Third Generation Cognitive Behavioural Therapy vs Treatment-as-usual for ADHD
- Conditions
- Adhd
- Interventions
- Behavioral: Mindfulness Cognitive Behavioral Therapy program
- Registration Number
- NCT03437772
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 248
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CBT with mindfulness Mindfulness Cognitive Behavioral Therapy program -
- Primary Outcome Measures
Name Time Method ADHD symptom severity Month 8 clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54
- Secondary Outcome Measures
Name Time Method Social well-being and school parameters for children Month 8 CONNERS for school teachers; cut-off for significant behavioral problem \>15 his questionnaire will be given to the first patients included to 149 th patient included
Anxiety and depression in parents Month 8 Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21
Anxiety in children Month 8 Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale
Parenting styles Month 8 Parental Authority Questionnaire (PAQ); 30 items per parent
The quality of life for parents. Month 8 Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85
Global function Month 8 Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100
Depression in children Month 8 Children depression inventory (CDI) questionnaire; score ranges from 0-54
Self-Esteem and behaviour for children. Month 8 CONNERS questionnaire for parents; cut-off for significant behavioral problem \>15
Trial Locations
- Locations (4)
CHU Montpellier
🇫🇷Montpellier, France
CHU Nimes
🇫🇷Nîmes, France
APHP - Hôpital Robert Debré
🇫🇷Paris, France
Chu de Strasbourg
🇫🇷Strasbourg, France