Dataset Information

Using Play to Improve Infant Sleep: A Mixed Methods Protocol to Evaluate the Effectiveness of the Play2Sleep Intervention.

ABSTRACT: Background:One in four Canadian families struggle with infant sleep disturbances. The aim of this study is to evaluate Play2Sleep in families of infants with sleep disturbances. In addition to parental education on infant sleep, Play2Sleep uses examples from a video-recorded, structured play session with mothers and fathers separately to provide feedback on parent-infant interactions and their infant's sleep-related social cues. The quantitative phase will answer the research question: Does one dose of Play2Sleep delivered during a home visit with mothers and fathers of infants aged 5?months reduce night wakings at age 7?months? The qualitative phase will answer the research question: What are parental perceptions of family experiences, processes, and contexts related to Play2Sleep and infant sleep? The overarching mixed methods research question is as follows: How do parental perceptions of family experiences, processes, and contexts related to infant sleep explain the effectiveness of Play2Sleep? Method and analysis:An explanatory sequential mixed methods design will be used. In the quantitative phase, a randomized controlled trial and RM-ANOVA will compare night wakings in infants whose parents receive Play2Sleep versus standard public health nursing information. Sixty English-speaking families (mothers and fathers) of full-term, healthy, singleton, 5-month-old infants who perceive that their infant has sleep disturbances will be recruited. The primary outcome measure will be change in the number of night wakings reported by parents. The qualitative component will use thematic analysis of family interviews to describe parental perceptions and experiences of infant sleep. Mixed methods integration will use qualitative findings to explain quantitative results. Discussion:Play2Sleep is a novel approach that combines information about infant sleep with personalized feedback on parent-infant interactions and infant cues. Including fathers and mixed methods should capture complex family experiences of infant sleep disturbances and Play2Sleep. If effective, Play2Sleep has possible application for preventing infant sleep disturbance and tailoring for other populations. Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02742155. Registered on 2016 April 23.

SUBMITTER: Keys E

PROVIDER: S-EPMC5913340 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Using Play to Improve Infant Sleep: A Mixed Methods Protocol to Evaluate the Effectiveness of the Play2Sleep Intervention.

Keys Elizabeth E Benzies Karen M KM Kirk Valerie V Duffett-Leger Linda L

Frontiers in psychiatry 20180417

<h4>Background</h4>One in four Canadian families struggle with infant sleep disturbances. The aim of this study is to evaluate Play2Sleep in families of infants with sleep disturbances. In addition to parental education on infant sleep, Play2Sleep uses examples from a video-recorded, structured play session with mothers and fathers separately to provide feedback on parent-infant interactions and their infant's sleep-related social cues. The quantitative phase will answer the research question: D ...[more]

PMID: 29719517

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Project description:Background and purposeSeveral studies have evaluated the effects of high-intensity aerobic training (HIAT) on pain severity and quality of life (QoL) among women with primary dysmenorrhea. However, to date, no studies have evaluated the effectiveness of HIAT on academic performance or absenteeism or examined the cost-effectiveness of HIAT relative to other treatments in women with primary dysmenorrhea. Furthermore, the mechanisms underlying aerobic exercise-induced analgesia in primary dysmenorrhea remain unclear. The objectives of this study are to: (1) evaluate the effects of HIAT on absenteeism and academic performance among university students, (2) identify the underlying mechanisms associated with aerobic exercise-induced analgesia in primary dysmenorrhea, and (3) determine the cost-effectiveness of HIAT compared with a wait-list control (WLC) group receiving usual care.MethodsA sequential, embedded, mixed-methods study design, including a crossover, randomised controlled trial (RCT) and semi-structured focus groups, will be conducted alongside an economic evaluation. A total of 130 women aged 18-24 years will be randomised into either HIAT (n = 65) or wait-list control (n = 65) groups. Primary outcomes will include average pain intensity, absenteeism from university, and academic performance. Primary mediators will include salivary progesterone and prostaglandin F2α levels. Outcome and meditator variables will be assessed at baseline and post-treatment, at 12 and 28 weeks. An economic analysis will be conducted from the societal and healthcare perspective of Hong Kong. Semi-structured focus groups will be conducted at 32 weeks. Of the 130 participants included in the RCT, 70 will be included in the focus groups.Statistical analysisAll statistical analyses will be performed on an intention-to-treat basis, using SPSS (version 24). Preliminary analysis using an independent samples t-test and a two-sided, unpaired Student's t-test will be performed to exclude carryover effects and identify within-participant differences in outcome variables between the study periods, respectively. Treatment effects will be evaluated using analysis of variance via a mixed-effects model with fixed effects for intervention, period, and sequence. In all models, random effects will include the participants nested within the sequence as a sampling cluster. The mediation effects will be assessed using the Sobel test. The EQ-5D responses will be converted into utility scores to estimate the gain or loss of quality-adjusted life-years. Seemingly unrelated regression analyses will be used to estimate the total cost differences and effect differences. Qualitative data will be analysed using the process of thematic analysis.

Project description:BackgroundChronic homelessness is a problem characterised by longstanding inability to attain or maintain secure accommodation. Longitudinal research with homeless populations is challenging, and randomised controlled trials that evaluate the effectiveness of intensive, case management interventions aimed at improving housing and health-related outcomes for chronically homelessness people are scant. More research is needed to inform programmatic design and policy frameworks in this area. This study protocol details an evaluation of the Journey to Social Inclusion - Phase 2 program, an intervention designed to reduce homelessness and improve outcomes in chronically homeless adults.Methods/designJ2SI Phase 2 is a three-year, mixed methods, multi-site, RCT that enrolled 186 participants aged 25 to 50 years between 07 January 2016 and 30 September 2016 in Melbourne. The intervention group (n = 90 recruited) receives the J2SI Phase 2 program, a trauma-informed intervention that integrates intensive case management and service coordination; transition to housing and support to sustain tenancy; and support to build social connections, obtain employment and foster independence. The comparison group (n = 96 recruited) receives standard service provision. Prior to randomisation, participants completed a baseline survey. Follow-up surveys will be completed every six months for three years (six in total). In addition to self-report data on history of homelessness and housing, physical and mental health, substance use, quality of life, social connectedness and public service utilisation, linked administrative data on participants' public services utilisation (e.g., hospitalisation, justice system) will be obtained for the three-year period pre- and post-randomisation. Semi-structured, qualitative interviews will be conducted with a randomly selected subset of participants and service providers at three time-points to explore changes in key outcome variables and to examine individual experiences with the intervention and standard service provision. An economic evaluation of the intervention and associated costs will also be undertaken.DiscussionResults of this trial will provide robust evidence on the effectiveness of J2SI Phase 2 compared to standard service provision. If the intervention demonstrates effectiveness in improving housing, health, quality-of-life, and other social outcomes, it may be considered for broader national and international dissemination to improve outcomes among chronically homeless adults.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000162415 (retrospectively registered 10-February-2016).

Project description:BACKGROUND:In low-income countries such as Zambia, where maternal mortality rates are persistently high, maternity waiting homes (MWHs) represent one potential strategy to improve access to safe delivery, especially for women living in remote areas. The Maternity Homes Access in Zambia project (MAHMAZ) is evaluating the impact of a MWH model on women's access to safe delivery in rural Zambia. There is a growing need to understand not only the effectiveness of interventions but also the effectiveness of their implementation in order to appropriately interpret outcomes. There is little evidence to guide effective implementation of MWH for both immediate uptake and to promote sustainability in this context. This protocol describes a study that aims to investigate the effectiveness of the implementation of MAHMAZ by not only documenting fidelity but also identifying factors that influence implementation success and affect longer-term sustainability. METHODS:This study will use mixed methods to evaluate the implementation effectiveness and sustainability of the MAHMAZ intervention. In our study, "implementation effectiveness" means to expand beyond measuring fidelity to the MWH model and includes assessing both the adoption and uptake of the model and identifying those factors that facilitate or inhibit uptake. Sustainability is defined as the routine implementation of an intervention after external support has ended. Quantitative methods include extracting data from existing records at the MWHs and health facilities to analyze patterns of utilization, and conducting a routine health facility assessment to determine facility-level factors that may influence MWH implementation and woman-level outcomes. We will also conduct an experience survey with MWH users and apply a checklist to assess fidelity to the MWH model. Qualitative methods include in-depth interviews and focus group discussions with MWH users, community members and other stakeholders. Qualitative data will be analyzed using an integrated framework drawing constructs from the Consolidated Framework for Implementation Research and the Conceptual Framework for Sustainability. DISCUSSION:The findings from this evaluation will be shared with policymakers formulating policy affecting the implementation of MWH and may be used as evidence for programmatic decisions by the government and supporting agencies in deciding to take this model to scale. TRIAL REGISTRATION:NCT02620436, Registered 3 December 2015, Prospectively registered (clinicaltrials.gov; for the overarching quasi-experimental impact study).

Project description:IntroductionLumbar radicular syndrome (LRS) can be a painful and debilitating condition. The optimum management strategies and their timing remain elusive despite extensive research. Surgery provides good short-term outcomes but has concomitant risks and costs. Physiotherapy is commonly practised for patients with LRS but its effects remain equivocal and there is a lack of consensus on the type, duration and timing of physiotherapy intervention. There is a lack of high-quality evidence into new and innovative management strategies and the timings of those strategies for LRS. This pilot trial is an essential preliminary to a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of early physiotherapy intervention for patients with LRS. The study will test the protocol, the intervention, the use of outcome measures and the ability to set-up and run the trial to enable refinement of a future definitive RCT.Methods and analysisThis is a mixed-methods study encompassing an external pilot RCT with integrated qualitative interviews with patients, clinicians and other key stakeholders. 80 patients will be recruited from primary care and randomised, after consent into 1 of 2 groups. Both groups will receive individually tailored, goal orientated physiotherapy. The usual care group will begin their physiotherapy 6 weeks after randomisation and the intervention group at 2 weeks after randomisation. Outcome measures will primarily be feasibility parameters including the ability to recruit and retain patients and to deliver the intervention. Data will be collected at baseline, and 6, 12 and 26 weeks following randomisation.Ethics and disseminationThe study has received favourable ethical review from the East of Scotland Research Ethics Service (EoSRES) on the 20 August 2015 (15/ES/0130). Recruitment began on the 1 March 2016 and is expected to close in January 2017. Data collection is anticipated to be complete in July 2017. The study results will be made available to participants, clinicians involved in the study and the wider clinical community through publication in a peer reviewed journal and at conference presentations.Trial registration numberISRCTN: 25018352, Pre-results; Clinical Trials.Gov: NCT02618278 Document version V1.1 23.9.2016.

Project description:IntroductionMental health services are stretched in the UK and are in need of support. One approach that could improve mental health symptoms is osteopathy. Research suggests that osteopathy influences psychophysiological factors, which could lead to improvements in mental health. The first objective of this protocol is to investigate the feasibility and acceptability of four osteopathic interventions. A secondary aim is to evaluate the interventions' effectiveness for improving psychophysiological and mental health outcomes.Methods and analysisThis study will be an explanatory mixed-methods design. Participants will be 30 adults who have mild to moderate mental health symptoms and not experiencing any issues with pain. The feasibility and acceptability of the interventions will be the primary outcomes. Secondary outcomes will be physiological measures including heart rate variability, interoceptive accuracy and blood pressure. Psychological outcomes, collected preintervention and postintervention, will also be measured by five standardised questionnaires, which include: (1) the Depression, Anxiety and Stress Scale (DASS); (2) the International Positive and Negative Affect Schedule-Short-Form; (3) Acceptance and Action Questionnaire-II; (4) the Self as Context Scale and (5) and the Multidimensional Assessment of Interoceptive Awareness Version 2. Participants will be randomised to one of four intervention groups and receive a single intervention treatment session. These intervention groups are: (1) high-velocity and articulation techniques, (2) soft-tissue massage, (3) craniosacral techniques, and (4) a combination of these three approaches. Mixed design two (preintervention and postintervention) by the four interventions analysis of covariance models will be used to analyse the quantitative data for each quantitative measure. Participants will also be interviewed about their experiences of the study and interventions and a thematic analysis will be used to analyse this qualitative data. This will aid the assessment of the feasibility and acceptability of the study design.Ethics and disseminationThe protocol for this feasibility study has received ethical approval from the Department of Psychology Ethics Committee at Swansea University, ethical review reference number: 2022-5603-4810. Feasibility results from this protocol will be published in a peer review journal and presented at both national and international conferences.DiscussionThis study will assess the feasibility and acceptability of conducting osteopathic interventions for improving mental health outcomes. The results from this will help to inform the development of a future randomised controlled trial. The study will also produce original data which could provide preliminary evidence of whether osteopathic approaches are of benefit to individual's mental health in the form of effect sizes, even if they are pain-free.Trial registration numberNCT05674071.

Project description:BackgroundUniversity students are at risk for acquiring sexually transmitted infections and suffering other negative health outcomes. Sexual health services offer preventive and treatment interventions that aim to reduce these infections and associated health consequences. However, university students often delay or avoid seeking sexual health services. An in-depth understanding of the factors that influence student use of sexual health services is needed to underpin effective sexual health interventions.ObjectiveIn this study, we aim to design a behavior change intervention to address university undergraduate students' use of sexual health services at two universities in Nova Scotia, Canada.MethodsThis mixed methods study consists of three phases that follow a systematic approach to intervention design outlined in the Behaviour Change Wheel. In Phase 1, we examine patterns of sexual health service use among university students in Nova Scotia, Canada, using an existing dataset. In Phase 2, we identify the perceived barriers and enablers to students' use of sexual health services. This will include focus groups with university undergraduate students, health care providers, and university administrators using a semistructured guide, informed by the Capability, Opportunity, Motivation-Behaviour Model and Theoretical Domains Framework. In Phase 3, we identify behavior change techniques and intervention components to develop a theory-based intervention to improve students' use of sexual health services.ResultsThis study will be completed in March 2018. Results from each phase and the finalized intervention design will be reported in 2018.ConclusionsPrevious intervention research to improve university students' use of sexual health services lacks a theoretical assessment of barriers. This study will employ a mixed methods research design to examine university students' use of sexual health service and apply behavior change theory to design a theory- and evidence-based sexual health service intervention. Our approach will provide a comprehensive foundation to co-design a theory-based intervention with service users, health care providers, and administrators to improve sexual health service use among university students and ultimately improve their overall health and well-being.

Project description:BackgroundA growing body of evidence for digital interventions to improve sleep shows promising effects. The interventions investigated so far have been primarily web-based; however, app-based interventions may reach a wider audience and be more suitable for daily use.ObjectiveThis study aims to evaluate the intervention effects, adherence, and acceptance of an unguided app-based intervention for individuals who wish to improve their sleep.MethodsIn a randomized controlled trial, we evaluated the effects of an app-based short intervention (Refresh) to improve sleep compared with a waitlist condition. Refresh is an 8-week unguided intervention covering the principles of cognitive behavioral therapy for insomnia (CBT-I) and including a sleep diary. The primary outcome was sleep quality (insomnia symptoms) as self-assessed by the Regensburg Insomnia Scale (RIS). The secondary outcomes were depression (9-item Patient Health Questionnaire [PHQ-9] score) and perceived insomnia-related impairment.ResultsWe included 371 participants, of which 245 reported poor sleep at baseline. About 1 in 3 participants who were allocated to the intervention group never accessed the intervention. Active participants completed on average 4 out of 8 chapters. Retention rates were 67.4% (n=250) at postassessment and 57.7% (n=214) at the 6-month follow-up. At postintervention, insomnia symptoms in the intervention group had improved more than those in the waitlist group, with a small effect (d=0.26) in the whole sample and a medium effect (d=0.45) in the subgroup with poor sleep. Effects in the intervention group were maintained at follow-up. Perceived insomnia-related impairment also improved from pre- to postassessment. No significant intervention effect on depression was detected. Working alliance and acceptance were moderate to good.ConclusionsAn app-based, unguided intervention is a feasible and effective option to scale-up CBT-I-based treatment, but intervention uptake and adherence need to be carefully addressed.Trial registrationISRCTN Registry ISRCTN53553517; https://www.isrctn.com/ISRCTN53553517.

Project description:IntroductionPromoting healthy eating and active play in early life is critical, however few interventions have been delivered or sustained at scale. The evaluation of interventions at scale is a crucial, yet under-researched aspect of modifying population-level health behaviours. INFANT is an evidence-based early childhood healthy lifestyle intervention that aims to improve parents' knowledge and skills around promoting optimal energy balance-related behaviours that, in turn, influence children's diet, activity and adiposity. It consists of: 1) Four group sessions delivered via first time parent groups across the first 12 months of life; 2) access to the My Baby Now app from birth to 18 months of age. This research aims to assess real-world implementation, effectiveness and cost-effectiveness of INFANT when delivered at scale across Victoria, Australia.Methods and analysisA hybrid type II implementation-effectiveness trial applying a mixed methods design will be conducted. INFANT will be implemented in collaboration with practice and policy partners including maternal and child health services, population health and Aboriginal health, targeting all local government areas (n=79) in Victoria, Australia. Evaluation is based on criteria from the 'Outcomes for Implementation Research' and 'RE-AIM' frameworks. Implementation outcomes will be assessed using descriptive quantitative surveys and qualitative interviews with those involved in implementation, and include intervention reach, organisational acceptability, adoption, appropriateness, cost, feasibility, penetration and sustainability. Process measures include organizational readiness, fidelity, and adaptation. Effectiveness outcomes will be assessed using a sample of INFANT participants and a non-randomized comparison group receiving usual care (1,500 infants in each group), recruited within the same communities. Eligible participants will be first time primary caregivers of an infant aged 0-3 months, owning a personal mobile phone and able to communicate in English. Effectiveness outcomes include infant lifestyle behaviours and BMIz at 12 and 18 months of age.ImpactThis is the first known study to evaluate the scale up of an evidence based early childhood obesity prevention intervention under real world conditions. This study has the potential to provide generalisable implementation, effectiveness and cost-effectiveness evidence to inform the future scale up of public health interventions both in Australia and internationally.Clinical trial registrationAustralian and New Zealand Clinical Trial Registry https://www.anzctr.org.au/, identifier ACTRN12620000670976.

Dataset Information

Using Play to Improve Infant Sleep: A Mixed Methods Protocol to Evaluate the Effectiveness of the Play2Sleep Intervention.

Publications

Using Play to Improve Infant Sleep: A Mixed Methods Protocol to Evaluate the Effectiveness of the Play2Sleep Intervention.

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