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NCT Number: NCT00890331

Prevention of Self-care Deterioration in Early Adolescents With Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's National Medical Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TeamWork CS Sessions

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Parental involvement and Disease care behaviors

    Time frame: Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months

Secondary outcomes

  1. Glycohemoglobin levels, Adverse effects and Blood glucose variability

    Time frame: Baseline, 3, 6, 9, 12, 15, 18, and 24 months

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Children's National Research Institute
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Family Teamwork and Coping Skills Prevention Program

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2009
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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