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- Ensaio Clínico NCT07781527
Effectiveness of an Audiovisual Disaster-Education Intervention on Disaster Risk Perception and Preparedness Belief Among Senior High-School Adolescents (DERAP)
Effectiveness of an Audiovisual Disaster-Education Intervention on Disaster Risk Perception and Preparedness Belief Among Senior High-School Adolescents in West Kalimantan, Indonesia
This cluster-randomized controlled trial tests whether a short, standardized disaster-education video improves two psychological precursors of disaster preparedness among senior high-school students in a hazard-prone district of West Kalimantan, Indonesia.
Twelve intact classes at one senior high school will be randomized 1:1, stratified by grade level, either to view a purpose-built audiovisual disaster-education module (approximately 20 minutes, shown twice in a single classroom session) or to view an attention-matched general adolescent-health video of similar length on an unrelated topic. Randomization is at the class level to reduce contamination between students, and the individual student is the unit of analysis. All students in a participating class view the video allocated to that class; a randomly drawn subsample of twelve students per class, 144 in total, completes the study questionnaires.
Two co-primary outcomes are measured in every participant. The first is disaster preparedness belief, measured by the General Disaster Preparedness Belief (GDPB) scale. The second is disaster risk perception, measured by the Disaster Risk Perception Scale (DRPS). Both are collected at baseline before allocation, immediately after the session, and again four weeks later.
The intervention and both instruments are grounded in the Health Belief Model, which predicts that raising perceived threat contributes to readiness to act. An exploratory mediation analysis will test whether change in risk perception explains part of any effect on preparedness belief.
After the four-week assessment, control classes are offered the full disaster-education intervention.
Visão geral do estudo
Status
Condições
Descrição detalhada
Background. West Kalimantan, including Kubu Raya Regency, is exposed to recurrent seasonal flooding and to land and forest fires with associated haze. Adolescents are rarely the explicit target of preparedness interventions despite being reachable at scale through schools, capable of transmitting preparedness knowledge within households, and themselves vulnerable during emergencies. Audiovisual media engage sight and hearing simultaneously, simplify complex content, and standardize delivery, making a short video a plausible low-cost vehicle for shifting the cognitive precursors of preparedness behavior.
Theoretical framework. The intervention is grounded in the Health Belief Model (HBM). Disaster risk perception corresponds to the upstream perceived-threat component of the HBM, comprising perceived susceptibility and perceived severity. Disaster preparedness belief captures the fuller, more downstream readiness-to-act constellation, combining threat appraisal with perceived benefits, perceived barriers, self-efficacy, and cues to action. Each content block of the video is mapped a priori to a specific HBM construct and to the outcome subscales it is intended to move, which is the content-validity rationale for using one shared intervention to address both co-primary outcomes.
Design. Two-arm, parallel-group, stratified cluster-randomized controlled trial with 1:1 allocation and a superiority framework. The cluster and unit of randomization is the intact class; the unit of analysis is the individual student. Stratification is by grade level (X, XI, XII), so that within each grade an equal number of classes is assigned to each arm. A computer-generated sequence is produced by the study statistician with the seed recorded. Class identifiers without class names are provided to an independent allocation holder who applies the sequence, giving third-party concealed allocation. Within each eligible class a random subsample of twelve students is drawn from the class roster before any class is randomized, and baseline data are collected from all consented students in that subsample before allocation, so that both participant selection and recruitment are complete before assignment is known. Drawing the subsample before allocation is essential, because selecting participants after clusters have been assigned is the principal source of identification and recruitment bias in cluster trials.
Masking. Participants and facilitators cannot be masked because the intervention is overt. Questionnaires are self-administered and identical across arms. The data manager who enters and cleans the data is masked to allocation, and the statistician conducts the primary analysis on an arm-coded dataset. Unmasking occurs only after the primary analysis is locked.
Sample size. Detecting a moderate standardized difference (Cohen d = 0.50) with two-sided alpha 0.05 and 80 percent power requires approximately 63 students per arm under individual randomization. Because the primary analysis adjusts for the baseline score, this requirement is multiplied by (1 minus r squared), where r is the assumed baseline-to-immediate-post correlation, taken as 0.60, giving approximately 40 students per arm. Twelve intact classes are randomized, six per arm, with twelve students randomly sampled and assessed within each class. The resulting design effect is 1 + (12 minus 1) x 0.05 = 1.55, giving approximately 62 evaluable students per arm. Allowing 15 percent attrition to the four-week follow-up gives an enrollment target of 72 students per arm and 144 in total. All students in participating classes view the assigned video; only the randomly drawn subsample completes the questionnaires. Under these assumptions the trial detects a standardized difference of approximately 0.50 at alpha 0.05, or approximately 0.56 under a Bonferroni-adjusted alpha of 0.025 for a joint co-primary claim. If the true intracluster correlation is 0.02, plausible for attitudinal outcomes, the detectable difference falls to approximately 0.45; if it is 0.10, it rises to approximately 0.59. The mediation analysis is powered only for exploratory purposes at this sample size.
Statistical analysis. For each co-primary outcome the primary analysis is a linear mixed-effects model with a random intercept for class and fixed effects for arm, time, and the arm-by-time interaction, adjusting for the baseline score, the stratification factor (grade), and pre-specified confounders (sex, age, prior personal disaster experience, prior exposure to disaster education). The treatment effect is the adjusted between-arm difference at the immediate post-intervention assessment, reported with a 95 percent confidence interval. Because the sample size claims credit for baseline adjustment, the observed baseline-to-post correlation will be reported alongside the primary result, as will the observed intracluster correlation for each outcome. Generalized estimating equations with an exchangeable working correlation are specified as an equivalent alternative. Baseline balance is described rather than significance-tested, following the Consolidated Standards of Reporting Trials (CONSORT) extension for cluster randomized trials. The primary analysis follows the intention-to-treat principle; a per-protocol analysis is secondary. Missing outcome data are handled by multiple imputation under a missing-at-random assumption with complete-case sensitivity analysis. Each co-primary outcome is tested at two-sided alpha 0.05 within its own analysis, and a Bonferroni-adjusted threshold of 0.025 is applied for any combined family-wise claim. The analysis plan is fixed before unmasking.
Fidelity and contamination. Every session is documented on a fidelity log recording that the correct video was played in full and twice, absence of interruptions or substituted content, adherence to the facilitator script, equipment and room conditions, attendance, and any deviation or contaminating event. Contamination within the single school is mitigated by randomizing at class level, separating data-collection days by arm, and scheduling control assessments so they are not preceded by discussion with intervention classes. Residual contamination is expected to bias effects toward the null.
Post-trial provision. After the four-week assessment, control classes are offered the full audiovisual disaster-education intervention.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: I Made Moh. Yanuar Saifudin, S.Kep., Ns., M.Kep.
- Número de telefone: +6281225438514
- E-mail: imademohyanuar.s@ners.untan.ac.id
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Cluster (class) level:
- Intact class of grade X, XI, or XII within the participating school
Individual (student) level:
- Actively enrolled student in grade X, XI, or XII
- Present on the scheduled data-collection and intervention days
- Written informed consent provided by a parent or legal guardian, and written assent provided by the adolescent
- Able to view the full audiovisual session and complete the study questionnaires
Exclusion Criteria:
Cluster (class) level:
- Class unavailable for the full schedule of sessions during the study window (for example, examination or fieldwork commitments)
Individual (student) level:
- Acute illness preventing participation on the study day
- Withdrawal of adolescent assent or guardian consent at any point
- Unable to complete the intervention session (for example, must leave before the video ends); such records are retained for the intention-to-treat analysis but flagged for the per-protocol set
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Audiovisual disaster-education module
Classes allocated to this arm receive, in a single standardized classroom session, a purpose-built audiovisual disaster-education module of approximately 20 minutes, played twice consecutively, optionally followed by a fully scripted five-minute facilitator debrief in which each student names one personal preparedness action.
Content blocks cover the definition of disaster, how disasters occur, impacts and risks, benefits of preparedness, personal preparation steps, barriers and misconceptions, social and environmental roles, self-efficacy, environmental knowledge, and a closing call to action, each mapped to a Health Belief Model construct.
Delivery is standardized (identical file, equipment, and room set-up) by a trained facilitator following a fixed script and completing a fidelity checklist.
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A purpose-built educational video on disaster preparedness, approximately 20 minutes in duration, developed through a structured instructional-design cycle (needs analysis, learning objectives, storyboard, production, expert content validation withitem-level content validity index [I-CVI] of at least 0.78 and scale-level content validity index, average method [S-CVI/Ave], of at least 0.90, comprehension pilot, and lock).
The defined dose is one viewing repeated twice in the same session, identical for every intervention cluster.
An optional fully scripted five-minute debrief may follow.
No deviation from this dose is permitted without a documented protocol amendment.
Outros nomes:
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Comparador Ativo: Attention-matched general-health video
Classes allocated to this arm receive, in an equivalent session of similar length and under identical conditions, a general adolescent-health video unrelated to disaster preparedness (for example, on personal hygiene or balanced nutrition).
This attention-matched comparator controls for contact time, facilitator attention, and the novelty of receiving a video session, isolating the specific effect of the disaster content.
After the four-week follow-up assessment, classes in this arm are offered the full audiovisual disaster-education intervention.
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A general adolescent-health video on a topic unrelated to disaster preparedness (for example, personal hygiene or balanced nutrition), matched to the experimental module for duration, delivery format, room conditions, and facilitator contact time.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in disaster risk perception, measured by the Disaster Risk Perception Scale total score
Prazo: Baseline (Day 1, pre-intervention) and Day 1, within 30 minutes post-intervention
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Disaster risk perception measured by the Disaster Risk Perception Scale (DRPS), a 25-item instrument covering five dimensions: exposure and impact, probability, uncontrollability, worry and fear, and vulnerability.
Each item is scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).
The total score is the sum of all 25 items and ranges from a minimum of 25 to a maximum of 125.
A higher total score indicates greater perceived disaster risk.
Higher scores are not inherently better or worse for health; greater perceived risk is the direction of change the intervention is hypothesized to produce, because perceived threat is the upstream component of the Health Belief Model.
The estimand is the between-arm difference in DRPS total score immediately post-intervention, adjusted for the baseline score, grade, and pre-specified confounders, estimated in a linear mixed-effects model with a random intercept for class.
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Baseline (Day 1, pre-intervention) and Day 1, within 30 minutes post-intervention
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Change in disaster preparedness belief, measured by the General Disaster Preparedness Belief scale total score
Prazo: Baseline (Day 1, pre-intervention) and Day 1, within 30 minutes post-intervention
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Disaster preparedness belief measured by the General Disaster Preparedness Belief (GDPB) scale, a 38-item instrument based on the Health Belief Model.
Each item is scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with negatively worded items reverse-scored before summation.
The total score is the sum of all 38 items and ranges from a minimum of 38 to a maximum of 190.
A higher total score indicates stronger disaster preparedness belief, which is the better outcome.
The estimand is the between-arm difference in GDPB total score immediately post-intervention, adjusted for the baseline score, grade, and pre-specified confounders, estimated in a linear mixed-effects model with a random intercept for class.
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Baseline (Day 1, pre-intervention) and Day 1, within 30 minutes post-intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Retention of effect on disaster preparedness belief at four weeks, measured by the General Disaster Preparedness Belief scale total score
Prazo: Baseline (Day 1) and Week 4
|
Disaster preparedness belief at the four-week follow-up, measured by the General Disaster Preparedness Belief (GDPB) scale, a 38-item instrument based on the Health Belief Model.
Each item is scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with negatively worded items reverse-scored.
The total score ranges from a minimum of 38 to a maximum of 190, and a higher total score indicates stronger disaster preparedness belief, which is the better outcome.
The reported value is the adjusted between-arm difference in GDPB total score at four weeks, estimated in the same linear mixed-effects model used for the primary analysis, to assess whether any immediate post-intervention effect on preparedness belief is retained.
|
Baseline (Day 1) and Week 4
|
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Retention of effect on disaster risk perception at four weeks, measured by the Disaster Risk Perception Scale total score
Prazo: Baseline (Day 1) and Week 4
|
Disaster risk perception at the four-week follow-up, measured by the Disaster Risk Perception Scale (DRPS), a 25-item instrument covering exposure and impact, probability, uncontrollability, worry and fear, and vulnerability.
Each item is scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).
The total score ranges from a minimum of 25 to a maximum of 125, and a higher total score indicates greater perceived disaster risk, which is the direction of change the intervention is hypothesized to produce.
The reported value is the adjusted between-arm difference in DRPS total score at four weeks, estimated in the same linear mixed-effects model used for the primary analysis, to assess whether any immediate post-intervention effect on risk perception is retained.
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Baseline (Day 1) and Week 4
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General Disaster Preparedness Belief scale subscale scores
Prazo: Baseline (Day 1), Day 1 post-intervention, and Week 4
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Between-arm differences in the six Health Belief Model subscales of the General Disaster Preparedness Belief (GDPB) scale: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action.
Because the six subscales contain different numbers of items, each subscale is reported on a common metric as the mean score of its constituent items, so that all six share a single unit of measure.
Unit of measure: mean item score on a 5-point Likert scale.
The possible range for every subscale is a minimum of 1 to a maximum of 5, and a higher score indicates stronger belief on that construct, which is the better outcome.
Each subscale difference is adjusted for the corresponding baseline subscale mean.
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Baseline (Day 1), Day 1 post-intervention, and Week 4
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Disaster Risk Perception Scale dimension scores
Prazo: Baseline (Day 1), Day 1 post-intervention, and Week 4
|
Between-arm differences in the five dimensions of the Disaster Risk Perception Scale (DRPS): exposure and impact, probability, uncontrollability, worry and fear, and vulnerability.
Because the five dimensions contain different numbers of items, each dimension is reported on a common metric as the mean score of its constituent items, so that all five share a single unit of measure.
Unit of measure: mean item score on a 5-point Likert scale.
The possible range for every dimension is a minimum of 1 to a maximum of 5, and a higher score indicates greater perceived risk on that dimension, which is the direction of change the intervention is hypothesized to produce.
Each dimension difference is adjusted for the corresponding baseline dimension mean.
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Baseline (Day 1), Day 1 post-intervention, and Week 4
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Indirect effect of the intervention on disaster preparedness belief through change in disaster risk perception
Prazo: Baseline (Day 1), Day 1 post-intervention, and Week 4
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Exploratory mediation analysis estimating the indirect effect of allocated arm on change in General Disaster Preparedness Belief (GDPB) scale total score operating through change in Disaster Risk Perception Scale (DRPS) total score.
The indirect effect is estimated using a product-of-coefficients approach with bias-corrected bootstrap confidence intervals, accounting for clustering by class.
The single reported value is the indirect effect expressed in GDPB total score points, with its 95 percent confidence interval.
Unit of measure: GDPB total score points, on a scale ranging from 38 to 190 in which higher scores indicate stronger preparedness belief.
The trial is not powered for this contrast, so the analysis is exploratory and hypothesis-generating.
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Baseline (Day 1), Day 1 post-intervention, and Week 4
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Proportion of sessions delivered according to protocol (delivery fidelity)
Prazo: Day 1
|
Delivery fidelity: the percentage of classroom sessions meeting every pre-specified fidelity criterion.
Each session yields one binary classification (per protocol / not per protocol), recorded by the facilitator on a standardized fidelity log.
A session counts as per protocol only if all criteria are met: the video for the allocated arm was played; it was played in full; it was played twice, as specified for the audiovisual disaster-education module; no interruption occurred and no content was substituted; the facilitator followed the fixed script; and equipment and room conditions matched the standard set-up.
The reported value is the number of sessions classified as per protocol divided by the total number of sessions, expressed as a percentage.
Unit of measure: percentage of sessions.
Range 0 to 100 percent; a higher percentage indicates better delivery fidelity.
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Day 1
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Proportion of assessed participants completing the full session
Prazo: Day 1
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Session completion among participants in the outcome assessment subsample, expressed as the percentage of participants who were present at the start of the session allocated to their class and who remained present until the session ended.
Attendance at the start and at the end of each session is recorded on the same standardized session fidelity log.
The single reported value is the number of participants completing the full session divided by the number present at the start, expressed as a percentage.
Unit of measure: percentage of participants.
The possible range is 0 to 100 percent, and a higher percentage indicates better session completion.
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Day 1
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
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
- Comportamento
- Adesão e Cumprimento do Tratamento
- Conformidade do paciente
- Aceitação dos Cuidados de Saúde pelo Paciente
- Intervenções de adesão
- Adesão à Medicação
- Comportamento de saúde
- Educação saudável
- Pênfigo e Fogo Selvagem
- Comportamento adolescente
- Tecnologia, indústria e agricultura
- Tecnologia
- Gravação de fita
- AIDS audiovisual
- Tecnologia educacional
- Televisão
- Gravação em vídeo
Outros números de identificação do estudo
- 5023/UN22.9/PT.01.04/2025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
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