Anxiety, Depression, Psychological Stress
Conditions
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)
Interventions
BEHAVIORALMindfulness-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).
Sponsors
New York State Psychiatric Institute
Morgan Stanley Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
for the BYS parents- 1. BYS participants in the NY cohort (BYS-ECHO study record) 2. Have a child/children ages 3 to 12 years (BYS-ECHO study record) 3. Access to a smartphone, tablet, or computer with at least periodic internet access (Self-report) Inclusion criteria for community parents: 1. 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) 2. access to a smartphone, tablet, or computer with at least periodic internet access (Self-report) 3. 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)
Exclusion criteria
for all parents: 1. 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) 2. Severe depressive symptoms (i.e., PHQ-9=20 or above) (Self-report of PHQ-9) Inclusion criteria for all children: 1. Parents agreed to participate in the current study (Study consent form) 2. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress Scale (PSS-10) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Generalized Anxiety Disorder-7 (GAD-7) | Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks) | Anxiety symptoms were measured using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report scale. Items are rated from 0 to 3 and summed to produce a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity. |
| Change in Patient Health Questionnaire-9 (PHQ-9) | Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks) | Depressive symptoms were measured using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale. Each item is rated from 0 to 3 and summed to produce a total score ranging from 0 to 27, with higher scores indicating greater depressive symptom severity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCristiane Duarte, PhD
New York State Psychiatric Institute
STUDY_DIRECTORTenneill Murray, MPH
New York State Psychiatric Institute
Participant flow
Pre-assignment details
6 participants (3 parents and 3 children - dyads) were discontinued from the study due to being identified as fraudulent post-enrollment resulting and were consequently removed from the study. Therefore, 45 parent participants (or 90 parent-child dyads) were randomly assigned to the intervention vs. waitlist groups.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 45 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 16 | 0 / 29 | 0 / 16 |
| other Total, other adverse events | 0 / 29 | 0 / 16 | 0 / 29 | 0 / 16 |
| serious Total, serious adverse events | 0 / 29 | 0 / 16 | 0 / 29 | 0 / 16 |
Outcome results
None listed