Clinical trial NCT03437772: Third Generation Cognitive Behavioural Therapy vs Treatment-as-usual for ADHD
Official title: Third Generation Cognitive Behavioural Therapy Versus Treatment-as-usual for Attention Deficit and Hyperactivity Disorder: a Randomized, 2-parallel-group, Evaluator Blinded, Superiority Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adhd
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 248
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families consulting for attention deficit and hyperactivity disorder

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


Eligibility criteria: 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

Primary outcomes:
measure: ADHD symptom severity
timeFrame: baseline
measure: ADHD symptom severity
timeFrame: Month 5
measure: ADHD symptom severity
timeFrame: Month 8
Secondary outcomes:
measure: Parenting styles
timeFrame: Baseline
measure: Parenting styles
timeFrame: Month 5
measure: Parenting styles
timeFrame: Month 8
measure: The quality of life for parents.
timeFrame: Baseline
measure: The quality of life for parents.
timeFrame: Month 5
measure: The quality of life for parents.
timeFrame: Month 8
measure: Global function
timeFrame: Baseline
measure: Global function
timeFrame: Month 5
measure: Global function
timeFrame: Month 8
measure: Global function
timeFrame: Baseline
measure: Global function
timeFrame: Month 5
measure: Global function
timeFrame: Month 8
measure: Social well-being and school parameters for children
timeFrame: Baseline
measure: Social well-being and school parameters for children
timeFrame: Baseline
measure: Social well-being and school parameters for children
timeFrame: Month 5
measure: Social well-being and school parameters for children
timeFrame: Month 8
measure: Anxiety in children
timeFrame: Baseline
measure: Anxiety in children
timeFrame: Month 5
measure: Anxiety in children
timeFrame: Month 8
measure: Depression in children
timeFrame: Baseline
measure: Depression in children
timeFrame: Month 5
measure: Depression in children
timeFrame: Month 8
measure: Anxiety and depression in parents
timeFrame: Baseline
measure: Anxiety and depression in parents
timeFrame: Month 5
measure: Anxiety and depression in parents
timeFrame: Month 8
measure: Self-Esteem and behaviour for children.
timeFrame: Baseline
measure: Self-Esteem and behaviour for children.
timeFrame: Month 5
measure: Self-Esteem and behaviour for children.
timeFrame: Month 8
measure: Self-Esteem and behaviour for children.
timeFrame: Baseline
measure: Self-Esteem and behaviour for children.
timeFrame: Month 5
measure: Self-Esteem and behaviour for children.
timeFrame: Month 8
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
city: Nîmes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: APHP - Hôpital Robert Debré
city: Strasbourg
country: France
facility: Chu de Strasbourg
Study officials:
affiliation: CHU Nimes
name: Jorge Lopez Castroman, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.