Preventing Depression of Chinese American Adolescents by RRE

NCT05921201 | Recruiting DMC

• 1 other identifier: NortheasternU-23-04-26
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Subclinical Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  2-5 minutes

Secondary Outcomes (2)

• Flourishing Scale

  5-7 minutes

• Coping self-efficacy scale (CSES)

  10 minutes

Study Arms (2)

Relax, Reflect, and Empower application

EXPERIMENTAL

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.

Behavioral: Relax, Reflect, and Empower mobile application

Daily check-in text messages

ACTIVE COMPARATOR

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.

Behavioral: Relax, Reflect, and Empower mobile application

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.

Daily check-in text messages; Relax, Reflect, and Empower application

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northeastern University: lead
• Florida A&M University: collaborator
• Florida State University: collaborator

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

• Chieh Li, EdD

  Northeastern University

  PRINCIPAL INVESTIGATOR

• Huijun Li, PhD

  Florida A&M University

  PRINCIPAL INVESTIGATOR

• Shengli Dong, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHIEH LI, EdD

CONTACT

6173734683; c.li@northeastern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 27, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)