The Early Positive Approaches to Support (E-PAtS) study: study protocol for a feasibility cluster randomised controlled trial of a group programme (E-PAtS) for family caregivers of young children with intellectual disability

Background: Children with intellectual disability have an IQ < 70, associated deficits in adaptive skills and are at increased risk of having clinically concerning levels of behaviour problems. In addition, parents of children with intellectual disability are likely to report high levels of mental health and other psychological problems. The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children. The aim of this study is to assess the feasibility of delivering E-PAtS to family caregivers of children with intellectual disability by community parenting support service provider organisations. The study will inform a potential, definitive RCT of the effectiveness and cost-effectiveness of E-PAtS. Methods: This study is a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to 2 family caregivers will be recruited from 64 families with a child (18 months to 5 years) with intellectual disability at research sites in the UK. Participating families will be allocated to intervention: control on a 1:1 basis; intervention families will be offered the E-PAtS programme immediately, continuing to receive usual practice, and control participants will be offered the opportunity to attend the E-PAtS programme at the end of the follow-up period and will continue to receive usual practice. Data will be collected at baseline, 3 months post-randomisation and 12 months post-randomisation. The primary aim is to assess feasibility via the assessment of: recruitment of service provider organisations; participant recruitment; randomisation; retention; intervention adherence; intervention fidelity and the views of participants, intervention facilitators and service provider organisations regarding intervention delivery and study processes. The secondary aim is preliminary evaluation of a range of established outcome measures for individual family members, subsystem relationships and overall family functioning, plus additional health economic outcomes for inclusion in a future definitive trial. Discussion: The results of this study will inform a potential future definitive trial, to evaluate the effectiveness and cost-effectiveness of the E-PAtS intervention to improve parental psychosocial wellbeing. Such a trial would have significant scientific impact internationally in the intellectual disability field

Family-centred interventions by primary healthcare services for Indigenous early childhood wellbeing in Australia, Canada, New Zealand and the United States: a systematic scoping review

© 2017 The Author(s).Background: Primary healthcare services in Australia, Canada, New Zealand and the United States have embraced the concept of family-centred care as a promising approach to supporting and caring for the health of young Indigenous children and their families. This scoping review assesses the quality of the evidence base and identifies the published literature on family- centred interventions for Indigenous early childhood wellbeing. Methods: Fourteen electronic databases, grey literature sources and the reference lists of Indigenous maternal and child health reviews were searched to identify relevant publications from 2000 to 2015. Studies were included if the intervention was: 1) focussed on Indigenous children aged from conception to 5 years from the abovementioned countries; 2) led by a primary healthcare service; 3) described or evaluated; and 4) scored greater than 50% against a validated scale for family-centredness. The study characteristics were extracted and quality rated. Reported aims, strategies, enablers and outcomes of family-centredcare were identified using grounded theory methods. Results: Eighteen studies (reported in 25 publications) were included. Three were randomised controlled studies; most were qualitative and exploratory in design. More than half of the publications were published from 2012 to 2015. The overarching aim of interventions was to promote healthy families. Six key strategies were to: support family behaviours and self- care, increase maternal knowledge, strengthen links with the clinic, build the Indigenous workforce, promote cultural/ community connectedness and advocate for social determinants of health. Four enablers were: competent and compassionate program deliverers, flexibility of access, continuity and integration of healthcare, and culturally supportive care. Health outcomes were reported for Indigenous children (nutritional status; emotional/behavioural; and prevention of injury and illness); parents/caregivers (depression and substance abuse; and parenting knowledge, confidence and skills); health services (satisfaction; access, utilization and cost) and community/cultural revitalisation. Discussion and conclusion: The evidence for family-centred interventions is in the early stages of development, but suggests promise for generating diverse healthcare outcomes for Indigenous children and their parents/caregivers, as well as satisfaction with and utilisation of healthcare, and community/cultural revitalisation. Further research pertaining to the role of fathers in family-centred care, and the effects and costs of interventions is needed