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

Adhd Clinical Trial

— Hyper-mCBT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437772
• Other study ID #: PHRC-N/2016/JLC-01
• Status: Completed
• Start date: February 19, 2018
• Est. completion date: November 23, 2022

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: November 23, 2022
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhd

Intervention

Behavioral:
• Mindfulness Cognitive Behavioral Therapy program
16 simultaneous-but-separate therapy sessions for parents and children.

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier
France	CHU Nimes	Nîmes
France	APHP - Hôpital Robert Debré	Paris
France	Chu de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD symptom severity	clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54	baseline
Primary	ADHD symptom severity	clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54	Month 5
Primary	ADHD symptom severity	clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54	Month 8
Secondary	Parenting styles	Parental Authority Questionnaire (PAQ); 30 items per parent	Baseline
Secondary	Parenting styles	Parental Authority Questionnaire (PAQ); 30 items per parent	Month 5
Secondary	Parenting styles	Parental Authority Questionnaire (PAQ); 30 items per parent	Month 8
Secondary	The quality of life for parents.	Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85	Baseline
Secondary	The quality of life for parents.	Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85	Month 5
Secondary	The quality of life for parents.	Parental - Developmental Disorders - Quality of Life (PAR-DD-QoL) questionnaire; score ranges from 17-85	Month 8
Secondary	Global function	Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7	Baseline
Secondary	Global function	Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7	Month 5
Secondary	Global function	Clinical Global Impression Scale (CGI-S) questionnaire; score from 1-7	Month 8
Secondary	Global function	Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100	Baseline
Secondary	Global function	Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100	Month 5
Secondary	Global function	Children's Global Assessment Scale CGAS) questionnaire; score ranges from 0-100	Month 8
Secondary	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	Baseline
Secondary	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	Baseline
Secondary	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	Month 5
Secondary	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	Month 8
Secondary	Anxiety in children	Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale	Baseline
Secondary	Anxiety in children	Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale	Month 5
Secondary	Anxiety in children	Multidimensional Anxiety Scale for Children (MASC) questionnaire; 39-item, 4-point Likert scale	Month 8
Secondary	Depression in children	Children depression inventory (CDI) questionnaire; score ranges from 0-54	Baseline
Secondary	Depression in children	Children depression inventory (CDI) questionnaire; score ranges from 0-54	Month 5
Secondary	Depression in children	Children depression inventory (CDI) questionnaire; score ranges from 0-54	Month 8
Secondary	Anxiety and depression in parents	Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21	Baseline
Secondary	Anxiety and depression in parents	Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21	Month 5
Secondary	Anxiety and depression in parents	Hospital Anxiety and Depression Scale (HADS) questionnaire; 2 subscores each ranging from 0-21	Month 8
Secondary	Self-Esteem and behaviour for children.	Rosenberg scale; score ranges from 0-40	Baseline
Secondary	Self-Esteem and behaviour for children.	Rosenberg scale; score ranges from 0-40	Month 5
Secondary	Self-Esteem and behaviour for children.	Rosenberg scale; score ranges from 0-40	Month 8
Secondary	Self-Esteem and behaviour for children.	CONNERS questionnaire for parents; cut-off for significant behavioral problem >15	Baseline
Secondary	Self-Esteem and behaviour for children.	CONNERS questionnaire for parents; cut-off for significant behavioral problem >15	Month 5
Secondary	Self-Esteem and behaviour for children.	CONNERS questionnaire for parents; cut-off for significant behavioral problem >15	Month 8