Trial of Motivational Interviewing in Adolescents With Diabetes

NCT ID: NCT00326573

Last Updated: 2006-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2005-06-30

Brief Summary

The management of diabetes in adolescence presents significant difficulties due to psychological and physiological factors. Blood glucose control deteriorates in this age group and poor management threatens long-term health. Motivational Interviewing, a psychological intervention designed to facilitate behaviour change, has recently been used with a small group of teenagers, producing improved blood glucose control. To establish the impact of this intervention and its key components, we plan to compare the outcome in several clinics over a longer period of time in a larger number of adolescents selected at random to undergo motivational interviewing or to act as a control group. If successful this approach has potential to be incorporated into the routine clinical care of adolescents with diabetes.

Detailed Description

Diabetes in adolescence is associated with deterioration in glycaemic control and self-care, resulting in increased risk of long-term complications. Although psychosocial factors are recognized as playing an important part in these changes and therefore in clinical management, there are few indicators from research studies of practical, effective interventions. Motivational interviewing is a counselling approach designed to facilitate decision-making about behaviour change. It has been shown to be effective in a variety of clinical settings, including diabetes care in an adult population. In a BDA-funded pilot study of motivational interviewing with adolescents, our group has shown that the intervention improves glycaemic control (glycosylated haemoglobin), at least in the short-term. This study aims to replicate and extend the findings of the pilot study in a multicentre, randomised, controlled trial over a longer intervention period with a larger sample. The intervention will be monitored to facilitate analysis and description of key components. Other psychological variables thought to be of significance in the self-care of adolescents with diabetes will be measured. If the results indicate that this is a successful intervention, the method has potential to be disseminated and applied within routine clinical practice.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: ECT
• Blinding Strategy: NONE

Interventions

Motivational Interviewing

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 14-17
• With type 1 diabetes
• Attending diabetes clinic in participating centre

Exclusion Criteria

• Less than one year since diagnosis
• Learning disabilities
• Other medical conditions affecting diabetes management
• Accommodated by social services

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diabetes UK

OTHER

Sponsor Role: collaborator

Cardiff University

OTHER

Sponsor Role: lead

Principal Investigators

Sue Channon, D Clin Psych

Role: PRINCIPAL_INVESTIGATOR

Cardiff and Vale University Health Board

Locations

Dept of Child Health, UHW

Cardiff, South Glamorgan, United Kingdom

Countries

United Kingdom

Other Identifiers

RCUA008

Identifier Type: -

Identifier Source: org_study_id