Status:

COMPLETED

Third Generation Cognitive Behavioural Therapy vs Treatment-as-usual for ADHD

Lead Sponsor:

Centre Hospitalier Universitaire de Nīmes

Conditions:

Adhd

Eligibility:

All Genders

7-15 years

Brief Summary

The investigators hypothesize that the mindfulness Cognitive Behavioral Therapy program will lead to a reduction in attention deficit and hyperactivity disorder symptoms, anxiety and depression, and i...

Eligibility Criteria

Inclusion

  • If deemed able, the patient must have given his/her informed and signed consent
  • The parents (or legal guardian) of minor patients must have given their informed and signed consent.
  • The patient and participating parents must be insured or beneficiary of a health insurance plan
  • The patient is equal to or greater than 7 years old and less than or equal to 15 years old
  • The patient presents with attention deficit and hyperactivity disorder with an ADHDRS-PI score \> 27
  • The patient is currently not under treatment - OR - is treated with methylphenidate with a stable posology (not expected to vary in the near future) but remains symptomatic

Exclusion

  • The patient is participating in, or has participated in over the past three months, another trial or another study that may interfere with the results or conclusion of the present study
  • The patient is in an exclusion period determined by a previous study
  • The participating parent(s) is(are) under judicial protection, or is an adult under guardianship
  • It is impossible to correctly inform the patient or his/her parent or legal guardian
  • Patients or parents refusing participation, signature of the signed consent or follow-up procedures
  • Previously documented mental retardation (IQ \< 70) or suspicion thereof by the investigator
  • The patient has already participated in cognitive behavioural therapy (individual or group) in the six months preceding inclusion
  • Patients diagnosed with autism spectrum disorder, psychotic disorder or bipolar disorder
  • The family has participated in a parental guidance programme in the last 6 months.
  • The family has already participated in the present study

Key Trial Info

Start Date :

February 19 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 23 2022

Estimated Enrollment :

248 Patients enrolled

Trial Details

Trial ID

NCT03437772

Start Date

February 19 2018

End Date

November 23 2022

Last Update

January 4 2023

Active Locations (4)

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Page 1 of 1 (4 locations)

1

CHU Montpellier

Montpellier, France, 34295

2

CHU Nimes

Nîmes, France, 30029

3

APHP - Hôpital Robert Debré

Paris, France, 75935

4

Chu de Strasbourg

Strasbourg, France, 67091