Effects of a Cognitive Training Program With Game Elements Among ADHD
CogtrainADHD
1 other identifier
interventional
240
1 country
1
Brief Summary
This study examines the impact of cognitive training among participants with ADHD in Switzerland
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2018
CompletedFirst Posted
Study publicly available on registry
January 10, 2019
CompletedStudy Start
First participant enrolled
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJanuary 10, 2019
January 1, 2019
2.3 years
May 28, 2018
January 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
ADHD symptoms for adults
The Conners' Adult ADHD Rating Scales (CAARS) higher values represent worse outcome The Conners' Adult ADHD Rating Scales (CAARS) is used to assess ADHD symptoms among adults (Conners et al., 1999) depending on the DSM-IV-TR (APA, 2000). This short version includes 26 items and 4 possible ratings from from 0 (not at all) to 3 (very much). This scale comprises four factors: (1) inattention, memory problems, (2) hyperactivity, restlessness, (3) impulsivity, emotional lability, (4) problems with self-concept and one ADHD index. score are summed. Range 0 to 100.
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
ADHD symptoms for children
The Conners Scale, 3rd edition higher values represent a worse outcome Questionnaire is rated by the legal guardian. This questionnaire assesses ADHD symptoms.Score are summed. Score range 0 to 100.
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 (7)
Impulsivity
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
executive function
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
Reward
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
Reward
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
Memory
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
- +2 more secondary outcomes
Study Arms (3)
active control group low-intensity
ACTIVE COMPARATORLow 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
experimental training group cognitive training
EXPERIMENTALa 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
control healthy participants
NO INTERVENTIONJust a control group including healthy participants No intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age between 6 and 65 years' old
- ADHD diagnostic by a specialist
- IQ-score higher than 80 for adult according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
- Treatment with or without medication for ADHD
- Computer and Internet connexion at home
- Informed consent from participants and the legal guardian of the minors (under 14 years old) involved - as documented by signature (Appendix Informed Consent Form).
- Age between 6 and 65 years' old
- No ADHD diagnostic by a specialist
- IQ-score higher than 80 for adult according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
- No medication treatment for ADHD
- Informed consent from participants and the legal guardian of the minors involved - as documented by signature (Appendix Informed Consent Form).
You may not qualify if:
- Age younger than 6 and older than 65 years' old
- No diagnosis of ADHD
- IQ-score lower than 80 points according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
- No computer and Internet access at home
- No written consent from participants and from the legal guardians of minors involved as less than 14 years old.
- Age younger than 6 and older than 65 years' old
- Diagnosis of ADHD or other mental disorders
- IQ-score lower than 80 points according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
- No written consent from participants and from the legal guardians of minors involved (for participants under 14 years old)
- In case of suicidal risk, the participant is encouraged to consult the medical staff.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Fribourglead
- Paris West University Nanterre La Défensecollaborator
Study Sites (1)
Dentz Amélie
Montreal, Quebec, 2000, Canada
Related Publications (2)
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.
PMID: 27875585BACKGROUNDGathercole 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.
PMID: 24438534RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amélie Dentz, Ph.D
University of Fribourg
- PRINCIPAL INVESTIGATOR
Martin Soelch Chantal, PR
University of Fribourg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participant are blind on their group assignation. Investigator are blind on group assignation
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator Ph.D
Study Record Dates
First Submitted
May 28, 2018
First Posted
January 10, 2019
Study Start
February 20, 2019
Primary Completion
June 1, 2021
Study Completion
December 1, 2023
Last Updated
January 10, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share