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Adolescent Acts of Kindness Intervention

Primary Purpose

Inflammation, Mental Health Wellness 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Focused Acts of Kindness Intervention
Other-Focused Acts of Kindness Intervention
Daily Reports
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation focused on measuring adolescence, immune function, gene expression, psychological well-being, social connection, kindness

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between the ages of 14-17

Exclusion Criteria:

  • None

Sites / Locations

  • Adolescent Development Lab at UCLA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Kindness to Others

Kindness to Self

Daily Report

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

Average Positive Affect
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.

Secondary Outcome Measures

Inflammatory Gene Expression
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.
Average Psychological Flourishing
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.
Average Negative Affect
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.

Full Information

First Posted
October 23, 2017
Last Updated
February 19, 2019
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03322397
Brief Title
Adolescent Acts of Kindness Intervention
Official Title
Study of Daily Life and Health
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 8, 2017 (Actual)
Primary Completion Date
January 13, 2019 (Actual)
Study Completion Date
January 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Mental Health Wellness 1
Keywords
adolescence, immune function, gene expression, psychological well-being, social connection, kindness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
90 participants will randomly be assigned to one of three interventions. Participants will complete a 4-week intervention. All outcomes will be measured before and after the intervention, and some psychological measures will be collected weekly throughout the intervention.
Masking
Participant
Masking Description
Participants will be told that the investigatos are studying the daily lives of teens. They will not be informed of the other arms of the experiment.
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kindness to Others
Arm Type
Experimental
Arm Description
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.
Arm Title
Kindness to Self
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Daily Report
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Focused Acts of Kindness Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Other-Focused Acts of Kindness Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Daily Reports
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Positive Affect
Description
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.
Time Frame
Weekly over 5 weeks
Secondary Outcome Measure Information:
Title
Inflammatory Gene Expression
Description
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.
Time Frame
Baseline and one-week post intervention (elapsed time of 5 weeks)
Title
Average Psychological Flourishing
Description
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.
Time Frame
Baseline and one-week post intervention (elapsed time of 5 weeks)
Title
Average Negative Affect
Description
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.
Time Frame
Weekly over 5 weeks
Other Pre-specified Outcome Measures:
Title
Average Stress
Description
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.
Time Frame
Weekly over 5 weeks
Title
Sleep Quality
Description
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.
Time Frame
Weekly over 5 weeks
Title
Inflammatory Composite
Description
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).
Time Frame
Baseline and one-week post intervention (elapsed time of 5 weeks)
Title
Respiratory Sinus Arrythmia (RSA)
Description
Change in RSA from baseline to one week following the intervention as assessed by high-frequency heart rate variability during paced breathing.
Time Frame
Baseline and one-week post intervention (elapsed time of 5 weeks)
Title
Average Social connection
Description
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.
Time Frame
Weekly over 5 weeks
Title
Donation
Description
Donation as assessed by the amount of money participants donated (maximum of $10) to a charity for foster youth.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between the ages of 14-17 Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Fuligni, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adolescent Development Lab at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90066
Country
United States

12. IPD Sharing Statement

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Adolescent Acts of Kindness Intervention

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