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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05444881
• Other study ID #: IRB #8273
• Status: Suspended
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: March 28, 2025

Study information

• Verified date: November 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: March 28, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Mindfulness-based Intervention (Headspace TM)
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).

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Morgan Stanley Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Perceived Stress Scale (PSS-10)	Perceived Stress (10 items, rated 1-4, higher scores mean higher perceived stress)	Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)
Secondary	Change in Generalized Anxiety Disorder-7 (GAD-7)	Anxiety symptoms (7 items, rated 0-3, higher scores mean higher generalized anxiety symptoms)	Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)
Secondary	Change in Patient Health Questionnaire-9 (PHQ-9)	Depression Symptoms (9 items, rated 0-3, higher scores mean higher depressive symptoms)	Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)