title: The Family Startup Program: study protocol for a randomized controlled trial of a universal group-based parenting support program.
abstract: BACKGROUND
  Inadequate parenting is an important public health problem with possible severe and long-term consequences related to child development. We have solid theoretical and political arguments in favor of efforts enhancing the quality of the early family environment in the population at large. However, little is known about effect of universal approaches to parenting support during the transition to parenthood. This protocol describes an experimental evaluation of group based parenting support, the Family Startup Program (FSP), currently implemented large scale in Denmark.
  
  
  METHODS
  Participants will be approximately 2500 pregnant women and partners. Inclusion criteria are parental age above 18 and the mother expecting first child. Families are recruited when attending routine pregnancy scans provided as a part of the publicly available prenatal care program at Aarhus University Hospital, Skejby. Families are randomized within four geographically defined strata to one of two conditions a) participation in FSP or b) Treatment As Usual (TAU). FSP aims to prepare new families for their roles as parents and enhance parental access to informal sources of support, i.e. social network and community resources. The program consists of twelve group sessions, with nine families in each group, continuing from pregnancy until the child is 15 months old. TAU is the publicly available pre- and postnatal care available to families in both conditions. Analyses will employ survey data, administrative data from health visitors, and administrative register based data from Statistics Denmark. All data sources will be linked via the unique Danish Civil Registration Register (CPR) identifier. Data will be obtained at four time points, during pregnancy, when the child is nine months, 18 months and seven years. The primary study outcome is measured by the Parenting Sense of Competence scale (PSOC) J Clin Child Psychol 18:167-75, 1989. Other outcomes include parenting and couple relationship quality, utility of primary sector service and child physical health, socio-emotional and cognitive development.
  
  
  CONCLUSIONS
  The protocol describes an ambitious experimental evaluation of a universal group-based parenting support program; an evaluation that has not yet been made either in Denmark or internationally.
  
  
  BACKGROUND
  ClinicalTrials.gov ID: NCT02294968. Registered November 14 2014.
authors.affiliation: Department of Psychology and Behavioural Sciences, Aarhus University, Bartholins Allé 9, 8000, Aarhus C, Denmark. teatri@psy.au.dk.
authors.forename: Tea
authors.initials: T
authors.lastname: Trillingsgaard
authors.affiliation: Department of Clinical Medicine & Department of Obstetrics and Gynaecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Skejby, 8200, Aarhus N, Denmark. rmai@clin.au.dk.
authors.forename: Rikke Damkjær
authors.initials: RD
authors.lastname: Maimburg
authors.affiliation: Department of Economics and Business, Aarhus University, Fuglesangs Allé 4, 8210, Aarhus V, Denmark. msimonsen@econ.au.dk.
authors.forename: Marianne
authors.initials: M
authors.lastname: Simonsen
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D000067576:Child Health; D003718:Denmark; D004505:Education, Nonprofessional; D005191:Family Characteristics; D005260:Female; D006296:Health Services; D006801:Humans; D008297:Male; D009035:Mothers / Q000523:psychology; D016487:Parenting; D011247:Pregnancy; D011295:Prenatal Care; D015397:Program Evaluation; D012107:Research Design; D012657:Self-Help Groups