Study Stopped
Recruitment difficulties (study stopped before the expected 80 inclusions)
Cognitive-Behavioral Therapy (CBT) in Children With Diabetes
DI-CO
Assessment of a Cognitive-behavioral Group Intervention in Children With Diabetes Mellitus and Their Parents
1 other identifier
interventional
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2015
CompletedFirst Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedSeptember 6, 2019
September 1, 2019
3.3 years
July 18, 2016
September 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycated hemoglobin (HbA1c) level
up to 12 months
Study Arms (2)
"CBT" group
EXPERIMENTALControl group
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montpellier University Hospital
Montpellier, 34295, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2016
First Posted
July 20, 2016
Study Start
March 11, 2015
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
September 6, 2019
Record last verified: 2019-09