title: The Children and Parents in Focus project: a population-based cluster-randomised controlled trial to prevent behavioural and emotional problems in children.
abstract: BACKGROUND
  There is large body of knowledge to support the importance of early interventions to improve child health and development. Nonetheless, it is important to identify cost-effective blends of preventive interventions with adequate coverage and feasible delivery modes. The aim of the Children and Parents in Focus trial is to compare two levels of parenting programme intensity and rate of exposure, with a control condition to address impact and cost-effectiveness of a universally offered evidence-based parenting programme in the Swedish context.
  
  
  METHODS
  The trial has a cluster randomised controlled design comprising three arms: Universal arm (with access to participation in Triple P - Positive Parenting Program, level 2); Universal Plus arm (with access to participation in Triple P - Positive Parenting Program, level 2 as well as level 3, and level 4 group); and Services as Usual arm. The sampling frame is Uppsala municipality in Sweden. Child health centres consecutively recruit parents of children aged 3 to 5 years before their yearly check-ups (during the years 2013-2017). Outcomes will be measured annually. The primary outcome will be children's behavioural and emotional problems as rated by three informants: fathers, mothers and preschool teachers. The other outcomes will be parents' behaviour and parents' general health. Health economic evaluations will analyse cost-effectiveness of the interventions versus care as usual by comparing the costs and consequences in terms of impact on children's mental health, parent's mental health and health-related quality of life.
  
  
  CONCLUSIONS
  This study addresses the need for comprehensive evaluation of the long-term effects, costs and benefits of early parenting interventions embedded within existing systems. In addition, the study will generate population-based data on the mental health and well-being of preschool aged children in Sweden.
  
  
  BACKGROUND
  ISRCTN16513449.
authors.affiliation: Department of Women's and Children's Health, Samariterhemmets Hospital, Uppsala University, Box 609, 751 25 Uppsala, Sweden. raziye.salari@kbh.uu.se.
authors.forename: Raziye
authors.initials: R
authors.lastname: Salari
authors.forename: Helena
authors.initials: H
authors.lastname: Fabian
authors.forename: Ron
authors.initials: R
authors.lastname: Prinz
authors.forename: Steven
authors.initials: S
authors.lastname: Lucas
authors.forename: Inna
authors.initials: I
authors.lastname: Feldman
authors.forename: Amanda
authors.initials: A
authors.lastname: Fairchild
authors.forename: Anna
authors.initials: A
authors.lastname: Sarkadi
mesh_terms: D000328:Adult; D002653:Child Behavior Disorders / Q000517:prevention & control*; D002656:Child Day Care Centers; D002675:Child, Preschool; D016000:Cluster Analysis; D005260:Female; D006293:Health Promotion; D006801:Humans; D019964:Mood Disorders / Q000517:prevention & control*; D016487:Parenting; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013548:Sweden