Skip to main content
OpenTrials
Completed

NCT Number: NCT03159221

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Specialty Care

Jacksonville, Florida, 32207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BFST for Teens with Type 2 Diabetes

Behavioral

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 names: BFST - Behavioral Family Systems Therapy

Primary outcomes

  1. Change in Body Mass Index (weight status) at 6 months and at 12 months

    Time frame: baseline, 6 months after baseline, 12 months after baseline

    Body Mass Index (adjusted for height, gender, and age) - height and weight in kg and meters (kg/m^2) - change in BMI across time points is being studied - change in weight from baseline to 6 months and change in weight from baseline to 12 months

Secondary outcomes

  1. metabolic control (HbA1c)

    Time frame: baseline, 6 months after baseline, 12 months after baseline

    Metabolic control is measured using HbA1c values

  2. Treatment Adherence

    Time frame: baseline, 6 months after baseline, 12 months after baseline

    Treatment Adherence is measured using the Diabetes Self Management Survey for Teens with Type 2 Diabetes.

  3. Family Problem-solving

    Time frame: baseline, 6 month after baseline

    Family problem-solving is measured using the Revised Diabetes Family Conflict Scale

  4. Physical activity

    Time frame: baseline, 6 months after baseline

    Physical activity is measured by an accelerometer

  5. Body Fat (weight status)

    Time frame: baseline, 6 months after baseline, 12 months after baseline

    Body fat percent change - measured by a hand-held body fat impedance device

  6. Waist Circumference (weight status)

    Time frame: baseline, 6 months after baseline, 12 months after baseline

    Waist circumference in cm

  7. Food intake

    Time frame: baseline, 6 months after baseline

    Nutrition/food intake as measured by the Nutrition Data Systems for Research interview

  8. Family communication skills

    Time frame: baseline, 6 months after baseline

    Family communication skills are measured by the Family Communication (Interaction Behavior Code)

  9. Teen Self-esteem

    Time frame: baseline, 6 months after baseline

    Teen Self-Perception/Self-esteem is measured by the Harter Self-Perception Profile

  10. Teen Quality of Life

    Time frame: baseline, 6 months after baseline

    Teen Quality of Life is measured by The Pediatric Quality of Life Inventory (PedsQL)

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

Behavioral Family Systems Therapy for Teens With Type 2 Diabetes: A Pilot

Acronym: ADAPT

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 18, 2017
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.