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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03437772
Acronym
Hyper-mCBT
Enrollment
248
Registered
2018-02-19
Start date
2018-02-19
Completion date
2022-11-23
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhd

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.

Interventions

BEHAVIORALMindfulness Cognitive Behavioral Therapy program

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ADHD symptom severitybaselineclinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54

Secondary

MeasureTime frameDescription
The quality of life for parents.BaselineParental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85
Global functionBaselineClinical Global Impression Scale (CGI-S) questionnaire; score from 1-7
Social well-being and school parameters for childrenBaselineCONNERS 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
Parenting stylesBaselineParental Authority Questionnaire (PAQ); 30 items per parent
Depression in childrenBaselineChildren depression inventory (CDI) questionnaire; score ranges from 0-54
Anxiety and depression in parentsBaselineHospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21
Self-Esteem and behaviour for children.BaselineRosenberg scale; score ranges from 0-40
Anxiety in childrenBaselineMultidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026