Boricua Youth Study COVID-19 Coping Intervention Study

Depression Clinical Trial

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

Status Suspended

Clinical 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 under-resourced settings.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Stress
• Stress, Psychological

• NCT number: NCT05444881
• Study type: Interventional
• Source: New York State Psychiatric Institute
• Status: Suspended
• Phase: N/A
• Start date: March 28, 2022
• Completion date: March 28, 2025