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Testing a New Method to Improve Informed Consent in Prison Research

Study acronym: Spark BATIR
StatusRecruiting
PhaseNot applicable
Started2024-05-01
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 3 times since 2024-04-18; most recent filed 2026-03-13. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-03-13
Amendment Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v3
2024-12-03
Amendment Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v2
2024-04-20
Amendment Study Status, Sponsor/Collaborators v1
2024-04-18
Original filing
Trial Details
NCT Number NCT06378281
Lead Sponsor Stéphanie Baggio
Collaborators: University of Bern, Leiden University, School of Health Sciences Fribourg, University Hospital, Geneva, University of Lausanne
Conditions ADHD
Enrollment 100 participants
Start Date 2024-05-01
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-17