NCT05921201 · Northeastern University
Preventing Depression of Chinese American Adolescents by RRE
What this study is about
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.
View original scientific description
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 days/week for 3 months and 55 to the control group who will receive a wellness check-in text message 5 days/week for 3 months. The main aims/research 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must be CAAs (ethnic Chinese descent, born or grew up in the U.S) from the Greater Boston Area, Massachusetts, and meet the following inclusion criteria:
- 14 -18 years old enrolled in school.
- Understand and sign an informed consent (or assent for minors) document.
- Sixth grade reading level (in order to understand and complete proposed tasks).
Exclusion criteria
- Those who do not have sixth grade reading level to understand and complete the measures
- Those who have a diagnosis of major depression or other mental disorders (that needs more extensive treatment than the Relax, Reflect, and Empower application -RRE program can provide)
- Those who have a score of 3 or above in Patient Health Questionnaire-2 or Generalized Anxiety Disorder- 2 (who need more extensive treatment than the RRE program can provide)
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations