Cognitive-Behavioral Therapy (CBT) in Children With Diabetes

Not Applicable

Terminated

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Control (telephonic support without CBT content); Behavioral: "CBT" (Cognitive-Behavioral Therapy)

• Registration Number: NCT02839031
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-11
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-20
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control (telephonic support without CBT content)	-
"CBT" group	"CBT" (Cognitive-Behavioral Therapy)	-

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1c) level	up to 12 months

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France