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

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ClinicalTrials.gov Identifier: NCT03799029
Recruitment Status : Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Paris West University Nanterre La Défense
Information provided by (Responsible Party):
Amelie Dentz, University of Fribourg

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

Condition or disease Intervention/treatment Phase
ADHD Other: Cognitive training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Masking Description: Participant are blind on their group assignation. Investigator are blind on group assignation
Primary Purpose: Treatment
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
Estimated Study Start Date : February 20, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2023

Arm Intervention/treatment
Active Comparator: 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
Other: 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.

Experimental: 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
Other: 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.

No Intervention: control healthy participants
Just a control group including healthy participants No intervention



Primary Outcome Measures :
  1. ADHD symptoms for adults [ 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 ]
    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.

  2. ADHD symptoms for children [ 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 ]
    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 :
  1. Impulsivity [ 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 ]
    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.

  2. executive function [ 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 ]
    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

  3. Reward [ 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 ]

    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.


  4. Reward [ 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 ]
    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.

  5. Memory [ 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 ]

    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.


  6. Memory [ 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 ]

    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.


  7. Neural activity [ 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799029


Contacts
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Contact: amelie dentz, Ph.D 0676951881 ameliedentz@hotmail.com
Contact: Chantal Martin Soelch, Pr +41 26 300 7687 chantal.martinsoelch@unifr.ch

Locations
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Canada, Quebec
Dentz Amélie
Montréal, Quebec, Canada, 2000
Sponsors and Collaborators
University of Fribourg
Paris West University Nanterre La Défense
Investigators
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Principal Investigator: Amélie Dentz, Ph.D University of Fribourg
Principal Investigator: Martin Soelch Chantal, PR University of Fribourg

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
No web site is provided yet

Publications of Results:
Other Publications:
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Responsible Party: Amelie Dentz, principal investigator Ph.D, University of Fribourg
ClinicalTrials.gov Identifier: NCT03799029     History of Changes
Other Study ID Numbers: University of Fribourg
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amelie Dentz, University of Fribourg:
Cognitive training
treatment
ADHD