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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05080426
Other study ID # 2R42AG050347-02A1
Secondary ID 2R42AG050347-02A
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 27, 2022
Est. completion date May 2023

Study information

Verified date May 2023
Source Work Life Help
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1400
Est. completion date May 2023
Est. primary completion date May 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - To be 18 years and older - To be a supervisor with at least six employees or an employee of a participating supervisor Exclusion Criteria: - There is no exclusion criterion.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Family Supportive Supervisor Training 2.0
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 45-60 minute online training modules (family-supportive supervisor training and supervisors' leave supportive behavior training), a webinar, behavior training, and individualized feedback reports.

Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (2)

Lead Sponsor Collaborator
Work Life Help National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (15)

Barnett, R. C., Brennan, R. T., & Gareis, K. C.. A closer look at the measurement of Burnout. Journal of Applied Biobehavioral Research.1999; 4(2), 65-78.

Boroff, K E, & Lewin, D Loyalty, voice, and intent to exit a union firm: A conceptual and empirical analysis. Industrial and Labor Relations Review. 1997; 51(1), 50-63.

Cammann, C., Fichman, M., Jenkins, G. D., & Klesh, J. Michigan Organizational Assessment Questionnaire.1983. In S. E. Seashore, E. E. Lawler, P. H. Mirvis, & C. Cammann (Eds.), Assessing organizational change: A guide to methods, measures, and practices, (pp. 71-138). New York: Wiley-Interscience

Carlson, DS, Kacmar, KM, Wayne, JH, & Grzwacz, JG Measuring the positive side of the work-family interface: Development and validation of a work-family enrichment scale. Journal of Vocational Behavior. 2006. 68, 131-164. doi:10.1016/j.jvb.2005.02.002

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. — View Citation

Griffin, MA, Neal, A, & Parker, SK. A new model of work role performance: Positive behavior in uncertain and interdependent contexts. 2007; Academy of Management Journal, 50(2), 327-347.

Hammer LB, Ernst Kossek E, Bodner T, Crain T. Measurement development and validation of the Family Supportive Supervisor Behavior Short-Form (FSSB-SF). J Occup Health Psychol. 2013 Jul;18(3):285-96. doi: 10.1037/a0032612. Epub 2013 Jun 3. — View Citation

Hobfoll, SE, Vinokur, AD, Pierce, PF, & Lewandowski-Romps, L. The combined stress of family life, work, and war in Air Force men and women: A test of conservation of resources theory. International Journal of Stress Management. 2012; 19(3), 217-237.

Kessler RC, Barker PR, Colpe LJ, Epstein JF, Gfroerer JC, Hiripi E, Howes MJ, Normand SL, Manderscheid RW, Walters EE, Zaslavsky AM. Screening for serious mental illness in the general population. Arch Gen Psychiatry. 2003 Feb;60(2):184-9. doi: 10.1001/archpsyc.60.2.184. — View Citation

Kossek, EE, Colquitt, JA, & Noe, RA. Caregiving decisions, well-being, and performance: The effects of place and provider as a function of dependent type and work-family climates, Academy of Management Journal.2001; 44(1), 29-44.

Kossek, EE, Ruderman, MN, Braddy, PW, & Hannum, KM Work-nonwork boundary management profiles: A person-centered approach. Journal of Vocational Behavior.2012; 81, 112-128. doi:10.1016/j.jvb.2012.04.003

Matthews RA, Kath LM, Barnes-Farrell JL. A short, valid, predictive measure of work-family conflict: item selection and scale validation. J Occup Health Psychol. 2010 Jan;15(1):75-90. doi: 10.1037/a0017443. — View Citation

Matthews, RA, Pineault, L, & Hong, YH. Normalizing the use of single-item measures. Validation of the single-item compendium for organizational psychology, Journal of Business and Psychology. 2022; Doi:10.1007/s10869-022-09813-3

Thomas, LT, & Ganster, DC. Impact of family-supportive work variables on work-family conflict and strain: A control perspective. Journal of Applied Psychology. 1995; 80(1), 6-15.

Yoon, J, , Lim, J. Organizational support in the workplace: The case of Korean hospital employees. Human Relations. 1999; 82, 923-945.

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary change in Family supportive supervisor behaviors Family supportive behavior scale Hammer et al., 2013 at baseline and 3 and 6 months after the intervention
Primary change in Leave supportive supervisor behaviors developed by Kossek & Hammer (2022) at baseline and 3 and 6 months after the intervention
Secondary change in work-family conflict Matthews et al., 2010 work family conflict scale at baseline and 3 and 6 months after the intervention
Secondary change in emotional exhaustion Barnett et al., 1999 emotional exhaustion scale at baseline and 3 and 6 months after the intervention
Secondary change in employee's leave use number of days of leave used at baseline and 3 and 6 months after the intervention
Secondary change in turnover intentions Boroff & Lewin, 1997 turnover intentions scale at baseline and 3 and 6 months after the intervention
Secondary change in control over work Thomas & Ganster (1995) control over work scale at baseline and 3 and 6 months after the intervention
Secondary change in boundary countrol Kossek et al. (2012) boundary control scale at baseline and 3 and 6 months after the intervention
Secondary change in work-life climate Allen (2001) adapted, Kossek et al (2001) work-life climate scale at baseline and 3 and 6 months after the intervention
Secondary change in work-to-family positive spillover Carlson et al (2006) WTF positive spillover scale at baseline and 3 and 6 months after the intervention
Secondary change in general supervisor support Yoon, J., & Lim, J. (1999) general supervisor support scale at baseline and 3 and 6 months after the intervention
Secondary change in supervisor performance support work family health network supervisor performance support scale at baseline and 3 and 6 months after the intervention
Secondary change in job satisfaction Cammann et al., (1983) job satisfaction scale at baseline and 3 and 6 months after the intervention
Secondary change in job performance Griffin et al., (2007) job performance scale at baseline and 3 and 6 months after the intervention
Secondary change in organizational commitment Matthews et al. (2022) organizational commitment item at baseline and 3 and 6 months after the intervention
Secondary change in perceived health Hobfoll et al. (2012), perceived health item at baseline and 3 and 6 months after the intervention
Secondary change in psychological distress K6 (Kessler et al., 2003) psychological distress scale at baseline and 3 and 6 months after the intervention
Secondary change in perceived stress Cohen, Kamarck, & Mermelstein (1983) perceived stress scale at baseline and 3 and 6 months after the intervention