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Clinical Trial Summary

This study will evaluate the effectiveness of FSST 2.0 (family supportive supervisor training plus support for use of family and sick leaves) using a randomized control trial design. We expect the intervention will increase supervisors' family supportive and leave supportive behaviors, which in turn will increase employees' leave use and decrease employees' work-family conflict, emotional exhaustion, depressive symptoms, and turnover intentions. This study will enroll a minimum 200 groups of managers and their employees. Managers in the intervention condition will complete pre- and 2 post-intervention Workplace Assessments, 2 online training modules, 1 webinar where managers can review intervention content and ask questions and share reactions on the materials. Managers in the control group and employees in both groups will complete pre- and 2 post-intervention Workplace Assessments. The post-intervention Workplace Assessment will be completed 3 and 6 months after the intervention. The total duration of the study is 9 months as the wait list control group will be offered the intervention and 2nd follow up survey after the 6-month trial.


Clinical Trial Description

This study will evaluate the effectiveness of FSST 2.0 (family supportive supervisor training plus support for use of family and sick leaves) using a randomized control trial design. - Phase of the Trial Based on the NIH's definition, the current study is a Phase III clinical trial, which usually involves several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. - Type of trial - a randomized-control trial - Randomization strategy - Randomization method The current study employs a cluster randomization strategy to assign organizations to either Condition A (intervention group) or Condition B (control group) for a few key reasons. First, although only the supervisors will receive the training, the effectiveness of the training will be assessed at the employee' level, thereby needing a nested data structure. Second, cluster randomization is effective in reducing contamination (Puffer et al., 2005). Third, when the intervention is offered at a group level, cluster randomization increases the external validity of the results (Donner & Klar, 2000). Within each organization, we will use a balanced group randomization strategy such that there will be an equal number of workgroups/teams/departments in the intervention or control condition. In the event that there is an odd number of such units, a slight imbalance (i.e., groups per condition) will be off by one group, which has minimal impact on statistical power to detect intervention effects. - Unit of randomization - organization - Allocation ratio - the same number of teams (one supervisor and at least 6 employees) will be recruited in both organization - Timing of randomization - before the baseline assessment - The statistician of the study will generate and implement the randomization schema. - Specification of the number of study groups/arms - 2 - Duration of the study intervention - 6 months - Follow-up period - 3 and 6 months after the intervention - Name and brief description of study intervention FSST 2.0 is a workplace intervention package designed to increase supervisors' family and leave supportive behaviors and leave supportive behaviors. The package includes Workplace Assessment tool, 2 30-45-minute online training modules (family-supportive supervisor training and supervisors' leave supportive behavior training), a webinar, behavior training, and organizational reports. - Control group The current trial employs a wait-list control group, "whereby participants will receive the usual care and will later receive the intervention in addition to the usual care" (Kinser & Robins, 2013, p.2). One or more organization will be randomly assigned to receive the intervention and the other organization(s) will serve as a wait-list control group. Mangers in the intervention group will be asked to: 1. Complete a baseline online survey. 2. Take the Family Supportive Supervisor Training online (FSST). 3. Take the Supervisor Support for Leave Use module training online. 4. Track their behaviors for two weeks 5. Participate in a webinar with the opportunity to ask Q & A and make comments. 7. Complete up to 2 post-training surveys. 8. Focus groups may also be conducted to get feedback on the training after the study is over. Employees in the control group and employees in both groups will be asked to: 1. Complete a base line and follow up surveys over the course of 6 months. The wait list control group will be offered the training after the trial is over. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05080426
Study type Interventional
Source Work Life Help
Contact
Status Active, not recruiting
Phase N/A
Start date October 27, 2022
Completion date May 2023