Blood Glucose Awareness Training for Parents

NCT ID: NCT00315991

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-12-31

Brief Summary

The purpose of this study is to test a training program for parents of children with T1DM.

Detailed Description

Successful diabetes management relies on a process of self-regulation in which treatment behavior is guided by feedback about changing blood glucose (BG) levels and decision-making. The processes involved in self-regulation have been studied extensively in adults with Type 1 Diabetes Mellitus (T1DM), leading to the development of sophisticated research tools that have significantly advanced our understanding and ability to predict clinical outcome. Additionally, this research has led to the development of a highly effective, empirically based,pyschobehavioral intervention, Blood Glucose Awareness Training (BGAT) that improves self-regulation and clinical outcome in adults with T1DM. Unfortunately, the processes involved in the self-regulation of pediatric diabetes have received virtually no empirical attention. The purpose of this project is to correct the scientific neglect of the self-regulation in pediatric diabetes by adapting the conceptual and methodological tools used in adult studies to investigate the process of diabetes regulation by school-aged children (6-11 years) with T1DM and their parents and to develop and test an intervention to enhance the skills critical to this process.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: NONE

Study Groups

BGAT Intervention

Blood Glucose Awareness Training for Parents

Group Type: EXPERIMENTAL

Blood Glucose Awareness Training for Parents

Intervention Type: BEHAVIORAL

Control

Enter PDA data and complete questionnaires only. No intervention received.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Blood Glucose Awareness Training for Parents

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Parent/Guardian with primary responsibility for a child's diabetes management
• Child with T1DM between the ages 6 - 11 years.
• Duration of child's diabetes > 1 year
• Routine self-testing of child's BG > 2x day
• Intention to remain in the study's geographical region for the next 5 months
• Have a computer at home

Exclusion Criteria

• Significant comorbidity in the child that could interfere with BG awareness or psychosocial status
• Medications taken by the child that interfere with symptom perception
• Psychiatric disorder in a parent or child
• Cognitive deficits/learning disabilities in the child that might preclude ability to complete the study protocol.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joslin Diabetes Center

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Gonder-Frederick, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research

Locations

Joslin Diabetes Center

Boston, Massachusetts, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

12202

Identifier Type: -

Identifier Source: org_study_id