Dataset Information

Effectiveness of an app-based intervention for unintentional injury among caregivers of preschoolers: protocol for a cluster randomized controlled trial.

ABSTRACT:

Background

Each year, over 15,000 preschoolers die from unintentional injuries in China. Many interventions proven to work in other nations have not been implemented nationwide in China. The rapid popularity of smartphones offers an opportunity to overcome this limitation and disseminate evidence-based interventions to the large population of China. This study aims to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among young Chinese children.

Method

A single-blinded, 6-month, parallel-group cluster randomized controlled trial with 1:1 allocation ratio will be conducted in Changsha, China. In total, 2626 caregivers of preschoolers ages 3-6 years old who own a smartphone will be recruited from 20 preschools. Clusters will be randomized at the preschool level and allocated to either the control group (routine education plus app-based parenting education excluding unintentional injury prevention) or the intervention group (routine education plus app-based parenting education including unintentional injury prevention). The app-based injury prevention program was developed based on the Theory of Planned Behavior, the Haddon Matrix, the Mobile Learning framework, and a needs assessment. Data collection will be conducted at baseline, 3-month, and 6-month follow-up via app-based survey plus printed questionnaire survey. The primary outcome measure is unintentional injury incidence among preschoolers in the past 3 months. Secondary outcome measures include economic losses due to unintentional injury in the past 3 months, the Incremental Cost-Effectiveness Ratios (ICERs), and parent's attitudes and behaviors concerning supervision to prevent preschooler unintentional injury in the past week. An intention-to-treat approach will be used to evaluate outcome measures. Chi-square tests will examine differences for outcome measures between groups at each time point and generalized estimation equations (GEE) will test the overall effectiveness of the app-based intervention. Missing outcome data will be imputed using the Expectation Maximization algorithm (EM).

Discussion

This trial will examine evidence concerning the effectiveness of an innovative app-based intervention for caregivers of Chinese preschoolers. If effective, the app-based intervention could offer an effective population-based intervention option to cost-effectively promote unintentional injury prevention in countries and regions where injury control is under-supported.

Trial registration

ChiCTR-IOR-17010438 . Registered 15 January 2017.

SUBMITTER: Ning P

PROVIDER: S-EPMC6042388 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of an app-based intervention for unintentional injury among caregivers of preschoolers: protocol for a cluster randomized controlled trial.

Ning Peishan P Chen Bo B Cheng Peixia P Yang Yang Y Schwebel David C DC Yu Renhe R Deng Jing J Li Shukun S Hu Guoqing G

BMC public health 20180711 1

<h4>Background</h4>Each year, over 15,000 preschoolers die from unintentional injuries in China. Many interventions proven to work in other nations have not been implemented nationwide in China. The rapid popularity of smartphones offers an opportunity to overcome this limitation and disseminate evidence-based interventions to the large population of China. This study aims to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury amon ...[more]

PMID: 29996813

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Project description:BackgroundApp-based interventions have the potential to reduce child injury in countries with limited prevention resources, but their effectiveness has not been rigorously examined.ObjectiveThis study aimed to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among Chinese preschoolers.MethodsA 6-month cluster randomized controlled trial was conducted from December 2017 to June 2018. Recruitment was conducted through preschools, which were randomly allocated to either the control group (ie, app-based parenting education excluding unintentional injury prevention) or the intervention group (ie, app-based parenting education including unintentional injury prevention). A total of 2920 caregivers of preschoolers aged 3-6 years from 20 preschools in Changsha, China, were recruited offline through the schools. The primary outcome was unintentional injury incidences among preschoolers in the past 3 months; this measure was assessed through an online caregiver-report at the baseline visit and at 3-month and 6-month follow-up visits. Secondary outcome measures included caregivers' self-reported attitudes and behaviors concerning child supervision during the last week. Generalized estimating equations (GEEs) were used to assess the effectiveness of the app-based intervention on responses at 3 and 6 months after adjusting for sociodemographic variables, baseline level of the outcome variable, and engagement with interventions in the assigned group. All analyses were intention-to-treat. A per-protocol sensitivity analysis was also conducted.ResultsIn total, 1980 of the 2920 caregivers completed the study. The mean age of participants was 32.0 years (SD 5.5) and 68.99% (1366/1980) of them were female. During the 6-month follow-up visit, unintentional injury incidence did not change significantly in either group: incidence in the intervention group went from 8.76% (94/1073) to 8.11% (87/1073), P=.59; incidence in the control group went from 9.4% (85/907) to 7.5% (69/907), P=.15. The changes did not differ between the groups (odds ratio [OR] 1.14, 95% CI 0.80-1.62). Changes in the average score in attitude concerning unintentional injury prevention were also similar between the groups (B .05, 95% CI -0.03 to 0.13). Changes in unintentional injury prevention behaviors were greater in the intervention group than in the control group after the intervention (B .87, 95% CI 0.33-1.42). Analyses of individual injury prevention behaviors showed that the intervention reduced three risky behaviors: unsafe feeding of children (OR 0.73, 95% CI 0.60-0.89); incorrectly placing children in cars (OR 0.73, 95% CI 0.57-0.93); and allowing children to ride bicycles, electric bicycles, or motorcycles unsupervised (OR 0.80, 95% CI 0.64-0.99). The intervention also improved scores on three safety-focused behaviors: testing water temperature before giving children a bath (OR 1.26, 95% CI 1.05-1.52); properly storing sharp objects (OR 1.24, 95% CI 1.01-1.52); and safely storing medicines, detergents, and pesticides (OR 1.24, 95% CI 1.02-1.51).ConclusionsThe app-based intervention did not reduce unintentional injury incidence among preschoolers but significantly improved caregivers' safety behaviors. This app-based intervention approach to improve caregiver behaviors surrounding child injury risk offers promise to be modified and ultimately disseminated broadly.Trial registrationChinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 (Archived by WebCite at http://www.webcitation.org/75jt17X84).International registered report identifier (irrid)RR2-10.1186/s12889-018-5790-1.

Project description:BackgroundInteractive and experiential learning programs have proven effective to teach children safety and prevent child unintentional injury. However, previously-published programs were designed primarily to address safety concerns of children living in urban, well-resourced areas, and therefore might be less effective or economically infeasible to distribute to children in resource-limited areas, such as those living in rural areas or underdeveloped regions. This proposed study will evaluate the effectiveness of teaching children safety lessons to rural preschoolers in China through the preschool-based Safety Experience Room intervention that was developed based on relevant theories, the lessons of previous intervention research, the characteristics of child injuries in underdeveloped rural areas, and the needs and circumstances of rural families and preschools in China. The study will also evaluate the cost-effectiveness of delivering the program.Methods and analysisA single-blinded, 12-month follow-up, parallel-group cluster randomized controlled trial with a 1:1 allocation ratio will be implemented in two selected counties. In total, at least 2378 rural preschoolers aged 3-6 years old will be recruited from 12 preschools, 6 in Yang County and 6 in Shicheng County. Clusters will be randomized at the preschool level and allocated to the control group (routine school-based education) or the intervention group (routine school-based education plus the Safety Experience Room education). External support strategies will be implemented by local partners to minimize attrition. Data collection will be conducted at baseline and then every 3 months during a 12-month follow-up time period. Intention-to-treat (ITT) data analysis will be used. Generalized estimation equations (GEE) will evaluate the effectiveness of the program and generalized cost-effectiveness analysis (GCEA) will evaluate the cost-effectiveness of it. A per-protocol (PP) sensitivity analysis will assess the robustness of ITT results. Subgroup analyses will be performed to evaluate the impact of socio-demographic factors on the intervention effect, following the same strategies as the primary analyses.DiscussionThe newly-designed Safety Experience Room program is expected to be feasible, effective, and financially beneficial. If these hypotheses prove true, we will take steps to disseminate the program to rural preschools across China.Trial registrationChinese Clinical Trial Registry ( http://www.chictr.org.cn ), CHiCTR2000038025, registered on 8 September 2020.

Project description:ObjectiveTo test the effectiveness of the web-based intervention "Koji-family.net 3-day program" (KF3 PGM) for life-change adaptation in family caregivers of community-dwelling individuals with acquired brain injury (ABI).DesignA cluster-randomized trial.SettingsAll 82 institutions for families of individuals with ABI in Japan.ParticipantsParticipants were 240 families at 16 different institutions for families of individuals with ABI. Inclusion criteria for participants were (1) families caring for an individual with ABI, (2) family members aged 20 years and over, and (3) the individual with ABI developed ABI when aged more than 16 years and less than 65 years.MethodsClusters were randomly assigned to the intervention (8 clusters, n = 120) or the control (8 clusters, n = 120) group. For the intervention group, the KF3 PGM was assigned, in addition to routine family group activities to enhance the life-change adaptation. The control group followed their daily routine and received usual services. The primary outcome was the life-change adaptation scale (LCAS); secondary outcomes were the multidimensional scale of perceived social support (MSPSS) and the positive appraisal of care (PAC) scale at the baseline, after 3 days (short-term follow-up), and after 1 month (long-term follow-up). A mixed model for repeated measures (MMRM) was applied.ResultsA total of 91 participants were enrolled. The mean age (SE) of the participants was 64.0 (9.2) years; 87.8% of them were female. The intervention group showed better improvement in the LCAS than the control group in the whole study period (F = 6.5, p = 0.002). The mean observed change in LCAS from baseline was +8.0 (SE = 2.0) at 3 days and +11.6 (SE = 2.0) at 1 month in the intervention group (F = 18.7, p < 0.001). No significant differences in MSPSS and PAC were observed among the intervention and control groups in the whole study.ConclusionsThe KF3 PGM can be an effective method of enhancing the adaptation to daily life in family caregivers of community-dwelling individuals with ABI. The results show that a potential web-based intervention in institutions for families of individuals with ABI plays a substantial, longer-term role in their support in Japan. Future studies could address the same research questions in different settings and cultures for family caregivers for even longer time periods.

Project description:BACKGROUND:Although major depression is a frequent disorder in non-professional caregivers and there are effective psychological interventions to prevent it, caregivers have difficulty accessing them. Interventions for depression applied through an app could improve accessibility; yet, to date, adherence to such interventions has been low. The objectives of this study are to (1) evaluate the efficacy of a cognitive behavioral depression prevention intervention administered through a smartphone app with and without telephone conference calls, (2) analyze the mediators of the change in the incidence of depression and depressive symptoms, and (3) assess adherence and satisfaction with the interventions. METHODS:A randomized controlled clinical trial will be conducted. Caregivers with elevated symptoms will be randomly assigned to a cognitive behavioral intervention administered by a smartphone app (CBIA) group, a CBIA plus telephone conference calls (TCCs) group (CBIA + TCC), or an attention control group. Each condition will consist of approximately 58 participants. Both interventions will be administered in five modules through a smartphone app and the CBIA + TCC group will receive additional TCCs in group format (four sessions of 30 min each). Trained blind assessors will conduct pre-treatment, post-treatment and follow-up assessments at 1, 3, 6, and 12 months. DISCUSSION:This study will provide evidence of the efficacy of a cognitive behavioral intervention to prevent depression in caregivers with elevated depressive symptoms administered through a smartphone app and the impact of feedback applied through conference calls to increase program adherence and efficacy. If the results were favorable, it would mean that we have developed a more effective, accessible, and clinically useful preventive depression intervention than the currently available ones for many present and future caregivers. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03110991 . Registered 5 April 2017.

Project description:BackgroundWith the growing popularity of mobile health technology, app-based interventions delivered by smartphone have become an increasingly important strategy toward injury prevention.ObjectiveThis study aimed to develop a framework supporting the design of an app-based intervention to prevent unintentional injury, targeted for caregivers of Chinese children aged 0 to 6 years.MethodsA theory-based mixed-method study, including focus groups and Web-based quantitative survey, was performed. Adult caregivers who care for children aged 0 to 6 years and own a smartphone were recruited into 2 sequential stages of research. First, focus groups were conducted among the caregivers at community health care centers and preschools from December 2015 to March 2016. Focus groups (8-10 participants per group) explored awareness, experiences, and opinions of caregivers toward using an app to prevent unintentional injury among children. Second, based on the focus groups findings, a Web-based quantitative survey was designed and distributed to caregivers in November 2016; it collected information on specific needs for the app-based intervention. Thematic analysis and quantitative descriptive analyses were performed.ResultsIn total, 12 focus groups were completed, involving 108 caregivers. Most participants expressed a strong desire to learn knowledge and skills about unintentional child injury prevention and held positive attitudes toward app-based interventions. Participants expressed multiple preferences concerning the app-based intervention, including their contents, functions, interactive styles, installation and registration logistics, and privacy protection and information security. Following the focus groups, 1505 caregivers completed a WeChat-based quantitative survey, which generated roughly similar results to those of focus groups and added numerical metrics concerning participants' preferences on what to learn, when to learn it, and how to learn it. A detailed framework was established involving 5 components: (1) content design, (2) functional design, (3) interactive style, (4) installation and registration logistics, and (5) privacy protection and information security, and 15 specific requirements.ConclusionsWe developed a framework that can be used as a guide to design app-based interventions for parents and caregivers, specifically for unintentional injury prevention of children aged 0 to 6 years.

Project description:Despite the health benefits of physical activity, data from the UK suggest that a large proportion of adolescents do not meet the recommended levels of moderate-to-vigorous physical activity (MVPA). This is particularly evident in girls, who are less active than boys across all ages and may display a faster rate of decline in physical activity throughout adolescence. The 'Girls Active' intervention has been designed by the Youth Sport Trust to target the lower participation rates observed in adolescent girls. 'Girls Active' uses peer leadership and marketing to empower girls to influence decision making in their school, develop as role models and promote physical activity to other girls. Schools are provided with training and resources to review their physical activity, sport and PE provision, culture and practices to ensure they are relevant and attractive to adolescent girls.This study is a two-arm cluster randomised controlled trial (RCT) aiming to recruit 20 secondary schools. Clusters will be randomised at the school level (stratified by school size and proportion of Black and Minority Ethnic (BME) pupils) to receive either the 'Girls Active' intervention or carry on with usual practice (1:1). The 20 secondary schools will be recruited from state secondary schools within the Midlands area. We aim to recruit 80 girls aged 11-14 years in each school. Data will be collected at three time points; baseline and seven and 14 months after baseline. Our primary aim is to investigate whether 'Girls Active' leads to higher objectively measured (GENEActiv) moderate-to-vigorous physical activity in adolescent girls at 14 months after baseline assessment compared to the control group. Secondary outcomes include other objectively measured physical activity variables, adiposity, physical activity-related psychological factors and the cost-effectiveness of the 'Girls Active' intervention. A thorough process evaluation will be conducted during the course of the intervention delivery.The findings of this study will provide valuable information on whether this type of school-based approach to increasing physical activity in adolescent girls is both effective and cost-effective in the UK.ISRCTN10688342. Registered 12 January 2015.

Project description:BackgroundThe majority of stroke survivors return to their homes and need assistance from family caregivers to perform activities of daily living. These increased demands coupled with the lack of preparedness for their new roles lead to a high risk for caregivers developing depressive symptoms and other negative outcomes. Follow-up home support and problem-solving interventions with caregivers are crucial for maintaining stroke survivors in their homes. Problem-solving interventions are effective but are underused in practice because they require large amounts of staff time to implement and are difficult for caregivers logistically.ObjectiveThe aim of this study is to test a problem-solving intervention for stroke caregivers that can be delivered over the telephone during the patient's transitional care period (time when the stroke survivor is discharged to home) followed by 8 asynchronous online sessions.MethodsThe design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 240 caregivers from eight Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a modified problem-solving intervention that uses telephone and web-based support and training with interactive modules, fact sheets, and tools on the previously developed and nationally available Resources and Education for Stroke Caregivers' Understanding and Empowerment Caregiver website. In the usual care group, no changes are made in the information, discharge planning, or care the patients who have had a stroke normally receive, and caregivers have access to existing VA resources (eg, caregiver support line, self-help materials). The primary outcome is a change in caregiver depressive symptoms at 11 and 19 weeks after baseline data collection. Secondary outcomes include changes in stroke caregivers' burden, knowledge, positive aspects of caregiving, self-efficacy, perceived stress, health-related quality of life, and satisfaction with care and changes in stroke survivors' functional abilities and health care use. The team will also determine the budgetary impact, facilitators, barriers, and best practices for implementing the intervention. Throughout all phases of the study, we will collaborate with members of an advisory panel.ResultsStudy enrollment began in June 2015 and is ongoing. The first results are expected to be submitted for publication in 2021.ConclusionsThis is the first known study to test a transitional care and messaging center intervention combined with technology to decrease caregiver depressive symptoms and to improve the recovery of stroke survivors. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post stroke.Trial registrationClinicalTrials.gov NCT01600131; https://www.clinicaltrials.gov/ct2/show/NCT01600131.International registered report identifier (irrid)DERR1-10.2196/21799.

Project description:BackgroundThe prevalence of mental health problems in childhood and adolescence has increased significantly, not least due to the COVID-19 pandemic in Germany and other countries worldwide. Although holistic school interventions to promote mental health and prevent mental health problems are considered promising, there is currently uncertainty about their effectiveness due to evaluation studies with heterogeneous methodological quality. This paper presents the study protocol for the evaluation of the primary school module of MindMatters.MethodsAs part of a universal mental health intervention, the MindMatters primary school module 'Learning Together with Emotions' aims to promote social-emotional learning (SEL) in the classroom across five skill areas. In addition to classroom activities, the intervention includes a school development module to help primary schools create structures and processes to maintain and promote mental health. To evaluate the effectiveness of the intervention, a two-arm cluster-randomised controlled trial will be conducted, including schools implementing MindMatters over a 12-month period and a control group with no access to the intervention. Data will be collected before and 18 months after initiation of the intervention. Controlled for baseline conditions, multilevel regression analysis will be used to examine primary intervention outcomes at the pupil level (i.e. reductions in mental and behavioural problems). Further mediation and moderation analyses will examine whether proximal outcomes predict changes in mental health outcomes and whether school-level factors influence the effectiveness of the intervention.DiscussionThis study will contribute to strengthen the evidence base for holistic school (mental) health promotion interventions using a study design with high internal validity. Based on an intervention model, the results will not only provide insights into the relationship between proximal and distal outcomes, but will also allow conclusions to be drawn about how the implementation of the intervention affects its effectiveness. Finally, the findings also address the question of whether improved mental health has a positive effect on primary school pupils' academic performance.Trial registrationGerman Clinical Trials Register DRKS00023762. Registered on 5 January 2021.

Project description:BackgroundThere are up to 19.4 million children who are still unvaccinated and face unnecessary deaths, especially among refugees. However, growing access to smartphones, among refugees, can be a leading factor to improve vaccination rates.ObjectiveThis study aims to determine whether a smartphone app can improve the vaccination uptake among refugees and determine the app's effectiveness in improving the documentation of vaccination records.MethodsWe developed and planned to test an app through a cluster randomized trial that will be carried out at the Zaatari refugee camp in Jordan. The study will be open to all parents who carry Android smartphones, have at least one child, and agree to participate in the study. The parents will be recruited to the study by trained volunteers at the vaccination sites around the Zaatari camp. Inclusion criteria will be the following: having at least one child of 0 to 5 years, being a local resident of the camp, and having an Android smartphone.ResultsThe intervention includes an app that will allow storing Jordanian vaccination records, per child, on the parents' smartphones in Arabic and English (in an interchangeable fashion). Every record will have a set of automated reminders before the appointment of each child. The app will summarize immunization records in form of due, taken, or overdue appointments, labeled in orange, green, and red, respectively. Baseline will include the collection of our primary and secondary outcomes that are needed for the pre and postdata measurements. This includes social demographic data, any previous vaccination history, and electronic health literacy. Participants, in both study arms, will be monitored for their follow-up visits to the clinic for vaccination doses. For the study outcome measures, we will measure any differences in the uptake of vaccinations. The secondary outcome is to analyze the effect of the children immunization app on visits for follow-up doses.ConclusionsOwing to the limited evidence of effective interventions for childhood vaccination among refugees, research in this area is greatly needed. The project will have a significant impact on the health of refugees and the public health system. In Jordan and the Middle East, the vaccination level is low. Given the influx of refugees from the area, it is crucial to ensure a high vaccination level among the children.International registered report identifier (irrid)PRR1-10.2196/13557.

Dataset Information

Effectiveness of an app-based intervention for unintentional injury among caregivers of preschoolers: protocol for a cluster randomized controlled trial.

Background

Method

Discussion

Trial registration

Publications

Effectiveness of an app-based intervention for unintentional injury among caregivers of preschoolers: protocol for a cluster randomized controlled trial.

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