      changes, and family problem-solving and communication skills. In addition, it is an aim to
      estimate treatment effect size to determine the sample size needed to power a larger
      multi-site trial of the BFST-DM2 intervention. Other aims include determining factors
      associated with feasibility (recruitment, retention, participation, generalizability) as well
      as to modify the intervention to be culturally sensitive and to be more relevant to the
      individual needs of the DM2 adolescent population. The BFST-DM2 intervention will be compared
      with standard medical therapy on measures of health outcomes (metabolic control, body mass
      index, weight, waist circumference, body fat) physical activity (accelerometer), nutritional
      intake, treatment adherence, psychological adjustment (self-esteem, quality of life), family
      communication, and problem solving. The researchers will analyze predictors of treatment
      outcome and the treatment effects at the immediate post-treatment interval (6 months from
      baseline). Health outcomes and medical adherence data also will be collected 12 months from
      baseline to determine maintenance of treatment effects over time.
    

Intervention name(s): BFST for Teens with Type 2 Diabetes
Intervention type(s): Behavioral
Intervention description(s): BFST for Teens with Type 2 Diabetes: 12 (90 minute sessions) over 6 months of Behavioral Family Systems Therapy (BFST), delivered by a Licensed clinical social worker. BFST consists of 4 components: problem-solving, communication skills training, cognitive restructuring, and functional and structural family therapy.
Other intervention name(s): BFST - Behavioral Family Systems Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes in adolescents; obesity in adolescents; behavioral family systems therapy