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

Diabetes Mellitus, Type 2 Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159221
• Other study ID #: Buckloh
• Status: Completed
• Phase: N/A
• First received: October 6, 2015
• Last updated: May 17, 2017
• Start date: April 2011
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Pediatric Obesity

Intervention

Behavioral:
• BFST for Teens with Type 2 Diabetes
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.

Locations

Country	Name	City	State
United States	Nemours Children's Specialty Care	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index (weight status) at 6 months and at 12 months	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	baseline, 6 months after baseline, 12 months after baseline
Secondary	metabolic control (HbA1c)	Metabolic control is measured using HbA1c values	baseline, 6 months after baseline, 12 months after baseline
Secondary	Treatment Adherence	Treatment Adherence is measured using the Diabetes Self Management Survey for Teens with Type 2 Diabetes.	baseline, 6 months after baseline, 12 months after baseline
Secondary	Family Problem-solving	Family problem-solving is measured using the Revised Diabetes Family Conflict Scale	baseline, 6 month after baseline
Secondary	Physical activity	Physical activity is measured by an accelerometer	baseline, 6 months after baseline
Secondary	Body Fat (weight status)	Body fat percent change - measured by a hand-held body fat impedance device	baseline, 6 months after baseline, 12 months after baseline
Secondary	Waist Circumference (weight status)	Waist circumference in cm	baseline, 6 months after baseline, 12 months after baseline
Secondary	Food intake	Nutrition/food intake as measured by the Nutrition Data Systems for Research interview	baseline, 6 months after baseline
Secondary	Family communication skills	Family communication skills are measured by the Family Communication (Interaction Behavior Code)	baseline, 6 months after baseline
Secondary	Teen Self-esteem	Teen Self-Perception/Self-esteem is measured by the Harter Self-Perception Profile	baseline, 6 months after baseline
Secondary	Teen Quality of Life	Teen Quality of Life is measured by The Pediatric Quality of Life Inventory (PedsQL)	baseline, 6 months after baseline