Prevention of Self-care Deterioration in Early Adolescents With Diabetes

Family Teamwork and Coping Skills Prevention Program

Establish the efficacy of a brief, clinic-based prevention program of teamwork coping skills for youth and their parents during in a high risk period of early adolescence (11-14 yrs) when parental involvement and self-care deterioration occurs.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Diabetes Education; Behavioral: TeamWork CS Sessions

Detailed Description

Promotion of optimal disease care and metabolic control in youth with Type 1 diabetes is an important goal of disease management during early adolescence. Typically youth assume increasing responsibility for these goals along with parental involvement and guidance. However, as youth progress through adolescence, parents often become less involved in diabetes management and poorer self-care and metabolic control often results.

The goal of the prevention program is to encourage parents to remain involved in their child's diabetes care throughout adolescence and to provide tools to help make that involvement a positive experience. To minimize parent/child conflict that may accompany sustained parental involvement, sessions of the active treatment review the following coping skills: communication, problem solving, conflict resolution, attitude and behavior change. Meetings occur in-clinic in conjunction with four consecutive medical appointments.

The educational comparison group also meets with study researchers for in-clinic sessions that occur in conjunction with four consecutive medical appointments. Families discuss a variety of helpful educational diabetes topics and resources.

The overarching project goal is to demonstrate the efficacy of a brief, prevention focused coping skills program for youth with type 1 diabetes and their parents with the ultimate goal of translation into routine pediatric care.

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Seen for Diabetes care at Virginia Commonwealth University or Children's National Medical Center
• Child ages 11-14
• Type 1 Diabetes
• Fluent in English
• Ability to comprehend and complete questionnaires independently

Exclusion Criteria:

• The presence of any other major disease
• The presence of any severe diabetic complications which could impair test performance
• Use of any medication that affects the CNS other than insulin
• Inability to speak/comprehend and read English
• Placement in special classes for the mentally disabled

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diabetes Education	Behavioral: Diabetes Education; Diabetes Education The education comparison group meets with an educational interventionist in conjunction with four consecutive medical appointments. This group focuses on diabetes educational and resource support for parents and their youth with type 1 diabetes.
Experimental: TeamWork CS Sessions	Behavioral: TeamWork CS Sessions; The intervention focuses on an authoritative parenting approach that emphasizes continued parental involvement in daily disease care. Dyadic coping skills of communication, problem solving, conflict resolution, along with attitude and behavior change are highlighted. Families meet with a study interventionist in conjunction with four consecutive medical appointments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parental involvement and Disease care behaviors	Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Glycohemoglobin levels, Adverse effects and Blood glucose variability	Baseline, 3, 6, 9, 12, 15, 18, and 24 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Children's National Research Institute
• Investigators: Principal Investigator: Randi Streisand, Ph.D., Children's National Research Institute; Principal Investigator: Clarissa S Holmes, Ph.D., Virginia Commonwealth University; Study Director: Rusan Chen, Ph.D., Georgetown University

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 23, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 6, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: DK70917; R01DK070917 (U.S. NIH Grant/Contract)