Preventing Depression of Chinese American Adolescents by RRE

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Northeastern University
Study ID
NCT05921201
Status
Recruiting

Conditions

  • Subclinical Depressive Symptoms

Eligibility Criteria

Sex
ALL
Age
14 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Relax, Reflect, and Empower mobile application — BEHAVIORAL
    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 wellness check-in of 5-minute/day (4 days/week), and a weekly full wellness check-in of 15 minutes/week 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.

Study Details

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.

Key Dates

Start date
Mar 25, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Relax, Reflect, and Empower application
    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-minute/day (4 days/week), and a weekly full wellness check-in of 15 minutes/week 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.
  • Active Comparator: Daily check-in text messages
    Participants will receive a wellness check-in text message 5 days/week \[4 daily wellness check-in (2-3 minutes/day) +1 weekly wellness check-in (4-5 minutes/week)\] for 3 months.

Primary Outcome Measure

Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: 2-5 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northeastern UniversityBostonMassachusetts02115
Chieh Li, EdD
617-373-4683

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