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Prevention of Self-care Deterioration in Early Adolescents With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00890331
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : January 8, 2016
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's National Research Institute
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: TeamWork CS Sessions Behavioral: Diabetes Education Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Family Teamwork and Coping Skills Prevention Program
Study Start Date : April 2007
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Parental involvement and Disease care behaviors [ Time Frame: Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months ]

Secondary Outcome Measures :
  1. Glycohemoglobin levels, Adverse effects and Blood glucose variability [ Time Frame: Baseline, 3, 6, 9, 12, 15, 18, and 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00890331

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United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
Virginia Commonwealth University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's National Research Institute
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Principal Investigator: Clarissa S Holmes, Ph.D. Virginia Commonwealth University
Principal Investigator: Randi Streisand, Ph.D. Children's National Research Institute
Study Director: Rusan Chen, Ph.D. Georgetown University
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Responsible Party: Virginia Commonwealth University Identifier: NCT00890331    
Other Study ID Numbers: DK70917
R01DK070917 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases