Trial of Motivational Interviewing in Adolescents With Diabetes

This study has been terminated.
Sponsor:
Collaborator:
Diabetes UK
Information provided by:
Cardiff University
ClinicalTrials.gov Identifier:
NCT00326573
First received: May 15, 2006
Last updated: NA
Last verified: October 2004
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: A Multicentre, Randomised Controlled Trial of Motivational Interviewing in Adolescents With Diabetes

Resource links provided by NLM:


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

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00326573     History of Changes
Other Study ID Numbers: RCUA008
Study First Received: May 15, 2006
Last Updated: May 15, 2006
Health Authority: United Kingdom: National Health Service

Keywords provided by Cardiff University:
Diabetes
Teenagers
Motivational Interviewing

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

ClinicalTrials.gov processed this record on July 20, 2014