Behavior Therapy for Families of Diabetic Adolescents

This study has been completed.
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by:
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00358059
First received: July 26, 2006
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to work together effectively to solve problems and resolve disagreements in order to achieve acceptable diabetic control and treatment adherence. Many studies show that problematic family communication, insufficient parental involvement in care and parent-adolescent conflict are associated with poor adherence and poor diabetic control. This study tests a family communication and problem solving intervention by randomizing families of adolescent with type 1 diabetes to 6 months' treatment either with the experimental intervention, continuation in standard medical care for diabetes, or participation in a multifamily educational support group. Families are then followed for an additional 12 months to examine the longer-term effects of the interventions on the targeted diabetes outcomes.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Behavioral: Behavioral Family Systems Therapy for Diabetes
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavior Therapy for Families of Diabetic Adolescents

Resource links provided by NLM:


Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbA1c)
  • Treatment adherence

Secondary Outcome Measures:
  • Parent-adolescent communication
  • Family problem solving and conflict resolution skills
  • Diabetes-related quality of life

Estimated Enrollment: 120
Study Start Date: October 2000
Estimated Study Completion Date: January 2006
Detailed Description:

Adolescents with Type 1 diabetes mellitus often struggle to maintain adequate treatment adherence and diabetic control, leading to preventable hospitalizations and emergency room visits. Numerous cross-sectional and prospective studies show that family communication and conflict resolution skills are important influences on adolescents' diabetic control, treatment adherence and psychological adjustment. Empirical validation of psychological interventions targeting these processes could reduce excess health care costs and risks of diabetic complications. In the parent grant, we showed that Behavioral Family Systems Therapy (BFST; Robin & Foster, 1989) yielded improvements in family communication skills and parent-adolescent relationships, but it had weaker and less durable effects on treatment adherence and diabetic control. In this competing continuation application, we have relied on extensive preliminary data, our clinical experience with BFST and the results of others' investigations to formulate refinements to BFST that are designed to maximize its impact on diabetes treatment adherence and metabolic control. These include required targeting of behavioral barriers to adherence and diabetic control for every family, lengthening treatment from 3 to 6 months, and incorporation of several treatment components that were shown to be effective in other studies. We propose a randomized, controlled trial of this refined BFST intervention compared with standard medical therapy or participation in a diabetes educational support group on measures of: family communication, parent-adolescent relationships, adolescent psychological adjustment, treatment adherence, diabetic control and health care use. We will analyze predictors of treatment outcome and evaluate the clinical significance, social validity and maintenance of treatment effects over 6month and 12-month follow-up intervals. The results could influence the clinical practice of diabetes management and health care policy regarding adolescents with diabetes and other chronic diseases.

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age of adolescent 12-<17 years Type 1 diabetes for >2 years Living in a home environment English reading ability at 5th grade level or above Established diabetes care at participating site Working telephone service Intent to remain living in same region for next 18 months -

Exclusion Criteria:

Presence of another chronic systemic disease Inpatient psychiatric treatment of patient or caregiver in prior 6 months Current outpatient treatment of psychosis, major depression or substance use disorder in parent/caregiver

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358059

Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
United States, Missouri
Washington University in St. Louis School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Nemours Children's Clinic
Washington University School of Medicine
Investigators
Principal Investigator: Tim Wysocki, Ph.D. Nemours Children's Clinic
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00358059     History of Changes
Other Study ID Numbers: R01-DK43802
Study First Received: July 26, 2006
Last Updated: July 26, 2006
Health Authority: United States: Federal Government

Keywords provided by Nemours Children's Clinic:
diabetes mellitus
adolescence
adherence
glycemic control
adaptation
communication

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014