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Field
Trial End Date
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Before
August 18, 2028
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After
March 31, 2029
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Field
Last Published
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Before
July 22, 2025 07:10 AM
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After
November 26, 2025 08:19 AM
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Field
Intervention End Date
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Before
August 18, 2025
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After
March 31, 2026
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Field
Randomization Method
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Before
The randomization process will be conducted via computer. The randomization outcome is displayed for each participant at the end of the baseline Qualtrics survey. For the randomization we create batches of 20 randomization outcomes for each of the three sites, consisting of 10 Extra Chance Group and 10 Regular Pre-trial Group (i.e., block randomization by time and site). These outcomes are assigned to consenting participants who complete the baseline survey in randomized order.
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After
The randomization process will be conducted via computer. The randomization outcome is displayed for each participant at the end of the baseline Qualtrics survey. For the randomization we create batches of 20 randomization outcomes for each of the four sites, consisting of 10 Extra Chance Group and 10 Regular Pre-trial Group (i.e., block randomization by time and site). These outcomes are assigned to consenting participants who complete the baseline survey in randomized order.
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Field
Planned Number of Observations
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Before
We aim to enroll 2,000 participants.
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After
We aim to enroll 2,000 participants. Because enrollment progressed more slowly than anticipated, the funder has granted an extension of the enrollment phase until March 31st 2026. To facilitate additional enrollment, we have also added a fourth, adjacent study site (see supporting document Study Sites and Eligibility). The funder has authorized recruitment throughout the entire extended enrollment period. Based on historical enrollment patterns, we now expect to enroll approximately 2,200 participants by the end of this period.
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Field
Sample size (or number of clusters) by treatment arms
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Before
Planned number of participants in Extra-Chance group: 1,000
Planned number of participants in Regular Pre-Trial group: 1’000
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After
Planned number of participants in Extra-Chance group: around 1,100
Planned number of participants in Regular Pre-Trial group: around 1’100
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