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NCT02839031 Clinical Trial

Cognitive-Behavioral Therapy (CBT) in Children With Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

— DI-CO  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02839031
Other study ID # UF 9369
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 11, 2015
Est. completion date July 1, 2018

Study information
Verified date September 2019
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 57
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• "CBT" (Cognitive-Behavioral Therapy)

• Control (telephonic support without CBT content)

Locations
Country Name City State
France Montpellier University Hospital Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glycated hemoglobin (HbA1c) level up to 12 months
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