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

January 2, 2023 updated by: Centre Hospitalier Universitaire de Nīmes

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ADHD symptom severity
Time Frame: baseline
clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54
baseline
ADHD symptom severity
Time Frame: Month 5
clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54
Month 5
ADHD symptom severity
Time Frame: Month 8
clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54
Month 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parenting styles
Time Frame: Baseline
Parental Authority Questionnaire (PAQ); 30 items per parent
Baseline
Parenting styles
Time Frame: Month 5
Parental Authority Questionnaire (PAQ); 30 items per parent
Month 5
Parenting styles
Time Frame: Month 8
Parental Authority Questionnaire (PAQ); 30 items per parent
Month 8
The quality of life for parents.
Time Frame: Baseline
Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85
Baseline
The quality of life for parents.
Time Frame: Month 5
Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85
Month 5
The quality of life for parents.
Time Frame: Month 8
Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85
Month 8
Global function
Time Frame: Baseline
Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7
Baseline
Global function
Time Frame: Month 5
Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7
Month 5
Global function
Time Frame: Month 8
Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7
Month 8
Global function
Time Frame: Baseline
Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100
Baseline
Global function
Time Frame: Month 5
Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100
Month 5
Global function
Time Frame: Month 8
Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100
Month 8
Social well-being and school parameters for children
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Month 5
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
Time Frame: 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
Month 8
Anxiety in children
Time Frame: Baseline
Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale
Baseline
Anxiety in children
Time Frame: Month 5
Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale
Month 5
Anxiety in children
Time Frame: Month 8
Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale
Month 8
Depression in children
Time Frame: Baseline
Children depression inventory (CDI) questionnaire; score ranges from 0-54
Baseline
Depression in children
Time Frame: Month 5
Children depression inventory (CDI) questionnaire; score ranges from 0-54
Month 5
Depression in children
Time Frame: Month 8
Children depression inventory (CDI) questionnaire; score ranges from 0-54
Month 8
Anxiety and depression in parents
Time Frame: Baseline
Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21
Baseline
Anxiety and depression in parents
Time Frame: Month 5
Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21
Month 5
Anxiety and depression in parents
Time Frame: Month 8
Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21
Month 8
Self-Esteem and behaviour for children.
Time Frame: Baseline
Rosenberg scale; score ranges from 0-40
Baseline
Self-Esteem and behaviour for children.
Time Frame: Month 5
Rosenberg scale; score ranges from 0-40
Month 5
Self-Esteem and behaviour for children.
Time Frame: Month 8
Rosenberg scale; score ranges from 0-40
Month 8
Self-Esteem and behaviour for children.
Time Frame: Baseline
CONNERS questionnaire for parents; cut-off for significant behavioral problem >15
Baseline
Self-Esteem and behaviour for children.
Time Frame: Month 5
CONNERS questionnaire for parents; cut-off for significant behavioral problem >15
Month 5
Self-Esteem and behaviour for children.
Time Frame: Month 8
CONNERS questionnaire for parents; cut-off for significant behavioral problem >15
Month 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jorge Lopez Castroman, M.D, CHU Nimes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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