Cognitive-Behavioral Therapy (CBT) in Children With Diabetes (DI-CO)

September 4, 2019 updated by: University Hospital, Montpellier

Assessment of a Cognitive-behavioral Group Intervention in Children With Diabetes Mellitus and Their Parents

Diabetes mellitus in children and adolescents is a source of stress and poor quality of life for themselves and their family. Development of adaptive coping strategies may be improved by focused parent and children training. This study assesses a cognitive behavioral treatment (CBT) for children/adolescents with diabetes and their parents in comparison with standard health educational interventions. The investigators main aim is to verify that the CBT program improves overall balance of glycaemia better than phone contact without CBT content (control group). Secondary objectives are expected improvements of health-related quality of life and coping styles in parents and children.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

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

  • France
      • Montpellier, France, 34295
        • Montpellier University Hospital

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

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children and teenagers from 6 years-old to 18 years-old
  • Having diabetes treated by insulin for at least 1 year
  • Followed in pediatric diabetology department of Arnaud de Villeneuve Hospital in University Hospital of Montpellier
  • Study Inform Consent signed by both children and parents

Exclusion Criteria:

  • Children with developmental delay, severe mental disorders or language delay
  • Non French-speaking family
  • Children who does not live with at least one of his/her parents
  • Children whose residence is not compatible with frequent visits at University Hospital of Montpellier
  • Clinical status not compatible with study questionnaires assessment.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group
Behavioral: Control (telephonic support without CBT content)
Experimental: "CBT" group
Behavioral: "CBT" (Cognitive-Behavioral Therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycated hemoglobin (HbA1c) level
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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 (Actual)

March 11, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 4, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 9369

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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