Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06468020 |
Other study ID # |
The Gather.town gaming |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 2024 |
Est. completion date |
January 2026 |
Study information
Verified date |
June 2024 |
Source |
National Taiwan University |
Contact |
Chotip Phonkusol |
Phone |
0905085846 |
Email |
d10426011[@]ntu.edu.tw |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Aim This study aims to explore the experience of depression among pregnant adolescents in
Thailand and assess the effectiveness of the Gather.town gaming intervention for relieving
depressive symptoms.
Methods The study will adopt an exploratory sequential mixed-methods design. It comprises two
phases: a qualitative and a quantitative sub-study to answer the research questions.
Phase one is a qualitative sub-study to gain a comprehensive understanding of the experiences
of pregnant adolescents with depression and their perceptions of interventions for relieving
depressive symptoms. This sub-study will conduct in-depth interviews and content analysis
with 20 pregnant adolescents selected through purposive sampling from an antenatal care
clinic. The interview results will be used to develop the Gather.town gaming intervention for
depression management.
Phase two is a quantitative sub-study conducted through a quasi-experimental design with 64
participants, divided into an intervention group of 32 and a control group of 32. Convenience
and snowball sampling will be performed. The effect of the oGBL intervention will be
evaluated on the primary outcome of depression symptoms/levels and secondary outcomes
including knowledge of depression, coping skills, perceived social support, and help-seeking
attitudes. Initial feedback from users on the Gather.town gaming intervention will also be
examined. Data will be collected using self-report questionnaires and open-ended questions.
Assessments will be conducted at four time points: baseline, after the intervention, and at
the 1-month and 3-month follow-ups. Descriptive statistics, Chi-square tests, and ANCOVA will
be used for data analysis. Finally, data from the qualitative and quantitative sub-studies
will be merged to interpret the effects of the Gather.town gaming intervention for depression
management among Thai pregnant adolescents.
Description:
Measurement
1. The pretest-posttest questionnaires 1.1 The sociodemographic data form The researcher
developed this form based on the literature review, which consisted of 11 questions regarding
age, education status, spouse's age, spouse's education, employment status, monthly income,
family type, marital status, gestational age, number of pregnancies, and pregnancy planning.
1.2 The Center for Epidemiological Studies Depression Scale (CES-D) will be used to evaluate
the inclusion criteria for the participants and assess current depressive symptoms. The scale
contains 20 items asking about symptoms associated with depression. Each item focuses on the
affective component of depressed mood (e.g., feelings of failure, guilt, hopelessness).
Respondents rate how often they experienced each of the symptoms in the past week on a
4-point Likert scale ranging from none of the time (0) to all of the time (3). The total
possible score is 0-60 points: a score between 0 and 15 indicates no depression, 16 to 20 is
mild, 21 to 30 is moderate, and 31 or greater is severe depression. This sub-study will use
the CES-D (Thai version). The Cronbach's alpha internal consistency coefficient of the scale
was reported to be 0.85.
1.3 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.
1.4 The Depression Literacy Questionnaire (D-Lit) evaluates individual knowledge of
depression. The questionnaire consists of 22 items regarding the signs, symptoms, and
treatments of depression. Respondents can answer each item with one of three options: "true,"
"false," and "do not know." Each correct response receives one point. Higher scores indicate
greater knowledge of depression. In this sub-study, the researcher will use the Thai version.
The Thai version contains 21 items; one question from the original version was excluded as it
was not culturally appropriate within the Thai context. The Cronbach's alpha internal
consistency coefficient of the scale was found to be 0.74.
1.5 The Brief COPE is an abbreviated version of the COPE and was created for use in
time-limited settings. It is a questionnaire designed to assess a broad range of coping
strategies. There are 28 items representing 14 types of coping strategies: active coping
(items 2 and 7), planning (items 14 and 25), positive reframing (items 12 and 17), acceptance
(items 20 and 24), humor (items 18 and 28), religion (items 22 and 27), using emotional
support (items 5 and 15), using instrumental support (items 10 and 23), self-distraction
(items 1 and 19), denial (items 3 and 8), venting (items 9 and 21), substance use (items 4
and 11), behavioral disengagement (items 6 and 16), and self-blame (items 13 and 26). Items
are rated on a 4-point Likert scale ranging from 1 (I haven't been doing this at all) to 4
(I've been doing this a lot). A higher total score demonstrates the application of coping
strategies. This sub-study will use the Brief COPE (Thai version). The Cronbach's alpha
internal consistency coefficient of the scale was found to be 0.70 in total.
1.6 The Multi-dimensional Scale of Perceived Social Support (MSPSS) is a brief and
easy-to-use scale used to measure an individual's perceived social support from three
sources: significant others, friends, and family. The scale consists of 12 items, with four
items each representing support from a significant other (items 1, 2, 5, and 10), family
(items 3, 4, 8, and 11), and friends (items 6, 7, 9, and 12). Each item is scored on a
7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). A high total
score indicates a high level of perceived social support. This sub-study will use the MSPSS
Thai version. The Cronbach's alpha internal consistency coefficient of the scale was found to
be 0.90 in total, and 0.88, 0.91, and 0.92, respectively, for the family, friends, and
significant other dimensions.
1.7 The Attitudes Toward Seeking Professional Psychological Help Scale-Short Form (ATSPPH-SF)
measures attitudes toward seeking mental health care from professionals. This sub-study will
use the ATSPPH-SF (Thai version). The scale is an abbreviated 10-item version. Items are
answered using a 4-point Likert scale ranging from 0 (disagree) to 3 (agree). Higher total
scores indicate more positive attitudes toward seeking help from a professional. The
questionnaire demonstrated good overall internal consistency (α = 0.84).