The Effectiveness of Cognitive-Functional Intervention to Reduce Driving Risk Factors of Adolescents With ADHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reducing errors while driving on a driving simulator
研究概览
简要总结
Background: Attention deficit hyperactivity disorder (ADHD) is associated with a high risk for driving accidents. Adolescents with ADHD are 1.2 to 4 times more prone to be involved in car accidents. Driving accidents are the leading cause of death among adolescents.
Objective: Examining a multidimensional applied intervention based on serious gaming principles to improve the driving capabilities and skills of adolescents with ADHD Methodology: The study will include 90 adolescents (aged 15-18 years old) with ADHD diagnosis who did not yet start driving lessons. Participants will undergo a stratified randomized clinical trial, single-blinded. The stratified randomization process will include gender, age, and medication status. There exist three different intervention modalities: (1) A personalized cognitive-functional intervention- 'Drive-Fun' (group1) (2) educational intervention (group2); and (3) no intervention (group3). Meetings will entail 11 once-a-week sessions. Participants will be evaluated before intervention (baseline), after the intervention, and at a 6-month follow-up. Evaluations will include simulated driving skills, meta-cognitive abilities, eye tracking, and brain activity (EEG) measures. The evaluation and the intervention will be conducted by two certified occupational therapists. Participants and the therapist performing the evaluations will be blinded to group type and intervention.
The potential scientific contribution of the proposed research: Given the great risks of injury to adolescents with ADHD and other road users, it is important to identify dangerous driving behaviors as well as develop methods that can lead to better driving skills and a safer driving experience. It is anticipated that evidence will be presented by the evaluation battery that the personalized intervention program developed will significantly improve potential driving skills on the simulator and hopefully also actual driving.
详细描述
Background: Attention deficit hyperactivity disorder (ADHD) is associated with a high risk for driving accidents. Adolescents with ADHD are 1.2 to 4 times more prone to be involved in car accidents. Driving accidents are the leading cause of death among adolescents.
Objective
Examining a multidimensional applied intervention based on serious gaming principles to improve the driving capabilities and skills of adolescents with ADHD Methodology: The study will include 90 adolescents (aged 15-18 years old) with ADHD diagnosis who did not yet start driving lessons. Participants will undergo a stratified randomized clinical trial, single-blinded. The stratified randomization process will include gender, age, and medication status. There exist three different intervention modalities: (1) A personalized cognitive-functional intervention- 'Drive-Fun' (group1) (2) educational intervention (group2); and (3) no intervention (group3). Meetings will entail 11 once-a-week sessions. Participants will be evaluated before intervention (baseline), after the intervention, and at a 6-month follow-up. Evaluations will include simulated driving skills, meta-cognitive abilities, eye tracking, and brain activity (EEG) measures. The evaluation and the intervention will be conducted by two certified occupational therapists. Participants and the therapist performing the evaluations will be blinded to group type and intervention.
The potential scientific contribution of the proposed research: Given the great risks of injury to adolescents with ADHD and other road users, it is important to identify dangerous driving behaviors as well as develop methods that can lead to better driving skills and a safer driving experience. It is anticipated that evidence will be presented by the evaluation battery that the personalized intervention program developed will significantly improve potential driving skills on the simulator and hopefully also actual driving.
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
- None
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of ADHD by a psychiatrist according to DSM -V
- •Did not begin driving lessons.
排除标准
- •A chronic primary psychiatric diagnosis A primary developmental disorder that is not ADHD (e.g., Autism Spectrum Disorder).
研究组 & 干预措施
Drive fun
The intervention will include 11 sessions and last 11-13 weeks. Seven intervention meetings will be individual sessions of one hour at the driving lab at Tel Aviv University and four 90-minute meetings will be group sessions (3-6 participants) and will be conducted remotely by Zoom. The parents will be present during the first and last individual sessions
干预措施: Drive fun (Behavioral)
educational intervention
7 individual sessions of one hour at the driving lab at Tel Aviv university and 4 group sessions- 90 minutes by Zoom of group sessions of an educational intervention of safe driving according to Ministry of Education. The intervention focuses only on the cognitive aspects since it is based on imparting educational knowledge regarding safe driving with opportunities for gamified, non-driving-related activities such as board games (e.g., rush hour) and social games
干预措施: educational intervention (Behavioral)
No Intervention
one-time short guidance on safe driving at the end of the study.
干预措施: No intervention (Other)
结局指标
主要结局
Reducing errors while driving on a driving simulator
时间窗: 1 year
The expectation is that the subjects will drive better and their simulation will have fewer mistakes such as going through a red light or driving at excessive speed
次要结局
未报告次要终点
研究者
Navah Ratzon
Head of Health Professions, Principal Investigator
Tel Aviv University