Trial of Motivational Interviewing in Adolescents With Diabetes

May 15, 2006 updated by: Cardiff University

A Multicentre, Randomised Controlled Trial of Motivational Interviewing in Adolescents With Diabetes

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

80

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 4XN
        • Dept of Child Health, UHW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: ECT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1C at 6 months, end of intervention and one year follow up

Secondary Outcome Measures

Outcome Measure
well being at baseline and end of one year intervention
family behaviour at baseline and end of one year intervention
quality of life at baseline and end of one year intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff University

Collaborators

Diabetes UK

Investigators

  • Principal Investigator: Sue Channon, D Clin Psych, Cardiff and Vale University Health Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (ESTIMATE)

May 17, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 17, 2006

Last Update Submitted That Met QC Criteria

May 15, 2006

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCUA008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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