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Cognitive-Behavioral Therapy (CBT) in Children With Diabetes (DI-CO)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Terminated

Conditions

Diabetes Mellitus, Type 1

Treatments

Behavioral: Control (telephonic support without CBT content)
Behavioral: "CBT" (Cognitive-Behavioral Therapy)

Study type

Interventional

Funder types

Other

Identifiers

NCT02839031
UF 9369

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

57 participants in 2 patient groups

"CBT" group
Experimental group
Treatment:
Behavioral: "CBT" (Cognitive-Behavioral Therapy)
Control group
Sham Comparator group
Treatment:
Behavioral: Control (telephonic support without CBT content)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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