abstract: 'Aim This paper describes a process evaluation that was conducted alongside a randomized controlled trial of out-of-home pre-school day care. The evaluation aimed to: (1) describe the intervention; (2) document the day care received by participating families; (3) describe the social context of the trial; and (4) provide data to assist in the interpretation of trial outcomes. Methods The setting for the trial was an out-of-home day care Centre in Hackney, East London. Process data were collected through the use of questionnaires, interviews, and researcher field-notes. Data from questionnaires were collected from 120 mothers and included data on 143 children. Interviews were undertaken with 21 participating mothers. Staff also completed questionnaires and the Head of the Centre was interviewed. The quality of care provided was assessed using the Early Childhood Environment Rating Scale. Results Process data collected during the trial suggest that the day care provided was education-led, flexible in catering to families'' needs, and was of a very high quality. The social context of the trial resulted in financial pressures, which may well have influenced the intervention provided. Data collected through in-depth interviews suggested that it may be the flexibility of day care that is particularly important in allowing women to return to paid employment, but that the loss of benefits when starting work may have meant no increase in household income. Conclusion The paper illustrates the value of conducting a process evaluation alongside a randomized trial, particularly where complex interventions are involved. In this case, where the intervention was not provided by the research team, the evaluation allowed an insight into the content of a multifaceted intervention, which is useful in interpreting the trial''s results, and in explaining the possible effects of the social context on the intervention.' affiliation: 'Toroyan, T (Corresponding Author), Univ London London Sch Hyg \& Trop Med, Dept Epidemiol \& Populat Hlth, Nutr \& Publ Hlth Intervent Res Unit, 1st Floor,Wolfson Bldg,Keppel St, London WC1E 7HT, England. Univ London London Sch Hyg \& Trop Med, Dept Epidemiol \& Populat Hlth, Nutr \& Publ Hlth Intervent Res Unit, London WC1E 7HT, England. Univ London, Inst Educ, Social Sci Res Unit, London WC1N 1AZ, England. City \& Hackney Primary Care Trust, Child \& Adolescent Serv, London, England. Univ E Anglia, Sch Med Hlth Policy \& Practice, Norwich NR4 7TJ, Norfolk, England. Mapledene Early Years Ctr, London, England.' author: Toroyan, T and Oakley, A and Laing, G and Roberts, I and Mugford, M and Turner, J author-email: toroyant@who.int author_list: - family: Toroyan given: T - family: Oakley given: A - family: Laing given: G - family: Roberts given: I - family: Mugford given: M - family: Turner given: J da: '2023-09-28' doi: 10.1111/j.1365-2214.2004.00481.x files: [] issn: 0305-1862 journal: CHILD CARE HEALTH AND DEVELOPMENT keywords: 'evaluation; pre-school day care; household income; social intervention; randomization' keywords-plus: HEALTH; INTERVENTIONS; DESIGN language: English month: NOV number: '6' number-of-cited-references: '20' pages: 691-698 papis_id: 4406412eaafbbc885ff48158354b2837 ref: Toroyan2004impactday times-cited: '17' title: 'The impact of day care on socially disadvantaged families: an example of the use of process evaluation within a randomized controlled trial' type: Article unique-id: WOS:000224921200014 usage-count-last-180-days: '0' usage-count-since-2013: '5' volume: '30' web-of-science-categories: Psychology, Developmental; Pediatrics year: '2004'