Testing a New Method to Improve Informed Consent in Prison Research

NCT06378281 | Recruiting DMC

• 1 other identifier: CRSK-3_221381
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Understanding of informed consent is often limited in prison, due to unique challenges faced by detained people. This study will test a modified "teach-to-goal" informed consent process compared to standard procedures. Conducted within a larger study on psychiatric outcomes, it aims to enhance ethical practices for vulnerable populations.

Conditions

ADHD

Keywords

Informed consent; Prison; Ethics

Outcome Measures

Primary Outcomes (1)

• Understanding of the informed consent (binary)

  20 questions (true/false) evaluating whether the participant understood the information. A binary variable coded 1 if all questions are answered correctly and 0 otherwise will be computed.

  Immediately after the intervention

Secondary Outcomes (2)

• Understanding of the informed consent (continuous)

  Immediately after the intervention

• Evaluation of the informed consent

  Immediately after the intervention

Study Arms (2)

Standard informed consent

NO INTERVENTION

According to ethical requirements of Swiss Human Research Act, the interviewer will explain the nature of the study, its purposes, duration, the potential risks and benefits it entails, and study procedures. He will inform that study participation is voluntary and that participants may withdraw at any time. He will also explain that the study is independent from the prison authorities. Participants will then be given time to read the informed consent, or, if they are not able to read, it will be read to them by the interviewer. The interviewer will answer all questions.

Modified teach-to-goal informed consent

EXPERIMENTAL

The standard process will first be used. After that, the interviewer will ask participants to summarize the content of the informed consent. The interviewer will correct not-well understood components and ask questions about forgotten components. In case of misconceptions, the participant will be asked to summarize again the corresponding components. A list of key components to be addressed will be developed by study team members, including experts in prison research and ethics, based on components listed in Art. 16 of the Swiss Human Research Act. The material of the informed consent of the parent-randomized controlled trial will be used.

Other: Modified teach-to-goal informed consent

Interventions

Modified teach-to-goal informed consent OTHER

Enhanced procedure to improve informed consent in vulnerable populations.

Modified teach-to-goal informed consent

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• good command of French
• absence of acute psychiatric disorder
• providing written informed consent for study participation in the parent-RCT

You may not qualify if:

• \- none.

Sponsors & Collaborators

• Stéphanie Baggio: lead
• University of Bern: collaborator
• Leiden University: collaborator
• School of Health Sciences Fribourg: collaborator
• University Hospital, Geneva: collaborator
• University of Lausanne: collaborator

Study Sites (2)

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

NOT YET RECRUITING

Geneva University Hospitals

Geneva, Canton of Geneva, 1226, Switzerland

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Stéphanie Baggio, Prof.

CONTACT

+41216923238; stephanie.baggio@unil.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. phil.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CH (2)