Prevention of Self-care Deterioration in Early Adolescents With Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Research Institute
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00890331
First received: April 23, 2009
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Type 1 Diabetes
Behavioral: TeamWork CS Sessions
Behavioral: Diabetes Education
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Family Teamwork and Coping Skills Prevention Program

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Parental involvement and Disease care behaviors [ Time Frame: Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycohemoglobin levels, Adverse effects and Blood glucose variability [ Time Frame: Baseline, 3, 6, 9, 12, 15, 18, and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: April 2007
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890331

Locations
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
Children's Research Institute
Investigators
Principal Investigator: Clarissa S Holmes, Ph.D. Virginia Commonwealth University
Principal Investigator: Randi Streisand, Ph.D. Children's Research Institute
Study Director: Rusan Chen, Ph.D. Georgetown University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00890331     History of Changes
Other Study ID Numbers: DK70917, R01DK070917
Study First Received: April 23, 2009
Last Updated: August 21, 2013
Health Authority: United States: Federal Government

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 August 20, 2014