Trial Outcomes & Findings for Boricua Youth Study COVID-19 Coping Intervention Study (NCT NCT05444881)
NCT ID: NCT05444881
Last Updated: 2026-06-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)
Results posted on
2026-06-30
Participant Flow
6 participants (3 parents and 3 children - dyads) were discontinued from the study due to being identified as fraudulent post-enrollment resulting and were consequently removed from the study. Therefore, 45 parent participants (or 90 parent-child dyads) were randomly assigned to the intervention vs. waitlist groups.
Participant milestones
| Measure |
Intervention
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.
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).
|
Waitlist Control
Waitlist Control This group receives the same assessments and intervention as the intervention group but includes a 6 week waiting period between baseline and the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
32
|
|
Overall Study
COMPLETED
|
34
|
6
|
|
Overall Study
NOT COMPLETED
|
24
|
26
|
Reasons for withdrawal
| Measure |
Intervention
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.
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).
|
Waitlist Control
Waitlist Control This group receives the same assessments and intervention as the intervention group but includes a 6 week waiting period between baseline and the intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
24
|
26
|
Baseline Characteristics
Exact age was not collected for participants.
Baseline characteristics by cohort
| Measure |
Intervention: Parents
n=29 Participants
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.
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).
|
Waitlist Control: Parents
n=16 Participants
Waitlist Controls were asked to wait a period of 6 weeks and were assessed for clinical outcomes at the end of this period before being given access to the intervention. Their procedures during the intervention period mirror those of the intervention group.
|
Intervention: Children
n=29 Participants
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.
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).
|
Waitlist Control: Children
n=16 Participants
Waitlist Controls were asked to wait a period of 6 weeks and were assessed for clinical outcomes at the end of this period before being given access to the intervention. Their procedures during the intervention period mirror those of the intervention group.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
29 Participants
n=29 Participants
|
16 Participants
n=16 Participants
|
45 Participants
n=90 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=29 Participants
|
16 Participants
n=16 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
45 Participants
n=90 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=90 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
—
|
0 Participants
Sex was not collected from participants.
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
—
|
0 Participants
Sex was not collected from participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
0 Participants
Race was not collected for participants.
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
—
|
—
|
0 Participants
Race was not collected for participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
0 Participants
Race was not collected for participants.
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
—
|
—
|
0 Participants
Race was not collected for participants.
|
|
Race (NIH/OMB)
White
|
—
|
—
|
—
|
—
|
0 Participants
Race was not collected for participants.
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
—
|
—
|
0 Participants
Race was not collected for participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
—
|
0 Participants
Race was not collected for participants.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=29 Participants
|
16 Participants
n=16 Participants
|
29 Participants
n=29 Participants
|
16 Participants
n=16 Participants
|
90 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=90 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
16 participants
n=16 Participants
|
29 participants
n=29 Participants
|
16 participants
n=16 Participants
|
90 participants
n=90 Participants
|
PRIMARY outcome
Timeframe: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)Population: 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.
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.
Outcome measures
| Measure |
Intervention Group
n=16 Participants
Participants who received the mindfulness intervention immediately after baseline.
|
Waitlist Group
n=3 Participants
Participants in the waitlist group received the intervention after a 6-week waiting period post baseline.
|
|---|---|---|
|
Change in Perceived Stress Scale (PSS-10)
Baseline
|
16.375 PSS-10 score (0-40)
Standard Deviation 5.32
|
10.667 PSS-10 score (0-40)
Standard Deviation 1.53
|
|
Change in Perceived Stress Scale (PSS-10)
Post Treatment
|
14.188 PSS-10 score (0-40)
Standard Deviation 5.49
|
9 PSS-10 score (0-40)
Standard Deviation 1
|
|
Change in Perceived Stress Scale (PSS-10)
Follow Up
|
14.444 PSS-10 score (0-40)
Standard Deviation 3.804
|
4 PSS-10 score (0-40)
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)Population: Only parent 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.
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.
Outcome measures
| Measure |
Intervention Group
n=16 Participants
Participants who received the mindfulness intervention immediately after baseline.
|
Waitlist Group
n=3 Participants
Participants in the waitlist group received the intervention after a 6-week waiting period post baseline.
|
|---|---|---|
|
Change in Generalized Anxiety Disorder-7 (GAD-7)
Baseline
|
5.13 GAD-7 score (0-21)
Standard Deviation 2.60
|
2.0 GAD-7 score (0-21)
Standard Deviation 2.0
|
|
Change in Generalized Anxiety Disorder-7 (GAD-7)
Post Treatment
|
1.69 GAD-7 score (0-21)
Standard Deviation 1.45
|
1.0 GAD-7 score (0-21)
Standard Deviation 1.0
|
|
Change in Generalized Anxiety Disorder-7 (GAD-7)
Follow Up
|
4.11 GAD-7 score (0-21)
Standard Deviation 4.148
|
2 GAD-7 score (0-21)
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)Population: Only parent 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.
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.
Outcome measures
| Measure |
Intervention Group
n=16 Participants
Participants who received the mindfulness intervention immediately after baseline.
|
Waitlist Group
n=3 Participants
Participants in the waitlist group received the intervention after a 6-week waiting period post baseline.
|
|---|---|---|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
Baseline
|
6.31 PHQ-9 score (0-27)
Standard Deviation 4.16
|
1.00 PHQ-9 score (0-27)
Standard Deviation 0.00
|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
Post Treatment
|
3.31 PHQ-9 score (0-27)
Standard Deviation 3.11
|
1.33 PHQ-9 score (0-27)
Standard Deviation 1.53
|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
Follow Up
|
4.22 PHQ-9 score (0-27)
Standard Deviation 4.779
|
0 PHQ-9 score (0-27)
Standard Deviation 0
|
Adverse Events
Intervention: Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control: Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention: Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control: Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cristiane Duarte, PhD, MPH
Columbia University/New York State Psychiatric Institute
Phone: (646)774-5801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place