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Effectiveness of a multi-level implementation strategy for ASD interventions: study protocol for two linked cluster randomized trials.

ABSTRACT: BACKGROUND:The Centers for Disease Control (2018) estimates that 1 in 59 children has autism spectrum disorder, and the annual cost of ASD in the U.S. is estimated to be $236 billion. Evidence-based interventions have been developed and demonstrate effectiveness in improving child outcomes. However, research on generalizable methods to scale up these practices in the multiple service systems caring for these children has been limited and is critical to meet this growing public health need. This project includes two, coordinated studies testing the effectiveness of the Translating Evidence-based Interventions (EBI) for ASD: Multi-Level Implementation Strategy (TEAMS) model. TEAMS focuses on improving implementation leadership, organizational climate, and provider attitudes and motivation in order to improve two key implementation outcomes-provider training completion and intervention fidelity and subsequent child outcomes. The TEAMS Leadership Institute applies implementation leadership strategies and TEAMS Individualized Provider Strategies for training applies motivational interviewing strategies to facilitate provider and organizational behavior change. METHODS:A cluster randomized implementation/effectiveness Hybrid, type 3, trial with a dismantling design will be used to understand the effectiveness of TEAMS and the mechanisms of change across settings and participants. Study #1 will test the TEAMS model with AIM HI (An Individualized Mental Health Intervention for ASD) in publicly funded mental health services. Study #2 will test TEAMS with CPRT (Classroom Pivotal Response Teaching) in education settings. Thirty-seven mental health programs and 37 school districts will be randomized, stratified by county and study, to one of four groups (Standard Provider Training Only, Standard Provider Training + Leader Training, Enhanced Provider Training, Enhanced Provider Training + Leader Training) to test the effectiveness of combining standard, EBI-specific training with the two TEAMS modules individually and together on multiple implementation outcomes. Implementation outcomes including provider training completion, fidelity (coded by observers blind to group assignment) and child behavior change will be examined for 295 mental health providers, 295 teachers, and 590 children. DISCUSSION:This implementation intervention has the potential to increase quality of care for ASD in publicly funded settings by improving effectiveness of intervention implementation. The process and modules will be generalizable to multiple service systems, providers, and interventions, providing broad impact in community services. TRIAL REGISTRATION:This study is registered with Clinicaltrials.gov ( NCT03380078 ). Registered 20 December 2017, retrospectively registered.

SUBMITTER: Brookman-Frazee L

PROVIDER: S-EPMC5944167 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Effectiveness of a multi-level implementation strategy for ASD interventions: study protocol for two linked cluster randomized trials.

Brookman-Frazee Lauren L Stahmer Aubyn C AC

Implementation science : IS 20180509 1

<h4>Background</h4>The Centers for Disease Control (2018) estimates that 1 in 59 children has autism spectrum disorder, and the annual cost of ASD in the U.S. is estimated to be $236 billion. Evidence-based interventions have been developed and demonstrate effectiveness in improving child outcomes. However, research on generalizable methods to scale up these practices in the multiple service systems caring for these children has been limited and is critical to meet this growing public health nee ...[more]

PMID: 29743090

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Project description:The protection and promotion of breastfeeding is considered a priority in Europe where only 22% of infants less than 6 months old are exclusively breastfed. In Spain this percentage reaches 24.8% but in our city it falls to 18.26%. Various studies emphasise that the improvement of these results should be based upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify the practice of health professionals and improve results with respect to exclusively or predominatly breastfed children at 6 months of age.This study involves a community based cluster randomized trial in primary healthcare centres in Leganés (Madrid, Spain). The project aims to determine whether the use of an implementation strategy (including training session, information distribution, opinion leader) of a breastfeeding guideline in primary care is more effective than usual diffusion. The number of patients required will be 240 (120 in each arm). It will be included all the mothers of infants born during the study period (6 months) who come to the health centre on the first visit of the child care programme and who give their consent to participate. The main outcome variable is the exclusive o predominant breastfeeding at 6 moths of age..Main effectiveness will be analyzed by comparing the percentage of infants with exclusive or predominant breastfeeding at 6 months between the intervention group and the control group. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.Strategies need to be found which facilitate the giving of effective advice on breastfeeding by professionals and which provide support to women during the breastfeeding period. By applying the guide's recommendations, clinical variability can be reduced and the care received by patients can be improved.The trial was registered with ClinicalTrials.gov, number NCT01474096.

Project description:Youth with autism spectrum disorder (ASD) have high rates of co-occurring mental health needs that necessitate mental health interventions. Given the unique clinical characteristics of youth with ASD, there have been significant efforts to adapt and test mental health interventions for this population. Yet, characterization of the nature and types of interventions adaptations is limited, especially across the wide range of interventions tested for youth with ASD with a focus on implementation factors. Additionally, understanding how these interventions may be implemented in community services is limited. The aims of this systematic review are to characterize the (1) types of interventions tested for co-occurring mental health conditions for youth with ASD; (2) adaptations to mental health interventions for use with youth with ASD; and (3) implementation strategies, outcomes, and determinants of mental health interventions to inform their translation to community service settings. Eighty-three articles testing interventions targeting mental health symptoms in youth with ASD that included implementation factors in analyses were reviewed. The Stirman et al. (2013; 2019) FRAME adaptation, Powell et al. (2012;2015) implementation strategies, and Proctor et al. (2011) implementation outcomes taxonomies were applied to characterize the nature and types of adaptations for use with youth with ASD and types of implementation strategies, outcomes, and determinants used, when available, respectively. Of the interventions examined, the majority (64.1%) were originally designed to target youth mental health concerns and were then adapted to be used with ASD. The most common adaptations included those to the intervention content, particularly adding elements with tailoring or refining aspects of the intervention while maintaining core functions. Half of the articles described at least one implementation strategy used during intervention testing. Fidelity and acceptability were the most frequently examined implementation outcomes, with some examination of appropriateness and feasibility. Nineteen percent of articles described implementation determinants (i.e. barriers/facilitators) of these implementation outcomes. The common adaptations for ASD provide direction for future intervention development and for training community therapists. Further examination, specification, and reporting of implementation strategies and outcomes within ongoing efforts to adapt and interventions to meet the co-occurring mental health needs of youth ASD are needed to facilitate their translation to community settings. Areas for future research as well as clinical implications are discussed.

Project description:Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

Project description:BackgroundGovernments internationally have invested hugely in the implementation and scale-up of school-based physical activity interventions, but have little evidence of how to best sustain these interventions once active implementation support ceases. This study will assess the effectiveness of a multi-strategy sustainability intervention on classroom teachers' sustainment of energisers (short 3-5 min physical activity breaks during class-time) scheduled across the school day from baseline to 12 and 24-month follow-up.MethodsA cluster randomised controlled trial will be conducted in 50 primary schools within the Hunter New England, Illawarra Shoalhaven, Murrumbidgee and Northern New South Wales (NSW) Local Health Districts of NSW Australia. Schools will be randomly allocated to receive either usual support or the multi-strategy sustainability intervention that includes: centralised technical assistance from a trained project officer; formal commitment and mandated change obtained from school principals; training in-school champions; reminders for teachers; educational materials provided to teachers; capturing and sharing local knowledge; and engagement of parents, carers and the wider school community. The primary trial outcome will be measured via a teacher logbook to determine the between-group difference in the change in mean minutes of energisers scheduled across the school day at 12 and 24-month follow-up compared to baseline. Analyses will be performed using an intention to treat framework. Linear mixed models will be used to assess intervention effects on the primary outcome at both follow-up periods.DiscussionThis study will be one of the first randomised controlled trials to examine the impact of a multi-strategy sustainability intervention to support schools' sustainment of a physical activity intervention. The proposed research will generate new evidence needed for the partnering organisations to protect their considerable investments to date in physical activity promotion in this setting and will provide seminal evidence for the field globally.Trial registrationACTRN12620000372987 version 1 registered 17th March 2020. Version 3 (current version) updated 4th August 2023.

Project description:BackgroundFor approximately one in five children who have social, emotional, and behavioral (SEB) challenges, accessible evidence-based prevention practices (EBPPs) are critical. In the USA, schools are the primary setting for children's SEB service delivery. Still, EBPPs are rarely adopted and implemented by front-line educators (e.g., teachers) with sufficient fidelity to see effects. Given that individual behavior change is ultimately required for successful implementation, focusing on individual-level processes holds promise as a parsimonious approach to enhance impact. Beliefs and Attitudes for Successful Implementation in Schools for Teachers (BASIS-T) is a pragmatic, multifaceted pre-implementation strategy targeting volitional and motivational mechanisms of educators' behavior change to enhance implementation and student SEB outcomes. This study protocol describes a hybrid type 3 effectiveness-implementation trial designed to evaluate the main effects, mediators, and moderators of the BASIS-T implementation strategy as applied to Positive Greetings at the Door, a universal school-based EBPP previously demonstrated to reduce student disruptive behavior and increase academic engagement.MethodsThis project uses a blocked randomized cohort design with an active comparison control (ACC) condition. We will recruit and include approximately 276 teachers from 46 schools randomly assigned to BASIS-T or ACC conditions. Aim 1 will evaluate the main effects of BASIS-T on proximal implementation mechanisms (attitudes, subjective norms, self-efficacy, intentions to implement, and maintenance self-efficacy), implementation outcomes (adoption, reach, fidelity, and sustainment), and child outcomes (SEB, attendance, discipline, achievement). Aim 2 will examine how, for whom, under what conditions, and how efficiently BASIS-T works, specifically by testing whether the effects of BASIS-T on child outcomes are (a) mediated via its putative mechanisms of behavior change, (b) moderated by teacher factors or school contextual factors, and (c) cost-effective.DiscussionThis study will provide a rigorous test of BASIS-T-a pragmatic, theory-driven, and generalizable implementation strategy designed to target theoretically-derived motivational mechanisms-to increase the yield of standard EBPP training and support strategies.Trial registrationClinicalTrials.gov ID: NCT05989568. Registered on May 30, 2023.

Project description:BackgroundTo overcome the three delays in triage, transport and treatment that underlie adverse pregnancy outcomes, we aimed to reduce all-cause adverse outcomes with community-level interventions targeting women with pregnancy hypertension in three low-income countries.MethodsIn this individual participant-level meta-analysis, we de-identified and pooled data from the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trials in Mozambique, Pakistan, and India, which were run in 2014-17. Consenting pregnant women, aged 12-49 years, were recruited in their homes. Clusters, defined by local administrative units, were randomly assigned (1:1) to intervention or control groups. The control groups continued local standard of care. The intervention comprised community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension. For this meta-analysis, as for the original studies, the primary outcome was a composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby), assessed by unmasked trial surveillance personnel. For this analysis, we included all consenting participants who were followed up with completed pregnancies at trial end. We analysed the outcome data with multilevel modelling and present data with the summary statistic of adjusted odds ratios (ORs) with 95% CIs (fixed effects for maternal age, parity, maternal education, and random effects for country and cluster). This meta-analysis is registered with PROSPERO, CRD42018102564.FindingsOverall, 44 clusters (69 330 pregnant women) were randomly assigned to intervention (22 clusters [36 008 pregnancies]) or control (22 clusters [33 322 pregnancies]) groups. 32 290 (89·7%) pregnancies in the intervention group and 29 698 (89·1%) in the control group were followed up successfully. Median maternal age of included women was 26 years (IQR 22-30). In the intervention clusters, 6990 group and 16 691 home-based community engagement sessions and 138 347 community health worker-led visits to 20 819 (57·8%) of 36 008 women (of whom 11 095 [53·3%] had a visit every 4 weeks) occurred. Blood pressure and dipstick proteinuria were assessed per protocol. Few women were eligible for methyldopa for severe hypertension (181 [1%] of 20 819) or intramuscular magnesium sulfate for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia). 1255 (6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral. The primary outcome was similar in the intervention (7871 [24%] of 32 290 pregnancies) and control clusters (6516 [22%] of 29 698; adjusted OR 1·17, 95% CI 0·90-1·51; p=0·24). No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.InterpretationThe CLIP intervention did not reduce adverse pregnancy outcomes. Future community-level interventions should expand the community health worker workforce, assess general (rather than condition-specific) messaging, and include health system strengthening.FundingUniversity of British Columbia, a grantee of the Bill & Melinda Gates Foundation.

Dataset Information

Effectiveness of a multi-level implementation strategy for ASD interventions: study protocol for two linked cluster randomized trials.

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Effectiveness of a multi-level implementation strategy for ASD interventions: study protocol for two linked cluster randomized trials.

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