Behavioral Family Systems Therapy (BFST) for Teens With Type 2 Diabetes

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.

Inclusion Criteria:

- Diagnosed with type 2 diabetes mellitus for 6 months or more

- Age-adjusted Body Mass Index at or above the 85th percentile (considered overweight)

- Established diabetes care in Nemours Children's Clinic system or diabetes care meets
minimum criteria for current American Diabetes Association Standards.

- Adolescent lives at home in the study geographical area (Jacksonville, FL)over the
course of the study duration (one year).

- One caregiver in the home is willing to participate in the family intervention.

Exclusion Criteria:

- Adolescent has another systemic chronic disease other than well-controlled asthma.

- Genetic syndrome or disorder (other than diabetes) known to affect glucose tolerance.

- Daily use of glucocorticoids or other medications known to affect glucose tolerance.

- Teen is enrolled in special education for students who have autism or are mentally
handicapped.

- Adolescent is pregnant or planning to be pregnant within 1 year.

- Teen resides in temporary foster care, group home, or juvenile detention center.

- The family has an open case with an agency investigating child abuse or neglect.

- Adolescent has been in an inpatient psychiatric facility or substance abuse treatment
in the past 6 months.