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Field
Last Published
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Before
December 06, 2023 08:43 AM
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After
May 14, 2024 06:08 PM
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Field
Planned Number of Observations
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Before
The sample size is determined by the enrollment window (from December 4, 2023 to September 30, 2026). Based on historical data, we expect roughly 5,100 subjects to enter pretrial detention in the cantons of Zurich and Bern during this period. We expect that 80% (i.e., 4082 subjects) will be eligible for at least one of the interventions, with the samples containing the following numbers of subjects: 766 subjects in sample A, 1’888 subjects in sample B, 1’428 subjects in sample C. As it was impossible to conduct a pilot, we expect implementation issues, particularly in the beginning of the study. We therefore keep the option to drop all initial observations from prisons as long as i) less than 80% of the participants from SOCIAL and PRISMA & SOCIAL who are still in jail were approached by social services for an interview within the first three workdays since randomization, and ii) less than 80% of the participants from PRISMA and PRISMA & SOCIAL who are still in jail got their first PRISMA session booked within two workdays since randomization.
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After
The sample size is determined by the enrollment window (from December 4, 2023 to September 30, 2026). Based on historical data, we expect roughly 5,100 subjects to enter pretrial detention in the cantons of Zurich and Bern during this period. We expect that 80% (i.e., 4082 subjects) will be eligible for at least one of the interventions, with the samples containing the following numbers of subjects: 766 subjects in sample A, 1’888 subjects in sample B, 1’428 subjects in sample C. We experienced some early implementation issues, in particular with respect to the PRISMA intervention. Moreover, due to lacking staff, PRISMA was only available in German until the second week of January. The project team met with the prison staff on January 22nd 2024 to identify and resolve key implementation issues. We will therefore only include data from January 22nd 2024 onwards in our analysis.
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Field
Sample size (or number of clusters) by treatment arms
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Before
Of the projected 5’100 people entering pretrial detention during the enrollment window, we expect that roughly 43% of (or 2’194 individuals) will be eligible for PRISMA and roughly 65% (or 3’316 individuals) will be eligible for the proactive social services intervention, respectively. Thus, we expect 1’428 individuals (or 28% = 43% of 65%) to be eligible for both interventions and, hence, constitute sample C. This means that 766 individuals (= 2’194 – 1’428) will be eligible for PRISMA only (sample A) and 1’888 individuals (= 3’316 – 1’428) for proactive social services only (sample B). 1’018 (= 5’100 – 1’428 – 766 – 1’888) individuals will not be eligible for any of the two interventions. If samples are split with equal probability into experimental groups, we expect the following group sizes:
Randomization sample A:
o REGULAR PRETRIAL: 383
o PRISMA: 383
Randomization sample B:
o REGULAR PRETRIAL: 944
o SOCIAL: 944
Randomization sample C:
o REGULAR PRETRIAL: 357
o PRISMA: 357
o SOCIAL: 357
o PRISMA & SOCIAL: 357
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After
Of the projected 5’100 people entering pretrial detention during the enrollment window, we expect that roughly 43% of (or 2’194 individuals) will be eligible for PRISMA and roughly 65% (or 3’316 individuals) will be eligible for the proactive social services intervention, respectively. Thus, we expect 1’428 individuals (or 28% = 43% of 65%) to be eligible for both interventions and, hence, constitute sample C. This means that 766 individuals (= 2’194 – 1’428) will be eligible for PRISMA only (sample A) and 1’888 individuals (= 3’316 – 1’428) for proactive social services only (sample B). 1’018 (= 5’100 – 1’428 – 766 – 1’888) individuals will not be eligible for any of the two interventions. If samples are split with equal probability into experimental groups, we expect the following group sizes:
Randomization sample A:
o REGULAR PRETRIAL: 383
o PRISMA: 383
Randomization sample B:
o REGULAR PRETRIAL: 944
o SOCIAL: 944
Randomization sample C:
o REGULAR PRETRIAL: 357
o PRISMA: 357
o SOCIAL: 357
o PRISMA & SOCIAL: 357
As mentioned above we will only include data from January 22nd 2024 onwards in our analysis. Hence, the actual sample size will be lower than the projected 5'100.
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Field
Secondary Identifying Number(s)
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Before
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After
https://clinicaltrials.gov/study/NCT06197711
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