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

University of Fribourg

Status: Unknown

Conditions: ADHD

Treatments: Other: Cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT03799029

University of Fribourg

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 6 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 3 patient groups

active control group low-intensity

Active Comparator group

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

Treatment:

Other: Cognitive training

experimental training group cognitive training

Experimental group

Description:

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

Treatment:

Other: Cognitive training

control healthy participants

No Intervention group

Description:

Just a control group including healthy participants No intervention