Cognitive-Behavioral Therapy (CBT) in Children With Diabetes

NCT ID: NCT02839031

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-11

Study Completion Date

2018-07-01

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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"CBT" group

Group Type EXPERIMENTAL

"CBT" (Cognitive-Behavioral Therapy)

Intervention Type BEHAVIORAL

Control group

Group Type SHAM_COMPARATOR

Control (telephonic support without CBT content)

Intervention Type BEHAVIORAL

Interventions

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"CBT" (Cognitive-Behavioral Therapy)

Intervention Type BEHAVIORAL

Control (telephonic support without CBT content)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Montpellier University Hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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UF 9369

Identifier Type: -

Identifier Source: org_study_id

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