NCT06468020

Brief Summary

Aim The study seeks to:

  1. 1.To assess the effect of the Gather.town gaming intervention on promoting depression literacy among pregnant adolescents in Thailand.
  2. 2.To compare the depression literacy before and after receiving the Gather.town gaming intervention in the experimental group.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jun 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jun 2025Jun 2026

First Submitted

Initial submission to the registry

May 7, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 7, 2024

Last Update Submit

May 13, 2025

Conditions

Keywords

Pregnant adolescentsDepression literacyGame-based learningGather.townDigital mental health intervention

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the knowledge of depression, as measured by a true or false questionnaire of the Depression Literacy Questionnaire (D-Lit)

    Scores are measured using a true or false questionnaire, with one point awarded for each correct answer. The score ranges from 0 to 21, with higher scores indicating greater knowledge.

    Baseline, immediately after the intervention, and at the 1-month and 3-month follow-ups

Secondary Outcomes (3)

  • Change from baseline in mental distress levels, as measured by the Likert scale of the 5-item Brief Symptom Rating Scale (BSRS-5)

    Baseline, immediately, and after the intervention

  • Change from baseline in depression levels, as measured by the Likert scale of The Edinburgh Postnatal Depression Scale (EPDS)

    Baseline, immediately, and after the intervention

  • To measure the usability of the Gather.town platform, as measured by the Likert scale of the System Usability Scale (SUS)

    immediately after the intervention

Study Arms (2)

The Gather.town gaming intervention

EXPERIMENTAL

The Gather.town intervention, based on Rational Emotive Behavior Therapy (REBT), was delivered over four weeks with two 40-50-minute sessions per week, totaling eight sessions. Conducted via laptops or desktops at antenatal care clinics, the program began with baseline assessments and distribution of a booklet. Participants were introduced to the Gather.town platform. Each session included a homework review (except Sessions 1 and 8), a brief educational video (excluding Session 2), and an interactive game guided by the avatar "Sati." Session 2 focused on scenario analysis to link thoughts, emotions, and behaviors. All sessions ended with debriefing, homework, and written reflection. Sessions 5 and 6 featured virtual relaxation practices. The final session included post-assessments and a closing activity. Participants also received routine antenatal care throughout.

Other: The Gather.town gaming intervention

Control group

NO INTERVENTION

Participants in the control group will receive a booklet and routine care that is regularly available in the health system for both adult and adolescent pregnant women. Antenatal care is provided by nurses in the antenatal care unit and includes health assessments and educational classes covering topics such as nutrition, exercise, sexual intercourse, fetal movement monitoring, childbirth preparation, and breastfeeding. Participants are expected to attend at least five antenatal visits throughout their pregnancy: the first visit should occur before 12 weeks of gestation, with subsequent visits at 18, 26, 32, and 38 weeks.

Interventions

The online game-based learning intervention (oGBL): The investigator will develop the oGBL intervention based on Rational Emotive Behavior Therapy (REBT), which consists of 8 sessions and plays a game through the Gather.Town platform.

The Gather.town gaming intervention

Eligibility Criteria

Age15 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • First-time pregnant adolescents aged 15-19 years with gestational ages not exceeding 21 weeks.
  • Being able to read Thai and use a computer or laptop to operate the intervention materials.

You may not qualify if:

  • Being unwilling to participate in this study.
  • Being unable to adhere to the entire intervention process or follow-up.
  • Self-reported psychiatric diagnosis of any severe mental illnesses, i.e., major depression, schizophrenia, or bipolar disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Chotip Phonkusol

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chotip Phonkusol

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2024

First Posted

June 21, 2024

Study Start

June 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

All collected IPD, all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Starting in June 2025
Access Criteria
The information on the study protocol will be shared with other researchers.