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

NCT ID: NCT05832957

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2025-06-01

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.

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.

Conditions

Driving Risk Factors Among Adolescents With ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Drive fun

Intervention Type: BEHAVIORAL

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.

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

Group Type: EXPERIMENTAL

educational intervention

Intervention Type: BEHAVIORAL

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

No Intervention

one-time short guidance on safe driving at the end of the study.

Group Type: OTHER

No intervention

Intervention Type: OTHER

one-time short guidance on safe driving at the end of the study.

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

No intervention

one-time short guidance on safe driving at the end of the study.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Navah Ratzon

Head of Health Professions, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

Anat Keren

Identifier Type: -

Identifier Source: org_study_id