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

NCT ID: NCT03437772

Last Updated: 2023-01-04

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

COMPLETED

Total Enrollment

248 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-19

Study Completion Date

2022-11-23

Brief Summary

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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 improve self-confidence, emotional control, social integration and school results.

Detailed Description

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Conditions

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Adhd

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CBT with mindfulness

Mindfulness Cognitive Behavioral Therapy program

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

CHU Nimes

Nîmes, , France

Site Status

APHP - Hôpital Robert Debré

Paris, , France

Site Status

Chu de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

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.

Reference Type DERIVED
PMID: 35090544 (View on PubMed)

Other Identifiers

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PHRC-N/2016/JLC-01

Identifier Type: -

Identifier Source: org_study_id

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