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

Study Overview
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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.

Official Title
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Third Generation Cognitive Behavioural Therapy Versus Treatment-as-usual for Attention Deficit and Hyperactivity Disorder: a Randomized, 2-parallel-group, Evaluator Blinded, Superiority Trial

Conditions
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Adhd

Intervention / Treatment
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* Behavioral: Mindfulness Cognitive Behavioral Therapy program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CBT with mindfulness<br> | Behavioral: Mindfulness Cognitive Behavioral Therapy program<br>* 16 simultaneous-but-separate therapy sessions for parents and children.<br>|
| Treatment as Usual: Barkley therapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD symptom severity | clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54 | baseline | 
| ADHD symptom severity | clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54 | Month 5 | 
| ADHD symptom severity | clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54 | Month 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting styles | Parental Authority Questionnaire (PAQ); 30 items per parent | Baseline | 
| Parenting styles | Parental Authority Questionnaire (PAQ); 30 items per parent | Month 5 | 
| Parenting styles | Parental Authority Questionnaire (PAQ); 30 items per parent | Month 8 | 
| The quality of life for parents. | Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85 | Baseline | 
| The quality of life for parents. | Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85 | Month 5 | 
| The quality of life for parents. | Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85 | Month 8 | 
| Global function | Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7 | Baseline | 
| Global function | Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7 | Month 5 | 
| Global function | Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7 | Month 8 | 
| Global function | Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100 | Baseline | 
| Global function | Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100 | Month 5 | 
| Global function | Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100 | Month 8 | 
| Social well-being and school parameters for children | 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 | Baseline | 
| Social well-being and school parameters for children | SDQ ; cut-off for significant behavioral problem >15 . his questionnaire will be given to the first patients included to 149 th patient included his questionnaire will be given to 150th patients included to 248th patient included | Baseline | 
| Social well-being and school parameters for children | SDQ ; cut-off for significant behavioral problem >15 . his questionnaire will be given to the first patients included to 149 th patient included his questionnaire will be given to 150th patients included to 248th patient included | Month 5 | 
| Social well-being and school parameters for children | 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 | Month 8 | 
| Anxiety in children | Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale | Baseline | 
| Anxiety in children | Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale | Month 5 | 
| Anxiety in children | Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale | Month 8 | 
| Depression in children | Children depression inventory (CDI) questionnaire; score ranges from 0-54 | Baseline | 
| Depression in children | Children depression inventory (CDI) questionnaire; score ranges from 0-54 | Month 5 | 
| Depression in children | Children depression inventory (CDI) questionnaire; score ranges from 0-54 | Month 8 | 
| Anxiety and depression in parents | Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21 | Baseline | 
| Anxiety and depression in parents | Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21 | Month 5 | 
| Anxiety and depression in parents | Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21 | Month 8 | 
| Self-Esteem and behaviour for children. | Rosenberg scale; score ranges from 0-40 | Baseline | 
| Self-Esteem and behaviour for children. | Rosenberg scale; score ranges from 0-40 | Month 5 | 
| Self-Esteem and behaviour for children. | Rosenberg scale; score ranges from 0-40 | Month 8 | 
| Self-Esteem and behaviour for children. | CONNERS questionnaire for parents; cut-off for significant behavioral problem >15 | Baseline | 
| Self-Esteem and behaviour for children. | CONNERS questionnaire for parents; cut-off for significant behavioral problem >15 | Month 5 | 
| Self-Esteem and behaviour for children. | CONNERS questionnaire for parents; cut-off for significant behavioral problem >15 | Month 8 |