Testing a New Method to Improve Informed Consent in Prison Research
ConditionADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStéphanie Baggio
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
screened in the parent-RCT
age ≥ 18 years
good command of French
absence of acute psychiatric disorder
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Modified teach-to-goal informed consent
Other interventionEnhanced procedure to improve informed consent in vulnerable populations.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Standard informed consentNo intervention 0 interventions
Group B: Modified teach-to-goal informed consentExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Immediately after the interventionSecondary outcomes
1
Understanding of the informed consent (continuous)
20 questions (true/false) evaluating whether the participant understood the information. A score between 0 and 20 will be developed.
Time frame
Immediately after the intervention2
Evaluation of the informed consent
10 questions evaluated on a Likert 6-point scale evaluating what the participants thought of the information. A score between 0 and 50 will be computed.
Time frame
Immediately after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stéphanie Baggio
Lead sponsor
University Hospital, Geneva
Sponsor institution
University of Bern
Collaborator
Leiden University
Collaborator
School of Health Sciences Fribourg
Collaborator
University Hospital, Geneva
Collaborator
University of Lausanne
Collaborator
Source ClinicalTrials.gov