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
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- ADHD symptoms for children
研究概览
简要总结
This study examines the impact of cognitive training among participants with ADHD in Switzerland
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participant are blind on their group assignation. Investigator are blind on group assignation
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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
干预措施: Cognitive training (Other)
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
干预措施: Cognitive training (Other)
control healthy participants
Just a control group including healthy participants No intervention
结局指标
主要结局
ADHD symptoms for children
时间窗: 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.
ADHD symptoms for adults
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
研究者
Amelie Dentz
principal investigator Ph.D
University of Fribourg