Clinical and cost effectiveness of a parent mediated intervention to reduce challenging behaviour in pre-schoolers with moderate to severe intellectual disability (EPICC-ID) study protocol: a multi-centre, parallel-group randomised controlled trial.

BACKGROUND: Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities. METHODS: This trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual, whilst the Treatment as Usual only group receive other available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data will also be collected to carry out a cost effectiveness and utility evaluation. DISCUSSION: Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov, NCT03086876. Registered 22nd March 2017, https://clinicaltrials.gov/ct2/show/NCT03086876.

Relationships and Sex Education Outcomes for Students With Intellectual Disability: Protocol for the Development of a Core Outcome Set.

BACKGROUND: People with intellectual disability are twice as likely to experience sexual abuse, unintended pregnancies, and sexually transmitted diseases as people in the general population. Despite this, very little is known about how to deliver relationships and sex education effectively to this vulnerable population, how to measure the impact of its delivery in schools, and what stakeholders perceive as important outcomes of this education. OBJECTIVE: To address these urgent issues, this study aims to develop a stakeholder consensus-based core outcome set of relationships and sex education for use in research and educational settings with students with intellectual disability. METHODS: The study will use a 2-stage mixed methods design. The first stage will involve a systematic review of relationships and sex education outcomes reported in the literature, followed by qualitative exploration with caregivers, teachers and school staff, policy makers, and researchers to investigate their perspectives of meaningful outcomes of this education. Students with intellectual disability will be enabled to take part to express their views on outcomes of importance to them. The second stage will use findings from stage 1 in a 2-round web-based Delphi study with caregivers, teachers and school staff, policy makers, and researchers to develop consensus on proposed outcomes for the evaluation of relationships and sex education with this population. RESULTS: As of September 2022, we have completed a systematic review and recruited 56 stakeholders (n=53, 95%, adults and n=3, 5%, students with intellectual disability) for the first stage of the study. We are still recruiting students with intellectual disability. Data analysis has not started yet. Recruitment for the second stage will commence in November 2022. We expect to complete the study by October 2023 and publish the results by the end of 2024. CONCLUSIONS: The development of a core outcome set of relationships and sex education will provide a significant first step to assist the implementation, delivery, evaluation, and sustainability of relationships and sex education for students with intellectual disability. Key audiences will be teachers, researchers, policy makers, and decision makers. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials 1787; https://www.comet-initiative.org/Studies/Details/1787. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39921.

Child and family-focused interventions for child maltreatment and domestic abuse: development of core outcome sets.

BACKGROUND: The current evidence for child maltreatment (CM) and domestic violence and abuse (DVA) interventions is limited by the diversity of outcomes evaluated and the variety of measures used. The result is studies that are difficult to compare and lack focus on outcomes reflecting service user or provider priorities. OBJECTIVE: To develop core outcome sets (COSs) for evaluations of child and family-focused interventions for: (1) CM and (2) DVA. DESIGN: We conducted a two-stage consensus process. Stage 1: a long list of candidate outcomes across CM and DVA was developed through rapid systematic reviews of intervention studies, qualitative and grey literature; stakeholder workshops; survivor interviews. Stage 2: three-panel, three-round e-Delphi surveys for CM and DVA with consensus meetings to agree with the final COSs. PARTICIPANTS: 287 stakeholders participated in at least one stage of the process (ie, either CM or DVA COS development): workshops (n=76), two e-Delphi surveys (n=170) and consensus meetings (n=43). Stakeholders included CM and DVA survivors, practitioners, commissioners, policymakers and researchers. RESULTS: Stage 1 identified 335 outcomes categorised into 9 areas and 39 domains. Following stage 2, the final five outcomes included in the CM-COS were: child emotional health and well-being; child's trusted relationships; feelings of safety; child abuse and neglect; service harms. The final five outcomes in the DVA-COS were: child emotional health and well-being; caregiver emotional health and well-being; family relationships; freedom to go about daily life; feelings of safety. CONCLUSIONS: We developed two COSs for CM and DVA with two common outcomes (child emotional health and well-being; feelings of safety). The COSs reflect shared priorities among service users, providers and researchers. Use of these COSs across trials and service evaluations for children and families affected by CM and DVA will make outcome selection more consistent and help harmonise research and practice.

Elective home education of children with neurodevelopmental conditions before and after the COVID-19 pandemic started.

COVID-19 brought disruptions to children's education and mental health, and accelerated school de-registration rates. We investigated Elective Home Education (EHE) in families of children with a neurodevelopmental condition. A total of 158 parents of 5-15 year-old children with neurodevelopmental conditions (80% autistic) provided information on reasons for de-registration, their experience of EHE, and children's mental health. Few differences were found between children participating in EHE before and after the pandemic started. Low satisfaction with school for not meeting children's additional needs was the main reason for de-registering in both groups. COVID-19 had a more limited role in parents' decision to de-register. The main advantage of EHE reported in both groups was the provision of personalised education and one-to-one support. Levels of anxiety, internalising and externalising problems were similar between children participating in EHE before and after the pandemic started, and also similar between all children in EHE and school-registered children (N = 1,079).

Process evaluation of a randomised controlled trial of PBS-based staff training for challenging behaviour in adults with intellectual disability.

BACKGROUND: Positive Behaviour Support (PBS) for challenging behaviour is a complex intervention. Process evaluation is pivotal in fully understanding the mechanisms and contextual factors that impact on participant outcomes. AIMS: To conduct a process evaluation of a national clinical trial investigating the impact of PBS-based staff training on the level of challenging behaviour in adults with intellectual disability. METHOD: The Medical Research Council guidance for process evaluation of complex interventions was followed. Semi-structured interviews with 62 stakeholders from the intervention arm (service users, family and paid carers, service managers, staff who delivered the intervention and PBS trainers), quantitative data from the study database and an external evaluation of the quality of the PBS plans were used. RESULTS: Twenty-one health staff volunteered to be trained in delivering PBS. Available log data from 17 therapists revealed that they worked with 63 participants a median of 11.50 hours (IQR 8-32). Only 33 out of 108 reports had included all elements of the intervention. Another 47 reports had some elements of the intervention. All PBS plans were rated weak, indicating insufficient quality to impact challenging behaviour. Stakeholders reported an appreciation of PBS and its potential to impact quality of care and engagement with the participant. However, they also identified important challenges including managing PBS-related caseloads, paid carer turnover and service commitment to the delivery of PBS. CONCLUSIONS: PBS-based staff training was well received, but therapists found it difficult to undertake all the elements of the intervention in routine care. Implementing a workforce training strategy is important to better define the active components of PBS, and resource implications if the intervention is no better than usual care.

Beginning at the beginning: Recall order and the number of words to be recalled.

When participants are asked to recall a short list of words in any order that they like, they tend to initiate recall with the first list item and proceed in forward order, even when this is not a task requirement. The current research examined whether this tendency might be influenced by varying the number of items that are to be recalled. In 3 experiments, participants were presented with short lists of between 4 and 6 words and instructed to recall 1, 2, 3, or all of the items from the lists. Data were collected using immediate free recall (IFR, Experiment 1), immediate serial recall (ISR, Experiment 2), and a variant of ISR that we call ISR-free (Experiment 3), in which participants had to recall words in their correct serial positions but were free to output the words in any order. For all 3 tasks, the tendency to begin recall with the first list item occurred only when participants were required to recall as many items from the list as they could. When participants were asked to recall only 1 or 2 items, they tended to initiate recall with end-of-list items. It is argued that these findings show for the first time a manipulation that eliminates the initial tendency to recall in forward order, provide some support for recency-based accounts of IFR and help explain differences between single-response and multiple-response immediate memory tasks. (PsycINFO Database Record