The Kiss of Kindness Study II

April 28, 2020 updated by: Jennifer Irwin, Western University, Canada

Kindness as an Intervention for Student Social Interaction Anxiety, Resilience, Affect, and Mood

The objective of this study is to assess the impact of engaging in deliberate acts of kindness on resilience (primary outcome); social interaction anxiety and affect (secondary outcomes); and mood (exploratory outcome) of undergraduate and graduate students at Western University (UWO). Recruitment of 200 participants consisting of 150 full-time undergraduate and 50 graduate students, randomized to either the intervention (n=100) or control group (n=100) will be achieved via a mass email to all full-time students at UWO. Both intervention and control groups will receive an email with access to a relaxation and stress management booklet from UWO's Wellness Education Centre (http://studentexperience.uwo.ca/docs/RelaxationAndStressManagement.pdf). In addition, the intervention group will be asked to (1) complete and log/submit a minimum of three deliberate acts of kindness per day for one month, and (2) join the study-dedicated online site to connect with, support, and share experiences and ideas with each other around acts of kindness. Individuals in the intervention group will also receive a list of deliberate acts of kindness ideas, for reference. Baseline, immediate post intervention, and three-months post intervention data will be collected using previously validated questionnaires associated with each outcome of interest, and posted to Qualtrics, an online survey tool. Additionally, immediately following the intervention and 3 months post intervention all participants will complete an open-ended question asking them to describe their overall experience being involved in the study. Quantitative and qualitative data analysis will occur upon the completion of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Poor mental health is a significant public health concern that disproportionally affects university students, compared to their community counterparts, and stress is a main culprit. Although privileged in terms of attending higher education, the stress-related inequity experienced among university students stems from "academic load, constant pressure to succeed, competition with peers, financial burdens, and peer, teacher or parental pressure". These stressors can trigger or exacerbate anxiety levels, which are on the rise among students. The most recent National College Health Assessment Survey, which included Canadian postsecondary institutions, showed a marked increase in student anxiety between 2013 to 2016. Although less studied than undergraduates, graduate students' mental health also is worrisome with over 60% feeling exhausted, overwhelmed, hopeless, and/or depressed nearly all of the time. It is imperative that evidence-informed approaches to enhance resilience and reduce the negative mental health experiences of undergraduate and graduate students be implemented and evaluated. Although improving resilience and overall mental health is a growing focus across campuses, current programming is clearly unable to address the concern in its entirety, and additional interventions are required.

An emerging and promising approach to promoting positive mental health and resilience among secondary students is performing acts of kindness. Arguably, performing acts of kindness improves mental health through the strengthening of psychological resilience. Resilience, as an outcome, is predicated on six underlying dimensions: health, collaboration, purpose, composure, reasoning, and tenacity. In terms of health and collaboration, a small classroom-based kindness pilot entailing logging acts of kindness by undergraduate students at Western University (UWO), found improvements in individual levels of wellbeing (i.e. confidence and decreased stress), perceptions of positive classroom culture, and classroom cohesion. Performing acts of kindness is correlated with happiness which results in a positive sense of purpose, increased composure, and improved reasoning and resilience. Moreover, the physiological effects are well-known as functional magnetic resonance images (fMRIs) show activation in the reward centres of the brain when subjects are engaged in acts of kindness. Despite the strong theoretical foundation that links acts of kindness with resilience, this area of research has yet to be sufficiently explored. To that end, the objective of this study is to assess the impact of engaging in deliberate acts of kindness on resilience (primary outcome); social interaction anxiety and affect (secondary outcomes); and mood (exploratory outcome) of undergraduate and graduate students at UWO.

Methods

Study Design

A longitudinal repeated-measures, mixed methods randomized control trial grounded in an interpretive description paradigm will be used. Interpretive description is an inductive analysis approach that creates ways of understanding phenomena yielding application-based implications for practice. Recruitment of 200 participants consisting of 150 full-time undergraduate and 50 graduate students, randomized to either the intervention (n=100) or control group (n=100) will be achieved via a mass email to all full-time students at UWO once ethical approval is obtained and the trial is registered. This sample size was selected considering two criteria: 1) based on our previous work in the area the sample size is feasible; and 2) from a power analysis using resilience as the primary outcome, a sample of 100 per group is sufficient to detect significant differences between groups (p < 0.05). Participants will be eligible if they are: (a) full-time undergraduate or graduate students at UWO and/or the affiliate schools (Kings, Brescia, Huron) and (b) English-speaking. Both intervention and control group participants will receive an email with access to a relaxation and stress management booklet from UWO's Wellness Education Centre. In addition, the intervention group will be asked to (1) complete and log/submit a minimum of three deliberate acts of kindness per day for one month, and (2) join the study-dedicated online site to connect with, support, and share experiences and ideas with each other around acts of kindness. Deliberate acts of kindness will be defined for participants as purposeful acts benefitting others that the others would presumably like.

Data Collection/Metrics

Baseline, immediate post intervention, and three-months post intervention data will be collected using Qualtrics, an online survey tool. Baseline will consist of basic demographic information, and four previously validated scales: (1) Brief Resilience Scale (BRS); (2) Social Interaction Anxiety Scale-Straightforward (SIAS-S); (3) International Positive and Negative Affect Schedule-Short Form (I-PANAS-SF); and (4) Brief Mood Introspection Scale (BMIS). The assessments will take 15-minutes to complete. After the completion of the baseline assessment participants will be randomized using stratification by degree level (i.e., undergraduate or graduate). Immediately following the intervention and 3 months post intervention all participants will complete the same assessments administered at baseline (minus demographics) with the addition of an open-ended question asking participants to describe their overall experience being involved in the study.

Data analysis

Data analysis will occur upon the completion of the study and quantitative data analysis will initially involve computing measures of central tendency and dispersion as well as the computation of the validated scales. Next, general linear models will be used to examine both differences between groups and overtime. For the qualitative data, inductive content analysis using interpretive description will be conducted independently, and simultaneously by two researchers who will subsequently meet, upon the completion of analysis, to determine agreement in emerging findings. Statistical Package for Social Sciences (SPSS) will be used for quantitative analysis and QSR International NVivo software will be used to code and categorize qualitative data. Knowledge Translation will involve both traditional mechanisms (publications/conferences) and engagement with social media (infographics, youtube videos).

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • full-time undergraduate or graduate students at Western University (UWO) and/or the affiliate schools (Kings, Brescia, Huron)
  • English-speaking

Exclusion Criteria:

  • non-English-speaking (i.e. unable to understand and complete surveys/questionnaires)
  • part-time students

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants allocated to the intervention group will participate in the intervention (acts of kindness).
Both intervention and control groups will receive an email with access to a relaxation and stress management booklet from Western University's (UWO) Wellness Education Centre (http://studentexperience.uwo.ca/docs/RelaxationAndStressManagement.pdf). In addition, the intervention group will be asked to (1) complete and log/submit a minimum of three deliberate acts of kindness per day for one month, and (2) join the study-dedicated online site to connect with, support, and share experiences and ideas with each other around acts of kindness.
No Intervention: Control Group
Participants allocated to the control group will not participate in the intervention and will act as the comparison condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resilience (Brief Resilience Scale)
Time Frame: Change from baseline resilience at immediate post-intervention and 3-month post-intervention
The Brief Resilience Scale (BRS) includes 6-items; items 1, 3, and 5 are positively worded and items 2, 4, and 6 are negatively worded. Participants will be asked the extent to which they agree or disagree with the statements using a 5-point scale; 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree. The BRS is scored by reverse coding items 2, 4, and 6, such that 5 = strongly disagree, 4 = disagree, 3 = neutral, 2 = agree, and 1 = strongly agree. The mean of the six items is then determined to score the scale.
Change from baseline resilience at immediate post-intervention and 3-month post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social interaction anxiety (Social Interaction Anxiety Scale-Straightforward)
Time Frame: Change from baseline social interaction anxiety at immediate post-intervention and 3-month post-intervention
The Social Interaction Anxiety Scale-Straightforward (SIAS-S) includes 20 items assessing cognitive, affective and behavioural aspects of social interaction anxiety using a five-point scale; 0 = not at all, 1 = slightly, 2 = moderately, 3 = very and 4 = extremely. Participants will be asked to indicate the degree to which they feel the statement is characteristic or true to them. The SIAS-S uses reverse coding, such that items 5, 9 and 11 are reverse scored; however, they are not included in the total score. A total score of 28 or higher indicates probable social interaction anxiety.
Change from baseline social interaction anxiety at immediate post-intervention and 3-month post-intervention
Affect (International Positive and Negative Affect Schedule-Short Form)
Time Frame: Change from baseline affect at immediate post-intervention and 3-month post-intervention
The International Positive and Negative Affect Schedule-Short Form (I-PANAS-SF) includes 20 items from the Positive and Negative Affect Schedule (10 items = positive affect; 10 items = negative affect) using a five-point scale; 1 = very slightly or not at all, 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. Participants will be asked to indicate the extent they have felt the adjective over the past week. The positive affect score is obtained by adding the scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17 and 19. The negative affect score is obtained by adding the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20.
Change from baseline affect at immediate post-intervention and 3-month post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood (Brief Mood Introspection Scale)
Time Frame: Change from baseline mood at immediate post-intervention and 3-month post-intervention
The Brief Mood Introspection Scale (BMIS) is a mood-adjective scale that includes 16-items selected from eight mood states: (a) happy (happy, lively), (b) loving (loving, caring), (c) calm (calm, content), (d) energetic (active, peppy), (e) fearful/anxious (jittery, nervous), (f) angry (grouchy, fed up), (g) tired (tired, drowsy), and (h) sad (gloomy, sad). Participants will be asked to indicate how well each adjective or phrase describes their present mood. To score the BMIS, the numerical values from 1 to 4 are assigned to the Likert scale; 1 = definitely do not feel, 2 = do not feel, 3 = slightly feel and 4 = definitely feel, for both the positive and negative mood adjectives. Reverse scoring is used in order to accurately depict the participant's mood. To reverse score the BMIS, the numerical values assigned previously are reversed, such that 4 = definitely do not feel and 1 = definitely feel.
Change from baseline mood at immediate post-intervention and 3-month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jennifer D Irwin, PhD, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2019

Primary Completion (Actual)

February 18, 2020

Study Completion (Actual)

March 23, 2020

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) will be disseminated via publications and presentations.

IPD Sharing Time Frame

The intervention will take place during the month of November 2019 and the trial protocol will be submitted for publication; manuscript preparation will occur starting April 2020.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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