Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-05-07
Brief Title:
GatherTown Gaming for Pregnant Adolescents With Depression
Sponsor:
National Taiwan University
Organization:
National Taiwan University
Study Overview
Official Title:
The GatherTown Gaming Intervention for Depression Management Among Pregnant Adolescents in Thailand A Mixed Methods Study Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim This study aims to explore the experience of depression among pregnant adolescents in Thailand and assess the effectiveness of the Gathertown 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 Gathertown 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 symptomslevels and secondary outcomes including knowledge of depression coping skills perceived social support and help-seeking attitudes Initial feedback from users on the Gathertown 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 Gathertown gaming intervention for depression management among Thai pregnant adolescents
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 Gathertown 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 symptomslevels and secondary outcomes including knowledge of depression coping skills perceived social support and help-seeking attitudes Initial feedback from users on the Gathertown 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 Gathertown gaming intervention for depression management among Thai pregnant adolescents
Detailed Description:
Measurement
1 The pretest-posttest questionnaires 11 The sociodemographic data form The researcher developed this form based on the literature review which consisted of 11 questions regarding age education status spouses age spouses education employment status monthly income family type marital status gestational age number of pregnancies and pregnancy planning
12 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 eg 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 Cronbachs alpha internal consistency coefficient of the scale was reported to be 085
13 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 Cronbachs alpha coefficient ranging from 077 to 090 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
14 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 Cronbachs alpha internal consistency coefficient of the scale was found to be 074
15 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 havent been doing this at all to 4 Ive 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 Cronbachs alpha internal consistency coefficient of the scale was found to be 070 in total
16 The Multi-dimensional Scale of Perceived Social Support MSPSS is a brief and easy-to-use scale used to measure an individuals 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 Cronbachs alpha internal consistency coefficient of the scale was found to be 090 in total and 088 091 and 092 respectively for the family friends and significant other dimensions
17 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 084
1 The pretest-posttest questionnaires 11 The sociodemographic data form The researcher developed this form based on the literature review which consisted of 11 questions regarding age education status spouses age spouses education employment status monthly income family type marital status gestational age number of pregnancies and pregnancy planning
12 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 eg 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 Cronbachs alpha internal consistency coefficient of the scale was reported to be 085
13 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 Cronbachs alpha coefficient ranging from 077 to 090 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
14 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 Cronbachs alpha internal consistency coefficient of the scale was found to be 074
15 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 havent been doing this at all to 4 Ive 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 Cronbachs alpha internal consistency coefficient of the scale was found to be 070 in total
16 The Multi-dimensional Scale of Perceived Social Support MSPSS is a brief and easy-to-use scale used to measure an individuals 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 Cronbachs alpha internal consistency coefficient of the scale was found to be 090 in total and 088 091 and 092 respectively for the family friends and significant other dimensions
17 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 084
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None