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Effects of a Cognitive Training Program With Game Elements Among ADHD (CogtrainADHD)

Primary Purpose

ADHD

Status

Not yet recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Cognitive training

About this trial

This is an interventional treatment trial for ADHD focused on measuring Cognitive training, treatment, ADHD

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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).

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

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).

Exclusion Criteria:

Exclusion criteria

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

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.

(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:

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)
FMRI exclusion: claustrophobia, Pregnancy known or suspected, metallic implants in their bodies (e.g: pacemakers, aneurism clips, metal Prosthetic, cochlear implant)
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

Sites / Locations

Dentz Amélie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

active control group low-intensity

experimental training group cognitive training

control healthy participants

Arm Description

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

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

Just a control group including healthy participants No intervention

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Impulsivity

The Impulsivity Behavior Scale (UPPS) higher values represent a worse outcome. score are summed short version contains 20 items measuring the following five dimensions of impulsivity: positive urgency, negative urgency, lack of perseverance, lack of premeditation and sensation seeking. This scale is based on Cyder and Smith (2007) and Whiteside and Lynam (2001) theory of impulsivity. Range 0 to 50.

executive function

The Behavior Rating Inventory of Executive Function higher values represent a worse outcome Score are summed. This questionnaire measures executive functionning in everyday life. The BRIEF includes 75 questions and eight sub-domains: Inhibit Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials and Monitor. Score range 0 to 100

Reward

Subjects will perform a reward under stress task adapted from the spatial delayed response task from (Glahn et al., 2002) measure reward (Martin-Soelch, C., et al.,2009: Gaillac et al., 2016). Reaction time is calculated. The sensitivity to Punishment and Sensitivity to Reward questionnaire for Children, adolescents (SPSRQ-C) (Colder and O'Connor 2004) and adults (SPSRQ, Torrubia, Ávila, Moltó, & Caseras, 2001) are used. These questionnaires are based on Gray's reinforcement sensitivity theory of personality (1981, 1987, 2000). Reward task higher values represent a better outcome. Score range 0 to 110.

Reward

The sensitivity to Punishment and Sensitivity to Reward questionnaire for Children, adolescents (SPSRQ-C) (Colder and O'Connor 2004) and adults (SPSRQ, Torrubia, Ávila, Moltó, & Caseras, 2001) are used. These questionnaires are based on Gray's reinforcement sensitivity theory of personality (1981, 1987, 2000). Reward task higher values represent a better outcome. Score range 0 to 110.

Memory

WISC-IV higher values represent a better outcome. The Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV, Wechsler, 2003) Score are standardized from 0 to 20 for subtest and summed from 0 to 150. The Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV, Wechsler, 2003) and the Weschler adult intelligent scale measure verbal memory. Score are standardized from 0 to 20 for subtest and summed from 0 to 150.

Memory

WAIS-IV higher values represent a better outcome .the Weschler adult intelligent scale to (WAIS-IV; Wechsler, 2008). Score are standardized from 0 to 20 for subtest and summed from 0 to 150. The Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV, Wechsler, 2003) and the Weschler adult intelligent scale measure verbal memory. Score are standardized from 0 to 20 for subtest and summed from 0 to 150.

Neural activity

The fMRI measure include. Resting-state functional MRI.Task-free. Subjects are instructed to just lie quietly in the scanner and to think of nothing in particular and let their mind wander.- binding potential (ΔBP) is measured.

Full Information

NCT ID

NCT03799029

First Posted

May 28, 2018

Last Updated

January 7, 2019

Sponsor

University of Fribourg

Collaborators

Paris West University Nanterre La Défense

1. Study Identification

Unique Protocol Identification Number

NCT03799029

Brief Title

Effects of a Cognitive Training Program With Game Elements Among ADHD

Acronym

CogtrainADHD

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 20, 2019 (Anticipated)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Fribourg

Collaborators

Paris West University Nanterre La Défense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ADHD

Keywords

Cognitive training, treatment, ADHD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantInvestigator

Masking Description

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

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

active control group low-intensity

Arm Type

Active Comparator

Arm Description

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

Arm Title

experimental training group cognitive training

Arm Type

Experimental

Arm Description

Arm Title

control healthy participants

Arm Type

No Intervention

Arm Description

Just a control group including healthy participants No intervention

Intervention Type

Other

Intervention Name(s)

Cognitive training

Intervention Description

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.

Primary Outcome Measure Information:

Title

ADHD symptoms for adults

Description

Time Frame

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

Title

ADHD symptoms for children

Description

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.

Time Frame

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 Outcome Measure Information:

Title

Impulsivity

Description

Time Frame

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

Title

executive function

Description

Time Frame

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

Title

Reward

Description

Time Frame

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

Title

Reward

Description

Time Frame

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

Title

Memory

Description

Time Frame

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

Title

Memory

Description

Time Frame

Title

Neural activity

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Participants fulfilling all of the following inclusion criteria are eligible for the study for the patients'group: 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). Participants fulfilling all of the following inclusion criteria are eligible for the study for the control group of healthy participants: 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). Exclusion Criteria: Exclusion criteria The exclusion criteria for the participants in the patient's group are: 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. (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: 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) FMRI exclusion: claustrophobia, Pregnancy known or suspected, metallic implants in their bodies (e.g: pacemakers, aneurism clips, metal Prosthetic, cochlear implant) 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

amelie dentz, Ph.D

Phone

0676951881

ameliedentz@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chantal Martin Soelch, Pr

Phone

+41 26 300 7687

chantal.martinsoelch@unifr.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amélie Dentz, Ph.D

Organizational Affiliation

University of Fribourg

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Martin Soelch Chantal, PR

Organizational Affiliation

University of Fribourg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dentz Amélie

City

Montréal

State/Province

Quebec

ZIP/Postal Code

2000

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27875585

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.

Results Reference

background

PubMed Identifier

24438534

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.

Results Reference

result

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Effects of a Cognitive Training Program With Game Elements Among ADHD

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