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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Daily Reports
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.
Behavioral: Other-Focused Acts of Kindness Intervention
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.
Behavioral: Self-Focused Acts of Kindness Intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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