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Completed

NCT Number: NCT05444881

Boricua Youth Study COVID-19 Coping Intervention Study

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for the BYS parents-

  • 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)

Inclusion criteria

for community parents:

  • 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)

Exclusion criteria

for all parents:

  • 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)

Inclusion criteria

for all children:

  • 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)

Exclusion criterion for all children:

  • Psychiatric risks (e.g., homicidally, suicidality including ideation and attempts, psychosis) (Parent report on Child Screener)

Treatment and study plan

Mindfulness-based Intervention (Headspace TM)

Behavioral

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)

    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.

  2. Change in Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)

    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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Morgan Stanley Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 6, 2022
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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