Abstract
BackgroundInfancy 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/DesignThis 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.DiscussionThis 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 registrationThis trial was registered with Clinicaltrials.gov (identifier: NCT01931917) on 27 August 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0859-y) contains supplementary material, which is available to authorized users.
Highlights
Infancy is an important period in a child’s life, with rapid growth and development
It is crucial that appropriate parenting interventions are available to families with infants, especially since interventions in early childhood have been shown to be effective [8,9,10,11,12,13], and to be more effective than interventions later in life, because it is easier to intervene before problems become entrenched [1, 14]
Parent satisfaction with the Incredible YearsTM Parenting and Babies Program (IYPB) is measured by a questionnaire, and a qualitative study looking into how parents experience participation in the IYPB as a universal prevention will be performed
Summary
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. The main advantages are: that there is no labelling or stigmatization involved, that the quality of the interventions tend to be high because the middle class is involved, and that at-risk families can be identified and offered more help if needed [15, 16]. The main disadvantages are: that universal programs are expensive, the individual benefits tend to be small, and it can be difficult to find overall effects It might enlarge social inequality if well-functioning families benefit the most from the interventions [15, 16]. Implementation and treatment fidelity During the trial, a qualitative study of the implementation of the IYPB in one of the municipalities will be performed to look into challenges and successes experienced when moving from using the IYPB as a targeted program to rolling it out as a universal intervention. Treatment fidelity is measured by session checklists completed by group leaders at the end of each session
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