Ignite Creation Date:
2024-05-06 @ 5:49 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05444881
Status:
SUSPENDED
Last Update Posted:
2023-11-07
First Post:
2022-06-24
Brief Title:
Boricua Youth Study COVID-19 Coping Intervention Study
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
THE BYS COVID-19 COPING INTERVENTION STUDY- PHASE II A RANDOMIZED CONTROLLED TRIAL OF AN mHEALTH MINDFULNESS PROGRAM
Status:
SUSPENDED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
US Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23 2023 This study will resume recruitment after OHRP has approved the resumption of research
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n25 parent-child pairs and a waitlist control n15 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 N40 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 waitlistPretreatment 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
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 N40 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 waitlistPretreatment 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None