Prevention of Self-care Deterioration in Early Adolescents With Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TeamWork CS Sessions
Diabetes Education
Sponsored by
About this trial
This is an interventional prevention trial for Type 1 Diabetes
Eligibility 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
Sites / Locations
- Children's National Medical Center
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Diabetes Education
TeamWork CS Sessions
Arm Description
Outcomes
Primary Outcome Measures
Parental involvement and Disease care behaviors
Secondary Outcome Measures
Glycohemoglobin levels, Adverse effects and Blood glucose variability
Full Information
NCT ID
NCT00890331
First Posted
April 23, 2009
Last Updated
January 6, 2016
Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00890331
Brief Title
Prevention of Self-care Deterioration in Early Adolescents With Diabetes
Official Title
Family Teamwork and Coping Skills Prevention Program
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's National Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes Education
Arm Type
Active Comparator
Arm Title
TeamWork CS Sessions
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
TeamWork CS Sessions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parental involvement and Disease care behaviors
Time Frame
Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months
Secondary Outcome Measure Information:
Title
Glycohemoglobin levels, Adverse effects and Blood glucose variability
Time Frame
Baseline, 3, 6, 9, 12, 15, 18, and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarissa S Holmes, Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Randi Streisand, Ph.D.
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rusan Chen, Ph.D.
Organizational Affiliation
Georgetown University
Official's Role
Study Director
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prevention of Self-care Deterioration in Early Adolescents With Diabetes
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