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Preventing Depression of Chinese American Adolescents by RRE

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Mar 2026 to Dec 31, 2026
    • Study completion date: Mar 31, 2026 to Jan 31, 2027
    v6
  2. Notable Primary completion date: Mar 2025 to Mar 2026
    • Study completion date: Mar 31, 2025 to Mar 31, 2026
    v5
  3. Minor Primary completion date: Feb 2025 to Mar 2025v4
  4. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Primary completion date: Jul 2024 to Feb 2025
    • Start date changed from estimate of Aug 2023 to Mar 25, 2024
    • Study completion date: Aug 2024 to Mar 31, 2025
    • Eligibility criteria expanded, about 6 words
    • Site details revised
  5. Notable Primary endpoint revised
    • Secondary endpoints revised (2)
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05921201
Lead Sponsor Northeastern University
Collaborators: Florida A&M University, Florida State University
Conditions
(from sponsor)
Subclinical Depressive Symptoms
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov