Effects of a Cognitive Training Program With Game Elements Among ADHD

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

Patrocinadores

Patrocinador principal: University of Fribourg

Colaborador: Paris West University Nanterre La Défense

Fuente University of Fribourg
Resumen breve

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

Descripción detallada

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.

Estado general Not yet recruiting
Fecha de inicio February 20, 2019
Fecha de Terminación December 1, 2023
Fecha de finalización primaria June 1, 2021
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
ADHD symptoms for adults 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 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
Resultado secundario
Medida Periodo de tiempo
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
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
Neural activity 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
Inscripción 240
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: Cognitive training

Descripción: 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.

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 6 Years

Edad máxima: 65 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Contacto general

Apellido: amelie dentz, Ph.D

Teléfono: 0676951881

Email: [email protected]

Ubicación
Instalaciones: Dentz Amélie
Ubicacion Paises

Canada

Fecha de verificación

January 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of Fribourg

Nombre completo del investigador: Amelie Dentz

Título del investigador: principal investigator Ph.D

Palabras clave
Tiene acceso ampliado No
Número de brazos 3
Grupo de brazo

Etiqueta: active control group low-intensity

Tipo: Active Comparator

Descripción: 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

Etiqueta: experimental training group cognitive training

Tipo: Experimental

Descripción: 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

Etiqueta: control healthy participants

Tipo: No Intervention

Descripción: Just a control group including healthy participants No intervention

Acrónimo CogtrainADHD
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: 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.

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Descripción de enmascaramiento: Participant are blind on their group assignation. Investigator are blind on group assignation

Fuente: ClinicalTrials.gov