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Clinical Trials/NCT02839031
NCT02839031
Terminated
Not Applicable

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

University Hospital, Montpellier1 site in 1 country57 target enrollmentMarch 11, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 1
Sponsor
University Hospital, Montpellier
Enrollment
57
Locations
1
Primary Endpoint
Glycated hemoglobin (HbA1c) level
Status
Terminated
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 11, 2015
End Date
July 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Glycated hemoglobin (HbA1c) level

Time Frame: up to 12 months

Study Sites (1)

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