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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
"CBT" (Cognitive-Behavioral Therapy)
Control (telephonic support without CBT content)
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring diabetes mellitus, glycaemia, cognitive-behavioral treatment, coping, parents, children

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Montpellier University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

"CBT" group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Glycated hemoglobin (HbA1c) level

Secondary Outcome Measures

Full Information

First Posted
July 18, 2016
Last Updated
September 4, 2019
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02839031
Brief Title
Cognitive-Behavioral Therapy (CBT) in Children With Diabetes
Acronym
DI-CO
Official Title
Assessment of a Cognitive-behavioral Group Intervention in Children With Diabetes Mellitus and Their Parents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties (study stopped before the expected 80 inclusions)
Study Start Date
March 11, 2015 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
diabetes mellitus, glycaemia, cognitive-behavioral treatment, coping, parents, children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"CBT" group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
"CBT" (Cognitive-Behavioral Therapy)
Intervention Type
Behavioral
Intervention Name(s)
Control (telephonic support without CBT content)
Primary Outcome Measure Information:
Title
Glycated hemoglobin (HbA1c) level
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Cognitive-Behavioral Therapy (CBT) in Children With Diabetes

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