Title: Early Positive Approaches to Support (E-PAtS) for families of young children with learning disability (sometimes referred to as developmental delay or intellectual disability): Feasibility study
Funder: Department of Health and Social Care

Abstract: Design: feasibility study including randomisation into a 2-arm trial, of Early Positive Approaches to Support (E-PAtS) for parents of young children with intellectual disability (ID). Feasibility questions: willingness/feasibility of randomisation, recruitment: providers/parents, retention, Usual Practice (UP)-E-PAtS differs, adherence, fidelity, feasibility of measures. Setting: Families recruited from community (eg 3rd sector, local authority services, special schools) + self-referral. E-PAtS delivered by trained community-based providers. Population: families of children with ID. Inclusion: family has at least one ID child 1.5-5 years; at least 1 biological, step, adoptive, foster parent; English language ability (spoken) sufficient for E-PAtS; informed consent (parents). Exclusions: ID child 24hr residential placement; primary caregiver already enrolled at baseline in group/individually-delivered parenting programme or psychological therapy; family currently in crisis. Intervention: E-PAtS in groups (two caregivers from family invited) 8x2.5hr group sessions; over 8 weeks. 3 group sessions from each intervention arm E-PAtS videoed, rated independently for fidelity. E-PAtS delivered in addition to usual practice (UP) access. Comparator: UP - any other support provided to family, including other parenting support (excluding other manualised parenting programme at baseline). Parent diaries/focus group/reports of service use to define UP. Costs/measures (baseline, 3m, and 12m full follow-up): Primary outcome parent well-being on WEMWBS well-being at 12m. Secondary: Parent anxiety/depression, parenting efficacy, positive perceptions, coping strategies, social support, partner relationship, co-parenting, relationship with ID child, parenting, EQ-5D, family functioning, child with ID and sibling behavioural/emotional problems, child with ID QoL, sibling relationship, VABS for ID child adaptive skills, service use . Analyses: mainly descriptive addressing feasibility questions, quantitative data reported with confidence intervals. Exploratory statistical analysis ITT-based, non-hypothesis testing, accounting for clustering (parents in families, groups in intervention arm). Primary analysis mean WEMWBS scores between arms at 12m post-randomisation (baseline WEMWBS covaried). Secondary outcomes analysed similarly. Practitioner/parent interviews (N=40): barriers/facilitators, adherence, therapeutic relationship, change mechanisms, group processes, daily life impact, E-PAtS and research process acceptability. Process evaluation guided by MRC framework. Sample: 64 families randomised 1:1 (E-PAtS=32, UP=32) - to provide estimates of key parameters for a future trial, with reasonable degree of precision. Randomisation: 16 families in a local area to ensure viable E-PAtS groups using dynamic balancing algorithm for cluster randomised trials, then individual randomisation of families using minimisation.

Lay abstract: Children with intellectual disability (ID) have a low level of intellectual ability and usually need help with everyday tasks (e.g., self-care, communication). Their parents can also experience additional stress. We have developed a parenting programme for parents of young children (1½ to 5 years) with ID called Early Positive Approaches to Support (E-PAtS). In E-PAtS, parents are taught in a group to learn practical strategies over 8 weeks that help them to look after themselves, and help them with their child’s development. A parent of a child with ID and a parenting professional co-deliver E-PAtS, after they receive training themselves. In this research, we plan to recruit 64 families of young children with ID to take part in a study where they will be assigned by chance to attend one of four E-PAtS groups or to only receive their usual supports. If they are assigned to receive usual supports, families will have chosen whether they would like to have access after 12 months to E-PAtS. All families will also continue to receive support as usual in their local area. Mothers and fathers (or other adult caregivers in the home) will both be invited to take part. Single parents can take part too. All parents, whether they attend the E-PAtS groups or not, will be asked to complete some measures of things that might change during E-PAtS. The most important measure will be changes in parents’ psychological well-being. Other measures include: the parents’ mental health, positive perceptions, approaches to parenting, relationships with their partner (if they have one) and child with ID, the positive and problem behaviour of a brother or sister, sibling relationships, and how much the families access a variety of different services (especially social care, health services). This study is called a feasibility study – we will check out if the research works well so that a much bigger study can be planned in future. Amongst other things, we will find out if parents are willing to take part in the research, if they attend most of the E-PAtS course, whether they complete the research measures, and whether organisations who deliver parenting courses would be interested in taking part in a larger study. After the E-PAtS courses have been run, we will also interview mothers and fathers, the facilitators (people delivering E-PAtS), and people from the organisations delivering E-PAtS. We will ask about what encouraged them to take part in the research, and what got in the way of this. We will also ask about their positive and difficult experiences in the E-PAtS groups. This information will also be used to inform a future bigger study. We have worked with parents and a family carer-led organisation for the past 4 years on a project that makes us think that this research on E-PAtS is important for families. We have also talked to parents to help us make decisions about the design of this research. The family carer-led organisation, and a group of parent advisors, will be involved throughout the research. Family carers will give us advice on finding parents to take part in the research and how to keep parents involved in the study. Our family carer advisors will make sure that the research stays relevant to families and that the information about the results of the study reaches families. The findings from the research will be published in academic journals. We will communicate the findings to family carers, and parenting practitioners.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: GENERIC HEALTH RELEVANCE