Validity and reliability test of the Indonesian version of the PedHALshort questionnaire.

INTRODUCTION: The PedHAL questionnaire is employed in measuring the activities of haemophilia children. The PedHALshort was developed in 2022 to determine the most relevant item for the assessment. Haemo-QoL questionnaire assesses the quality of life of haemophilia children. AIM: Determine the validity and reliability of the PedHALshort Indonesia language version compared to the Haemo-QoL in the Indonesian population. METHODS: A cross-sectional study was conducted in Jakarta, Indonesia. The subjects were children (4-16 years old) with moderate or severe haemophilia A or B with repeated joint bleeding. The daily activity was assessed using the PedHALshorts and Haemo-QoL. The validity and reliability were tested. The validity was determined with Pearson correlation test, construct validity was assessed using convergent and discriminant validity. The Spearman correlation was used to determine which domains of Haemo-QoL correlated with PedHALshort. The reliability was analyzed using test-retest reliability. Cronbach's α was used to determined internal consistency. RESULTS: Fifty children were included in the study (78% haemophilia A, 70% severe group). All domains were valid (r > .284). The convergent validity test showed PedHALshort had a moderate negative correlation with physical health and sports school domain of Haemo-QoL (r = -.479, p < .001). The discriminant validity test showed the PedHALshort demonstrated a moderate negative correlation with physical health (r = -.585), view (r = -.590), sport school domain (r = -.430) in severe haemophilia subjects. The internal consistency of the PedHALshort questionnaire was high (Cronbach's α of .85 (.74-.92)). CONCLUSION: The PedHALshort is valid and reliable, hence, it can be used to measure the functional physical activity of children with haemophilia.

A Qualitative Exploration of Parenting Adolescents in Indonesia.

OBJECTIVE: To explore how parents of Indonesian adolescents conceptualize adolescence and to identify the challenges faced in parenting adolescents, focusing on parents from different sociodemographic backgrounds. METHOD: Focus group discussions (FGD) were undertaken with parents of adolescents aged 10-18 years old from different sociodemographic backgrounds (urban high socioeconomic; urban low socioeconomic; rural low socioeconomic) using a semi-structured interview guide. Content and thematic analysis were assisted by Nvivo version 12.6.0. RESULTS: Forty-three parents participated in four FGD. All parents recognized that adolescence was a distinct developmental stage, reflected in changing behaviors, escalation of peer influences and sexual development. Parents from poor, rural backgrounds had relatively limited understanding of the emerging capabilities of adolescents and had a narrow repertoire of responses to challenging behaviors, with heavy reliance on religious rules and punishment. Parents from higher socioeconomic backgrounds displayed a wider range of warmer, more engaging approaches that they reported using to shape their children's behaviors. CONCLUSION FOR PRACTICE: These findings highlight opportunities to enhance parenting skills, which appear most warranted in parents of adolescents from disadvantaged backgrounds. Embedding basic adolescent parenting information within community programs appears indicated, and enhancing religious leaders' understanding of different approaches to parenting could be helpful in more religious communities.

"What is already known on this subject? Parenting practices play an important role in adolescent health, development, and well-being. Parenting practices are influenced by socio-economic, demographic and cultural determinants. The evidence for how Indonesian parents conceptualize adolescence and how parenting practices might differ across diverse sociodemographic contexts is scarce."What this study adds? While parents from different sociodemographic groups had a common conceptual understanding of some aspects of adolescence, there were substantial differences in their approaches to parenting. There are opportunities to enhance parenting skills, especially in more disadvantaged regions.

Evaluating the Efficacy of a Social Media-Based Intervention (Warna-Warni Waktu) to Improve Body Image Among Young Indonesian Women: Parallel Randomized Controlled Trial.

BACKGROUND: Body dissatisfaction is a global issue, particularly among adolescent girls and young women. Effective body image interventions exist but face barriers to scaling up, particularly in lower- and middle-income countries, such as Indonesia, where a need exists. OBJECTIVE: We aimed to evaluate the acceptability and efficacy of Warna-Warni Waktu, a social media-based, fictional 6-episode video series with self-guided web-based activities for improving body image among young Indonesian adolescent girls and young women. We hypothesized that Warna-Warni Waktu would increase trait body satisfaction and mood and decrease internalization of appearance ideals and skin shade dissatisfaction relative to the waitlist control condition. We also anticipated improvements in state body satisfaction and mood immediately following each video. METHODS: We conducted a web-based, 2-arm randomized controlled trial among 2000 adolescent girls and young women, aged 15 to 19 years, recruited via telephone by an Indonesian research agency. Block randomization (1:1 allocation) was performed. Participants and researchers were not concealed from the randomized arm. Participants completed self-report assessments of trait body satisfaction (primary outcome) and the internalization of appearance ideals, mood, and skin shade dissatisfaction at baseline (before randomization), time 2 (1 day after the intervention [T2]), and time 3 (1 month after the intervention [T3]). Participants also completed state body satisfaction and mood measures immediately before and after each video. Data were evaluated using linear mixed models with an intent-to-treat analysis. Intervention adherence was tracked. Acceptability data were collected. RESULTS: There were 1847 participants. Relative to the control condition (n=923), the intervention group (n=924) showed reduced internalization of appearance ideals at T2 (F1,1758=40.56, P<.001, partial η2=0.022) and T3 (F1,1782=54.03, P<.001, partial η2=0.03) and reduced skin shade dissatisfaction at T2 (F1,1744=8.05, P=.005, partial η2=0.005). Trait body satisfaction improvements occurred in the intervention group at T3 (F1, 1781=9.02, P=.005, partial η2=0.005), which was completely mediated by the internalization change scores between baseline and T2 (indirect effect: ß=.03, 95% CI 0.017-0.041; direct effect: ß=.03, P=.13), consistent with the Tripartite Influence Model of body dissatisfaction. Trait mood showed no significant effects. Dependent sample t tests (2-tailed) found each video improved state body satisfaction and mood. Cumulative analyses found significant and progressive improvements in pre- and poststate body satisfaction and mood. Intervention adherence was good; participants watched an average of 5.2 (SD 1.66) videos. Acceptability scores were high for understandability, enjoyment, age appropriateness, usefulness, and likelihood to recommend. CONCLUSIONS: Warna-Warni Waktu is an effective eHealth intervention to reduce body dissatisfaction among Indonesian adolescent girls and young women. Although the effects were small, Warna-Warni Waktu is a scalable, cost-effective alternative to more intense interventions. Initially, dissemination through paid social media advertising will reach thousands of young Indonesian women. TRIAL REGISTRATION: ClinicalTrials.gov NCT05383807, https://clinicaltrials.gov/ct2/show/NCT05383807 ; ISRCTN Registry ISRCTN35483207, https://www.isrctn.com/ISRCTN35483207. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/33596.

'Dove Confident Me Indonesia: Single Session': study protocol for a randomised controlled trial to evaluate a school-based body image intervention among Indonesian adolescents.

BACKGROUND: Due to the prevalence and associated adverse health consequences of negative body image among adolescents globally, there is a need to develop acceptable, effective, and scalable interventions. School-based body image interventions delivered by trained teachers show promise in reducing negative body image in adolescents. However, there is currently a lack of evidenced-based body image interventions for use in low- and middle-income countries (LMICs). This paper outlines a protocol for the development and evaluation of Dove Confident Me Indonesia: Single Session, a single-session, teacher-led body image intervention for Indonesian adolescents. METHOD: The effectiveness of the intervention will be evaluated using a cluster randomised controlled trial design. Due to the COVID-19 pandemic, the trial will be conducted online. Trained teachers or school guidance counsellors will deliver the intervention. Self-report questionnaires will be collected at three time points: baseline, post-intervention, and two-month follow-up. The primary outcome is body esteem. Secondary outcomes are internalisation of appearance ideals, mood, engagement in life activities, tendency to engage in appearance comparisons, and skin shade satisfaction. A minimum of 1000 participants will provide 95% power to detect small-to-medium intervention effects. To account for attrition and potential internet issues, the sample will comprise of 2000 Indonesian adolescents in grades 7-9, attending state junior high schools in Surabaya, East Java. Quantitative and qualitative data on acceptability of the intervention will also be collected from teachers and students. Additionally, fidelity of lesson implementation will be assessed. This project received ethical approval from the Universitas Indonesia and the University of the West of England. The intervention will be disseminated in junior high schools throughout Indonesia via UNICEF's Life Skills Education (LSE) programme, which will be freely available for teachers to download. DISCUSSION: This paper presents Dove Confident Me Indonesia: Single Session, a culturally adapted school-based intervention designed to improve Indonesian adolescents' body image. It details the plan for evaluation, highlighting the strengths and limitations of the proposed study design. It will be informative for others aiming to adapt evidence-based school curricula to promote well-being among adolescents in LMICs. TRIAL REGISTRATION: NCT04665557 . Registered 11th December 2020.

A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report.

BACKGROUND: Typhoid fever caused by Salmonella enteric serovar Typhi (S. Typhi) is a common cause of morbidity in the world. In 2017, 14.3 million cases of Typhoid and paratyphoid fever occurred globally. School age children between 3 to 19 years old are the most affected. Poor sanitation and multi drug resistance have increased the need for vaccines to reduce the global burden of disease. Based on previous trials, typhoid conjugate vaccines have longer- lasting protection, higher efficacy, require fewer doses and are suitable from infancy that allows them to be incorporated into the routine immunization program. Our previous phase I trial proved that a novel Vi-DT typhoid conjugate vaccine is safe and immunogenic in subjects 2-5 and 18-40 years. Our phase II trial consisted of subjects 6 months to 40 years. Our previously published paper on subjects 6 to < 24 months proved that this vaccine is safe and immunogenic for this age group. Therefore, with this paper we aimed to evaluate the safety and immunogenicity in children 2-11 years. METHODS: A randomized, observer-blind, superiority design of Vi-DT Typhoid conjugate vaccine compared to Vi-polysaccharide vaccine (Vi-PS) phase II study was conducted from October 2018 to December 2018 where 200 subjects aged 2-11 years were recruited. A blood sample prior to vaccination was taken, followed by administration of a single dose of either test vaccine (Vi-DT) or control vaccine (Vi-PS) and then a second blood sample was collected 28 days post vaccination. Adverse reactions were assessed and antibody increment was evaluated at 28 days post vaccination through collected serum sample. RESULTS: Pain was the most common local reaction. Fever and muscle pain were the most common systemic reactions. Both Vi-DT and Vi-PS groups had roughly the same number of adverse reactions. At 28 days post vaccination, 100% of subjects in the Vi-DT group and 93% of subjects in the Vi-PS group produced antibody increment ≥4 times. The Vi-DT group produced a higher GMT as compared to Vi-PS. CONCLUSION: Vi-DT vaccine is safe and immunogenic in children 2-11 years old. TRIAL REGISTRATION: Trial registration number: NCT03460405 .

DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18-24 months old.

BACKGROUND: The new combination of DTwP-HB-Hib vaccines has been developed in Indonesia following World Health Organization (WHO) recommendation and integrated into national immunization program. The aims of the study were to measure 1) antibody persistence 12-18 months after a primary series, 2) immune response and safety after a booster dose of DTwP-HB-Hib. METHODS: This was a multi-center, open-labeled, prospective, interventional study. Subjects who had received complete primary dose of DTwP-HB-Hib vaccine from the previous phase III trial were recruited in this trial. Subjects were given one dose of DTwP-HB-Hib (Pentabio®) booster at age 18-24 months old. Diphtheria, tetanus, pertussis, hepatitis B, Hemophilus influenza type B antibodies were measured before and after booster to determine antibody persistence and immune response. Vaccine adverse events were assessed immediately and monitored until 28 days after the booster recorded with parent's diary cards. RESULTS: There were 396 subjects who completed the study. Increased proportion of seroprotected subjects from pre-booster to post-booster were noted in all vaccine antigens: 74.5 to 99.7% for diphtheria; 100 to 100% for tetanus; 40.4 to 95.5% for pertussis; 90.2 to 99.5% for hepatitis B; and 97.7 to 100% for Hib. Common systemic adverse events (AEs) were irritability (23.7-25%) and fever (39.9-45.2%). Local AEs such as redness, swelling, and induration were significantly less common in the thigh group (7.7, 11.3, and 7.1%) than in the deltoid group (28.9, 30.7, and 25%) (P < 0.001). Most AEs were mild and resolved spontaneously within three-day follow-up period. CONCLUSIONS: Booster of DTwP-HB-Hib vaccine at age 18-24 months is required to achieve and maintain optimal protective antibody. The vaccine is safe and immunogenic to be used for booster vaccination. TRIAL REGISTRATION: NCT02095314 (retrospectively registered, March 24, 2014).

Key Influences on Oral Feeding Achievement in Preterm Infants: Insights From a Tertiary Hospital in Indonesia.

Objective: Effective oral feeding is one of the critical milestones that must be achieved by preterm infants. While gestational age and birth weight have been recognized as influential factors, recent studies have found additional variables impacting the achievement of full oral feeding (FOF). This study is aimed at describing factors associated with the attainment of FOF in preterm infants. Methods: This retrospective cohort study examines preterm infants born between 28 and 34 weeks' gestation admitted to Dr. Cipto Mangunkusumo General Hospital in Jakarta between July and December 2016. Comparative analysis utilized the Kruskal-Wallis test, while Cox's regression was employed for multivariate analysis to assess factors influencing the achievement of FOF. Results: This study included 87 preterm infants meeting the inclusion criteria. The median gestational age was 33 weeks (IQR: 3). The most common birth weight range was 1500-1999 g (51.7%). Median durations from birth to the first feed, full enteral feed, and FOF were observed to be 1 day (IQR: 1), 6 days (IQR: 10), and 14 days (IQR: 24), respectively. Notably, the duration of oxygen therapy, episodes of sepsis, and frequency of blood transfusions showed significant associations with the time taken to achieve FOF. Conclusion: This study found significant associations between the time to achieve FOF and factors such as oxygen therapy duration, sepsis episodes, and frequency of blood transfusion. These findings highlight the importance of considering these factors in managing preterm infants. However, a further prospective study is warranted to identify additional factors that influence feeding milestones in preterm infants.

Evaluating depression in Indonesian adolescents with epilepsy: Comprehensive validation and reliability assessment of the neurological disorders depression inventory-epilepsy for youth Indonesian version (NDDI-E-Y[ID]).

OBJECTIVES: Epilepsy is a common chronic neurological disorder in pediatrics. Depression is an often underdetected comorbidity in childhood epilepsy. This study aimed to adapt the Neurological Disorders Depression Inventory-Epilepsy for Youth (NDDI-E-Y) to the Indonesian language and population, as well as to validate the Indonesian version of NDDI-E-Y (NDDI-E-Y[ID]). METHODS: This three-stage study comprised instrument translation, cultural verification, and content validity testing (first stage), pilot testing (second stage), followed by concurrent validity and reliability testing (third stage) of the NDDI-E-Y(ID). Validation was done against the Centre for Epidemiologic Studies Depression Scale - Revised (CESD-R). Content validity, assessed by six experts, was quantified using the content validity index for items (I-CVI) and scale (S-CVI). Participants were adolescents aged 12-17 years diagnosed with any type of epilepsy who completed both instruments. Concurrent validity was evaluated using Spearman's correlation and reliability was measured using Cronbach's alpha. RESULTS: The first stage produced a culturally appropriate NDDI-E-Y(ID). Thirty healthy adolescents and 10 adolescents with epilepsy participated in the second stage. In the third stage, another group of 30 adolescents with epilepsy took part. We obtained I-CVI and S-CVI values averaging 1. The NDDI-E-Y(ID) showed a positive and significant correlation with CESD-R (Spearman's rho = 0.671, p < 0.001). A Cronbach's alpha of 0.928 reflected a high internal consistency. SIGNIFICANCE: Based on the results, the NDDI-E-Y(ID) was found to be a valid and reliable screening instrument for detecting depression in youth with epilepsy. PLAIN LANGUAGE SUMMARY: Depression is an under-recognized problem in youth with epilepsy. Currently available depression screening tools are in English, making it less suitable for detection purposes in Indonesia. This study developed and validated the Indonesian version of the NDDI-E-Y, a depression screening tool for youth with epilepsy.

Seroconversion among children with HBsAg-positive mothers in Indonesia and factors affecting the anti-HBs titers.

Background and aim: Around 2% of newborns are at risk of hepatitis B virus (HBV) infection from their mothers. To prevent this, infants born to HBsAg-positive mothers are given hepatitis B immune globulin (HBIG) and hepatitis B (HB) vaccine as immunoprophylaxis. This study aims to investigate the efficacy of immunoprophylaxis in infants born to HBsAg-positive mothers and the contributing factors. Methods: The study was conducted on a group of 87 children, ranging from nine months to under 36 months, born to HBsAg-positive mothers and received immunoprophylaxis within 24 h after birth followed by a national immunization schedule at the Community Health Center (CHC) in three administrative cities of DKI Jakarta. We measured the levels of HBsAg and anti-HBs, and utilized ordinal logistic regression models to identify factors that influence the anti-HBs titers after vaccination. Results: Out of 87 children, only one child had positive HBsAg results. The data showed that 88.5% of the children had seroprotection with anti-HBs levels ≥10 mIU/mL. Additionally, 48.3% of the children had a high protective response with anti-HBs levels ≥100 mIU/mL, while 11.5% had a non-protective response. Children under one year of age, with a family history of HBV carriers, and who received five doses of the HB vaccine exhibited higher levels of anti-HBs titer category with adjusted OR 3.9 (95%CI: 1.3-11.6), 5.3 (95%CI: 1.1-27.4), and 8.3 (95%CI: 2-34.8), respectively. Conclusion: The administration of HBIG and HB vaccine successfully prevented vertical transmission, resulting in a high seroprotection rate.

Immunization Simulation Using Actual-Size Infant Manikins for Medical Students in Indonesia: A Quasi-Experimental Study.

INTRODUCTION: Manikins are tools used in simulation training for medical students to develop important skills, one of which is immunization. However, conventional manikins often do not resemble the actual size of an infant's arm or leg. This study aimed to determine the impact of using actual-size manikins on students' knowledge and practical skills, evaluate their confidence in immunization practice, and assess students' responses and feedback regarding the practice using actual-size manikins. METHODS: This was a quasi-experimental study involving medical students at the Faculty of Medicine, Universitas Indonesia, from October 2020 to April 2021. Students in the intervention group used newly developed actual-size infant arm and leg manikins, while the control group used conventional manikins. All students underwent the objective structured clinical examination (OSCE) and the scores were compared between the 2 groups. Within the intervention group, data on pretest and posttest scores, feedback questionnaires, and self-confidence assessments were also obtained and analyzed. RESULTS: A total of 205 students were included. Statistically significant difference was found in the OSCE scores between the intervention and control groups (P < 0.01). Students in the intervention group (n = 108) showed significant improvement in knowledge scores after the workshop (P < 0.01). Most students (81.7%) expressed confidence in administering vaccines to live patients after practicing with manikins. In addition, 98.2% of students (n = 107) acknowledged the benefits of practicing with actual-size manikins in accurately determining the injection sites. CONCLUSIONS: Simulation with the actual-size manikins significantly improved students' knowledge and practical immunization skills, leading to increased confidence and competence in their immunization skills.

Translation and validation of the Body Esteem Scale in Adults and Adolescents among Indonesian adolescents.

There is a need for a psychometrically robust body image measure to advance body image scholarship among Indonesian adolescents. This study aimed to validate a Bahasa Indonesia version of the Body Esteem Scale for Adults and Adolescents (BESAA). The measure was forward and back translated from English into Bahasa Indonesia (i.e., primary Indonesian language) and was assessed for comprehension and cultural appropriateness using cognitive interviews and expert reviews. The factor structure, reliability, and validity of the measure was tested with adolescents aged 11-17 years from two districts in Indonesia (N = 650; 51.5 % girls). Exploratory factor analysis identified a suitable 17-item three-factor solution for the BESAA, with Appearance Positive, Appearance Negative, and Weight subscales. This model was confirmed via confirmatory factor analysis and found to be largely invariant across gender and age. Test re-test reliability and internal consistency of the subscales were acceptable. The Bahasa Indonesia version of the BESAA is a psychometrically robust measure suitable for use among Indonesian adolescents. Reasons as to why the factor structure of the BESAA differentiates across cultural contexts are discussed.

Evaluating a school-based body image lesson in Indonesia: A randomised controlled trial.

Negative body image is a common public health concern among adolescents, globally. The aim of the current study was to evaluate the effectiveness, implementation fidelity, and acceptability of a single session, school-based universal body image intervention in Indonesia. A total of 1926 adolescents (59.4 % girls) and 12 school guidance counsellors (lesson facilitators) from nine state junior secondary schools in Surabaya, East Java took part in a two-arm open parallel cluster randomised controlled trial. In response to the changing circumstances due to the COVID-19 pandemic, half of the lessons were conducted in person and half were delivered online. Results showed that the lesson did not significantly improve adolescent body image or secondary outcomes relative to the control, though there was no evidence of harm. There were no substantive findings regarding intervention effectiveness by gender. The mode of intervention delivery (online vs. in-person) did not significantly influence the main findings. Implementation fidelity varied widely, and the lesson content and pedagogy were largely acceptable, though there was a strong preference for in-person lesson delivery. Findings have implications for researchers aiming to improve adolescent body image in low- and middle-income countries. Lessons learned can inform future school-based efforts to support adolescent body image.

A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity.

BACKGROUND: Typhoid fever is commonly found until today, especially in developing countries. It has fatal complications and measures must be taken to reduce the incidence of typhoid. Vaccinations are a key factor in prevention. This is a phase II randomized observer-blind clinical trial on a novel Vi-DT conjugate vaccine on 200 subjects 12 to 40 years of age. METHODS: Subjects were screened for eligibility after which a blood sample was taken and one dose of vaccine was administered. Investigational vaccine used was Vi-DT and control was Vi-PS. Twenty-eight days after vaccination, subjects visited for providing blood sample to assess immunogenicity and were asked about local and systemic adverse reactions that occurred in the first 28 days. RESULTS: Subjects had minor adverse reactions. Pain was the most common local reaction. Muscle pain was the most common systemic reaction. There were no serious adverse events up to 28 days post vaccination. Seroconversion rates were 100% in the Vi-DT group and 95.96% in the Vi-PS group. Post vaccination GMTs were increased in both groups but it was significantly higher in the Vi-DT group (p < 0.001). CONCLUSIONS: Vi-DT typhoid conjugate vaccine is safe and immunogenic in healthy Indonesian subjects 12 to 40 years. TRIAL REGISTRATION: Approved by ClinicalTrials.gov. CLINICAL TRIAL REGISTRATION NUMBER: NCT03460405. Registered on 09/03/2018. URL: https://clinicaltrials.gov/ct2/show/NCT03460405 .

Immunogenicity Assessment of the SARS-CoV-2 Protein Subunit Recombinant Vaccine (CoV2-IB 0322) in a Substudy of a Phase 3 Trial in Indonesia.

BACKGROUND: COVID-19 is one of the most devastating pandemics of the 21st century. Vaccination is one of the most effective prevention methods in combating COVID-19, and one type of vaccine being developed was the protein subunit recombinant vaccine. We evaluated the efficacy of the CoV2-IB 0322 vaccine in Depok, Indonesia. METHODS: This study aimed to assess the humoral and cellular immune response of the CoV2-IB 0322 vaccine compared to an active control vaccine (COVOVAX™ Vaccine). A total of 120 subjects were enrolled and randomized into two groups, with 60 subjects in each group. Participants received either two doses of the CoV2-IB 0322 vaccine or two doses of the control vaccine with a 28-day interval between doses. Safety assessments were conducted through onsite monitoring and participant-reported adverse events. Immunogenicity was evaluated by measuring IgG anti-RBD SARS-CoV-2 and IgG-neutralizing antibodies. Cellular immunity was assessed by specific T-cell responses. Whole blood samples were collected at baseline, 14 days, 6 months, and 12 months after the second dose for cellular immunity evaluation. RESULTS: Both vaccines showed high seropositive rates, with neutralizing antibody and IgG titers peaking 14 days after the second dose and declining by 12 months. The seroconversion rate of anti-S IgG was 100% in both groups, but the rate of neutralizing antibody seroconversion was lower in the CoV2-IB 0322 vaccine group at 14 days after the second dose (p = 0.004). The CoV2-IB 0322 vaccine showed higher IgG GMT levels 6 and 12 months after the second dose (p < 0.001 and p = 0.01). T-cell responses, evaluated by IFN-γ, IL-2, and IL-4 production by CD4+ and CD8+ T-cells, showed similar results without significant differences between both groups, except for %IL-2/CD4+ cells 6 months after the second dose (p = 0.038). CONCLUSION: Both vaccines showed comparable B- and T-cell immunological response that diminish over time.

Understanding the pubertal, psychosocial, and cognitive developmental trajectories of stunted and non-stunted adolescents: protocol of a multi-site Indonesian cohort study.

Background: The prevalence of stunting among Indonesian children aged 5-12 years decreased from 30.7% in 2013 to 23.6% in 2018 but has remained among the highest rates worldwide. Furthermore, Indonesian children were shorter than the standard reported by the World Health Organization and experienced obesity. The Indonesian government has created many programs to reduce stunting in children under the age of 5 years. An early preventive strategy is necessary because stunting can manifest within the initial 1,000 days of life, including during pregnancy. Therefore, a newer perspective, such as that achieved by addressing stunting in adolescents, has been deemed useful, given that adolescents are in their pubertal stage and are undergoing lifestyle changes. This cohort study was designed to measure these factors comprehensively in stunted and non-stunted children as they pass through adolescence. Methods: For the prospective cohort, 560 individuals will be recruited from DKI Jakarta, DI Yogyakarta, and East Java. The participants will be categorized into stunted and non-stunted groups, then undergo annual examinations in which key objectives, such as weight, height, and body mass index ,will be assessed for the growth profile; waist circumference, middle-upper arm circumference, hand-grip strength, body fat percentage, and food intake will be evaluated in a nutritional assessment; psychosocial and mental issues will be evaluated according to behavioral problems, symptoms of depression, quality of life, sleep patterns, anxiety disorders, and parenting style through the use of specific questionnaires; and pubertal stage will be assessed using a self-report questionnaire. Some cross-sectional data, such as cognitive performance, hair zinc levels, vitamin D levels, bone mineral density, and bone age, will also be included. All the outcomes will be analyzed in accordance with the variable types. Discussion: This study provides a thorough dataset of Indonesian adolescents encompassing several elements, such as growth, nutrition, psychosocial wellbeing, mental health, and pubertal development, for both stunted and non-stunted individuals. The data acquired from this study can be used to formulate policies to prevent stunting through targeted interventions for adolescents. Finally, a better understanding of adolescent health could lead to improved strategies to decrease the number of stunted individuals in the next Indonesian generation.

Mental Health Problems Among Indonesian Adolescents: Findings of a Cross-Sectional Study Utilising Validated Scales and Innovative Sampling Methods.

PURPOSE: This study aimed to estimate the prevalence of mental health problems and identify potential risk and protective exposures for adolescents in Indonesia. METHODS: An innovative sampling approach was applied to simultaneously recruit school- and community-based adolescents aged 16-18 years old from Jakarta (urban megacity) and South Sulawesi (remote province). We used multistage cluster sampling for in-school (N = 1,337) and respondent driven sampling for out-of-school (N = 824) adolescents. Mental health was measured using two validated scales: Kessler-10 and Center for Epidemiologic Studies Depression Scale-Revised . Psychiatric interviews were conducted in a subsample (N = 196) of students from Jakarta to validate the self-report scales. RESULTS: The estimated population prevalence of psychological distress and depression were 24.3% (95% CI = 21.5-27.2) and 12.6% (10.5-14.4) for in-school and 23.7% (20.7-26.7) and 23.5% (20.4-26.5) for out-of-school adolescents, respectively. In participants who completed a psychiatric interview, common psychiatric morbidities were social anxiety, depression, and suicidality. Compared to in-school females, male in-school adolescents reported a lower prevalence of psychological distress (16.9% (13.1-20.7) vs. 30.4% (26.4-34.4)) and depression (10.1% (7.2-13.1) vs. 14.6 (11.4-17.8)). By contrast, for out-of-school adolescents, males reported a higher prevalence of psychological distress (25.2% (21.6-28.9) vs. 20.2% (15.1-25.3)) and depression (26.3% (22.5-30.1) vs. 16.9% (11.8-21.9)). In-school adolescents who did not seek healthcare despite a perceived need were more likely to report psychological distress and depression. DISCUSSION: Adolescent mental health problems are highly prevalent in Indonesia, with substantial variation by gender, geography, and school enrolment. This study and its approach to sampling and measurement may serve as a model to improving mental health surveillance across other settings.

Safety profile of inactivated COVID-19 vaccine in indonesian adults.

Background: Vaccines are urgently needed to handle the morbidity and mortality of the COVID-19 pandemic in Indonesia. The inactivated vaccine is widely used in Indonesia's national immunization program due to its eligibility of stock, easier to transport, and considered to be more established than newer platforms. In this study, we aimed to evaluate the safety profile of the inactivated vaccine and analyze the safety profile between adults and the elderly. Methods: A prospective analytical study was conducted to evaluate the safety profile of inactivated COVID-19 vaccine among healthy adults aged ≥ 18 years from September 2nd to December 28th, 2021, at ten primary health centers from 5 districts in Jakarta, Indonesia. The participants were instructed to record the symptoms after inactivated COVID-19 vaccine injection in the diary card for 28 days. Chi-square tests were carried out to analyze the relationship between the adverse event following immunization (AEFI) in adults and elderly groups. Results: Four of 1113 participants were not included in this study due to the lack of follow-up. Out of 1109 participants, there were 1044 adults (18-59 years) and 65 elderly (>59 years). There were no serious AEFI cases reported. Most AEFI cases were mild to moderate and resolved after several days of injection. Local pain, myalgia and fatigue were the most frequent adverse events reported. We found that there was no correlation between the adults and elderly age group with the incidence of AEFI (p = 0.924) for local reactions (p = 0.181) and most of the systemic reactions (p = 0.629). However, there is an increased risk of fever in the elderly group compared to the adult group (OR 4.046, 95 % CI 1.794-9.124, p = 0.003) following immunization. Conclusions: Our study demonstrated that the inactivated COVID-19 vaccine is safe, considering that all symptoms experienced were mild to moderate and resolved entirely.

Safety profile of inactivated COVID-19 in healthy adults aged ≥ 18 years: A passive surveillance in Indonesia.

Coronavirus Disease 2019 (COVID-19) vaccination in Indonesia has shown effectiveness in reducing the morbidity and mortality of Covid-19. The study aims to evaluate the incidence rate and severity of Adverse Events Following Immunization (AEFI) of inactivated SARS-CoV-2 vaccine during the first quarter of 2021 until the second quarter of 2022 in Indonesia. More than two hundred million Sinovac/CoronaVac were given from January 13th, 2021, until June 30th, 2022. Data for this study were collected manually and electronically from the national vaccine safety website managed by the National Committee (NC) of AEFI Indonesia and the Ministry of Health Indonesia. The total number of injections observed in the study was 264,311,992 doses consisting of 142,449,795 (first dose), 121,613,324 (second dose), and 248,873 (booster dose). Of the injections given, 301 subjects with Serious AEFIs (SAE) and 10.261 subjects with non-serious AEFIs (AE) reported, with a majority of SAE and AEs found in the first dose. Most of the SAEs were classified as coincidental events by the NC AEFI (IR 0.8/1 million doses on first dose injection; 0.31 on second dose injection). ISRR (immunization stress-related response) is in the second rank of SAEs reported (0.59 IR/1 million doses on the first dose; 0.14 on the second dose). The incidence rate of SAEs and AEs, both in the variable of age, sex, and symptoms per 1 million dose injections in Indonesia, was very rare according to WHO guidelines. Most SAEs were classified as coincidences or unrelated to the vaccine. The result showed that the Sinovac/CoronaVac in Indonesia is safe.

The efficacy and safety of first-line anti-seizure medications as substitution therapy for children with drug-resistant epilepsy: a randomized controlled trial protocol.

Although many anti-seizure medications (ASMs) are available, treatment failure, known as drug-resistant epilepsy (DRE), still occurs in around 30% of children with epilepsy. Second-line ASMs are usually used as substitution therapy in DRE to control seizures, although international consensus is not available yet. Previous studies focus on comparing the ASMs, whether as add-on or substitution therapy, mainly conducted in newly diagnosed epilepsy. However, the study that investigated first-line ASMs as substitution therapy compared to second-line ones, particularly among DRE children, is still lacking. A randomized controlled trial (RCT) enrolling 102 participants, aged 1-18, at three referral hospitals in Indonesia will be conducted, dividing them into intervention and control groups. The intervention group will be treated with first-line ASMs as the substitution therapy, while the other in the control group will get second-line ASMs. The primary outcome measure is the proportion difference of responders between groups who get first-line and second-line ASMs in 14 weeks of intervention. Clinical trial registration: ClinicalTrials.gov, identifier NCT05697614.

Mental Health Awareness and Promotion during the First 1000 Days of Life: An Expert Consensus.

The first 1000 days of life constitute a critical phase that will determine the optimum growth and development of a child. An important factor in this phase of life is the perinatal mental health of mothers and children. Mental health awareness is an important public health issue with significant impacts on mothers, spouses, and families, as well as the long-term emotional and cognitive development of children as well. However, the awareness and promotion of mental health within the realms of reproductive health, maternal health, and infant health, i.e., the first 1000 days of life, do not receive high prioritization in Indonesia. Nonetheless, Indonesia, with its existing primary healthcare system, has the potential to raise awareness of and promote the importance of perinatal mental health for its citizens. This experts' consensus proposes several strategies to maximize the usefulness of primary healthcare facilities in Indonesia, including Community Health Centers and Integrated Healthcare Posts, to support perinatal mental health awareness and promotion during the first 1000 days of life. The success of this program, in return, will improve the health status of women and children in Indonesia.