Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05921201
Status:
RECRUITING
Last Update Posted:
2023-06-28
First Post:
2023-06-19
Brief Title:
Preventing Depression of Chinese American Adolescents by RRE
Sponsor:
Northeastern University
Organization:
Northeastern University
Study Overview
Official Title:
Preventing Depression of Chinese American Adolescents Through Mobile Health Application
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to test if a culturally sensitive mobile health application Relax Reflect Empower-RRE is feasible and effective in promoting psychological wellbeing and reducing depressive symptoms among Chinese American adolescents CAA We will conduct a pilot study of a community sample of 110 CAAs ages 14-18 We will use adaptive randomization to assign 55 participants to the RRE intervention for 5 daysweek for 3 months and 55 to the control group who will receive a wellness check-in text message 5 daysweek for 3 months The main aimsresearch questions are 1 To evaluate feasibility and acceptability of RRE Assessments include both subjective CAAs perceptions of feasibility and acceptability of RRE through Mobile Application Rating Scale and open-ended questions and objective CAAs frequency and duration of RRE access automatically recorded measures Our hypothesis is that participants in the RRE group will find RRE feasible and acceptable 2 To investigate CAAs changes in depressive symptoms coping self-efficacy and psychological wellbeing We will compare if these changes differ in the RRE group and control group Participants in both RRE and control groups will complete measures of outcomes depression coping self-efficacy psychological wellbeing and influencing factors acculturative stress experiences of discrimination life events at three time points baseline the end of the preventive intervention the12th week and one-month after the intervention the16th week Our hypothesis is that CAAs in the RRE group will exhibit lower levels of depressive symptoms and higher levels of coping self-efficacy and psychological well-being in Weeks 12 and 16 than the baseline Additionally CAAs in the RRE group will exhibit greater improvement than the control group in the outcome measures from baseline to Weeks 12 and 16
Detailed Description:
Our clinical trial has two major aims First we will evaluate the feasibility and acceptability of RRE Secondly we will examine CAAs changes in depressive symptoms coping self-efficacy and psychological wellbeing controlling for covariates baseline acculturative stress experiences of discrimination life events As this project focuses on primary prevention for CAAs we will use a community sample of 110 CAAs based on power analyses and 20 attrition rate in the Great Boston area which ranks 5th metropolitan area with most Chinese Americans n277312 in the US The CAAs in this area are diverse in immigration history socioeconomic status SES and parent education levels which allows us to obtain representative participants from diverse socio-economic backgrounds and acculturation levels The inclusion criteria for CAAs are a ethnic Chinese descent born or grew up in the US ages14 -18 enrolled in school b understand and sign an informed consent or assent for minors and c have sixth grade reading level to understand and complete proposed tasks
Adaptive randomization by gender age acculturation levels SES depression score will be used to assign 55 participants to RRE for 5 daysweek for 3 months and 55 to the control condition who will receive a wellness check-in text message 5 daysweek for 3 months Participants in the RRE group will select an Avatar from a pool of 20 Avatars as their companion over the 3 months The Avatar wellness check-in in the RRE group includes a daily brief check-in of 5-minuteday 4 daysweek and a weekly full wellness check-in of 15 minutesweek for 3 months The daily brief check-in includes a wellbeing and mood check and a 3-minute relaxation meditation The weekly full wellness check-in includes reflection activities in addition to the daily check-in activities The reflection activities include 1 an innovative Ecomap to identify and quantify sources of stress and support using a weighing scale and 2 reflecting on existing and alternative coping strategies and their effectiveness Avatar will introduce 3 different strategies and resources matching the key wordsconditions from participants responses from the pool of resources The resources include evidence-based and culturally tailored self-help strategies including Mindfulness Based Cognitive Therapy MBCT and Critical Consciousness CC and online and community mental health resources For example if a CAA girl seeks strategies to cope with bullying in school and her fear and anger Avatar will present three relevant strategies from the tool bank of MBCT and CC based on the key words she enters The MBCT strategies will guide her how to cope with her feelings The CC strategies will encourage her to examine systemic issues stand up to bullying and seek support She can choose the strategies that she likes to try Avatar will also present resources online school and community support for her to consider When the participant completes a daily or weekly wellness check-in RRE will pop up the points earned toward monetary incentivereward
To ensure implementation fidelity of the prevention program and prevent attrition Avatar will prompt each participant in the RRE group to do the wellness check-in daily RRE will encourage CAAs to participate by showing the reward points earned each time completing a wellness check-in and the cumulated points for a monetary reward
Staff from Florida Center for Interactive Media FCIM will resolve technical issues that may arise To keep contact with participants in the control group we will send them text messages five days per week asking how they are doing wishing them a nice day Researchers will be monitoring the engagement activities in the RRE and control group daily
Adaptive randomization by gender age acculturation levels SES depression score will be used to assign 55 participants to RRE for 5 daysweek for 3 months and 55 to the control condition who will receive a wellness check-in text message 5 daysweek for 3 months Participants in the RRE group will select an Avatar from a pool of 20 Avatars as their companion over the 3 months The Avatar wellness check-in in the RRE group includes a daily brief check-in of 5-minuteday 4 daysweek and a weekly full wellness check-in of 15 minutesweek for 3 months The daily brief check-in includes a wellbeing and mood check and a 3-minute relaxation meditation The weekly full wellness check-in includes reflection activities in addition to the daily check-in activities The reflection activities include 1 an innovative Ecomap to identify and quantify sources of stress and support using a weighing scale and 2 reflecting on existing and alternative coping strategies and their effectiveness Avatar will introduce 3 different strategies and resources matching the key wordsconditions from participants responses from the pool of resources The resources include evidence-based and culturally tailored self-help strategies including Mindfulness Based Cognitive Therapy MBCT and Critical Consciousness CC and online and community mental health resources For example if a CAA girl seeks strategies to cope with bullying in school and her fear and anger Avatar will present three relevant strategies from the tool bank of MBCT and CC based on the key words she enters The MBCT strategies will guide her how to cope with her feelings The CC strategies will encourage her to examine systemic issues stand up to bullying and seek support She can choose the strategies that she likes to try Avatar will also present resources online school and community support for her to consider When the participant completes a daily or weekly wellness check-in RRE will pop up the points earned toward monetary incentivereward
To ensure implementation fidelity of the prevention program and prevent attrition Avatar will prompt each participant in the RRE group to do the wellness check-in daily RRE will encourage CAAs to participate by showing the reward points earned each time completing a wellness check-in and the cumulated points for a monetary reward
Staff from Florida Center for Interactive Media FCIM will resolve technical issues that may arise To keep contact with participants in the control group we will send them text messages five days per week asking how they are doing wishing them a nice day Researchers will be monitoring the engagement activities in the RRE and control group daily
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None