Randomised controlled trial of improvisational music therapy's effectiveness for children with autism spectrum disorders (TIME-A): study protocol Systematic instruction for individuals with acquired brain injury: Results of a randomised controlled trial Teaching emotion recognition skills to young children with autism: a randomised controlled trial of an emotion training programme. Designing theoretically-informed implementation interventions Effects and Moderators of a Short Theory of Mind Intervention for Children with Autism Spectrum Disorder: A Randomized Controlled Trial Using high quality clinical databases to complement the results of randomised controlled trials: the case of recombinant human activated protein C The Social Communication Intervention Project: a randomized controlled trial of the effectiveness of speech and language therapy for school-age children who have pragmatic and social communication problems with or without autism spectrum disorder. A systematic review of peer-mediated interventions for children with autism spectrum disorder. ‘Everyday Memory’ Impairments in Autism Spectrum Disorders Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions Developmental Profiles of Infants and Toddlers with Autism Spectrum Disorders Identified Prospectively in a Community-Based Setting Parent-Implemented Social Intervention for Toddlers With Autism: An RCT Measuring child social communication across contexts: Similarities and differences across play and snack routines A Randomised Controlled Trial of an Information Communication Technology Delivered Intervention for Children with Autism Spectrum Disorder Living in Regional Australia Training phonological awareness skills in children with Down syndrome. Supplementing clinic-based skills training with manual-based community support sessions: effects on social adjustment of patients with schizophrenia. TEACCH-based group social skills training for children with high-functioning autism: a pilot randomized controlled trial Research designs for studies evaluating the effectiveness of change and improvement strategies Effectiveness of simulation on health profession students' knowledge, skills, confidence and satisfaction The General Practitioner-Pharmacist Collaboration (GPPC) study: a randomised controlled trial of clinical medication reviews in community pharmacy. Learning through interaction in children with autism: Preliminary data from asocial-communication-based intervention Increasing physical activity among young children from disadvantaged communities: study protocol of a group randomised controlled effectiveness trial Behavioral manifestations of autism in the first year of life
Background Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication . However , generalisability of previous findings has been restricted , as studies were limited in either method ological accuracy or the clinical relevance of their approach . The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders . An additional aim of the study is to examine if variation in dose of treatment ( i.e. , number of music therapy sessions per week ) affects outcome of therapy , and to determine cost-effectiveness . Methods / Design Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be r and omly assigned to one of three conditions . Parents of all participants will receive three sessions of parent counselling ( at 0 , 2 , and 5 months ) . In addition , children r and omised to the two intervention groups will be offered individual , improvisational music therapy over a period of five months , either one session ( low-intensity ) or three sessions ( high-intensity ) per week . Generalised effects of music therapy will be measured using st and ardised scales completed by blinded assessors ( Autism Diagnostic Observation Schedule , ADOS ) and parents ( Social Responsiveness Scale , SRS ) before and 2 , 5 , and 12 months after r and omisation . Cost effectiveness will be calculated as man years . A group sequential design with first interim look at N = 235 will ensure both power and efficiency . Discussion Responding to the need for more rigorously design ed trials examining the effectiveness of music therapy in autism spectrum disorders , this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice . Addressing the issue of dose variation , this study 's results will also provide information on the relevance of session frequency for therapy outcome .Trial Registration Current Controlled Trials IS RCT N78923965 The goal of this study was to evaluate experimentally systematic instruction compared with trial- and -error learning ( conventional instruction ) applied to assistive technology for cognition ( ATC ) , in a double-blind , pre-test – post-test , r and omised controlled trial . Twenty-nine persons with moderate – severe cognitive impairments due to acquired brain injury ( 15 in systematic instruction group ; 14 in conventional instruction ) completed the study . Both groups received 12 , 45-minute individual training sessions targeting selected skills on the Palm Tungsten E2 personal digital assistant ( PDA ) . A criterion-based assessment of PDA skills was used to evaluate accuracy , fluency/efficiency , maintenance , and generalisation of skills . There were no significant differences between groups at immediate post-test with regard to accuracy and fluency . However , significant differences emerged at 30-day follow-up in favour of systematic instruction . Furthermore , systematic instruction participants performed significantly better at immediate post-test generalising trained PDA skills when interacting with people other than the instructor . These results demonstrate that systematic instruction applied to ATC results in better skill maintenance and generalisation than trial- and -error learning for individuals with moderate – severe cognitive impairments due to acquired brain injury . Implication s , study limitations , and directions for future research are discussed BACKGROUND Children with autism have difficulties in emotion recognition and a number of interventions have been design ed to target these problems . However , few emotion training interventions have been trialled with young children with autism and co-morbid ID . This study aim ed to evaluate the efficacy of an emotion training programme for a group of young children with autism with a range of intellectual ability . METHODS Participants were 55 children with autistic disorder , aged 4 - 7 years ( FSIQ 42 - 107 ) . Children were r and omly assigned to an intervention ( n = 28 ) or control group ( n = 27 ) . Participants in the intervention group watched a DVD design ed to teach emotion recognition skills to children with autism  ( the Transporters ) , whereas the control group watched a DVD of Thomas the Tank Engine . Participants were assessed on their ability to complete basic emotion recognition tasks , mindreading and theory of mind ( TOM ) tasks before and after the 4-week intervention period , and at 3-month follow-up . RESULTS Analyses controlled for the effect of chronological age , verbal intelligence , gender and DVD viewing time on outcomes . Children in the intervention group showed improved performance in the recognition of anger compared with the control group , with few improvements maintained at 3-month follow-up . There was no generalisation of skills to TOM or social skills . CONCLUSIONS The Transporters programme showed limited efficacy in teaching basic emotion recognition skills to young children with autism with a lower range of cognitive ability . Improvements were limited to the recognition of expressions of anger , with poor maintenance of these skills at follow-up . These findings provide limited support for the efficacy of the Transporters programme for young children with autism of a lower cognitive range Clinical and health services research is continually producing new findings that may contribute to effective and efficient patient care . However , the transfer of research findings into practice is unpredictable and can be a slow and haphazard process . Ideally , the choice of implementation strategies would be based upon evidence from r and omised controlled trials or systematic review s of a given implementation strategy . Unfortunately , review s of implementation strategies consistently report effectiveness some , but not all of the time ; possible causes of this variation are seldom reported or measured by the investigators in the original studies . Thus , any attempts to extrapolate from study setting s to the real world are hampered by a lack of underst and ing of the effects of key elements of individuals , interventions , and the setting s in which they were trialled . The explicit use of theory offers a way of addressing these issues and has a number of advantages , such as providing : a generalisable framework within which to represent the dimensions that implementation studies address , a process by which to inform the development and delivery of interventions , a guide when evaluating , and a way to allow for an exploration of potential causal mechanisms . However , the use of theory in design ing implementation interventions is method ologically challenging for a number of reasons , including choosing between theories and faithfully translating theoretical constructs into interventions . The explicit use of theory offers potential advantages in terms of facilitating a better underst and ing of the generalisability and replicability of implementation interventions . However , this is a relatively unexplored method ological area Limited perspective taking or “ Theory of Mind ” ( ToM ) abilities are a core deficit of autism , and many interventions are aim ed to improve ToM abilities . In this study , we investigated the effectiveness of a ToM treatment for children with autism spectrum disorders ( ASD ) and , for the first time , the moderating roles of social interaction style ( SIS ) and disruptive behavior ( DB ) , to determine which children are most likely to respond to this intervention . The trial protocol is registered at www.trialregister.nl , trial number 2327 and published before the data collection was finished ( www.trialsjournal.com ) . Children with autism aged 7–12 years ( n = 97 ) were r and omized over a waitlist control or a treatment condition . Outcome measures included ToM and emotion underst and ing , parent and teacher question naires on children 's social skills , ToM‐related social behavior , and autistic traits . Six‐month follow‐up parent reported data were collected for the treatment group . The treatment had a positive effect on ToM underst and ing , parent‐reported ToM behavior , and autistic traits , but not on parent or teacher‐reported social behavior . Passive SIS was associated with diminished treatment effects on autistic traits , but DB was unrelated to outcomes . The ToM intervention  improved conceptual social underst and ing and ToM‐related behavior of children with ASD . However , broader application of learned skills to other domains of functioning was limited . Individual differences with regard to treatment response are discussed . Autism Res 2015 , 8 : 738–748 . © 2015 International Society for Autism Research , Wiley Periodicals , Underst and ing the generalisability ( or applicability ) of the results of r and omised controlled trials in typical clinical practice remains one of the key method ological challenges to achieving a more scientific basis for health care.1 Little effort is made to use a scientific approach to assess generalisability , document the use of a new intervention systematic ally , or determine whether the trials ' results are replicated in real life , either in the original patient groups studied or in other patients who receive the intervention . To explore these issues , we use a case study to describe the practical difficulties that exist for policymakers and clinicians in interpreting the results of a r and omised controlled trial evaluating recombinant human activated protein C , a new drug for treating severe sepsis in intensive care patients . We suggest how an existing , high quality , clinical data base could provide information on the generalisability of the trial results and on the likely financial consequences of the drug 's introduction , and how it could be used to monitor the diffusion and effectiveness of the drug in typical clinical practice . # # # # Summary points R and omised controlled trials may be performed in atypical setting s with atypical patients , making it difficult to assess the generalisability of the results High quality clinical data bases could be used to facilitate this assessment and to provide evidence of clinical effectiveness in typical clinical practice The case for using a high quality clinical data base in the assessment of recombinant human activated protein C , a new drug for treating severe sepsis in intensive care patients , provides an important topical example Evidence based medicine has focused on underst and ing the factors affecting the internal validity of r and omised controlled trials but has paid far less attention to their generalisability . This is reflected in the many instruments for assessing the quality of trials , which concentrate predominantly on identifying factors that may challenge internal BACKGROUND Children who show disproportionate difficulty with the pragmatic as compared with the structural aspects of language are described as having pragmatic language impairment ( PLI ) or social communication disorder ( SCD ) . Some children who have PLI also show mild social impairments associated with high-functioning autism or autism spectrum disorder ( ASD ) . There is little robust evidence of effectiveness of speech- language interventions which target the language , pragmatic or social communication needs of these children . AIMS To evaluate the effectiveness of an intensive manualized social communication intervention ( SCIP ) for children who have PLI with or without features of ASD . METHODS & PROCEDURES In a single-blind RCT design , 88 children with pragmatic and social communication needs aged 5;11 - 10;8 , recruited from UK speech and language therapy services , were r and omly assigned in a 2:1 ratio to SCIP or to treatment-as-usual . Children in the  SCIP  condition received up to 20 sessions of direct intervention from a specialist research speech and language therapist working with supervised assistants . All therapy content and methodology was derived from an intervention manual . A primary outcome measure of structural language and secondary outcome measures of narrative , parent-reported pragmatic functioning and social communication , blind-rated perceptions of conversational competence and teacher-reported ratings of classroom learning skills were taken pre-intervention , immediately post-intervention and at 6-month follow-up . Analysis was by intention to treat . OUTCOMES & RESULTS No significant treatment effect was found for the primary outcome measure of structural language ability or for a measure of narrative ability . Significant treatment effects were found for blind-rated perceptions of conversational competence , for parent-reported measures of pragmatic functioning and social communication , and for teacher-reported ratings of classroom learning skills . CONCLUSIONS & IMPLICATION S There is some evidence of an intervention effect on blind and parent/teacher-reported communication outcomes , but not st and ardized language assessment outcomes , for 6 - 11-year-old children who have pragmatic and social communication needs . These findings are discussed in the context of the increasingly central role of service user outcomes in providing evidence for an intervention . The substantial overlap between the presence of PLI and ASD ( 75 % ) across the whole cohort suggests that the intervention may also be applicable to some verbally able children with ASD who have pragmatic communication needs BACKGROUND Peer mediated intervention ( PMI ) is a promising practice used to increase social skills in children with autism spectrum disorder ( ASD ) .  PMIs engage typically developing peers as social models to improve social initiations , responses , and interactions . METHOD The current study is a systematic review examining PMIs for children and adolescents with ASD conducted using group design s. Five studies met the pre-specified review inclusion criteria : four r and omized controlled trials and one pre- and post-test design . RESULTS Four of the studies were conducted in school setting s , whereas one study was conducted in a camp setting . The studies all reported that participants improved in social skills ( e.g. , social initiations , social responses , social communication ) post intervention . Additionally , sustainment , generalization , and fidelity of implementation were examined . CONCLUSION PMI is a promising approach to address social skills in children with ASD , and this approach can be conducted in meaningful real-word context s , such as schools . Limitations of the studies as well as future directions are discussed Abstract ‘ Everyday memory ’ is conceptualised as memory within the context of day-to-day life and , despite its functional relevance , has been little studied in individuals with autism spectrum disorders ( ASDs ) . In the first study of its kind , 94 adolescents with an ASD and 55 without an ASD completed measures of everyday memory  from the Rivermead Behavioural Memory Test ( RBMT ) and a st and ard word recall task ( Children ’s Auditory Verbal Learning Test-2 : CAVLT-2 ) . The ASD group showed significant impairments on the RBMT  , including in prospect i ve memory , alongside impaired performance on the CAVLT-2 . Social and communication ability was significantly associated with prospect i ve remembering in an everyday memory context but not with the CAVLT-2 . The complex nature of everyday memory and its relevance to ASD is discussed Background A number of single case reports have suggested that the context within which intervention studies take place may challenge the assumptions that underpin r and omised controlled trials ( RCTs ) . However , the diverse ways in which context may challenge the central tenets of the RCT , and the degree to which this information is known to research ers or subsequently reported , has received much less attention . In this paper , we explore these issues by focusing on seven RCTs of interventions varying in type and degree of complexity , and across diverse context s. Methods This in-depth multiple case study using interviews , focus groups and documentary analysis was conducted in two phases . In phase one , a RCT of a nurse-led intervention  provided a single exploratory case and informed the design , sampling and data collection within the main study . Phase two consisted of a multiple explanatory case study covering a spectrum of trials of different types of complex intervention . A total of eighty-four data sources across the seven trials were accessed . Results We present consistent empirical evidence across all trials to indicate that four key elements of context ( personal , organisational , trial and problem context ) are crucial to underst and ing how a complex intervention works and to enable both assessment s of internal validity and likely generalisability to other setting s. The ways in which context challenged trial operation was often complex , idiosyncratic , and subtle ; often falling outside of current trial reporting formats . However , information on such issues appeared to be available via first h and ‘ insider accounts ’ of each trial suggesting that improved reporting on the role of context is possible . Conclusions Sufficient detail about context needs to be understood and reported in RCTs of complex interventions , in order for the transferability of complex interventions to be assessed . Improved reporting formats that require and encourage the clarification of both general and project-specific threats to the likely internal and external validity need to be developed . In addition , a cultural change is required in which the open and honest reporting of such issues is seen as an indicator of study strength and research er integrity , rather than a symbol of a poor quality study or investigator ability This prospect i ve , longitudinal , study charted the developmental profiles of young children with Autism Spectrum Disorders ( ASD ) identified through routine developmental surveillance . 109 children with Autistic Disorder ( AD ) , ‘ broader ’ ASD , and developmental and /or language delays ( DD/LD ) were assessed using the Mullen Scales of Early Learning ( MSEL ) at 12-months ( n = 10 assessment s ) , 18-months ( n = 45 assessment s ) , and 24-months ( n = 99 assessment s ) . The children with AD performed most poorly , overall , than the ASD and DD/LD groups on the MSEL . Furthermore , the children with AD/ASD displayed an uneven cognitive profile , with poorer performance on verbal ( particularly receptive language ) relative to nonverbal skills . There was also evidence of developmental slowing in verbal skills from 18- to 24-months for children on the spectrum , especially those with AD . Given that the poor receptive , relative to expressive , language profile emerges very early in life for children with AD/ASD , this cognitive profile may serve as an additional red flag to social attention and communication deficits . Receptive language should therefore be stringently monitored in any developmental surveillance program for autism spectrum disorders in the second year of life OBJECTIVES : To compare the effects of two 9-month  parent-implemented interventions within the Early Social Interaction ( ESI ) Project . Both individual-ESI , offered 2 or 3 times per week at home or in the community , and group-ESI , offered once per week in a clinic , taught parents how to embed strategies to support social communication throughout everyday activities . METHODS : Participants in the r and omized controlled trial included 82 children diagnosed with autism spectrum disorder at 16 to 20 months . Children were matched on pretreatment nonverbal developmental level and pairs were r and omly assigned to treatment condition . Child outcomes included measures of social communication , autism symptoms , adaptive behavior , and developmental level . Child outcomes are reported from baseline to the end of the 9-month interventions . RESULTS : Children in individual-ESI showed differential change on a st and ardized examiner-administered observational measure of social communication , as they improved at a faster rate than children in group-ESI . Individual-ESI also showed differential efficacy on a parent report measure of communication , daily living , and social skills , as they showed improvement or stability , whereas group-ESI led to worsening or no significant change on these skills . Finally , individual-ESI showed differential change on examiner-administered measures of receptive language skills , as children in individual-ESI improved significantly , whereas group-ESI showed no change . CONCLUSIONS : These findings support the efficacy of individual-ESI compared with group-ESI on child outcomes , suggesting the importance of individualized parent coaching in natural environments . The efficacy of a parent-implemented intervention using little professional time has potential for community viability , which is particularly important in light of the lack of main effects on child outcomes of most other parent-implemented interventions Improving measurement of outcomes in r and omized controlled trials of early interventions for autism spectrum disorder ( ASD ) has been identified as a priority in the field . In addition , the importance of measurement across context s has been indicated by research ers and community stakeholders alike [ Lord et al. , ; McConachie et al. , ; Schreibman et al. , ] . The Brief Observation of Social Communication Change ( BOSCC ; Grzadzinski et al. , ) , an observational rating scheme of brief play interactions , was developed to address a need for measures that are reliable , sensitive to change , and valid for use in research setting s. The goal of this study was to examine the feasibility and utility of applying the BOSCC to a new context : a home snack routine . Results suggest that rating the BOSCC on home snack routines is feasible and psychometrically sound , and captures change in child social communication behaviors . However , the utility of the BOSCC for measuring restricted and repetitive behaviors ( RRBs ) is less clear . Nonetheless , differences in RRBs across play and snack lend support for the cl aim that measurement across context s is essential . Application of the BOSCC across context s may allow research ers to obtain a more accurate estimate of intervention response and help capture context ‐specific changes in social communication . It may also provide a method for research ers to evaluate the effect of context on child social communication more broadly . Autism Res 2019 , 12 : 636–644 . © 2019 International Society for Autism Research , Wiley Periodicals , This exploratory r and omised controlled trial tested the effectiveness of a tablet-based information communication technology early intervention application to augment existing therapy with the aim of improving visual motor , imitation , language and social skills in young children with ASD who reside in regional areas . Fifty-nine participants were recruited and r and omised to either a therapy-as-usual group or intervention group . With the exception of the expressive language subscale on the Mullen Scales of Early Learning , no significant between-group differences were recorded for visual motor , imitation , receptive language and social skills of participants between baseline and post-intervention . When all participants were pooled and measured over time , improvements were shown in receptive and pragmatic language and social skills ; these gains were maintained , thus suggesting skill acquisition Increasingly , children with Down syndrome receive literacy instruction based on a phonological awareness philosophy with the expectation of acquiring functional reading skills . Previous research demonstrates that a phonological awareness based reading programme delivers excellent results in terms of literacy acquisition and improvements in speech production for children with speech and language delays . Unfortunately , little research exists to support the effectiveness of this approach for children with Down syndrome . The current research study examined using a phonological awareness based intervention programme with three children with Down syndrome ( aged 7;2 , 8;4 , and 8;10 ) . A multiple baseline across behaviours design was selected . The intervention programme focused on the key skills of alliteration detection , phoneme isolation , spelling of orthographically regular words and rhyme detection . Two tasks ( comprehension of passive structures and spatial structures ) were selected as control behaviours . Phoneme segmentation and speech intelligibility were selected to investigate generalisation of intervention targets to other related skill areas . The results indicated that the participants improved the phonological awareness skills targeted in the intervention programme . Unfortunately , no generalisation to other areas of phonological awareness was noted . In summary , the results indicate that children with Down syndrome can benefit from a  phonological awareness based approach  to literacy OBJECTIVE Although skills training is a vali date d psychosocial treatment for schizophrenia , generalization of the skills to everyday life has not been optimal . This study evaluated a behaviorally oriented method of augmenting clinic-based skills training in the community with the aim of improving opportunities , encouragement , and reinforcement for out patients to use their skills in their natural environment . METHOD Sixty-three individuals with schizophrenia were r and omly assigned to 60 weeks of clinic-based skills training alone or of clinic-based skills training supplemented with manual-based generalization sessions in the community . Patients were also r and omly assigned to receive either haloperidol or risperidone . Therapists ' fidelity to the manuals was measured . Patients ' acquisition of the skills from pre- to posttraining was evaluated . The primary outcome measures were the Social Adjustment Scale-II and the Quality of Life Scale . RESULTS Seventy-one percent of the patients completed the trial . Only six participants experienced psychotic exacerbations during the trial . There was no evidence of a differential medication effect on social functioning . Social functioning improved modestly in both psychosocial conditions over time ; participants who received augmented skills training in the community showed significantly greater and /or quicker improvements . CONCLUSIONS Given judicious and effective antipsychotic medication that limited exacerbations to less than 10 % during the trial , a wide range of out patients with schizophrenia demonstrated substantial learning of illness management and social skills in the clinic . When clinic-based skills training was augmented by in vivo training and consultation , transfer of the skills to everyday life was enhanced . These benefits were established regardless of the medications prescribed Background Although social skills training programs for people with high-functioning autism ( HFA ) are widely practice d , the st and ardization of curricula , the examination of clinical effectiveness , and the evaluation of the feasibility of future trials have yet to be done in Asian countries . To compensate for this problem , a Japanese pilot r and omized controlled trial ( RCT ) of the Treatment and Education of Autistic and Related Communication H and icapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted . Methods Eleven children with HFA , aged 5–6 years , and their mothers were r and omly assigned to the TEACCH program ( n=5 ) or a waiting-list control group ( n=6 ) . The program involved comprehensive group intervention and featured weekly 2-hour sessions , totaling 20 sessions over six months . The adaptive behaviors and social reciprocity of the children , parenting stress , and parent – child interactions were assessed using the Strengths and Difficulties Question naire ( SDQ ) , Parenting Stress Index ( PSI ) , Beck depression inventory-II ( BDI-II ) , and Interaction Rating Scale ( IRS ) . Results Through this pilot trial , the intervention and evaluation of the program has been shaped . There were no dropouts from the program and the mothers ’ satisfaction was high . The outcome measurements improved more in the program group than in the control group , with moderate effect sizes ( SDQ , 0.71 ; PSI , 0.58 ; BDI-II , 0.40 ; and IRS , 0.69 ) . This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not . Conclusion We have st and ardized the TEACCH program , confirmed the feasibility of a future trial , and successfully estimated the positive effect size . These findings will contribute to a larger trial in the future and to forthcoming systematic review s with meta-analyses . Trial registration The methods of evaluating change and improvement strategies are not well described . The design and conduct of a range of experimental and non-experimental quantitative design s are considered . Such study design s should usually be used in a context where they build on appropriate theoretical , qualitative and modelling work , particularly in the development of appropriate interventions . A range of experimental design s are discussed including single and multiple arm r and omised controlled trials and the use of more complex factorial and block design s. The impact of r and omisation at both group and individual levels and three non-experimental design s ( uncontrolled before and after , controlled before and after , and time series analysis ) are also considered . The design chosen will reflect both the needs ( and re sources ) in any particular circumstances and also the purpose of the evaluation . The general principle underlying the choice of evaluative design is , however , simple — those conducting such evaluations should use the most robust design possible to minimise bias and maximise generalisability Background Despite the recent wave of interest being shown in high‐fidelity simulators , they do not represent a new concept in healthcare education . Simulators have been a part of clinical education since the 1950s . The growth of patient simulation as a core educational tool has been driven by a number of factors . Declining inpatient population s , concerns for patient safety and advances in learning theory are forcing healthcare educators to look for alternatives to the traditional clinical encounter for skill acquisition for students . Objective The aim of this review was to identify the best available evidence on the effectiveness of using simulated learning experiences in pre‐licensure health profession education . Inclusion criteria Types of studies : This review considered any experimental or quasi‐experimental studies that addressed the effectiveness of using simulated learning experiences in pre‐licensure health profession practice . In the absence of r and omised controlled trials , other research design s were considered for inclusion , such as , but not limited to : non‐r and omised controlled trials and before‐ and ‐after studies . Types of participants : This review included participants who were pre‐licensure practitioners in nursing , medicine , and rehabilitation therapy . Types of intervention(s)/phenomena of interest : Studies that evaluated the use of human physical anatomical models with or without computer support , including whole‐body or part‐body simulators were included . Types of outcome measures Student outcomes included knowledge acquisition , skill performance , learner satisfaction , critical thinking , self‐confidence and role identity . Search strategy Using a defined search and retrieval method , the following data bases were accessed for the period 1995‐2006 : Medline , CINAHL , Embase , PsycINFO , HealthSTAR , Cochrane Data base of Systematic Review s and ERIC . Method ological quality Each paper was assessed by two independent review ers for method ological quality prior to inclusion in the review using the st and ardised critical appraisal instruments for evidence of effectiveness , developed by the Joanna Briggs Institute . Disagreements were dealt with by consultations with a third review er . Data collection Information was extracted from each paper independently by two review ers using the st and ardised data extraction tool from the Joanna Briggs Institute . Disagreements were dealt with by consultation with a third review er . Data synthesis Due to the type of design s and quality of available studies , it was not possible to pool quantitative research study results in statistical meta‐ analysis . As statistical pooling was not possible , the findings are presented in descriptive narrative form . Results Twenty‐three studies were selected for inclusion in this review including partial task trainers and high‐fidelity  human patient simulators . The results indicate that there is high learner satisfaction with using simulators to learn clinical skills . The studies demonstrated that human patient simulators which are used for teaching higher level skills , such as airway management , and physiological concepts are useful . While there are short‐term gains in knowledge and skill performance , it is evident that performance of skills over time after initial training decline . Conclusion At best , simulation can be used as an adjunct for clinical practice , not a replacement for everyday practice . Students enjoyed t he sessions and using the models purportedly makes learning easier . However , it remains unclear whether the skills learned through a simulation experience transfer into real‐world setting s. More research is needed to evaluate whether the skills acquired with this teaching methodology transfer to the practice setting such as the impact of simulation training on team function OBJECTIVES There are conflicting results in studies of pharmacists undertaking medication review s for older people . With increasing promotion and funding for ' medication review s ' there is a need for them to be st and ardised , and to determine their effectiveness and the feasibility of providing them from a community pharmacy . The objective was to determine whether involvement of community pharmacists undertaking clinical medication review s , working with general practitioners , improved medicine-related therapeutic outcomes for patients . METHODS A r and omised controlled trial was carried out in people 65 years and older on five or more prescribed medicines . Community pharmacists undertook a clinical medication review ( Comprehensive Pharmaceutical Care ) and met with the patient 's general practitioner to discuss recommendations about possible medicine changes . The patients were followed-up 3-monthly . The control group received usual care . The main outcome measures were Quality of Life ( SF-36 ) and Medication Appropriateness Index . KEY FINDINGS A total of 498 patients were enrolled in the study . The quality -of-life domains of emotional role and social functioning were significantly reduced in the intervention group compared to the control group . The Medication Appropriateness Index was significantly improved in the intervention group . Only 39 % of the 44 pharmacists who agreed to participate in the study provided adequate data , which was a limitation of the study and indicated potential barriers to the generalisability of the study . CONCLUSION Clinical medication review s in collaboration with general practitioners can have a positive effect on the Medication Appropriateness Index . However , pharmacist withdrawal from the study suggests that community pharmacy may not be an appropriate environment from which to exp and clinical medication review s in primary care The study evaluates a social-communication-based approach to autism intervention aim ed at improving the social interaction skills of children with autism spectrum disorder . We report preliminary results from an ongoing r and omized controlled trial of 51 children aged 2 years 0 months to 4 years 11 months . Participants were assigned to either a target treatment or community treatment group . Families in the target treatment group were given 2 hours of therapy and coaching each week in an intervention emphasizing social-interaction and the parent-child relationship . Children in the community treatment group received a variety of services averaging 3.9 hours per week . After 12 months , outcomes were measured to determine changes in the groups in social interaction and communication . In addition , a regression analysis was conducted to determine whether changes in social interaction skills were associated with language development . Results suggest that children in the treatment group made significantly greater gains in social interaction skills in comparison to the community treatment group , but no between-group differences were found for st and ard language assessment s. Initiation of joint attention , involvement , and severity of language delay were found to be significantly associated with improvement of language skills in children with autism . Finally caregiver skills targeted by the intervention were found to be significantly associated with changes in children ’s interaction skills Background Participation in regular physical activity ( PA ) during the early years helps children achieve healthy body weight and can substantially improve motor development , bone health , psychosocial health and cognitive development . Despite common assumptions that young children are naturally active , evidence shows that they are insufficiently active for health and developmental benefits . Exploring strategies to increase physical activity in young children is a public health and research priority . Methods Jump Start is a multi-component , multi- setting PA and gross motor skill intervention for young children aged 3–5 years in disadvantaged areas of New South Wales , Australia . The intervention will be evaluated using a two-arm , parallel group , r and omised cluster trial . The Jump Start protocol was based on Social Cognitive Theory and includes five components : a structured gross motor skill lesson ( Jump In ) ; unstructured outdoor PA and gross motor skill time ( Jump Out ) ; energy breaks ( Jump Up ) ; activities connecting movement to learning experiences ( Jump Through ) ; and a home-based family component to promote PA and gross motor skill ( Jump Home ) . Early childhood education and care centres will be demographically matched and r and omised to Jump Start ( intervention ) or usual practice ( comparison ) group . The intervention group receive Jump Start professional development , program re sources , monthly newsletters and ongoing intervention support . Outcomes include change in total PA ( accelerometers ) within centre hours , gross motor skill development ( Test of Gross Motor Development-2 ) , weight status ( body mass index ) , bone strength ( Sunlight MiniOmni Ultrasound Bone Sonometer ) , self-regulation ( Heads-Toes-Knees-Shoulders , executive function tasks , and proxy-report Temperament and Approaches to learning scales ) , and educator and parent self-efficacy . Extensive quantitative and qualitative process evaluation and a cost-effectiveness evaluation will be conducted . Discussion The Jump Start intervention is a unique program to address low levels of PA and gross motor skill proficiency , and support healthy lifestyle behaviours among young children in disadvantaged communities . If shown to be efficacious , the Jump Start approach can be expected to have implication s for early childhood education and care policies and practice s , and ultimately a positive effect on the health and development across the life course . Trial registration Australian and New Zeal and Clinical Trials Registry No : ACTRN12614000597695 , first received : June 5 , 2014 In the interest of more systematic ally documenting the early signs of autism , and of testing specific hypotheses regarding their underlying neurodevelopmental substrates , we have initiated a longitudinal study of high-risk infants , all of whom have an older sibling diagnosed with an autistic spectrum disorder . Our sample currently includes 150 infant siblings , including 65 who have been followed to age 24 months , who are the focus of this paper . We have also followed a comparison group of low-risk infants . Our measures include a novel observational scale ( the first , to our knowledge , that is design ed to assess autism-specific behavior in infants ) , a computerized visual orienting task , and st and ardized measures of temperament , cognitive and language development . Our preliminary results indicate that by 12 months of age , siblings who are later diagnosed with autism may be distinguished from other siblings and low-risk controls on the basis of : ( 1 ) several specific behavioral markers , including atypicalities in eye contact , visual tracking , disengagement of visual attention , orienting to name , imitation , social smiling , reactivity , social interest and affect , and sensory-oriented behaviors ; ( 2 ) prolonged latency to disengage visual attention ; ( 3 ) a characteristic pattern of early temperament , with marked passivity and decreased activity level at 6 months , followed by extreme distress reactions , a tendency to fixate on particular objects in the environment , and decreased expression of positive affect by 12 months ; and ( 4 ) delayed expressive and receptive language . We discuss these findings in the context of various neural networks thought to underlie neurodevelopmental abnormalities in autism , including poor visual orienting . Over time , as we are able to prospect ively study larger numbers and to examine interrelationships among both early-developing behaviors and biological indices of interest , we hope this work will advance current underst and ing of the neurodevelopmental origins of autism
The findings did not support the widely reported generalisation ' difficulties ' associated with autism .
Research ers have generally considered autistic individuals to have difficulties generalising learned skills across novel context s. Successful generalisation is necessary for an intervention to have benefits in everyday life beyond the original learning environment .
We conducted a systematic review of r and omised controlled trials of early social communication interventions for children with autism in order to explore generalisation and its measurement .