Psychological StressNCT05444881

Boricua Youth Study COVID-19 Coping Intervention Study

A study testing Mindfulness-based Intervention (Headspace TM) in people with Psychological Stress and Depression, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The current study is the second phase of a two-part study to examine the feasibility and utility of using an mHealth mindfulness intervention to help parents mitigate the stress associated with the impact of sustained community crisis situations, such as COVID-19 and its consequences, on low-income families living in… Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Psychological Stress, Depression, Anxiety
What is being tested?: Mindfulness-based Intervention (Headspace TM)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 28 Mar 2022to 28 Jan 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

BYS participants in the NY cohort (BYS-ECHO study record)
Have a child/children ages 3 to 12 years (BYS-ECHO study record)
Access to a smartphone, tablet, or computer with at least periodic internet access (Self-report)
Latinx parents with a child/children ages 3 to 12 years who express interest in the study, self-referred or referred by our community collaborators (Self-report)
access to a smartphone, tablet, or computer with at least periodic internet access (Self-report)
Residents of the NYC Metropolitan Area (i.e., individuals living approximately within 1 hour driving distance from NYC) (Self-report. If deemed necessary, research team may ask to check ID or relevant documents to verify information, e.g. name, address, etc)
Parents agreed to participate in the current study (Study consent form)
Ages 3 to 12 (BYS-ECHO study record or parent report of child age)

Who cannot join

Psychiatric risks (e.g., homicidality, suicidality including ideation and attempts, psychosis; answering "yes" to the PHQ-9 suicidal idea question, Q9) (As determined by BYS-ECHO study record or self-report of PHQ-9)
Severe depressive symptoms (i.e., PHQ-9=20 or above) (Self-report of PHQ-9)
1. Psychiatric risks (e.g., homicidally, suicidality including ideation and attempts, psychosis) (Parent report on Child Screener)

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

Official title: THE BYS COVID-19 COPING INTERVENTION STUDY- PHASE II: A RANDOMIZED CONTROLLED TRIAL OF AN mHEALTH MINDFULNESS PROGRAM

Read the detailed description

The current pilot study is a randomized controlled trial with an intervention (n=25 parent-child pairs) and a waitlist control (n=15 parent-child pairs) group that examines the feasibility, acceptability, and preliminary outcomes of the mHealth mindfulness program for parents. Parent participants will utilize a commercially available mobile phone application, Headspace TM, to complete 10-20 minutes of mindfulness exercises daily for six weeks. The investigators will measure the feasibility and acceptability of the mHealth mindfulness program for parents and clinical outcomes in both parents and children and also explore the effects of the intervention on stress markers including cortisol and inflammation (C-reactive protein (CRP) and Interleukin-6 (Il-6)).

Participants will recruit from an existing longitudinal cohort, the Boricua Youth Study (BYS; NYSPI IRB protocols #4187R and #6476) and BYS-ECHO (NYSPI IRB Protocols # 7377). The BYS is an epidemiological study on the development of psychiatric disorders in Puerto Rican children. Participants for the current study are a subsample G1 BYS participants who are parents of youth (G2) ages 3 to 12 years old.

Aim 1: To exam the feasibility and acceptability of an mHealth mindfulness program to reduce psychosocial distress among parents of children between 5 and 12 years old (N=40 parent-child pairs) Aim 2: To test preliminary clinical outcome for parents (psychosocial distress and functioning) and child (behavioral and emotional problems) Exploratory Aim: To explore the effects of an mHealth mindfulness-based intervention (MBI) on stress markers including cortisol and inflammation (CRP and IL-6)

Study procedure:

Intervention group:

Screen
Consent
Randomization
Baseline assessments for the parent (30 minutes including parent self-reports and parent reports of child) and child self-reports (15 minutes)
6-week Intervention with daily assignments (10-20 minutes per day)
Posttreatment assessments for the parent (40 minutes including self-reports, parent report of child, and a brief exit interview) and child self-reports (15 minutes)
4-8 week posttreatment follow up assessments for the parent (5-10 minutes)

Waitlist group :

Screen
Consent
Randomization
Baseline assessments for the parent (30 minutes including parent self-reports and parent report of child) and child self-report (15 minutes)
6-week waitlist
Post waitlist/Pretreatment for the parent (30 minutes including parent self-reports and parent report of child) and child self-report (15 minutes)
6-week Intervention with daily assignments (10-20 minutes per day)
Posttreatment assessments for the parent (20-30 minutes including parent self-reports, parent report of child, and exit interview)
4-8 week posttreatment follow up assessments of parent self-reports (5-10 minutes)

Conditions: Psychological Stress, Depression, Anxiety
Being tested: Mindfulness-based Intervention (Headspace TM)
Medical subject headings: Stress, Psychological, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-based Intervention (Headspace TM)Behavioural
A commercially available mindfulness mobile phone application (HeadspaceTM) will be used. The use of HeadspaceTM in the current protocol is approved by NYSPI Information Technology Services.
An mHealth mindfulness program such as Headspace provides self-paced, guided mindfulness meditations through a website or mobile app (iOS and Android). The program consists of basic meditation courses as well as courses targeting stress management, anxiety, depression, and parenting. Based on the qualitative interviews with parents in Phase I, psychoeducation will be included on mindfulness practice and mental health, emphasizing basic meditation courses, and asking parents to complete daily assignments of 10 to 20 min a day during the 6-week period. As an engagement strategy, every week participants in the intervention group will receive a call or an email or text message (depends on preference; partisans may opt out to receive email/text messages).

Study groups in NCT05444881
Study group	Role	What they receive
Intervention	Experimental	10-20 minutes a day of mindfulness meditation practice through the Headspace app. Participants will receive daily reminders to participate and receive weekly calls to assess adherence. Participants will be briefed on the telephone on how to use the app and receive recommendations of possible meditations they can engage with throughout the 6 weeks of participation. Receives: Behavioral: Mindfulness-based Intervention (Headspace TM)
Waitlist Control	No intervention	Waitlist Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Perceived Stress Scale (PSS-10)
Perceived stress was measured using the Perceived Stress Scale (PSS-10), a 10-item self-report questionnaire. Each item is rated on a 0-4 scale and summed to produce a total score ranging from 0 to 40, with higher scores indicating greater perceived stress.
Measured: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)

Secondary outcomes (2)

Change in Generalized Anxiety Disorder-7 (GAD-7)
Anxiety symptoms were measured using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report scale. Items are rated from 0 to 3 and summed to produce a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity.
Measured: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)
Change in Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms were measured using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale. Each item is rated from 0 to 3 and summed to produce a total score ranging from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 202228 Jan 2026

First posted6 Jul 2022
Study start28 Mar 2022
Primary completion1 Feb 2025
Study completion28 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Psychological StressStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parents will be randomly assigned to either receive treatment immediately after consent is obtained or wait for 6 weeks. Parents and children in the intervention group will be asked to complete a phone assessment at baseline and immediately after the intervention (posttreatment) to assess preliminary clinical outcomes. Hair and saliva samples will be collected from both parents and children at baseline and posttreatment. Parents will also complete a brief semi-structured interview on the feasibility and acceptability of the mHealth mindfulness program at posttreatment. There will be a brief follow-up phone assessment for clinical outcomes in parents at 4-8 weeks posttreatment. Parents and children in the waitlist group will complete the same measures as those in the intervention group at baseline and after their six weeks wait before they complete the mHealth intervention. There will be a brief phone assessment at posttreatment (parent and child) and 4-8 weeks follow-up (parent only).
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05444881
Sponsor's protocol ID: IRB #8273/AAAV5485
Status last verified: Jun 2026
First submitted: 24 Jun 2022
Last updated: 30 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: THE BYS COVID-19 COPING INTERVENTION STUDY- PHASE II: A RANDOMIZED CONTROLLED TRIAL OF AN mHEALTH MINDFULNESS PROGRAM
ClinicalTrials.gov ID: NCT05444881
Acronym / sponsor ID: IRB #8273/AAAV5485
Conditions: Psychological Stress, Depression, Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: Morgan Stanley Children's Hospital
Study start: 28 Mar 2022 (actual)
Primary completion: 1 Feb 2025 (actual)
Study completion: 28 Jan 2026 (actual)
First posted: 6 Jul 2022 (actual)
Results: Posted 30 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study procedure:

Intervention group:

Screen
Consent
Randomization
Baseline assessments for the parent (30 minutes including parent self-reports and parent reports of child) and child self-reports (15 minutes)
6-week Intervention with daily assignments (10-20 minutes per day)
Posttreatment assessments for the parent (40 minutes including self-reports, parent report of child, and a brief exit interview) and child self-reports (15 minutes)
4-8 week posttreatment follow up assessments for the parent (5-10 minutes)

Waitlist group :

Screen
Consent
Randomization
Baseline assessments for the parent (30 minutes including parent self-reports and parent report of child) and child self-report (15 minutes)
6-week waitlist
Post waitlist/Pretreatment for the parent (30 minutes including parent self-reports and parent report of child) and child self-report (15 minutes)
6-week Intervention with daily assignments (10-20 minutes per day)
Posttreatment assessments for the parent (20-30 minutes including parent self-reports, parent report of child, and exit interview)
4-8 week posttreatment follow up assessments of parent self-reports (5-10 minutes)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Parents will be randomly assigned to either receive treatment immediately after consent is obtained or wait for 6 weeks. Parents and children in the intervention group will be asked to complete a phone assessment at baseline and immediately after the intervention (posttreatment) to assess preliminary clinical outcomes. Hair and saliva samples will be collected from both parents and children at baseline and posttreatment. Parents will also complete a brief semi-structured interview on the feasibility and acceptability of the mHealth mindfulness program at posttreatment. There will be a brief follow-up phone assessment for clinical outcomes in parents at 4-8 weeks posttreatment. Parents and children in the waitlist group will complete the same measures as those in the intervention group at baseline and after their six weeks wait before they complete the mHealth intervention. There will be a brief phone assessment at posttreatment (parent and child) and 4-8 weeks follow-up (parent only).

Arm	Type	Receives
Intervention	Experimental	Behavioral: Mindfulness-based Intervention (Headspace TM)10-20 minutes a day of mindfulness meditation practice through the Headspace app. Participants will receive daily reminders to participate and receive weekly calls to assess adherence. Participants will be briefed on the telephone on how to use the app and receive recommendations of possible meditations they can engage with throughout the 6 weeks of participation.
Waitlist Control	No intervention	–Waitlist Control

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

BYS participants in the NY cohort (BYS-ECHO study record)
Have a child/children ages 3 to 12 years (BYS-ECHO study record)
Access to a smartphone, tablet, or computer with at least periodic internet access (Self-report)
Latinx parents with a child/children ages 3 to 12 years who express interest in the study, self-referred or referred by our community collaborators (Self-report)
access to a smartphone, tablet, or computer with at least periodic internet access (Self-report)

Key exclusion criteria (3 listed)

Psychiatric risks (e.g., homicidality, suicidality including ideation and attempts, psychosis; answering "yes" to the PHQ-9 suicidal idea question, Q9) (As determined by BYS-ECHO study record or self-report of PHQ-9)
Severe depressive symptoms (i.e., PHQ-9=20 or above) (Self-report of PHQ-9)
1. Psychiatric risks (e.g., homicidally, suicidality including ideation and attempts, psychosis) (Parent report on Child Screener)

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
Mindfulness-based Intervention (Headspace TM)A commercially available mindfulness mobile phone application (HeadspaceTM) will be used. The use of HeadspaceTM in the current protocol is approved by NYSPI Information Technology Services. An mHealth mindfulness program such as Headspace provides self-paced, guided mindfulness meditations through a website or mobile app (iOS and Android). The program consists of basic meditation courses as well as courses targeting stress management, anxiety, depression, and parenting. Based on the qualitative interviews with parents in Phase I, psychoeducation will be included on mindfulness practice and mental health, emphasizing basic meditation courses, and asking parents to complete daily assignments of 10 to 20 min a day during the 6-week period. As an engagement strategy, every week participants in the intervention group will receive a call or an email or text message (depends on preference; partisans may opt out to receive email/text messages).	Behavioural	Intervention

Primary outcome

Change in Perceived Stress Scale (PSS-10)
Time frame: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)
Perceived stress was measured using the Perceived Stress Scale (PSS-10), a 10-item self-report questionnaire. Each item is rated on a 0-4 scale and summed to produce a total score ranging from 0 to 40, with higher scores indicating greater perceived stress.

2 secondary outcomes

Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)

Results and safety

Results posted to the registry on 30 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	58	34
Waitlist Control	32	6

Primary outcome: Change in Perceived Stress Scale (PSS-10)

Time frame: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks). Mean (Standard Deviation). Unit: PSS-10 score (0-40)

Measure	Intervention Group n = 16	Waitlist Group n = 3
Baseline	16.375 (5.32)	10.667 (1.53)
Post Treatment	14.188 (5.49)	9 (1)
Follow Up	14.444 (3.804)	4 (2)

Intervention Group vs Waitlist Group: Mean Difference (Net): 0.52 (95% CI -4.57 to 5.61), p = 0.899, ANOVA

Population analysed: Only participants who completed both baseline and post-treatment assessments for each outcome measure were included in the final analysis. Follow Up data was not analyzed due to limited data post treatment (lost to follow up) for both the Intervention and Waitlist groups.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of study completion - a total average of approximately 6 months (baseline to the end of follow-up).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention: Parents	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Waitlist Control: Parents	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Intervention: Children	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Waitlist Control: Children	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Cristiane Duarte, PhD principal investigator

New York State Psychiatric Institute

Tenneill Murray, MPH study director

New York State Psychiatric Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-based Intervention (Headspace TM) in people with Psychological Stress and Depression, run by New York State Psychiatric Institute 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 8 inclusion and 3 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 30 Jun 2026. 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. 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?

Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Perceived Stress Scale (PSS-10) (time frame: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05444881.

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 30 Jun 2026.