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

Sponsor
Tel Aviv University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05832957
Collaborator
(none)
90
3
16

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Drive fun
  • Behavioral: educational intervention
  • Other: No intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Cognitive-Functional Intervention to Reduce Driving Risk Factors of Adolescents With ADHD
Anticipated Study Start Date :
May 2, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Reducing errors while driving on a driving simulator [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tel Aviv University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Navah Ratzon, Head of Health Professions, Principal Investigator, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT05832957
Other Study ID Numbers:
  • Anat Keren
First Posted:
Apr 27, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 1, 2023