Clinical trial NCT06468020: Gather.Town Gaming for Pregnant Adolescents With Depression Literacy
Official title: The Effect of the Gather.Town Gaming Intervention for Promoting Depression Literacy Among Pregnant Adolescents in Thailand
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gamification
Keywords: Pregnant adolescents
Depression literacy
Game-based learning
Gather.town
Digital mental health intervention
Lead sponsor: National Taiwan University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 64
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Aim

The study seeks to:

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

Methods This quasi-experimental study employed a two-group, pretest-posttest design to assess the effect of a Gather.town gaming intervention on promoting depression literacy among pregnant adolescents in Thailand. 64 first-time pregnant adolescents aged 15-19 years with gestational age under 21 weeks were recruited from three hospitals using stratified random sampling. Participants were randomly assigned to the experimental group (n = 32) or control group (n = 32).

The experimental group participated in eight sessions of REBT-based interactive gaming on the Gather.town platform over four weeks (two sessions per week), while the control group received routine antenatal care and a depression literacy booklet. Quantitative data were collected at four time points (baseline, immediate post-intervention, 1-month, and 3-month follow-ups) using validated tools, including the Depression Literacy Questionnaire (D-Lit), depressive symptoms (EPDS), mental distress (BSRS-5), and platform usability (SUS). Qualitative data were gathered through focus group interviews after the intervention. Statistical analyses were performed using SPSS version 22. Descriptive statistics summarized participant characteristics. Chi-square tests examined group differences. Generalized Estimating Equations (GEE) were used to compare depression literacy scores across time points while accounting for clustering by hospital and adjusting for covariates. The significance level was set at p \< 0.05.

Detailed description: Measurement

1. The researcher has developed this information based on a review of the literature, consisting of 17 questions. These include six items on socio-demographic information: age, educational level, marital status, current living situation, employment status, and household monthly income. There are 11 items related to health information, including week of pregnancy, pregnancy planning, history of abortion, number of abortions, abnormal symptoms during pregnancy, history of alcohol drinking, history of cigarette/e-cigarette smoke, stress coping behaviors, help-seeking behavior for emotional problems, sources of mental health support, and sources of payment for health care.
2. The Depression Literacy Questionnaire (D-Lit) will be used to evaluate an individual's level of depression literacy, covering incidence, recognition of depressive symptoms, differentiation of symptoms from other mental illnesses, non-medication effectiveness, and knowledge of medication. The questionnaire consists of 22 true-or-false items. Respondents can answer each item with one of three options: "true," "false," or "don't know." Each correct response receives one point, while "don't know" is counted as an incorrect response. In this study, one question from the original version-"Not stepping on cracks in the footpath may be a sign of depression"-was omitted as it was not culturally suitable for the Thai context. The overall score ranges from 0 to 21, with higher scores representing higher depression literacy levels. The scale has a Cronbach's alpha coefficient of 0.70.
3. The Edinburgh Postnatal Depression Scale (EPDS) was designed to screen for depressive symptoms among postpartum women in a community setting. Meanwhile, the EPDS is also a widely accepted instrument for screening depression in the prenatal period. This scale consists of 10 items to assess depressive symptoms, including mood changes, anxiety, and self-harm ideation, over the past 7 days. Respondents are asked to rate how often they experienced each symptom in the past week on a 4-point Likert scale, with scores of 0, 1, 2, and 3 assigned based on the severity of the symptoms. Items 3 and 5 to 10 are reverse-scored (3, 2, 1, and 0). The total score is calculated by summing each of the ten items, with possible scores ranging from 0 to 30. A cut-off score of 12 or 13 indicates those likely to be suffering from depression. Psychometrically, the EPDS scale demonstrates good construct validity and high internal consistency reliability in primary care and clinical settings, with Cronbach's alpha values of 0.87. The cut-off score of the Thai version of the EPDS is suitable for diagnosing depression among pregnant women at ≥ 11, with an acceptable Cronbach's alpha of 0.77.
4. The 5-item Brief Symptom Rating Scale (BSRS-5) is commonly used for screening psychological disorders. It consists of 5 self-rated items measuring brief psychological symptoms, including insomnia, anxiety, hostility, depression, and inferiority. Each item is rated on a Likert scale ranging from 0 (not at all) to 4 (extremely). A total score on the BSRS-5 of more than 15 indicates severe mental distress; scores between 10 and 14 indicate moderate distress, scores between 6 and 9 indicate mild distress, and scores lower than 6 indicate normal status. The scale has a Cronbach's alpha coefficient ranging from 0.77 to 0.90. In this sub-study, the researcher will translate the scale into Thai and have it back-translated by two experts proficient in both English and Thai.
5. The System Usability Scale (SUS) will be used to measure the usability of the Gather.town platform. The scale of SUS consists of 10 simple questions. The respondents are asked to rate how they perceive usability on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges with the range of possible scores from 0 to 100. A score less than 51 indicates system usability at a minimum level, 51-68 points mean system usability at a low level, 68 points represent a moderate level of system usability, 68-80.3 points suggest system usability at a good level, and scores more than 80.3 points represent an excellent level of system usability. The SUS has demonstrated good construct validity and high reliability, with an acceptable Cronbach's alpha from 0.77 to 0.97.
6. Pre-intervention survey We will ask three open-ended questions before the intervention: "Have you heard of the Gather.town platform before?", "What are your expectations for the Gather.town gaming intervention for mental health support during pregnancy?", and "What features or activities would you like in the Gather.town gaming intervention to help you cope with stress during pregnancy?". These questions aim to gather pregnant adolescents' opinions and expectations for addressing mental health problems via the Gather.town gaming intervention.
7. Qualitative feedback collected after each session of the program After each session of the program, we will add three open-ended questions to obtain qualitative initial feedback from pregnant adolescents: "What did you like the most about the Gather.town gaming intervention?", "What did you not like about the Gather.town gaming intervention?", and "What suggestions do you have to improve the Gather.town gaming intervention?"
8. Qualitative reflection collected after the intervention via the focus group interview For the focus group interview after the intervention, we will add three open-ended questions to explore participants' experiences with the Gather.town gaming intervention and its impact on their depression literacy. "How have your knowledge and beliefs about depression changed after participating in the Gather.town gaming intervention?", "What aspects of the Gather.town intervention did you find most helpful in improving your understanding of depression?", and "How has the Gather.town gaming intervention influenced your attitude toward seeking help for mental health?"

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline in the knowledge of depression, as measured by a true or false questionnaire of the Depression Literacy Questionnaire (D-Lit)
timeFrame: Baseline, immediately after the intervention, and at the 1-month and 3-month follow-ups
Secondary outcomes:
measure: Change from baseline in mental distress levels, as measured by the Likert scale of the 5-item Brief Symptom Rating Scale (BSRS-5)
timeFrame: Baseline, immediately, and after the intervention
measure: Change from baseline in depression levels, as measured by the Likert scale of The Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline, immediately, and after the intervention
measure: To measure the usability of the Gather.town platform, as measured by the Likert scale of the System Usability Scale (SUS)
timeFrame: immediately after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University
name: Chotip Phonkusol
role: PRINCIPAL_INVESTIGATOR
References: