Boricua Youth Study COVID-19 Coping Intervention Study

Not Applicable

Suspended

• Conditions: Anxiety; Depression; Psychological Stress
• Interventions: Behavioral: Mindfulness-based Intervention (Headspace TM)

• Registration Number: NCT05444881
• Lead Sponsor: New York State Psychiatric Institute

Brief 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 under-resourced settings.

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)

Study Timeline

• Study Start: 2022-03-28
• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-06
• Primary Completion: 2025-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. BYS participants in the NY cohort
2. Have a child/children ages 3 to 12 years
3. access to a smartphone, tablet, or computer with at least periodic internet access

Exclusion Criteria

1. Psychiatric risks (e.g., homicidally, suicidality including ideation and attempts, psychosis; answering "yes" to the PHQ-9 suicidal idea question, Q9)
2. Severe depressive symptoms (i.e., PHQ-9=20 or above)
3. Engagement of regular mindfulness, meditation, or yoga practice 3 or more times per week or enrollment in a mindfulness program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in Perceived Stress Scale (PSS-10)	Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)	Perceived Stress (10 items, rated 1-4, higher scores mean higher perceived stress)

Secondary Outcome Measures

Name	Time	Method
Change in Generalized Anxiety Disorder-7 (GAD-7)	Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)	Anxiety symptoms (7 items, rated 0-3, higher scores mean higher generalized anxiety symptoms)
Change in Patient Health Questionnaire-9 (PHQ-9)	Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)	Depression Symptoms (9 items, rated 0-3, higher scores mean higher depressive symptoms)

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States