- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03322397
Adolescent Acts of Kindness Intervention
February 19, 2019 updated by: Andrew J. Fuligni, PhD, University of California, Los Angeles
Study of Daily Life and Health
Adolescents will complete a 4-week intervention, during which they will either complete a kind act for others, complete a kind act for themselves, or report their daily activities three days per week.
Psychological and physiological measures will be indexed before and after the intervention.
Study Overview
Status
Completed
Conditions
Detailed Description
Stress and early adversity have been found to influence immune function via enhanced expression of the conserved transcriptional response to adversity (CTRA) genetic profile.
Expression of this genetic profile was reduced in adults who completed a prosocial behavior intervention.
This project aims to implement this intervention in adolescents.
90 high school students will be recruited and assigned to one of three groups (30/group).
Participants will either conduct 3 acts of kindness for themselves, conduct 3 acts of kindness for others, or report about their day 3 times per week for 4 weeks.
During this intervention, they will receive text messages 3 days per week instructing them to complete their respective act.
Participants will provide a brief description of this act that evening, as well as complete brief surveys at the end of the week for each week of the intervention.
Participants will come into the lab twice, once before and once after the 4-week intervention.
During these lab sessions participants will complete survey measures, have their heart rate measured, and have a blood draw conducted by a trained phlebotomist.
Participants' parents will also complete a brief survey to provide demographic information and an idea of what prosocial behaviors participants witnessed in their home.
The investigators will use these data to assess the effects of prosocial behavior on health and the psychological mechanisms underlying these effects.
At the second study visit, participants will be given the opportunity to donate part of their study payment to a charity to measure prosociality.
Any donations will be vetted with the psychology department's accounting group prior to making any donations in the university's name.
Scott Monatlik, Director, Tax and Information Practices, at smonatlik@finance.ucla.edu
or (310) 794-6724 will be contacted and information regarding the appropriate steps to take to ensure that the donation is made to an acceptable charity prior to any donations.
Actual helping behavior (donations) is measured to provide an ecologically valid experimental evaluation of prosociality rather than traditional metrics of computerized, fictional giving.
Conceptual frameworks from developmental and health psychology guide the hypothesis that prosocial behavior will influence adolescents.
Study Type
Interventional
Enrollment (Actual)
97
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
-
-
California
-
Los Angeles, California, United States, 90066
- Adolescent Development Lab at UCLA
-
-
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
14 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between the ages of 14-17
Exclusion Criteria:
- None
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Daily Report
Participants will complete the 'Daily Reports' and be asked to report their daily activities throughout the week for 4 weeks.
They will receive text messages three days per week (either Tuesday, Thursday, and Saturday or Wednesday, Friday, and Sunday) and will list activities from their day.
|
Participants will report their daily activities three times per week.
Aside from reporting at the end of the day, no changes should be made to the individual's normal routine.
|
Experimental: Kindness to Others
Participants will complete the 'Other-Focused Acts of Kindness Intervention' by performing acts of kindness for others.
They be asked to complete 3 kind acts for others throughout the week for 4 weeks.
They will receive text messages three days per week (either Tuesday, Thursday, and Saturday or Wednesday, Friday, and Sunday) and will report on their kind act later that day.
|
Participants engage in positive behaviors by completing acts of kindness for others three times per week.
These acts should require effort and be outside of an individual's normal routine.
|
Active Comparator: Kindness to Self
Participants will complete the 'Self-Focused Acts of Kindness Intervention' by performing acts of kindness for themselves.
They be asked to complete 3 kind acts for others throughout the week for 4 weeks.
They will receive text messages three days per week (either Tuesday, Thursday, and Saturday or Wednesday, Friday, and Sunday) and will report on their kind act later that day.
|
Participants engage in positive behaviors by completing acts of kindness for themselves three times per week.
These acts should require effort and be outside of an individual's normal routine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Positive Affect
Time Frame: Weekly over 5 weeks
|
Average Positive Affect as assessed by the positive affect subscale of the Affect Adjective Checklist.
An average is taken across four items, and scores range from 1 to 5 with higher scores indicating more positive affect over the week.
|
Weekly over 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Psychological Flourishing
Time Frame: Baseline and one-week post intervention (elapsed time of 5 weeks)
|
Change in average psychological flourishing from baseline to one week following the intervention as assessed by Mental Health Continuum-Short Form at week 5.
An average is taken across 20 items, and scores range from 1 to 6, with higher values representing greater psychological flourishing.
|
Baseline and one-week post intervention (elapsed time of 5 weeks)
|
Average Negative Affect
Time Frame: Weekly over 5 weeks
|
Average negative affect as assessed by the negative affect subscale of the Affect Adjective Checklist.
An average is taken across five items, and scores range from 1 to 5 with higher scores indicating more negative affect over the week.
|
Weekly over 5 weeks
|
Inflammatory Gene Expression
Time Frame: Baseline and one-week post intervention (elapsed time of 5 weeks)
|
Change in inflammatory gene expression from baseline to one week following the intervention as assessed by assays of the conserved transcriptional response to adversity profile of gene expression in leukocytes.
|
Baseline and one-week post intervention (elapsed time of 5 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Stress
Time Frame: Weekly over 5 weeks
|
Average stress as assessed by the Perceived Stress Scale.
An average is taken across 10 items, and scores range from 1 to 5 with higher scores indicating greater stress.
|
Weekly over 5 weeks
|
Sleep Quality
Time Frame: Weekly over 5 weeks
|
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI).
The assessment has 7 components, each scored from 0 to 3. A sum is taken across these components, such that total scores range from 0 to 21 with higher scores indicating poorer sleep.
|
Weekly over 5 weeks
|
Inflammatory Composite
Time Frame: Baseline and one-week post intervention (elapsed time of 5 weeks)
|
Change in inflammation from baseline to one week following the intervention as assessed by the concentration of a variety of inflammatory cytokines (e.g., IL-6, IL-1).
|
Baseline and one-week post intervention (elapsed time of 5 weeks)
|
Respiratory Sinus Arrythmia (RSA)
Time Frame: Baseline and one-week post intervention (elapsed time of 5 weeks)
|
Change in RSA from baseline to one week following the intervention as assessed by high-frequency heart rate variability during paced breathing.
|
Baseline and one-week post intervention (elapsed time of 5 weeks)
|
Average Social connection
Time Frame: Weekly over 5 weeks
|
Average social connection as assessed by the relatedness subscale of the Balanced Measure of Psychological Needs.
An average is taken across 6 items, and scores range from 1 to 5 with higher scores indicating greater social connection.
|
Weekly over 5 weeks
|
Donation
Time Frame: 5 weeks
|
Donation as assessed by the amount of money participants donated (maximum of $10) to a charity for foster youth.
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew Fuligni, PhD, Professor
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)
October 8, 2017
Primary Completion (Actual)
January 13, 2019
Study Completion (Actual)
January 13, 2019
Study Registration Dates
First Submitted
October 23, 2017
First Submitted That Met QC Criteria
October 23, 2017
First Posted (Actual)
October 26, 2017
Study Record Updates
Last Update Posted (Actual)
February 21, 2019
Last Update Submitted That Met QC Criteria
February 19, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-001018
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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