Clinical trial NCT03159221: Behavioral Family Systems Therapy (BFST) for Teens With Type 2 Diabetes
Official title: Behavioral Family Systems Therapy for Teens With Type 2 Diabetes: A Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Childhood Obesity
Keywords: type 2 diabetes in adolescents
obesity in adolescents
behavioral family systems therapy
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 24
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Body Mass Index (weight status) at 6 months and at 12 months
timeFrame: baseline, 6 months after baseline, 12 months after baseline
Secondary outcomes:
measure: metabolic control (HbA1c)
timeFrame: baseline, 6 months after baseline, 12 months after baseline
measure: Treatment Adherence
timeFrame: baseline, 6 months after baseline, 12 months after baseline
measure: Family Problem-solving
timeFrame: baseline, 6 month after baseline
measure: Physical activity
timeFrame: baseline, 6 months after baseline
measure: Body Fat (weight status)
timeFrame: baseline, 6 months after baseline, 12 months after baseline
measure: Waist Circumference (weight status)
timeFrame: baseline, 6 months after baseline, 12 months after baseline
measure: Food intake
timeFrame: baseline, 6 months after baseline
measure: Family communication skills
timeFrame: baseline, 6 months after baseline
measure: Teen Self-esteem
timeFrame: baseline, 6 months after baseline
measure: Teen Quality of Life
timeFrame: baseline, 6 months after baseline
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Specialty Care
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Lisa M Buckloh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: