Clinical trial NCT05444881: Boricua Youth Study COVID-19 Coping Intervention Study
Official title: THE BYS COVID-19 COPING INTERVENTION STUDY- PHASE II: A RANDOMIZED CONTROLLED TRIAL OF AN mHEALTH MINDFULNESS PROGRAM
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Psychological Stress
Depression
Anxiety
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Morgan Stanley Children's Hospital
First posted: 2022-07-06
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parents will be randomly assigned to either receive treatment immediately after consent is obtained or wait for 6 weeks. Parents and children in the intervention group will be asked to complete a phone assessment at baseline and immediately after the intervention (posttreatment) to assess preliminary clinical outcomes. Hair and saliva samples will be collected from both parents and children at baseline and posttreatment. Parents will also complete a brief semi-structured interview on the feasibility and acceptability of the mHealth mindfulness program at posttreatment. There will be a brief follow-up phone assessment for clinical outcomes in parents at 4-8 weeks posttreatment. Parents and children in the waitlist group will complete the same measures as those in the intervention group at baseline and after their six weeks wait before they complete the mHealth intervention. There will be a brief phone assessment at posttreatment (parent and child) and 4-8 weeks follow-up (parent only).
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in Perceived Stress Scale (PSS-10)
timeFrame: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)
Secondary outcomes:
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Cristiane Duarte, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York State Psychiatric Institute
name: Tenneill Murray, MPH
role: STUDY_DIRECTOR
References: