Third Generation Cognitive Behavioural Therapy vs Treatment-as-usual for ADHD
NCT ID: NCT03437772
Last Updated: 2023-01-04
Study Results
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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COMPLETED
248 participants
OBSERVATIONAL
2018-02-19
2022-11-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CBT with mindfulness
Mindfulness Cognitive Behavioral Therapy program
16 simultaneous-but-separate therapy sessions for parents and children.
Treatment as Usual: Barkley therapy
No interventions assigned to this group
Interventions
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Mindfulness Cognitive Behavioral Therapy program
16 simultaneous-but-separate therapy sessions for parents and children.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
7 Years
15 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Jorge Lopez Castroman, M.D
Role: PRINCIPAL_INVESTIGATOR
CHU Nimes
Locations
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CHU Montpellier
Montpellier, , France
CHU Nimes
Nîmes, , France
APHP - Hôpital Robert Debré
Paris, , France
Chu de Strasbourg
Strasbourg, , France
Countries
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References
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Crouzet L, Gramond A, Suehs C, Fabbro-Peray P, Abbar M, Lopez-Castroman J. Third-generation cognitive behavioral therapy versus treatment-as-usual for attention deficit and hyperactivity disorder: a multicenter randomized controlled trial. Trials. 2022 Jan 28;23(1):83. doi: 10.1186/s13063-021-05983-2.
Other Identifiers
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PHRC-N/2016/JLC-01
Identifier Type: -
Identifier Source: org_study_id
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