THE BYS COVID-19 COPING INTERVENTION STUDY- PHASE II: A RANDOMIZED CONTROLLED TRIAL OF AN mHEALTH MINDFULNESS PROGRAM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Perceived Stress Scale (PSS-10)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for the BYS parents-
- •BYS participants in the NY cohort (BYS-ECHO study record)
- •Have a child/children ages 3 to 12 years (BYS-ECHO study record)
- •Access to a smartphone, tablet, or computer with at least periodic internet access (Self-report)
- •Inclusion criteria for community parents:
- •Latinx parents with a child/children ages 3 to 12 years who express interest in the study, self-referred or referred by our community collaborators (Self-report)
- •access to a smartphone, tablet, or computer with at least periodic internet access (Self-report)
- •Residents of the NYC Metropolitan Area (i.e., individuals living approximately within 1 hour driving distance from NYC) (Self-report. If deemed necessary, research team may ask to check ID or relevant documents to verify information, e.g. name, address, etc)
排除标准
- •for all parents:
- •Psychiatric risks (e.g., homicidality, suicidality including ideation and attempts, psychosis; answering "yes" to the PHQ-9 suicidal idea question, Q9) (As determined by BYS-ECHO study record or self-report of PHQ-9)
- •Severe depressive symptoms (i.e., PHQ-9=20 or above) (Self-report of PHQ-9)
- •Inclusion criteria for all children:
- •Parents agreed to participate in the current study (Study consent form)
- •Ages 3 to 12 (BYS-ECHO study record or parent report of child age)
- •Exclusion criterion for all children:
- •1. Psychiatric risks (e.g., homicidally, suicidality including ideation and attempts, psychosis) (Parent report on Child Screener)
研究组 & 干预措施
Intervention
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.
干预措施: Mindfulness-based Intervention (Headspace TM) (Behavioral)
Waitlist Control
Waitlist Control
结局指标
主要结局
Change in Perceived Stress Scale (PSS-10)
时间窗: Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks)
Perceived stress was measured using the Perceived Stress Scale (PSS-10), a 10-item self-report questionnaire. Each item is rated on a 0-4 scale and summed to produce a total score ranging from 0 to 40, with higher scores indicating greater perceived stress.
次要结局
- Change in Generalized Anxiety Disorder-7 (GAD-7)(Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks))
- Change in Patient Health Questionnaire-9 (PHQ-9)(Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks))
研究者
Cristiane Duarte
Ruane Professor for the Implementation of Science for Child and Adolescent mental Health (in Psychiatry) at CUMC
New York State Psychiatric Institute