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Trial of Motivational Interviewing in Adolescents With Diabetes

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00326573
First Posted: May 17, 2006
Last Update Posted: May 17, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Diabetes UK
Information provided by:
Cardiff University
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus Behavioral: Motivational Interviewing Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: A Multicentre, Randomised Controlled Trial of Motivational Interviewing in Adolescents With Diabetes

Further study details as provided by Cardiff University:

Primary Outcome Measures:
  • HbA1C at 6 months, end of intervention and one year follow up

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 80
Study Start Date: October 2001
Estimated Study Completion Date: June 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326573


Locations
United Kingdom
Dept of Child Health, UHW
Cardiff, South Glamorgan, United Kingdom, CF14 4XN
Sponsors and Collaborators
Cardiff University
Diabetes UK
Investigators
Principal Investigator: Sue Channon, D Clin Psych Cardiff and Vale University Health Board
  More Information

ClinicalTrials.gov Identifier: NCT00326573     History of Changes
Other Study ID Numbers: RCUA008
First Submitted: May 15, 2006
First Posted: May 17, 2006
Last Update Posted: May 17, 2006
Last Verified: October 2004

Keywords provided by Cardiff University:
Diabetes
Teenagers
Motivational Interviewing

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases