The Effectiveness of Cognitive-Functional Intervention to Reduce Driving Risk Factors of Adolescents With ADHD
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2023
CompletedFirst Submitted
Initial submission to the registry
April 16, 2023
CompletedFirst Posted
Study publicly available on registry
April 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2026
CompletedFebruary 11, 2026
February 1, 2026
3 years
April 16, 2023
February 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Reducing errors while driving on a driving simulator
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
1 year
Study Arms (3)
Drive fun
EXPERIMENTALThe 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
educational intervention
EXPERIMENTAL7 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
No Intervention
OTHERone-time short guidance on safe driving at the end of the study.
Interventions
The "Drive Fun" intervention program aims to promote the development of adaptive self-awareness and facilitate the acquisition of management strategies that foster safe and confident driving among participants. The program utilizes a driving simulator to provide a guided learning experience, which incorporates various sources of information, as well as games and thinking tasks. Additionally, participants will engage in reflective exercises that draw upon their occupational experiences and their driving performance within the simulator. Parental involvement is also incorporated to ensure ongoing support for the continued practice of learned skills.
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
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of ADHD by a psychiatrist according to DSM -V
- Did not begin driving lessons.
You may not qualify if:
- A chronic primary psychiatric diagnosis A primary developmental disorder that is not ADHD (e.g., Autism Spectrum Disorder).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
; The faculty of medicine & health professions, Tel-Aviv University,
Tel Aviv, Tel Aviv, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Health Professions, Principal Investigator
Study Record Dates
First Submitted
April 16, 2023
First Posted
April 27, 2023
Study Start
February 2, 2023
Primary Completion
February 10, 2026
Study Completion
February 10, 2026
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share