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Field
Trial Start Date
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Before
January 01, 2021
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After
October 01, 2022
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Field
Trial End Date
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Before
December 31, 2023
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After
July 31, 2026
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Field
Last Published
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Before
October 15, 2022 08:08 AM
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After
October 15, 2022 08:32 AM
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Field
Intervention Start Date
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Before
January 01, 2021
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After
October 01, 2022
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Field
Intervention End Date
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Before
July 31, 2023
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After
July 31, 2025
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Field
Experimental Design (Public)
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Before
Women who attend the Yale/New Haven health system will be recruited and once consent has been obtained as well as baseline data they will be screened for eligibility and depression. Eligible women will be randomised to treatment and two control groups, forming groups of about 6-8 treated women and 6-8 women in control. One control group will receive nothing, while the other will receive a tablet and internet connection, just like the treatment but without any intervention. Once a group is formed the intervention will start on that group and we will continue recruiting for the next group.
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After
Women who attend the Yale/New Haven health system will be recruited and once consent has been obtained as well as baseline data they will be screened for eligibility and depression. Eligible women will be randomized to treatment and control group, forming groups of about 6-8 treated women and 6-8 women in control. Both treatment and control group will receive a tablet with internet connection as well as basic services (information on safe sleep and nutrition for their children.) Once a group is formed the intervention will start for the group randomized into treatment.
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Field
Planned Number of Observations
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Before
500 women and their newborn child.
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After
300 women and their newborn child.
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Field
Sample size (or number of clusters) by treatment arms
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Before
200 women in treatment, 150 in one control (without control) and 150 in the second control (with tablet)
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After
150 women in treatment, 150 in control (with tablet)
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Field
Power calculation: Minimum Detectable Effect Size for Main Outcomes
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Before
0.30 of a standard deviation
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After
0.32 of a standard deviation
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Field
Did you obtain IRB approval for this study?
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Before
No
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After
Yes
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