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

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

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.

Study Overview

• Status: Completed
• Conditions: Adhd
• Intervention / Treatment: Behavioral: Mindfulness Cognitive Behavioral Therapy program

• Study Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU Montpellier
  • Nîmes, France, 30029
    • CHU Nîmes
  • Paris, France, 75935
    • APHP - Hôpital Robert Debré
  • Strasbourg, France, 67091
    • CHU de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Families consulting for attention deficit and hyperactivity disorder

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CBT with mindfulness	Behavioral: Mindfulness Cognitive Behavioral Therapy program; 16 simultaneous-but-separate therapy sessions for parents and children.
Treatment as Usual: Barkley therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jorge Lopez Castroman, M.D, CHU Nîmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): November 23, 2022

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PHRC-N/2016/JLC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No