Prevention of Self-care Deterioration in Early Adolescents With Diabetes
Family Teamwork and Coping Skills Prevention Program
2 other identifiers
interventional
285
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2007
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 23, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedJanuary 8, 2016
January 1, 2016
6.9 years
April 23, 2009
January 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Parental involvement and Disease care behaviors
Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months
Secondary Outcomes (1)
Glycohemoglobin levels, Adverse effects and Blood glucose variability
Baseline, 3, 6, 9, 12, 15, 18, and 24 months
Study Arms (2)
Diabetes Education
ACTIVE COMPARATORTeamWork CS Sessions
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Virginia Commonwealth University
Richmond, Virginia, 23284, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2009
First Posted
April 29, 2009
Study Start
April 1, 2007
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
January 8, 2016
Record last verified: 2016-01