NCT05921201 Preventing Depression of Chinese American Adolescents by RRE
| NCT ID | NCT05921201 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northeastern University |
| Condition | Subclinical Depressive Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-03-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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: 1. 14 -18 years old enrolled in school. 2. Understand and sign an informed consent (or assent for minors) document. 3. Sixth grade reading level (in order to understand and complete proposed tasks). Exclusion Criteria: 1. Those who do not have sixth grade reading level to understand and complete the measures 2. 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) 3. 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)
Contact & Investigator
Chieh Li, EdD
PRINCIPAL INVESTIGATOR
Northeastern University
Frequently Asked Questions
Who can join the NCT05921201 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 18 Years, studying Subclinical Depressive Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05921201 currently recruiting?
Yes, NCT05921201 is actively recruiting participants. Contact the research team at c.li@northeastern.edu for enrollment information.
Where is the NCT05921201 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05921201 clinical trial?
NCT05921201 is sponsored by Northeastern University. The principal investigator is Chieh Li, EdD at Northeastern University. The trial plans to enroll 110 participants.