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Prevention of Self-care Deterioration in Early Adolescents With Diabetes

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status and phase

Completed
Phase 1

Conditions

Type 1 Diabetes

Treatments

Behavioral: Diabetes Education
Behavioral: TeamWork CS Sessions

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00890331
DK70917
R01DK070917 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

285 patients

Sex

All

Ages

11 to 14 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

285 participants in 2 patient groups

Diabetes Education
Active Comparator group
Treatment:
Behavioral: Diabetes Education
TeamWork CS Sessions
Experimental group
Treatment:
Behavioral: TeamWork CS Sessions

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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