Prevention of Self-care Deterioration in Early Adolescents With Diabetes

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Diabetes Education; Behavioral: TeamWork CS Sessions

• Registration Number: NCT00890331
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Education	Diabetes Education	-
TeamWork CS Sessions	TeamWork CS Sessions	-

Primary Outcome Measures

Name	Time	Method
Parental involvement and Disease care behaviors	Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months

Secondary Outcome Measures

Name	Time	Method
Glycohemoglobin levels, Adverse effects and Blood glucose variability	Baseline, 3, 6, 9, 12, 15, 18, and 24 months

Trial Locations

Locations (2)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States