The effectiveness of the Incredible Years™ Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial

BACKGROUND: Infancy is an important period in a child’s life, with rapid growth and development. Early experiences shape the developing brain, and adverse experiences can have both an immediate and lifelong impact on health and wellbeing. Parenting interventions offered to parents of newborns can support parents in providing sensitive and responsive care, and reinforce healthy development for their infants. This study aims to evaluate the impact of the Incredible Years™ Parents and Babies Program in a universal setting for parents with infants. METHODS/DESIGN: This is a pragmatic, two-arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome is parenting confidence measured after 20 weeks by the Karitane Parenting Confidence Scale and Parental Stress Scale. Secondary outcomes include measures of parent health, reflective functioning, relationship with the infant, and infant development. Interviewers and data analysts are blind to allocation status. DISCUSSION: This is the first RCT of the Incredible Years Parents and Babies Program, and one of the first rigorous evaluations of a universally offered preventive intervention for parents with infants. The trial will provide important information on the effectiveness of a relatively brief, universally offered parenting intervention for parents of infants, and will also provide information on infant measures, parent recruitment and participation, and implementation of the program, which could inform future trials. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov (identifier: NCT01931917) on 27 August 2013. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0859-y) contains supplementary material, which is available to authorized users.