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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.

ABSTRACT: 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.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.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.This trial was registered with Clinicaltrials.gov (identifier: NCT01931917) on 27 August 2013.

SUBMITTER: Pontoppidan M

PROVIDER: S-EPMC4557844 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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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.

Pontoppidan Maiken M

Trials 20150902

<h4>Background</h4>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 ...[more]

PMID: 26329163

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Project description: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.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.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 (? = -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 (? = 5.33 [0.27,10.38]), lower parenting confidence (? = -2.37 [-4.45,-0.29]), and worse mental health than control mothers (? = -18.62 [-32.40,-4.84]). In contrast, the highest functioning intervention mothers reported significantly lower parent stress post-intervention (? = -6.11 [-11.07,-1.14]).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.ClinicalTrials.gov NCT01931917.

Dataset Information

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.

Publications

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.

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