Boricua Youth Study COVID-19 Coping Intervention Study

NCT05444881 | Suspended

• 1 other identifier: IRB #8273
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Stress; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Mindfulness-based Intervention (Headspace TM)

Waitlist Control

NO INTERVENTION

Waitlist Control

Interventions

Mindfulness-based Intervention (Headspace TM) BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• BYS participants in the NY cohort
• Have a child/children ages 3 to 12 years
• access to a smartphone, tablet, or computer with at least periodic internet access

You may not qualify if:

• Psychiatric risks (e.g., homicidally, suicidality including ideation and attempts, psychosis; answering "yes" to the PHQ-9 suicidal idea question, Q9)
• Severe depressive symptoms (i.e., PHQ-9=20 or above)
• Engagement of regular mindfulness, meditation, or yoga practice 3 or more times per week or enrollment in a mindfulness program

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Morgan Stanley Children's Hospital: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Cristiane Duarte, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

• Tenneill Murray, MPH

  New York State Psychiatric Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ruane Professor for the Implementation of Science for Child and Adolescent mental Health (in Psychiatry) at CUMC

Model Details: 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).

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 6, 2022
• Study Start: March 28, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)