Clinical trial NCT03799029: Effects of a Cognitive Training Program With Game Elements Among ADHD
Official title: Effects of a Cognitive Training Program With Game Elements and a Reward Feedback System on Children, Adolescents and Adults Presenting ADHD: an Experimental Study. A Multi-centred Study: Neuchatel, Fribourg and Lausanne
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Keywords: Cognitive training
treatment
ADHD
Lead sponsor: University of Fribourg
Sponsor class: OTHER
Collaborators: name: Paris West University Nanterre La Défense
First posted: 2019-01-10
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: will compare the ADHD group with a control group including healthy participants .The experimental study uses a pseudo-randomized, double-blind, controlled multi-center design.Participants will be assigned to an experimental group (cognitive training ) or in a control active group.
Primary purpose: TREATMENT

Brief summary: This study examines the impact of cognitive training among participants with ADHD in Switzerland

Detailed description: The main aim of the experimental study is to investigate cognitive functioning, behavioral and neural levels in ADHD, both before and after cognitive training where there has been the addition of motivation elements. Near and far transfers effects of this new program are evaluated. For far transfers, ambulatory assessment is used to improve ecological validity. Neural activity has rarely been examined in cognitive training with ADHD participants, and that is why this study also includes FMRI measures. Long-term effects, defined as three and six months following the completion of cognitive training, are also investigated. This study focuses on children, adolescents and adults with ADHD. Indeed, cognitive training effects have been rarely studied over the lifespan.

Eligibility criteria: Inclusion Criteria:

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Participants fulfilling all of the following inclusion criteria are eligible for the study for the patients'group:

1. Age between 6 and 65 years' old
2. ADHD diagnostic by a specialist
3. IQ-score higher than 80 for adult according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
4. Treatment with or without medication for ADHD
5. Computer and Internet connexion at home
6. Informed consent from participants and the legal guardian of the minors (under 14 years old) involved - as documented by signature (Appendix Informed Consent Form).

Participants fulfilling all of the following inclusion criteria are eligible for the study for the control group of healthy participants:

1. Age between 6 and 65 years' old
2. No ADHD diagnostic by a specialist
3. IQ-score higher than 80 for adult according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
4. No medication treatment for ADHD
5. Informed consent from participants and the legal guardian of the minors involved - as documented by signature (Appendix Informed Consent Form).

Exclusion Criteria:

* Exclusion criteria

The exclusion criteria for the participants in the patient's group are:

1. Age younger than 6 and older than 65 years' old
2. No diagnosis of ADHD
3. IQ-score lower than 80 points according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
4. No computer and Internet access at home
5. No written consent from participants and from the legal guardians of minors involved as less than 14 years old.

(7) FMRI exclusion: claustrophobia, Pregnancy known or suspected,metallic implants in their bodies (e.g: pacemakers, aneurism clips, metal Prosthetic, cochlear implant) (8) In case of suicidal risk, the participant is encouraged to consult the medical staff (9) Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (10) Participation in another study on cognitive training (11) Previous enrolment into the current study (12) Enrolment of the investigator, his/her family members, employees and other dependent persons

The exclusion criteria for the participants in the control group of healthy participants are:

1. Age younger than 6 and older than 65 years' old
2. Diagnosis of ADHD or other mental disorders
3. IQ-score lower than 80 points according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
4. No written consent from participants and from the legal guardians of minors involved (for participants under 14 years old)
5. FMRI exclusion: claustrophobia, Pregnancy known or suspected, metallic implants in their bodies (e.g: pacemakers, aneurism clips, metal Prosthetic, cochlear implant)
6. In case of suicidal risk, the participant is encouraged to consult the medical staff.
7. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
8. Previous enrolment into the current study
9. Enrolment of the investigator, his/her family members, employees and other dependent persons

Primary outcomes:
measure: ADHD symptoms for adults
timeFrame: Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4
measure: ADHD symptoms for children
timeFrame: Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4
Secondary outcomes:
measure: Impulsivity
timeFrame: Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4
measure: executive function
timeFrame: Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4
measure: Reward
timeFrame: Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4
measure: Reward
timeFrame: Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4
measure: Memory
timeFrame: Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 training 4. Six months after cognitive training
measure: Memory
timeFrame: Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 training 4. Six months after cognitive training
measure: Neural activity
timeFrame: Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Dentz Amélie
state: Quebec
Study officials:
affiliation: University of Fribourg
name: Amélie Dentz, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Fribourg
name: Martin Soelch Chantal, PR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spencer-Smith M, Klingberg T. Correction: Benefits of a Working Memory Training Program for Inattention in Daily Life: A Systematic Review and Meta-Analysis. PLoS One. 2016 Nov 22;11(11):e0167373. doi: 10.1371/journal.pone.0167373. eCollection 2016.
citation: Gathercole SE. Commentary: Working memory training and ADHD - where does its potential lie? Reflections on Chacko et al. (2014). J Child Psychol Psychiatry. 2014 Mar;55(3):256-7. doi: 10.1111/jcpp.12196. Epub 2014 Jan 20.