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Psychosocial DeprivationFSSTNCT05080426

Family Supportive Supervisor Training and Workplace Assessment Tool

A study testing Family Supportive Supervisor Training 2.0 in people with Psychosocial Deprivation and Work-Related Stress, run by Work Life Help at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Family Supportive Supervisor Training 2.0
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,175 participants
Where
1 siteUnited States
Study dates
27 Oct 2022to 30 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To be 18 years and older
  • To be a supervisor with at least six employees or an employee of a participating supervisor

Who cannot join

  • There is no exclusion criterion.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Purdue University

    West Lafayette, Indiana, 47907

Other trials in United States

About this study

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.

Read the detailed 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 5 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) - http://wlhmodule1.s3-website.us-east-2.amazonaws.com/
  3. Take the Supervisor Support for Leave Use module training online - http://wlhmodule2.s3-website.us-east-2.amazonaws.com/
  4. Track their behaviors for two weeks
  5. Participate in a webinar with the opportunity to ask Q \& A and make comments.
  6. 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 5 months.

The wait list control group will be offered the training after the trial is over.

Being tested
Family Supportive Supervisor Training 2.0
Keywords
family supportive supervisor behaviors, work-family intervention, supervisor support for family, sick leave, family leave, workplace intervention, work life balance, supervisor training, manager training, work-family conflict, turnover intentions, flexible workplace, psychosocial intervention
Medical subject headings
Occupational Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Supportive Supervisor Training 2.0Behavioural

    Also called FSST 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.

Study groups in NCT05080426
Study groupRoleWhat they receive
Intervention Group - ManagersExperimentalMangers in the intervention group will be asked to: 1. Complete an online survey; 2. Take the Family Supportive Supervisor Training online (FSST); 3. Take the Supervisor Support for Leave Use module; 4. Track their behaviors for two weeks; 5. Participate in a webinar and have the opportunity to ask questions and give comments; 6. Complete a post-training survey; 7. 8-10 managers may also participate in the focus group.
Receives: Behavioral: Family Supportive Supervisor Training 2.0
Control Group - ManagersNo interventionManagers in the control group will be asked to: 1. Complete an online survey three times over the course of 5 months.
Intervention Group - EmployeesExperimentalEmployees in the intervention group will be asked to: 1. Complete an online survey three times over the course of 6 months.
Receives: Behavioral: Family Supportive Supervisor Training 2.0
Control Group - EmployeesNo interventionEmployees in the control group will be asked to: 1. Complete an online survey three times over the course of 5 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Family Supportive Supervisor Behaviors

    Family supportive supervisor behavior scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

  2. Change in Leave Supportive Supervisor Behaviors

    Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

Secondary outcomes (16)
  1. Change in Work-family Conflict

    Work family conflict scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (worse outcome). Negative scores = decrease in scores over time (better outcome).

    Measured: 5 months after the intervention

  2. Change in Emotional Exhaustion

    Emotional exhaustion scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (worse outcome). Negative scores = decrease in scores over time (better outcome).

    Measured: 5 months after the intervention

  3. Change in Employee's Leave Use

    Number of days of leave used for sick or family leave in the past 6 months. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time. Negative scores = decrease in scores over time.

    Note: higher scores do not represent better or worse outcomes. They are descriptions of use needed for sick or family leave.

    Measured: 5 months after the intervention

  4. Change in Turnover Intentions

    Turnover intentions scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (worse outcome). Negative scores = decrease in scores over time (better outcome).

    Measured: 5 months after the intervention

  5. Change in Control Over Work

    Control over work scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

  6. Change in Boundary Countrol

    Boundary control scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

  7. Change in Work-life Climate

    Work-life climate scale. Original scale: Minimum value = 1, Maximum value = 5. Higher scores = expected to make more family sacrifices. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (worse outcome). Negative scores = decrease in scores over time (better outcome).

    Measured: 5 months after the intervention

  8. Change in Work-to-family Positive Spillover

    WTF positive spillover scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

  9. Change in General Supervisor Support

    General supervisor support scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

  10. Change in Supervisor Performance Support

    Supervisor performance support scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

  11. Change in Job Satisfaction

    Job satisfaction scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

  12. Change in Job Performance

    Job performance scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

  13. Change in Organizational Commitment

    Organizational commitment item. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

  14. Change in Perceived Health

    Perceived health item. Original scale: Minimum value = 1, Maximum value = 5. Higher scores = better health. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (better outcome). Negative scores = decrease in scores over time (worse outcome).

    Measured: 5 months after the intervention

  15. Change in Psychological Distress

    Psychological distress scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (worse outcome). Negative scores = decrease in scores over time (better outcome).

    Measured: 5 months after the intervention

  16. Change in Perceived Stress

    Perceived stress scale. Original scale: Minimum value = 1, Maximum value = 5. Reported numbers represent change in these values over time: Time 3 (5-months post-baseline survey) - Time 1 (baseline survey) scores.

    Positive scores = increase in scores over time (worse outcome). Negative scores = decrease in scores over time (better outcome).

    Measured: 5 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start27 Oct 2022
  3. Primary completion30 May 2023
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The current study employs a cluster randomization strategy to assign organizations to either Condition A (intervention group) or Condition B (control group). One organization will be randomly assigned to the intervention and the other organization to the control group.
Masking
Single blind
Who is masked
Investigator
Enrolment
1,175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05080426
Sponsor's protocol ID
2R42AG050347-02A1
Other IDs
2R42AG050347-02A1
Acronym
FSST
Status last verified
Sep 2024
First submitted
30 Aug 2021
Last updated
8 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All de-identified data and referenced resources from a publication will be made available by depositing them at dataverse.org. The dataset will include variables used for the publication with an accompanying codebook containing variables labels and codes in XLSX format. Metadata will be prepared as an XML file, which is compliant with the Data Documentation Initiative (DDI) specification. The data and metadata from a publication will be made available by the online publication date. The location of the public-use data and how to access the data, as well as acknowledgments of the repository and funding source, will be identified in any publications and presentations about these data.

Publications

  • 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.

    PubMed 6668417
  • 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.

    PubMed 23730803
  • 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.

    PubMed 12578436
  • 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

  • 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.

  • 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.

    PubMed 20063960
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Family Supportive Supervisor Training 2.0 in people with Psychosocial Deprivation and Work-Related Stress, run by Work Life Help at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Family Supportive Supervisor Behaviors (time frame: 5 months after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05080426, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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