Prevention of Self-care Deterioration in Early Adolescents With Diabetes
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 2012 |
| Estimated Primary Completion Date: | February 2012 (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 |
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| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Randi Streisand, Ph.D. 202-476-2730 rstreis@cnmc.org | |
| Principal Investigator: Randi Streisand, Ph.D. | |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23284 | |
| Contact: Clarissa S Holmes, Ph.D. 804-828-7486 csholme1@vcu.edu | |
| Principal Investigator: Clarissa S Holmes, Ph.D. | |
| 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: | Clarissa Holmes, Ph.D., Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00890331 History of Changes |
| Other Study ID Numbers: | DK70917, R01DK070917, 5R01DK70917 |
| Study First Received: | April 23, 2009 |
| Last Updated: | June 14, 2010 |
| 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 May 23, 2013