Boricua Youth Study COVID-19 Coping Intervention Study

New York State Psychiatric Institute

Status: Suspended

Conditions: Psychological Stress; Depression; Anxiety

Treatments: Behavioral: Mindfulness-based Intervention (Headspace TM)

Study type: Interventional

Funder types: Other

Identifiers

NCT05444881

IRB #8273

Details and patient eligibility

About

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.

Full 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)

Enrollment: 40 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-based Intervention (Headspace TM)

Waitlist Control

No Intervention group

Description:

Waitlist Control