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Completed

NCT Number: NCT03437772

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Montpellier, Montpellier, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Cognitive Behavioral Therapy program

Behavioral

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

Primary outcomes

  1. ADHD symptom severity

    Time frame: baseline

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

  2. ADHD symptom severity

    Time frame: Month 5

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

  3. ADHD symptom severity

    Time frame: Month 8

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

Secondary outcomes

  1. Parenting styles

    Time frame: Baseline

    Parental Authority Questionnaire (PAQ); 30 items per parent

  2. Parenting styles

    Time frame: Month 5

    Parental Authority Questionnaire (PAQ); 30 items per parent

  3. Parenting styles

    Time frame: Month 8

    Parental Authority Questionnaire (PAQ); 30 items per parent

  4. The quality of life for parents.

    Time frame: Baseline

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

  5. 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

  6. 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

  7. Global function

    Time frame: Baseline

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

  8. Global function

    Time frame: Month 5

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

  9. Global function

    Time frame: Month 8

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

  10. Global function

    Time frame: Baseline

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

  11. Global function

    Time frame: Month 5

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

  12. Global function

    Time frame: Month 8

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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Anxiety in children

    Time frame: Baseline

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

  18. Anxiety in children

    Time frame: Month 5

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

  19. Anxiety in children

    Time frame: Month 8

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

  20. Depression in children

    Time frame: Baseline

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

  21. Depression in children

    Time frame: Month 5

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

  22. Depression in children

    Time frame: Month 8

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

  23. Anxiety and depression in parents

    Time frame: Baseline

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

  24. Anxiety and depression in parents

    Time frame: Month 5

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

  25. Anxiety and depression in parents

    Time frame: Month 8

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

  26. Self-Esteem and behaviour for children.

    Time frame: Baseline

    Rosenberg scale; score ranges from 0-40

  27. Self-Esteem and behaviour for children.

    Time frame: Month 5

    Rosenberg scale; score ranges from 0-40

  28. Self-Esteem and behaviour for children.

    Time frame: Month 8

    Rosenberg scale; score ranges from 0-40

  29. Self-Esteem and behaviour for children.

    Time frame: Baseline

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

  30. Self-Esteem and behaviour for children.

    Time frame: Month 5

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

  31. Self-Esteem and behaviour for children.

    Time frame: Month 8

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: Hyper-mCBT

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 19, 2018
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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