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AdhdHyper-mCBTNCT03437772

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

An observational study of Adhd, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 15 years
Conditions the study is for
Adhd
What is being tested?
Mindfulness Cognitive Behavioral Therapy program
How many people
248 participants
Where
4 sitesFrance
Study dates
19 Feb 2018to 23 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Families consulting for attention deficit and hyperactivity disorder

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

4 sites in 1 country.

France4 sites

  • CHU Montpellier

    Montpellier, 34295

  • CHU Nimes

    Nîmes, 30029

  • APHP - Hôpital Robert Debré

    Paris, 75935

  • Chu de Strasbourg

    Strasbourg, 67091

Other trials in France

About this study

Official title: 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.

Conditions
Adhd
Being tested
Mindfulness Cognitive Behavioral Therapy program
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Cognitive Behavioral Therapy programBehavioural

    16 simultaneous-but-separate therapy sessions for parents and children.

Study groups in NCT03437772
Study groupRoleWhat they receive
CBT with mindfulnessNot described
Receives: Behavioral: Mindfulness Cognitive Behavioral Therapy program
Treatment as Usual: Barkley therapyNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ADHD symptom severity

    clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54

    Measured: baseline

  2. ADHD symptom severity

    clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54

    Measured: Month 5

  3. ADHD symptom severity

    clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54

    Measured: Month 8

Secondary outcomes (31)

  1. Parenting styles

    Parental Authority Questionnaire (PAQ); 30 items per parent

    Measured: Baseline

  2. Parenting styles

    Parental Authority Questionnaire (PAQ); 30 items per parent

    Measured: Month 5

  3. Parenting styles

    Parental Authority Questionnaire (PAQ); 30 items per parent

    Measured: Month 8

  4. The quality of life for parents.

    Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85

    Measured: Baseline

  5. The quality of life for parents.

    Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85

    Measured: Month 5

  6. The quality of life for parents.

    Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85

    Measured: Month 8

  7. Global function

    Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7

    Measured: Baseline

  8. Global function

    Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7

    Measured: Month 5

  9. Global function

    Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7

    Measured: Month 8

  10. Global function

    Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100

    Measured: Baseline

  11. Global function

    Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100

    Measured: Month 5

  12. Global function

    Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100

    Measured: Month 8

  13. 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

    Measured: Baseline

  14. 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

    Measured: Baseline

  15. 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

    Measured: Month 5

  16. 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

    Measured: Month 8

  17. Anxiety in children

    Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale

    Measured: Baseline

  18. Anxiety in children

    Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale

    Measured: Month 5

  19. Anxiety in children

    Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale

    Measured: Month 8

  20. Depression in children

    Children depression inventory (CDI) questionnaire; score ranges from 0-54

    Measured: Baseline

  21. Depression in children

    Children depression inventory (CDI) questionnaire; score ranges from 0-54

    Measured: Month 5

  22. Depression in children

    Children depression inventory (CDI) questionnaire; score ranges from 0-54

    Measured: Month 8

  23. Anxiety and depression in parents

    Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21

    Measured: Baseline

  24. Anxiety and depression in parents

    Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21

    Measured: Month 5

  25. Anxiety and depression in parents

    Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21

    Measured: Month 8

  26. Self-Esteem and behaviour for children.

    Rosenberg scale; score ranges from 0-40

    Measured: Baseline

  27. Self-Esteem and behaviour for children.

    Rosenberg scale; score ranges from 0-40

    Measured: Month 5

  28. Self-Esteem and behaviour for children.

    Rosenberg scale; score ranges from 0-40

    Measured: Month 8

  29. Self-Esteem and behaviour for children.

    CONNERS questionnaire for parents; cut-off for significant behavioral problem >15

    Measured: Baseline

  30. Self-Esteem and behaviour for children.

    CONNERS questionnaire for parents; cut-off for significant behavioral problem >15

    Measured: Month 5

  31. Self-Esteem and behaviour for children.

    CONNERS questionnaire for parents; cut-off for significant behavioral problem >15

    Measured: Month 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start19 Feb 2018
  3. Primary completion23 Nov 2022
  4. Study completion23 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03437772
Sponsor's protocol ID
PHRC-N/2016/JLC-01
Acronym
Hyper-mCBT
Status last verified
Jan 2023
First submitted
13 Feb 2018
Last updated
4 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 35090544

Questions about this trial

What is this clinical trial studying?

An observational study of Adhd, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADHD symptom severity (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03437772, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.

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