Third Generation Cognitive Behavioural Therapy vs Treatment-as-usual for ADHD (Hyper-mCBT)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Adhd

Treatments: Behavioral: Mindfulness Cognitive Behavioral Therapy program

Study type: Observational

Funder types: Other

Identifiers

NCT03437772

PHRC-N/2016/JLC-01

Details and patient eligibility

About

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.

Enrollment: 248 patients

Sex: All

Ages: 7 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

248 participants in 2 patient groups

CBT with mindfulness

Treatment:

Behavioral: Mindfulness Cognitive Behavioral Therapy program

Treatment as Usual: Barkley therapy