Prevention of Self-care Deterioration in Early Adolescents With Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Family Teamwork and Coping Skills Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890331
• Other study ID #: DK70917
• Secondary ID: R01DK070917
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2009
• Last updated: January 6, 2016
• Start date: April 2007
• Est. completion date: March 2014

Study information

• Verified date: January 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Children's Research Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental involvement and Disease care behaviors		Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months	No
Secondary	Glycohemoglobin levels, Adverse effects and Blood glucose variability		Baseline, 3, 6, 9, 12, 15, 18, and 24 months	No