- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07607301
Evaluation of the Effectiveness of the Genomics & Science DOJO 3.0 Learning Method in Improving Research Skills and Scientific Writing Among Researchers in Indonesia (DOJO)
Evaluation of the Effectiveness of the Genomics & Science DOJO 3.0 Learning Method in Improving Research Skills and Scientific Writing Among Researchers in Indonesia: A Randomized Controlled Trial
The goal of this study is to rigorously evaluate the effectiveness of the DOJO 3.0 learning methodology in enhancing research skills and scientific writing among researchers in Indonesia compared to non-DOJO learning method. The main questions it aims to answer are:
How effective is the Dojo 3.0 methodology in improving participants' research skills and scientific writing, including critical thinking, data analysis ability, knowledge acquisition, and scientific manuscript quality and publication progress? How do participants' experiences, perceptions of the learning process and teaching quality, as well as their engagement, performance, and learning behaviors, differ between the intervention (DOJO) and control groups throughout the program?
Researchers will compare two groups, control group and intervention group to see if there is a significant difference between these two groups.
Standard learning method Non-DOJO (Control) DOJO learning method (Intervention)
For the intervention group, participants will participate in Shinjitsu class, an interactive dynamic lecture with real time engagement, an offline minicamp session with lecture that is more intense, intentionally more provocative and dynamic, wounded healer, shinjitsu ninja obstacles, shinjitsu ninja run, sparring and Tournament.
Visão geral do estudo
Status
Condições
Descrição detalhada
Detailed Description
This study is using a randomised controlled trial method conducted in Jakarta, Indonesia, designed to rigorously evaluate the effectiveness of the DOJO 3.0 learning methodology in enhancing research skills and scientific writing among researchers in Indonesia compared to non-DOJO learning methods.
This study consists of a cluster randomized trial with two intervention arms, to evaluate the effectiveness of the genomics and science DOJO 3.0 learning method, specifically comparing between standard learning method and DOJO learning method. The DOJO learning method will be delivered through structured components, including modularized minicamps, structured mentoring, expanded Shinjitsu tournaments, and the introduction of the Shinjitsu Ninja component, providing a platform for scientific capacity building, collaboration, and innovation.
To support implementation across both study components, several structured operational procedures will be applied. To minimize contamination between groups,activities for the control and intervention arms will be conducted in separate locations. However, to ensure consistency in content delivery, both groups will receive the same core instructional materials and be taught by the same instructors (Sensei). The primary distinction between groups will lie in the learning approach and environment, with the intervention group receiving the DOJO learning method and the control group receiving a standard (non-DOJO) learning method.
- Sample Size and Statistical Considerations The sample size calculation is based on the expected effect size of the intervention on primary outcomes (critical thinking, knowledge improvement, data analysis, personal empowerment, manuscript quality and quality of teaching), anticipated attrition among participants, and statistical power considerations to ensure meaningful results. Taking these factors into account, it is estimated that approximately 48 teams or 96 individuals will be recruited and participating in this study.
- Quality Assurance and Data Management A comprehensive quality assurance framework will be implemented to ensure data integrity, accuracy, and consistency across all study sites. Electronic data capture systems will incorporate built-in validation rules, including range checks, consistency checks, and logical constraints across related variables.
Routine centralized data monitoring will be conducted to assess data completeness, timeliness, and internal consistency. Key indicators will include baseline/endline test results, activity logs, pre- and post-test results, and other study-related outputs, which will be systematically reviewed and used as primary inputs for analysis.
A standardized data management system will be implemented, including a comprehensive data dictionary that defines all study variables, formats, permissible values, coding structures, and data sources. Where applicable, standardized coding approaches will be applied to ensure consistency.
All study procedures will be guided by Standard Operating Procedures (SOPs) and a detailed manual to ensure standardized implementation across sites.
- Handling of Missing Data Data quality checks during data collection will aim to minimize missingness. During analysis, appropriate statistical techniques, such as multiple imputation will be applied as specified in the statistical analysis plan. In cases where key supporting variables, such as participants' educational background and research stage, are missing, efforts will be made to retrieve this information from participants or relevant records.
- Statistical Analysis Plan All analyses will follow the intention-to-treat principle. Primary analyses will assess effectiveness of the DOJO learning method across intervention arms using quantitative methods to account for cluster randomization and potential confounders.
Primary analysis will examine differences in participants' critical thinking, improvement of knowledge, data analysis skills, personal empowerment, manuscript quality, publication, and quality of teaching. These outcomes will be assessed using structured assessment scoring and appropriate statistical models, by comparing endline results with baseline measurement.
Secondary analysis will assess differences in activity effectiveness, such as lecture and activity (i.e Ninja obstacles), or lectures only. These outcomes will be assessed using a structured assessment scoring and appropriate statistical models, by comparing post-test results with pre-test results that are administered each day of the minicamp offline session.
Depending on the nature of the outcome variables, appropriate statistical models will be applied. Continuous outcome variables like daily pre and post test scores, knowledge improvements, critical thinking scores, journal scores, tournament or mini tournament scores, and days distance to submission, will be primarily analyzed with repeated ANCOVA which is implemented to assess the changes over the time for each observation within the teams. Binary outcomes, such as paper finished or workshop completion, will be analyzed with chi-square test or logistic regression. Beside being analyzed as a variable, days distance to publication that act as a time-related outcomes, may be explored using survival analysis.
All analysis will include baseline characteristics of the participants, including the stratification of the research stage when joining the program and educational background, to improve comparability and reduce confounding.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonésia, 12870
- Summit Institute for Development
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Registered participants of Genomics & Science DOJO 3.0
- Teams consisting of two members
- Submission of research concept note
- Completion of screening and assessment stages (administratively and substantially through blind concept note screening and team's curriculum vitae)
- Willingness and commitment to participate in the full program will be ensured through a structured confirmation process.
- In addition, participants will be required to review, sign, and submit a commitment letter outlining the full schedule, expectations for attendance, and participation requirements.
- Information regarding program schedule and participation expectations will be communicated at multiple stages, including during registration, program launch, and post-selection, to ensure participants are fully informed prior to confirming their participation.
- Involvement/ attendance of the first author
Exclusion Criteria:
- Incomplete registration or documentation
- Failure to meet team composition requirements
- Withdrawal before intervention
- Incomplete baseline data
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Standard Learning Method
Participants receive: Standard learning method Regular teaching style and digital material |
A structured standard learning approach that is conceptually adapted from the teaching and learning methods used in the MSc in Health Service Improvement and Evaluation (HSIE) at the University of Oxford. In the Shinjitsu class, the material will be delivered in a fully didactic, one-way format, limiting participant interaction to brief, moderator-led question-and-answer sessions. The Wounded Healer session will be conducted as a seminar focused on individual reflection rather than interactive sharing, resulting in a more passive reflective experience without the experiential and positive psychology components present in the DOJO intervention. For Ninja Run, participants will not be placed in a competitive environment but will instead be given time to complete tasks at their own pace without time pressure, thereby not experiencing the same level of cognitive demand as working under constraints. |
|
Experimental: Genomics & Science Learning Methodology
Participants receive: DOJO 3.0 Learning Method Regular teaching style and digital material |
The key characteristic of the DOJO approach lies in the Shinjitsu methodology, which integrates structured debate, confrontational argumentation, and real-time intellectual challenge as core mechanisms to stimulate critical thinking. The program will be implemented through structured components by continuing several activities such as Wounded Healer, Ninja Run, and Shinjitsu Tournament. Wounded Healer is based on the principles of active psychology and leverages direct and interactive experiences. In this session, participants actively share challenges encountered in a supportive environment, thereby fostering confidence and psychological safety. This is followed by Ninja Run, where participants train their critical thinking and decision-making skills under constrained conditions. Participants engage in a structured Shinjitsu Tournament, in which they not only present their arguments but also defend and critically challenge them in a confrontational yet structured setting. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Personal Empowerment
Prazo: Baseline and one month
|
Personal empowerment will be assessed based on participants' confidence and sense of agency in engaging with and completing program-related tasks.
Raw scores from the Dojo-specific validated questionnaire will be calculated separately at pre- and post-assessment.
Pre-to-post changes will be standardized (z-scores) to enable comparability across instruments with different scoring scales.
Standardized scores from both measures will then be equally weighted and combined to generate a composite Personal Empowerment Index.
Changes in the Personal Empowerment Index are compared between control and intervention groups to assess program impact.
|
Baseline and one month
|
|
Critical Thinking
Prazo: Baseline and one month
|
Critical thinking abilities will be measured using open-ended questions.
measured quantitatively using the Holistic Critical Thinking Scoring Rubric (HCTSR).
The primary metric is the mean change score between intervention and control groups, estimated using analysis of covariance (ANCOVA) with baseline MCQ scores as covariate.
Critical thinking is assessed using a 5-item questionnaire, which will be scored by trained reviewers on a 1-4 rubric (1: Significantly weak, 2: Unacceptable, 3: Acceptable, 4: Strong), with 0 indicating no responses or no demonstration of critical thinking.
Total score ranges from 0 to 20.
Higher scores indicate better critical thinking performance.
|
Baseline and one month
|
|
Knowledge Improvement
Prazo: Baseline and one month
|
Improvement of knowledge will be measured using multiple-choice questions (MCQs) through three sessions from each different program contents: Day 1(30 items, score range 0-30), Day 2 (40 items, score range 0-40), and Day 3 (30 items, score range 0-30).
One point is awarded for each session per correct answer.
A higher score means better knowledge.
Scores will be calculated as the percentage of correct answers (%) for each team participant.
The primary metric is the adjusted mean difference in endline MCQ scores between intervention and control groups, estimated using ANCOVA with baseline MCQ scores as covariate.
|
Baseline and one month
|
|
Data Analysis
Prazo: Baseline and one month
|
Data analysis skills are assessed at the individual participant level through case-based written assessments administered before and after the intervention. The pre-test (Ninja Obstacles) is completed individually by each participant before program content is delivered, and the post-test (Ninja Run) is completed individually on the final day of the program. In both assessments, participants independently analyze a real-world health dataset and submit a written response covering data interpretation, calculation, and application. The rubric assesses the responses in four criteria: data interpretation, application of basic quantitative analysis, evidence-based conclusions, and communication of key findings. Each criterion is scored on a 5-point scale (1= lowest performance, 5= highest performance), with 0 indicating performance of data analysis. Criterion scores are summed to a total individual score ranging from 4 to 20, with higher scores illustrating better data analysis performance |
Baseline and one month
|
|
Manuscript Quality
Prazo: Baseline and one month
|
The improvement in manuscript quality submitted by the team participants, comparing before and after to DOJO activity.
This variable will be measured using previous DOJO's evaluator scoring, specifically adapted from high-impact journal reviewer guidelines (BMJ, Nature, Elsevier, JAMA) and reporting guidelines (CONSORT, STROBE, PRISMA).
The rubric covers four domains: Scientific Content and Rigor (35 points), Reporting Quality (20 points), Scientific Writing Quality (25 points), and Journal Readiness and Impact (20 points).
Total scores range from 0 to 100, with higher scores indicating better manuscript quality.
Each manuscript is scored by at least two blinded evaluators.
|
Baseline and one month
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participants' Publication
Prazo: Baseline and nine months
|
This variable will be assessed based on efficiency and quality of participants' manuscript publications, including submission timelines, publication speed, and journal impact.
Impact on publication outcomes will be measured using a composite scoring approach.
The Submission-to-Publication Interval Score will be calculated based on the number of months between manuscript submission and publication, with shorter intervals receiving higher scores (≤3 months = 4; ≤5 months = 3; ≤7 months = 2; ≤9 months = 1; not published = 0).
Journal quality will be assessed using quartile rankings, with scores assigned as follows: Q1 = 3, Q2 = 2, Q3 = 1, and Q4 or unindexed journals = 0.
|
Baseline and nine months
|
|
Quality of Teaching
Prazo: Baseline and one month
|
This variable measures participants' perceptions of how effective the teaching was, both overall and at the Sensei level (clarity, structure, engagement, and learning support).
Average scores (1-5 scales) are calculated for overall teaching quality and per Sensei (1: Strongly disagree, 2: Disagree, 3: Neutral, 4: Agree, 5: Strongly Agree).
Then, it was aggregated for comparison between the intervention and control groups.
Higher scores indicate better quality of teaching.
|
Baseline and one month
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Publicações Gerais
- Chicco D, Sichenze A, Jurman G. A simple guide to the use of Student's t-test, Mann-Whitney U test, Chi-squared test, and Kruskal-Wallis test in biostatistics. BioData Min. 2025 Aug 20;18(1):56. doi: 10.1186/s13040-025-00465-6.
- Braga LH, Farrokhyar F, Donmez MI, Nelson CP, Haid B, Herbst K, Garriboli M, Cascio S, Nieuwhof-Leppink A, Kaefer M, Bagli DJ, Kalfa N, Ching C, Fossum M, Harper L. Randomized controlled trials - The what, when, how and why. J Pediatr Urol. 2025 Apr;21(2):397-404. doi: 10.1016/j.jpurol.2024.11.021. Epub 2024 Dec 3.
- Akobeng AK. Assessing the validity of clinical trials. J Pediatr Gastroenterol Nutr. 2008 Sep;47(3):277-82. doi: 10.1097/MPG.0b013e31816c749f.
- Widyahening IS, Wangge G, Saldi SR, Lestari BW, Apriani L, Sastroasmoro S, Glasziou P, van der Graaf Y, van der Heijden GJ. Quality and reporting of publications by Indonesian researchers: a literature survey. J Evid Based Med. 2014 Aug;7(3):163-71. doi: 10.1111/jebm.12112.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 096/UN18.F8/ETIK/2026 (Número de outro subsídio/financiamento: Foreign, Commonwealth and Development Office, British Embassy Jakarta)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .