title: The Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial.
abstract: BACKGROUND
  Infancy is an important period of life; adverse experiences during this stage can have both immediate and lifelong impacts on the child's mental health and well-being. This study evaluates the effects of offering the Incredible Years Parents and Babies (IYPB) program as a universal intervention.
  
  
  METHODS
  We conducted a pragmatic, two-arm, parallel pilot randomized controlled trial; 112 families with newborns were randomized to the IYPB program (76) or usual care (36) with a 2:1 allocation ratio. The primary outcome was parenting confidence at 20 weeks(Karitane Parenting Confidence Scale and Parental Stress Scale). Secondary outcomes include measures of parent health, parent-child relationship, infant development, parent-child activities, and network. Interviewers and data analysts were blind to allocation status. Multiple linear-regression analyses were used for evaluating the effects of the intervention.
  
  
  RESULTS
  There were no intervention effects on the primary outcomes. Only one effect was detected for secondary outcomes, intervention mothers reported a significantly smaller network than control mothers (β = -0.15 [-1.85,-0.28]). When examining the lowest-functioning mothers in moderator analyses, we found that intervention mothers reported significantly higher parent stress (β = 5.33 [0.27,10.38]), lower parenting confidence (β = -2.37 [-4.45,-0.29]), and worse mental health than control mothers (β = -18.62 [-32.40,-4.84]). In contrast, the highest functioning intervention mothers reported significantly lower parent stress post-intervention (β = -6.11 [-11.07,-1.14]).
  
  
  CONCLUSIONS
  Overall, we found no effects of the IYPB as a universal intervention for parents with infants. The intervention was developed to be used with groups of low functioning families and may need to be adapted to be effective with universal parent groups. The differential outcomes for the lowest and highest functioning families suggest that future research should evaluate the effects of delivering the IYPB intervention to groups of parents who have similar experiences with parenting and mental health.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01931917.
authors.affiliation: SFI-The Danish National Centre for Social Research, Department for Child and Family, Copenhagen, Denmark.|Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Maiken
authors.identifier: http://orcid.org/0000-0002-9491-3665
authors.initials: M
authors.lastname: Pontoppidan
authors.affiliation: Health Sciences Faculty, University of Tromsø, Arctic University of Norway, Tromsø, Norway.
authors.forename: Sihu K
authors.initials: SK
authors.lastname: Klest
authors.affiliation: SFI-The Danish National Centre for Social Research, Department for Child and Family, Copenhagen, Denmark.
authors.forename: Tróndur Møller
authors.initials: TM
authors.lastname: Sandoy
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002657:Child Development / Q000502:physiology*; D003718:Denmark; D004505:Education, Nonprofessional / Q000379:methods*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009035:Mothers; D010287:Parent-Child Relations; D016487:Parenting; D010290:Parents; D015397:Program Evaluation; D012959:Socioeconomic Factors; D055815:Young Adult