Early positive approaches to support for families of young children with intellectual disability: the E-PAtS feasibility RCT
Authors: Coulman Elinor , Gore Nick , Moody Gwenllian , Wright Melissa , Segrott Jeremy , Gillespie David , Petrou Stavros , Lugg-Widger Fiona , Kim Sungwook , Bradshaw Jill , McNamara Rachel , Jahoda Andrew , Lindsay Geoff , Shurlock Jacqui , Totsika Vaso , Stanford Catherine , Flynn Samantha , Carter Annabel , Barlow Christian , Hastings Richard 
Published: February 2022

Background
Parents of children with intellectual disability are 1.5–2 times more likely than other parents to report mental health difficulties. There is a lack of clinically effective and cost-effective group well-being interventions designed for family carers of young children with intellectual disability.

Aim
To examine the feasibility of a randomised controlled trial of the clinical effectiveness and cost-effectiveness of the Early Positive Approaches to Support (E-PAtS) intervention.

Design
A feasibility study (including randomisation of families into a two-arm trial), questionnaires to assess the feasibility of proposed outcome measures (including resource use and health-related quality of life) and practitioner/family carer interviews. An additional question was included in an online UK survey of families, conducted by the research team to assess usual practice, and a survey of provider organisations.

Setting
Families recruited from community contexts (i.e. third sector, local authority services, special schools) and self-referral. The E-PAtS intervention was delivered by trained community-based providers.

Participants
Families with at least one child aged 1.5–5 years with an intellectual disability. At least one parent had to have English-language ability (spoken) for E-PAtS programme participation and participants had to provide informed consent.

Interventions
E-PAtS intervention – two caregivers from each family invited to eight 2.5-hour group sessions with usual practice. Usual practice – other support provided to the family, including other parenting support.

Objectives
To assess randomisation willingness/feasibility, recruitment of providers/parents, retention, usual practice, adherence, fidelity and feasibility of proposed outcome measures (including the Warwick–Edinburgh Mental Well-Being Scale as the proposed primary outcome measure, and parent anxiety/depression, parenting, family functioning/relationships, child behavioural/emotional problems and adaptive skills, child and parent quality of life, and family services receipt as the proposed secondary outcome measures).

Results
Seventy-four families (95 carers) were recruited from three sites (with 37 families allocated to the intervention). From referrals, the recruitment rate was 65% (95% confidence interval 56% to 74%). Seventy-two per cent of families were retained at the 12-month follow-up (95% confidence interval 60% to 81%). Exploratory regression analysis showed that the mean Warwick–Edinburgh Mental Well-Being Scale well-being score was 3.96 points higher in the intervention group (95% confidence interval –1.39 to 9.32 points) at 12 months post randomisation. High levels of data completeness were achieved on returned questionnaires. Interviews (n = 25) confirmed that (1) recruitment, randomisation processes and the intervention were acceptable to family carers, E-PAtS facilitators and community staff; (2) E-PAtS delivery were consistent with the logic model; and (3) researchers requesting consent in future for routine data would be acceptable. Recorded E-PAtS sessions demonstrated good fidelity (96% of components present). Adherence (i.e. at least one carer from the family attending five out of eight E-PAtS sessions) was 76%. Health-related quality-of-life and services receipt data were gathered successfully. An online UK survey to assess usual practice (n = 673) showed that 10% of families of young children with intellectual disability received any intervention over 12 months. A provider survey (n = 15) indicated willingness to take part in future research.

Limitations
Obtaining session recordings for fidelity was difficult. Recruitment processes need to be reviewed to improve diversity and strategies are needed to improve primary outcome completion.

Conclusions
Study processes were feasible. The E-PAtS intervention was well received and outcomes for families were positive. A barrier to future organisation participation is funding for intervention costs. A definitive trial to test the clinical effectiveness and cost-effectiveness of E-PAtS would be feasible.

Trial registration
Current Controlled Trials ISRCTN70419473.

Funding
This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 2. See the NIHR Journals Library website for further project information.