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| Name | Class |
|---|---|
| Morgan Stanley Children's Hospital | OTHER |
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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.
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:
Waitlist group :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Waitlist Control | No Intervention | Waitlist Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perceived Stress Scale (PSS-10) | 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. | Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Generalized Anxiety Disorder-7 (GAD-7) | 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. | Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks) |
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Inclusion Criteria for the BYS parents-
Inclusion criteria for community parents:
Exclusion criteria for all parents:
Inclusion criteria for all children:
Exclusion criterion for all children:
1. Psychiatric risks (e.g., homicidally, suicidality including ideation and attempts, psychosis) (Parent report on Child Screener)
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| Name | Affiliation | Role |
|---|---|---|
| Cristiane Duarte, PhD | New York State Psychiatric Institute | Principal Investigator |
| Tenneill Murray, MPH | New York State Psychiatric Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). |
| FG001 | Waitlist Control | Waitlist Control This group receives the same assessments and intervention as the intervention group but includes a 6 week waiting period between baseline and the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
58 participants (29 parents and 29 children) in the intervention group and 32 (16 parents and 16 children) in the Waitlist group
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: Parents | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age information for 58 participants (27 parent-child dyads) in the intervention group and 32 (16 parent-child dyads) in the Waitlist group |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Perceived Stress Scale (PSS-10) | 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. | Only participants who completed both baseline and post-treatment assessments for each outcome measure were included in the final analysis. Follow Up data was not analyzed due to limited data post treatment (lost to follow up) for both the Intervention and Waitlist groups. | Posted | Mean | Standard Deviation | PSS-10 score (0-40) | Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks) |
|
Duration of study completion - a total average of approximately 6 months (baseline to the end of follow-up).
Definition does not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention: Parents | 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. 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristiane Duarte, PhD, MPH | Columbia University/New York State Psychiatric Institute | (646)774-5801 | cristiane.duarte@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 9, 2026 | Jan 28, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2026 | Jan 28, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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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).
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|
| Change in Patient Health Questionnaire-9 (PHQ-9) | 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. | Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks) |
| BG001 | Waitlist Control: Parents | Waitlist Controls were asked to wait a period of 6 weeks and were assessed for clinical outcomes at the end of this period before being given access to the intervention. Their procedures during the intervention period mirror those of the intervention group. |
| BG002 | Intervention: Children | 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. 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). |
| BG003 | Waitlist Control: Children | Waitlist Controls were asked to wait a period of 6 weeks and were assessed for clinical outcomes at the end of this period before being given access to the intervention. Their procedures during the intervention period mirror those of the intervention group. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Age information for 58 participants (27 parent-child dyads) in the intervention group and 32 (16 parent-child dyads) in the Waitlist group | Exact age was not collected for participants. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Sex information from 58 participants (27 parent-child dyads) in the intervention group and 32 (16 parent-child dyads) in the Waitlist group | Sex was not collected from participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race information for 58 participants (27 parent-child dyads) in the intervention group and 32 (16 parent-child dyads) in the Waitlist group | Race was not collected for participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity information of 58 participants (27 parent-child dyads) in the intervention group and 32 (16 parent-child dyads) in the Waitlist group | Count of Participants | Participants |
|
| Region of Enrollment | Region of enrollment for 58 participants (27 parent-child dyads) in the intervention group and 32 (16 parent-child dyads) in the Waitlist group | Number | participants |
|
| OG001 |
| Waitlist Group |
Participants in the waitlist group received the intervention after a 6-week waiting period post baseline. |
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|
|
| Secondary | Change in Generalized Anxiety Disorder-7 (GAD-7) | 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. | Only parent participants who completed both baseline and post-treatment assessments for each outcome measure were included in the final analysis. Follow Up data was not analyzed due to limited data post treatment (lost to follow up) for both the Intervention and Waitlist groups. | Posted | Mean | Standard Deviation | GAD-7 score (0-21) | Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks) |
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| Secondary | Change in Patient Health Questionnaire-9 (PHQ-9) | 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. | Only parent participants who completed both baseline and post-treatment assessments for each outcome measure were included in the final analysis. Follow Up data was not analyzed due to limited data post treatment (lost to follow up) for both the Intervention and Waitlist groups. | Posted | Mean | Standard Deviation | PHQ-9 score (0-27) | Baseline, Posttreatment (6 weeks), Follow up (10-14 weeks) |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Waitlist Control: Parents | Waitlist Control | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Intervention: Children | 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. 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). | 0 | 29 | 0 | 29 | 0 | 29 |
| EG003 | Waitlist Control: Children | Waitlist Control | 0 | 16 | 0 | 16 | 0 | 16 |
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| Between 18 and 65 years |
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| >=65 years |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Post Treatment |
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| Follow Up |
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| Follow Up |
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