Effects of a Cognitive Training Program With Game Elements Among ADHD

NCT ID: NCT03799029

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-20

Study Completion Date

2023-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Participant are blind on their group assignation. Investigator are blind on group assignation

Study Groups

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active control group low-intensity

Low intensity version of the same cognitive training program Exercice are realized at home using a computer 25 sessions of 30-45 minutes are realized five days per week during 5 weeks

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type OTHER

Participants will train at home during 25 sessions (about 45 minutes each) over a maximum of 5 weeks. Investigators will verify compliance via Internet and call participants and their legal guardians once a week. A reward system will be established with participants. Five sessions of metacognition (1 hour each) are added.

experimental training group cognitive training

a multifactorial cognitive program that tackles working memory, attention, inhibition, planification and reasoning Exercice are realized at home using a computer 25 sessions of 30-45 minutes are realized five days per week during 5 weeks

Group Type EXPERIMENTAL

Cognitive training

Intervention Type OTHER

Participants will train at home during 25 sessions (about 45 minutes each) over a maximum of 5 weeks. Investigators will verify compliance via Internet and call participants and their legal guardians once a week. A reward system will be established with participants. Five sessions of metacognition (1 hour each) are added.

control healthy participants

Just a control group including healthy participants No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive training

Participants will train at home during 25 sessions (about 45 minutes each) over a maximum of 5 weeks. Investigators will verify compliance via Internet and call participants and their legal guardians once a week. A reward system will be established with participants. Five sessions of metacognition (1 hour each) are added.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-


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).


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

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


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
Minimum Eligible Age

6 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Paris West University Nanterre La Défense

OTHER

Sponsor Role collaborator

University of Fribourg

OTHER

Sponsor Role lead

Responsible Party

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Amelie Dentz

principal investigator Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amélie Dentz, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Fribourg

Martin Soelch Chantal, PR

Role: PRINCIPAL_INVESTIGATOR

University of Fribourg

Locations

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Dentz Amélie

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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amelie dentz, Ph.D

Role: CONTACT

0676951881

Chantal Martin Soelch, Pr

Role: CONTACT

+41 26 300 7687

References

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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.

Reference Type BACKGROUND
PMID: 27875585 (View on PubMed)

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.

Reference Type RESULT
PMID: 24438534 (View on PubMed)

Other Identifiers

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University of Fribourg

Identifier Type: -

Identifier Source: org_study_id

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