About this trial
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
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Relax, Reflect, and Empower mobile application
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Patient Health Questionnaire 9 (PHQ-9)
A 9-item valid, quick, and commonly used screening instrument for depression, It has demonstrated 90% of sensitivity and 78% of specificity in adolescents and is valid for Chinese American adolescents. Score ranges from 0 to 27. Scores 0 - 4 = No or Minimal depression. Higher scores indicate more severity of depression.
Secondary outcomes
Flourishing Scale
An 8-item measure of self-perceived success in relationships, self-esteem, purpose, and optimism. The measure has good psychometric properties and has been validated with Chinese and Chinese Americans. Score ranges from 8 to 56. Higher scores indicate more positive perception of oneself in important areas of functioning such as relationships, self-esteem, purpose, and optimism.
Coping self-efficacy scale (CSES)
CSES has 26 items with an 11-point scale for each item (with "Cannot do at all" = 0 at the lowest end, "Moderately certain can do" = 5 in the middle, and "Certain can do" =10 at the highest end of the scale. The CSES includes three factors: (a) problem-focused coping, (b) emotion-focused coping, and c) social support. CSES has demonstrated satisfactory reliability with culturally diverse adolescents. Higher scores represent higher self-reported abilities to cope with stressful circumstances.
Sponsors and contacts
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Northeastern University
Lead sponsor
Florida A&M University
Collaborator
Florida State University
Collaborator