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A randomised safety promotion intervention trial among low-income families with toddlers.

ABSTRACT: BACKGROUND:Toddler-aged children are vulnerable to unintentional injuries, especially those in low-income families. OBJECTIVE:To examine the effectiveness of an intervention grounded in social cognitive theory (SCT) on the reduction of home safety problems among low-income families with toddlers. METHODS:277 low-income mother-toddler dyads were randomised into a safety promotion intervention (n=91) or an attention-control group (n=186). Mothers in the safety promotion intervention group received an eight-session, group-delivered safety intervention targeting fire prevention, fall prevention, poison control and car seat use, through health education, goal-setting and social support. Data collectors observed participants' homes and completed a nine-item checklist of home safety problems at study enrolment (baseline), 6 and 12?months after baseline. A total score was summed, with high scores indicating more problems. Linear mixed models compared the changes over time in home safety problems between intervention and control groups. RESULTS:The intent-to-treat analysis indicated that the safety promotion intervention group significantly reduced safety problems to a greater degree than the attention-control group at the 12-month follow-up (between-group difference in change over time ?=-0.54, 95% CI -0.05 to -1.03, p=0.035), with no significant differences at the 6-month follow-up. CONCLUSIONS:A safety promotion intervention built on principles of SCT has the potential to promote toddlers' home safety environment. Future studies should examine additional strategies to determine whether better penetration/compliance can produce more clinically important improvement in home safety practices. TRIAL REGISTRATION NUMBER:NCT02615158; post-results.

SUBMITTER: Wang Y

PROVIDER: S-EPMC6252264 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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A randomised safety promotion intervention trial among low-income families with toddlers.

Wang Yan Y Gielen Andrea C AC Magder Laurence S LS Hager Erin R ER Black Maureen M MM

Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention 20170406 1

<h4>Background</h4>Toddler-aged children are vulnerable to unintentional injuries, especially those in low-income families.<h4>Objective</h4>To examine the effectiveness of an intervention grounded in social cognitive theory (SCT) on the reduction of home safety problems among low-income families with toddlers.<h4>Methods</h4>277 low-income mother-toddler dyads were randomised into a safety promotion intervention (n=91) or an attention-control group (n=186). Mothers in the safety promotion inter ...[more]

PMID: 28385953

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Project description:IntroductionFamily-based physical activity (PA) interventions present a promising avenue to promote children's activity; however, high-quality experimental research is lacking. This paper describes the protocol for the FRESH (Families Reporting Every Step to Health) pilot trial, a child-led family-based PA intervention delivered online.Methods and analysisFRESH is a three-armed, parallel-group, randomised controlled pilot trial using a 1:1:1 allocation ratio with follow-up assessments at 8 and 52 weeks postbaseline. Families will be eligible if a minimum of one child in school Years 3-6 (aged 7-11 years) and at least one adult responsible for that child are willing to participate. Family members can take part in the intervention irrespective of their participation in the accompanying evaluation and vice versa.Following baseline assessment, families will be randomly allocated to one of three arms: (1) FRESH; (2) pedometer-only or (3) no-intervention control. All family members in the pedometer-only and FRESH arms receive pedometers and generic PA promotion information. FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to 'travel' to target cities around the world, log steps and track progress as they virtually globetrot. Control families will receive no treatment. All family members will be eligible to participate in the evaluation with two follow-ups (8 and 52 weeks). Physical (eg, fitness and blood pressure), psychosocial (eg, social support) and behavioural (eg, objectively measured family PA) measures will be collected at each time point. At 8-week follow-up, a mixed methods process evaluation will be conducted (questionnaires and family focus groups) assessing acceptability of the intervention and evaluation. FRESH families' website engagement will also be explored.Ethics and disseminationThis study received ethical approval from the Ethics Committee for the School of the Humanities and Social Sciences at the University of Cambridge. Findings will be disseminated via peer-reviewed publications, conferences and to participating families.Trial registration numberISRCTN12789422.

Project description:IntroductionThis study assessed the feasibility and acceptability of FRESH (Families Reporting Every Step to Health), a theory-based child-led family physical activity (PA) intervention delivered online. We also assessed the preliminary effectiveness of the intervention on outcomes of interest and whether pre-specified criteria were met to progress to a full-scale definitive trial.MethodsIn a three-armed randomised pilot trial, 41 families (with a 7-11-year-old index child) were allocated to a: 'family' (FAM), 'pedometer-only' (PED), or a no-treatment control (CON) arm. The FAM arm received access to the FRESH website, allowing participants to select step challenges to 'travel' to target cities around the world, log their steps, and track progress as families virtually globetrot. FAM and PED arms also received family sets of pedometers. All family members could participate in the evaluation. Physical (e.g., fitness, blood pressure), psychosocial (e.g., social support), behavioural (e.g., objectively-measured PA), and economic (e.g., expenditure for PA) data were collected at baseline, 8- and 52-weeks.ResultsAt 8- and 52-weeks, 98 and 88% of families were retained, respectively. Most children liked participating in the study (> 90%) and thought it was fun (> 80%). Compared to the PED (45%) and CON (39%) arms, a higher percentage of children in the FAM (81%) arm reported doing more activities with their family. Adults agreed that FRESH encouraged their family do more PA and made their family more aware of the amount of PA they do. No notable between-group differences were found for childrens' minutes in moderate-to-vigorous PA. Sizeable changes of 9.4 (95%CI: 0.4, 18.4) and 15.3 (95%CI: 6.0, 24.5) minutes in moderate-to-vigorous PA was found for adults in the FAM group compared to those in the PED or CON groups, respectively. No other notable differences were found.ConclusionThis study demonstrates feasibility and acceptability of the FRESH intervention. All progression criteria were at least partially satisfied. However, we failed to recruit the target sample size and did not find a signal of effectiveness on PA particularly long-term or in children. Further refinements are required to progress to a full-scale trial.Trial registrationThis study was prospectively registered ( ISRCTN12789422 ) on 16/03/2016.

Project description:BackgroundIncreasing access to health and social services through service-integration approaches may provide a direct and sustainable way to improve health and social outcomes in low-income families.MethodsWe did a community-based randomized trial evaluating the effects of two service-integration practices (healthy family lifestyle and recreational activities for children) among low-income families in Alberta, Canada. These two practices in combination formed four groups: Self-Directed (no intervention), Family Healthy Lifestyle, Family Recreation, and Comprehensive (Family Healthy Lifestyle plus Family Recreation programs). The primary outcome was the total number of service linkages.ResultsWe randomized 1168 families, 50 % of which were retained through the last follow-up visit. The number of service linkages for all three intervention groups was not significantly different from the number of linkages in the Self-Directed group (Comprehensive 1.15 (95 % CI 0.98-1.35), Family Healthy Lifestyle 1.17 (0.99-1.38), and Family Recreation 1.12 (0.95-1.32) rate ratios). However, when we explored the number of linkages by the categories of linkages, we found significantly more healthcare service linkages in the Comprehensive group compared to the Self-Directed group (1.27 (1.06-1.51)) and significantly more linkages with child-development services in the Family Healthy Lifestyle group compared to the Self-Directed group (3.27 (1.59-6.74)). The monthly hours of direct intervention was much lower than the assigned number of hours (ranging from 5 to 32 % of the assigned hours).ConclusionsOur findings are relevant to two challenges faced by policymakers and funders. First, if funds are to be expended on service-integration approaches, then, given the lack of intervention fidelity found in this study, policymakers need to insist, and therefore fund a) a well-described practice, b) auditing of that practice, c) retention of family participants, and d) examination of family use and outcomes. Second, if child-development services are widely required and are difficult for low-income families to access, then current policy needs to be examined.Trial registrationClinicalTrials.gov, NCT00705328 . Registered on 24 June 2008.

Project description:INTRODUCTION:Low-income and middle-income settings like India have large treatment gaps in mental healthcare. People with severe mental disorders face impediments to their clinical and functional recovery, and have large unmet needs. The infrastructure and standards of care are poor in colonial period psychiatric hospitals, with no clear pathways to discharge and successfully integrate recovered individuals into the community. Our aim is to study the impact of psychiatric hospital reform on individual patient outcomes in a psychiatric hospital in India. METHODS AND ANALYSIS:Structured Individualised inTervention And Recovery (SITAR) is a two-arm pragmatic randomised controlled trial, focusing on patients aged 18-60 years with a hospital stay of 12-120 months and a primary diagnosis of psychosis. It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life. A computer-generated permuted block randomisation schedule will allocate recruited subjects to the two study arms. We aim to recruit 100 people into each trial arm. Baseline and outcome measures will be undertaken by trained researchers independent to the case managers providing the individual intervention. A health economic analysis will determine the costing of implementing the individually tailored recovery plan. ETHICS AND DISSEMINATION:The study will provide answers to important questions around the nature and process of reforms in institutional care that promote recovery while being cognizant of protecting human rights, and dignity. Ethical approval for SITAR was obtained from a registered ethics committee in India (Institutional Ethics Committee VikasAnvesh Foundation, VAF/2018-19/012 dated 6 December 2018) and the University of Warwick's Biomedical and Scientific Research Ethics Committee (REGO-2019-2332, dated 21 March 2019), and registered on the Central Trial Registry of India (CTRI/2019/01/017267). Trial results will be published in accordance to CONSORT guidelines.

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A randomised safety promotion intervention trial among low-income families with toddlers.

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A randomised safety promotion intervention trial among low-income families with toddlers.

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