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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03322397
Other study ID # 17-001018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 8, 2017
Est. completion date January 13, 2019

Study information

Verified date February 2019
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date January 13, 2019
Est. primary completion date January 13, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 17 Years
Eligibility Inclusion Criteria:

- Between the ages of 14-17

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
United States Adolescent Development Lab at UCLA Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Average Stress 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
Other Sleep Quality 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
Other Inflammatory Composite 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)
Other Respiratory Sinus Arrythmia (RSA) 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)
Other Average Social connection 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
Other Donation Donation as assessed by the amount of money participants donated (maximum of $10) to a charity for foster youth. 5 weeks
Primary 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. Weekly over 5 weeks
Secondary 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. Baseline and one-week post intervention (elapsed time of 5 weeks)
Secondary 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. Baseline and one-week post intervention (elapsed time of 5 weeks)
Secondary 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. Weekly over 5 weeks
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