InflammationNCT03322397
Adolescent Acts of Kindness Intervention
A study testing Self-Focused Acts of Kindness Intervention, Other-Focused Acts of Kindness Intervention and Daily Reports in people with Inflammation and Mental Health Wellness 1, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Mental Health Wellness 1
- What is being tested?
- Self-Focused Acts of Kindness Intervention, Other-Focused Acts of Kindness Intervention and Daily Reports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2017to 13 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between the ages of 14-17
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Adolescent Development Lab at UCLA
Los Angeles, California, 90066
About this study
Official title: 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.
Read the 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.
- Conditions
- Inflammation, Mental Health Wellness 1
- Being tested
- Self-Focused Acts of Kindness Intervention, Other-Focused Acts of Kindness Intervention, Daily Reports
- Keywords
- adolescence, immune function, gene expression, psychological well-being, social connection, kindness
- Medical subject headings
- Inflammation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Focused Acts of Kindness InterventionBehavioural
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 InterventionBehavioural
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 ReportsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Kindness to Others | Experimental | 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. Receives: Behavioral: Other-Focused Acts of Kindness Intervention |
| Kindness to Self | Active comparator | 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. Receives: Behavioral: Self-Focused Acts of Kindness Intervention |
| Daily Report | Sham comparator | 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. Receives: Behavioral: Daily Reports |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly over 5 weeks
Secondary outcomes (3)
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.
Measured: Baseline and one-week post intervention (elapsed time of 5 weeks)
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.
Measured: Baseline and one-week post intervention (elapsed time of 5 weeks)
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.
Measured: Weekly over 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start8 Oct 2017
- Primary completion13 Jan 2019
- Study completion13 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew J. Fuligni, PhD, University of California, Los Angeles
- Investigators
- Andrew Fuligni, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322397
- Sponsor's protocol ID
- 17-001018
- Status last verified
- Feb 2019
- First submitted
- 23 Oct 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Daily Life and Health
- ClinicalTrials.gov ID
- NCT03322397
- Acronym / sponsor ID
- 17-001018
- Conditions
- Inflammation, Mental Health Wellness 1
- Keywords
- adolescence, immune function, gene expression, psychological well-being, social connection, kindness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 8 Oct 2017 (actual)
- Primary completion
- 13 Jan 2019 (actual)
- Study completion
- 13 Jan 2019 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kindness to Others | Experimental | Behavioral: Other-Focused Acts of Kindness InterventionParticipants 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. |
| Kindness to Self | Active comparator | Behavioral: Self-Focused Acts of Kindness InterventionParticipants 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. |
| Daily Report | Sham comparator | Behavioral: Daily ReportsParticipants 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Between the ages of 14-17
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Focused Acts of Kindness InterventionParticipants 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. | Behavioural | Kindness to Self |
| Other-Focused Acts of Kindness InterventionParticipants 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. | Behavioural | Kindness to Others |
| Daily ReportsParticipants 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. | Behavioural | Daily Report |
Primary outcome
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.
3 secondary outcomes
Inflammatory Gene Expression
Time frame: Baseline and one-week post intervention (elapsed time of 5 weeks)
Average Psychological Flourishing
Time frame: Baseline and one-week post intervention (elapsed time of 5 weeks)
Average Negative Affect
Time frame: Weekly over 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
Related trials for Inflammation
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Fuligni, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Focused Acts of Kindness Intervention, Other-Focused Acts of Kindness Intervention and Daily Reports in people with Inflammation and Mental Health Wellness 1, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Positive Affect (time frame: Weekly over 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.