The Effectiveness of Cognitive-Functional Intervention to Reduce Driving Risk Factors of Adolescents With ADHD

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.

Study Overview

• Status: Completed
• Conditions: Driving Risk Factors Among Adolescents With ADHD
• Intervention / Treatment: Behavioral: Drive fun; Behavioral: educational intervention; Other: No intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv
    • Tel Aviv, Tel Aviv, Israel
      • ; The faculty of medicine & health professions, Tel-Aviv University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Clinical diagnosis of ADHD by a psychiatrist according to DSM -V
• Did not begin driving lessons.

Exclusion Criteria:

A chronic primary psychiatric diagnosis A primary developmental disorder that is not ADHD (e.g., Autism Spectrum Disorder).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Drive fun; 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.; Other Names: educational intervention
Experimental: 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	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
Other: No Intervention; one-time short guidance on safe driving at the end of the study.	Other: No intervention; one-time short guidance on safe driving at the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Actual): February 10, 2026
• Study Completion (Actual): February 10, 2026

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Early Intervention, Educational
• Other Study ID Numbers: Anat Keren

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No