Dataset Information

An App-Based Intervention for Caregivers to Prevent Unintentional Injury Among Preschoolers: Cluster Randomized Controlled Trial.

ABSTRACT:

Background

App-based interventions have the potential to reduce child injury in countries with limited prevention resources, but their effectiveness has not been rigorously examined.

Objective

This study aimed to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among Chinese preschoolers.

Methods

A 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.

Results

In 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).

Conclusions

The 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 registration

Chinese 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.

SUBMITTER: Ning P

PROVIDER: S-EPMC6713040 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

An App-Based Intervention for Caregivers to Prevent Unintentional Injury Among Preschoolers: Cluster Randomized Controlled Trial.

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

JMIR mHealth and uHealth 20190809 8

<h4>Background</h4>App-based interventions have the potential to reduce child injury in countries with limited prevention resources, but their effectiveness has not been rigorously examined.<h4>Objective</h4>This study aimed to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among Chinese preschoolers.<h4>Methods</h4>A 6-month cluster randomized controlled trial was conducted from December 2017 to June 2018. Recruitment was con ...[more]

PMID: 31400105

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Project description:BackgroundEach 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.MethodA 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).DiscussionThis 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 registrationChiCTR-IOR-17010438 . Registered 15 January 2017.

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: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:BackgroundWhile nonprofessional caregivers often experience a sense of fulfillment when they provide care, there is also a significant risk of emotional and physical burnout. Consequently, this can negatively affect both the caregiver and the person being cared for. Intervention programs can help empower nonprofessional caregivers of people with chronic diseases and develop solutions to decrease the physical and psychological consequences resulting from caregiving. However, most clinically tested intervention programs for nonprofessional caregivers require face-to-face training, and many caregivers encounter obstacles that hinder their participation in such programs. Consequently, it is necessary to design internet-based intervention programs for nonprofessional caregivers that address their needs and test the efficacy of the programs.ObjectiveThe aim of this study was to evaluate the effectiveness of a smartphone app-based intervention program to increase positive mental health for nonprofessional caregivers.MethodsThis study was a randomized controlled trial of 3 months' duration. A total of 152 caregivers over 18 years of age with a minimum of 4 months' experience as nonprofessional caregivers were recruited from primary health care institutions. Nonprofessional caregivers were randomized into two groups. In the intervention group, each caregiver installed a smartphone app and used it for 28 days. This app offered them daily activities that were based on 10 recommendations to promote positive mental health. The level of positive mental health, measured using the Positive Mental Health Questionnaire (PMHQ), and caregiver burden, measured using the 7-item short-form version of the Zarit Caregiver Burden Interview (ZBI-7), were the primary outcomes. Users' satisfaction was also measured.ResultsIn all, 113 caregivers completed the study. After the first month of the intervention, only one factor of the PMHQ, F1-Personal satisfaction, showed a significant difference between the groups, but it was not clinically relevant (0.96; P=.03). However, the intervention group obtained a higher mean change for the overall PMHQ score (mean change between groups: 1.40; P=.24). The results after the third month of the intervention showed an increment of PMHQ scores. The mean difference of change in the PMHQ score showed a significant difference between the groups (11.43; P<.001; d=0.82). Significant changes were reported in 5 of the 6 factors, especially F5-Problem solving and self-actualization (5.69; P<.001; d=0.71), F2-Prosocial attitude (2.47; P<.001; d=1.18), and F3-Self-control (0.76; P=.03; d=0.50). The results of the ZBI-7 showed a decrease in caregiver burden in the intervention group, although the results were inconclusive. Approximately 93.9% (46/49) of the app users indicated that they would recommend the app to other caregivers and 56.3% (27/49) agreed that an extension of the program's duration would be beneficial.ConclusionsThe app-based intervention program analyzed in this study was effective in promoting positive mental health and decreasing the burden of caregivers and achieved a high range of user satisfaction. This study provides evidence that mobile phone app-based intervention programs may be useful tools for increasing nonprofessional caregivers' well-being. The assessment of the effectiveness of intervention programs through clinical trials should be a focus to promote internet-based programs in health policies.Trial registrationISRCTN Registry ISRCTN14818443; http://www.isrctn.com/ISRCTN14818443.International registered report identifier (irrid)RR2-10.1186/s12889-019-7264-5.

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:BackgroundHigh prevalence of excessive screen time among preschool children is attributable to certain parental factors such as lack of knowledge, false perception about screen time, and inadequate skills. Lack of strategies to implement screen time guidelines, in addition to multiple commitments that may hinder parents from face-to-face interventions, demands the need to develop a technology-based parent-friendly screen time reduction intervention.ObjectiveThis study aims to develop, implement, and evaluate the effectiveness of Stop and Play, a digital parental health education intervention to reduce excessive screen time among preschoolers from low socioeconomic families in Malaysia.MethodsA single-blind, 2-arm cluster randomized controlled trial was conducted among 360 mother-child dyads attending government preschools in the Petaling district, who were randomly allocated into the intervention and waitlist control groups between March 2021 and December 2021. This 4-week intervention, developed using whiteboard animation videos, infographics, and a problem-solving session, was delivered via WhatsApp (WhatsApp Inc). Primary outcome was the child's screen time, whereas secondary outcomes included mother's screen time knowledge, perception about the influence of screen time on the child's well-being, self-efficacy to reduce the child's screen time and increase physical activity, mother's screen time, and presence of screen device in the child's bedroom. Validated self-administered questionnaires were administered at baseline, immediately after the intervention, and 3 months after the intervention. The intervention's effectiveness was evaluated using generalized linear mixed models.ResultsA total of 352 dyads completed the study, giving an attrition rate of 2.2% (8/360). At 3 months after the intervention, the intervention group showed significantly reduced child's screen time compared with the control group (β=-202.29, 95% CI -224.48 to -180.10; P<.001). Parental outcome scores also improved in the intervention group as compared with that in the control group. Mother's knowledge significantly increased (β=6.88, 95% CI 6.11-7.65; P<.001), whereas perception about the influence of screen time on the child's well-being reduced (β=-.86, 95% CI -0.98 to -0.73; P<.001). There was also an increase in the mother's self-efficacy to reduce screen time (β=1.59, 95% CI 1.48-1.70; P<.001) and increase physical activity (β=.07, 95% CI 0.06-0.09; P<.001), along with reduction in mother's screen time (β=-70.43, 95% CI -91.51 to -49.35; P<.001).ConclusionsThe Stop and Play intervention was effective in reducing screen time among preschool children from low socioeconomic families, while improving the associated parental factors. Therefore, integration into primary health care and preschool education programs is recommended. Mediation analysis is suggested to investigate the extent to which secondary outcomes are attributable to the child's screen time, and long follow-up could evaluate the sustainability of this digital intervention.Trial registrationThai Clinical Trial Registry (TCTR) TCTR20201010002; https://tinyurl.com/5frpma4b.

Project description:BackgroundHousehold air pollution from biomass fuels burning in traditional cookstoves currently appeared as one of the most serious threats to public health with a recent burden estimate of 2.6 million premature deaths every year worldwide, ranking highest among environmental risk factors and one of the major risk factors of any type globally. Improved cookstove interventions have been widely practiced as potential solutions. However, studies on the effect of improved cookstove interventions are limited and heterogeneous which suggested the need for further research.MethodsA cluster randomized controlled trial study was conducted to assess the effect of biomass-fuelled improved cookstove intervention on the concentration of household air pollution compared with the continuation of an open burning traditional cookstove. A total of 36 clusters were randomly allocated to both arms at a 1:1 ratio, and improved cookstove intervention was delivered to all households allocated into the treatment arm. All households in the included clusters were biomass fuel users and relatively homogenous in terms of basic socio-demographic and cooking-related characteristics. Household air pollution was determined by measuring the concentration of indoor fine particulate, and the effect of the intervention was estimated using the Generalized Estimating Equation.ResultsA total of 2031 household was enrolled in the study across 36 randomly selected clusters in both arms, among which data were obtained from a total of 1977 households for at least one follow-up visit which establishes the intention-to-treat population dataset for analysis. The improved cookstove intervention significantly reduces the concentration of household air pollution by about 343 μg/m3 (Ḃ = - 343, 95% CI - 350, - 336) compared to the traditional cookstove method. The overall reduction was found to be about 46% from the baseline value of 859 (95% CI 837-881) to 465 (95% CI 458-472) in the intervention arm compared to only about 5% reduction from 850 (95% CI 828-872) to 805 (95% CI 794-817) in the control arm.ConclusionsThe biomass-fuelled improved cookstove intervention significantly reduces the concentration of household air pollution compared to the traditional method. This suggests that the implementation of these cookstove technologies may be necessary to achieve household air pollution exposure reductions.Trial registrationThe trial project was retrospectively registered on August 2, 2018, at the clinical trials.gov registry database ( https://clinicaltrials.gov/ ) with the NCT03612362 registration identifier number.

Project description:IntroductionReducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing.Study designCluster RCT with randomization at the center level and N=160 participants.Setting/participantsLatino children aged 3-5 years and their parents were recruited from six Head Start centers in Houston TX in 2010-2012 with analyses in 2013-2014.InterventionF5K was culturally adapted for Latino preschoolers and the overall goal was to reduce TV viewing. Study staff taught F5K over 7-8 weeks during the regular Head Start day directly to intervention students. Control schools provided the usual Head Start curriculum, which did not specifically cover TV viewing.Main outcome measuresIndividual-level outcomes were measured prior to (Time 1) and immediately following (Time 2) the intervention. The primary outcome, TV viewing (minutes/day), was measured by validated 7-day TV diaries (parent-reported). Sedentary time was measured by accelerometers.ResultsPer the adjusted repeated measures linear mixed effects model for TV viewing (minutes/day), intervention children decreased from 76.2 (9.9) at Time 1 to 52.1 (10.0) at Time 2, whereas control children remained about the same from 84.2 (10.5) at Time 1 to 85.4 (10.5) at Time 2. The relative difference from Time 1 to Time 2 was -25.3 (95% CI= -45.2, -5.4) minutes for intervention versus control children (N=160, p=0.01). In a similar adjusted model, there was a relative decrease in sedentary time (minutes/day) from Time 1 to Time 2 favoring the intervention children (-9.5, 95% CI= -23.0, 4.1), although not significant at p<0.05.ConclusionsF5K reduced Latino preschoolers' TV viewing by >25 minutes daily. These findings have implications for prevention of obesity, related disorders, and health equity.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01216306.

Dataset Information

An App-Based Intervention for Caregivers to Prevent Unintentional Injury Among Preschoolers: Cluster Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

An App-Based Intervention for Caregivers to Prevent Unintentional Injury Among Preschoolers: Cluster Randomized Controlled Trial.

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