scholarly journals Social Stories™ to alleviate challenging behaviour and social difficulties exhibited by children with autism spectrum disorder in mainstream schools: design of a manualised training toolkit and feasibility study for a cluster randomised controlled trial with nested qualitative and cost-effectiveness components

2016 ◽  
Vol 20 (6) ◽  
pp. 1-258 ◽  
Author(s):  
Barry Wright ◽  
David Marshall ◽  
Joy Adamson ◽  
Hannah Ainsworth ◽  
Shehzad Ali ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Feasibility Study ◽  
Single Case ◽  
Controlled Trial ◽  
Social Stories ◽  
Autism Spectrum ◽  
Feasibility Trial ◽  
Social Difficulties ◽  
Single Case Designs ◽  
Randomised Controlled

BackgroundA Social Story™ (Carol Gray) is a child-friendly intervention that is used to give children with autism spectrum disorders (ASDs) social information in situations where they have social difficulties. Limited evidence mainly using single-case designs suggests that they can reduce anxiety and challenging behaviour.ObjectivesThe objectives were to conduct a systematic review, use this to develop a manualised intervention and run a feasibility trial to inform a fully powered randomised controlled trial (RCT) on their clinical effectiveness and cost-effectiveness in schools.DesignThis is a three-stage study following the Medical Research Council framework for complex interventions. Specifically, it involved a theoretical phase, a qualitative stage and a feasibility trial stage.SettingQualitative interviews and focus groups took place in Child and Adolescent Mental Health Service and primary care settings. The feasibility study took place in 37 local mainstream schools.ParticipantsFifty children (aged 5–15 years) in mainstream school settings with a diagnosis of ASD were entered into the trial. For each child, an associated teacher and parent was also recruited.InterventionsThe intervention was a goal-setting session followed by a manualised toolkit (including a training session) for creating Social Stories™ for use with school-aged children. The comparator treatment was a goal-setting session followed by an attention control. Both arms received treatment as usual.Main outcome measuresOutcomes tested as part of the feasibility study included child- and proxy-completed questionnaires for mental health, quality of life and goal-based outcome measures. Adults additionally completed behaviour diaries and the parental stress index.ResultsThe review found that the research into social stories is predominantly based in the USA, carried out in under-12-year-olds and using single-case designs. Most studies either did not follow established Social Story criteria or did not report if they did. The assessment of effectiveness presents a largely positive picture but is limited by methodological issues. There were no adequate RCTs and insufficient information to assess a number of important sources of potential bias in most studies. A manualised intervention was produced using an iterative process between user focus groups and a writing team, and assessed in the feasibility study. All 50 participant groups were recruited within the study time frame. Two outcome measures, the Social Responsiveness Scale-2 and the custom-made goal-based measure, showed high levels of completion rates and appeared to be capturing social and behaviour skills targeted by the use of Social Stories. Detailed recommendations for a full trial are provided.LimitationsBlinding of participants was not feasible. Treatment fidelity was not assessed because of low levels of story return rates.ConclusionsThe study showed that a fully powered RCT is feasible with an extended geographical footprint. A large amount of data and information has helped to inform the design of this RCT, which will be the subject of a future research grant application. Future work could focus on developing an appropriate blinded outcome measure for this population.Study registrationThis study is registered as PROSPERO CRD42011001440.Trial registrationCurrent Controlled Trials ISRCTN96286707.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 6. See the NIHR Journals Library website for further project information.

scholarly journals Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019142 ◽  
Author(s):  
Kate Jolly ◽  
Jenny Ingram ◽  
Joanne Clarke ◽  
Debbie Johnson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Feasibility Study ◽  
Breast Feeding ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Study Results ◽  
Service Staff ◽  
Before And After ◽  
Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

scholarly journals A randomised controlled feasibility trial of music-assisted language telehealth intervention for minimally verbal autistic children—the MAP study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Tim I. Williams ◽  
Tom Loucas ◽  
Jacqueline Sin ◽  
Mirjana Jeremic ◽  
Georgia Aslett ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Educational Interventions ◽  
Autism Spectrum ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Language Therapy ◽  
Minimally Verbal ◽  
Children With Asd ◽  
Wide Range ◽  
Randomised Controlled

Abstract Background About 30% of children with autism spectrum disorder (ASD) do not develop functional speech and remain non-verbal or minimally verbal even after years of speech, language and educational interventions. A wide range of interventions have been developed for improving communication in ASD, but none have proved effective in eliciting functional language in ASD children. Research has found that people with ASD are more likely to have perfect pitch and prefer music to language. Further, it seems that language delay tends to co-occur with better musical skills. Brain imaging research has found that music alongside words increases the attention that people with ASD pay to spoken words. Methods In this protocol, we describe our music-assisted programmes (MAP) that will use music to attract the attention of people with ASD to speech. MAP may open the brain pathways to language and therefore help improve communication skills for people with ASD more than standard communication protocols. In particular, we aim to develop and test whether individualised, easily used MAP would increase spoken language in 24–60-month-old, nonverbal or minimally verbal children with ASD. We will develop a structured training method, delivered through naturalistic, interactive activities (e.g. songs) to teach language to ASD children. We will test this by comparing two groups: one undertaking music-assisted programmes, and the other receiving speech and language therapy in the way that is recommended in NHS clinics. Participants will be allocated to groups randomly. The feasibility of MAP will be assessed through estimations of recruitment and retention rates, the sensitivity and reliability of the outcome measures, the intensity and frequency of the trial, the usability of the MAP app (beta version), and the burden of the assessments for the children and parents. Discussion This feasibility randomised controlled trial will establish the acceptability and estimate the power of the MAP intervention to improve early word learning in children with ASD. In the longer term, this research will help us develop an app for parents or carers of children with ASD to design their own songs and implement their own individualised MAP. Trial registration ISRCTN, ISRCTN12536062. Registered on 26 June 2019.

scholarly journals SAFE, a new therapeutic intervention for families of children with autism: a randomised controlled feasibility trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038411
Author(s):  
Rebecca McKenzie ◽  
Rudi Dallos ◽  
Jacqui Stedmon ◽  
Helen Hancocks ◽  
Patricia Jane Vickery ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Controlled Trial ◽  
Children With Autism ◽  
Primary Outcome Measure ◽  
Positive Change ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Recommended Care ◽  
Related Family ◽  
Randomised Controlled

ObjectivesTo establish the feasibility of a definitive randomised controlled trial of Systemic Autism-related Family Enabling (SAFE), an intervention for families of children with autism.DesignA randomised, controlled, multicentred feasibility study.SettingParticipants were identified from three National Health Service (NHS) diagnosing centres in Plymouth and Cornwall and a community pathway.Participants34 families of a child with a diagnosis of autism severity level 1 or 2 between 3 and 16 years. Four families were lost to follow-up.InterventionsSAFE is a manualised five-session family therapy-based intervention delivered over 16 weeks and designed for families of children with autism. SAFE involves families attending five 3-hour sessions led by systemic practitioners.Primary and secondary outcome measuresThe proposed primary outcome measure was the Systemic CORE 15 (SCORE-15). Proposed secondary outcome measures: Patient Health Questionnaire-Somatic Anxiety Depressive Symptoms, the Coding of Attachment-Related Parenting for use with children with Autism, the Child Behaviour Checklist (CBCL), the Reflective Functioning Questionnaire (RFQ) and the Caregiving Helplessness Questionnaire. Outcome measures were collected at baseline and 24 weeks post randomisation.ResultsAll primary caregivers retained in the study completed the SCORE-15 at both time points. 34 of the target of 36 families were recruited and 88% of families were retained. Training for therapists was effective. Feedback revealed willingness to undergo randomisation. There was 100% attendance at appropriate sessions for core family members. The SCORE-15 showed reduction in scores for families receiving SAFE compared with controls suggesting positive change. Qualitative data also revealed that families found the study acceptable and families receiving SAFE experienced positive change. Feedback indicated that the SCORE-15 should be retained as a primary measure in a future trial, but secondary measures should be reduced.ConclusionsThis study indicates that a larger trial of SAFE is feasible. Findings suggest that SAFE can address current gaps in recommended care, can be confidently delivered by NHS staff and has potential as a beneficial treatment.Trial registration numbersISCTRN83964946 and IRAS213527.

scholarly journals Effectiveness of Educational Module of Autism Spectrum Disorder (EMASD) in Identifying Children with ASD among preschool teachers: A Study Protocol for Parallel Cluster-Randomized Controlled Trial feasibility study

2021 ◽  
Author(s):  
Sahar Mohammed Taresh ◽  
Nor Aniza Ahmad ◽  
Samsilah Roslan ◽  
Aini Marina Ma'rof ◽  
sumaia mohammed Zaid
Keyword(s):  
Autism Spectrum Disorder ◽  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Preschool Teachers ◽  
Controlled Trial ◽  
Autism Spectrum ◽  
Spectrum Disorder ◽  
Educational Module ◽  
Children With Asd ◽  
Randomised Controlled

Abstract Background: Increasing efforts have been focused on providing a quality education for children with Autism Spectrum Disorder (ASD) after identifying them at an early stage. Preschool teachers play a major role in the main ASD identification system as they represent the gatekeepers to identify and refer any children suspected of ASD to specialists. However, there is little literature available on the ability of preschool teachers of their perception regarding this role.Aim: The main objective of this study is to evaluate the feasibility and acceptability of an educational module to identify children with ASD (EMASD). The second objective is to assess the initial impact of the EMASD on improving preschool teacher’s ability to identify children with ASD in a normal school.Method: This pilot study will examine the feasibility of the randomised controlled trial (RCT) using EMASD as an intervention. The intervention will be ten weekly group-based sessions designed to improve the knowledge, belief, identification skills, and self-efficacy to identify children with ASD among Yemeni preschool teachers. The teachers will be randomly assigned to the intervention group that will receive the EMASD and the control group without any intervention. The feasibility will be determined based on the effectiveness as measured by questionnaires and open-ended questions. General linear measurement (GLM) will be used to compare the outcome scores in the questionnaire between the two groups and within the group whereas thematic analysis will be used to analyse the open-ended questions. Expected outcomes: The findings from this study will give critical empirical data about the feasibility of EMASD.Discussion: EMASD has the potential to increase the ability of preschool teachers to detect children with ASD. The findings from the feasibility study will be utilised to improve the research protocol of the randomised controlled trial and to ensure a better design of an intervention for a larger powered trial in the future.

Sign in / Sign up

Export Citation Format

Share Document