NCT03437772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 19, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2022

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

4.8 years

First QC Date

February 13, 2018

Last Update Submit

January 2, 2023

Conditions

Adhd

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (31)

  • Parenting styles

    Baseline

  • Parenting styles

    Month 5

  • Parenting styles

    Month 8

  • The quality of life for parents.

    Baseline

  • The quality of life for parents.

    Month 5

  • +26 more secondary outcomes

Study Arms (2)

CBT with mindfulness

Behavioral: Mindfulness Cognitive Behavioral Therapy program

Treatment as Usual: Barkley therapy

Interventions

Mindfulness Cognitive Behavioral Therapy programBEHAVIORAL

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

CBT with mindfulness

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Families consulting for attention deficit and hyperactivity disorder

You may qualify if:

  • 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

You may not qualify if:

  • 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 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Montpellier

Montpellier, 34295, France

Location

CHU Nimes

Nîmes, 30029, France

Location

APHP - Hôpital Robert Debré

Paris, 75935, France

Location

Chu de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

  • 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.

    PMID: 35090544DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jorge Lopez Castroman, M.D

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 19, 2018

Study Start

February 19, 2018

Primary Completion

November 23, 2022

Study Completion

November 23, 2022

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations

FR(4)