title: The impact of day care on socially disadvantaged families: an example of the use of process evaluation within a randomized controlled trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Nutrition and Public Health Intervention Research Unit, Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK. toroyant@who.int
authors.forename: T
authors.initials: T
authors.lastname: Toroyan
authors.forename: A
authors.initials: A
authors.lastname: Oakley
authors.forename: G
authors.initials: G
authors.lastname: Laing
authors.forename: I
authors.initials: I
authors.lastname: Roberts
authors.forename: M
authors.initials: M
authors.lastname: Mugford
authors.forename: J
authors.initials: J
authors.lastname: Turner
mesh_terms: D000328:Adult; D002675:Child, Preschool; D003631:Day Care, Medical; D005192:Family Health; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D017064:Process Assessment, Health Care; D011610:Psychosocial Deprivation; D016032:Randomized Controlled Trials as Topic; D006113:United Kingdom