Clinical trial NCT01931917: The Incredible Years Parents and Babies Program in Denmark
Official title: A Randomised Controlled Pilot Trial of The Incredible Years Parents and Babies Program in Denmark
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Keywords: Prevention
Parenting
Infants
Family programs
Early intervention
Lead sponsor: VIVE - The Danish Center for Social Science Research
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
First posted: 2013-08-30
Enrollment: 112
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the pilot study is to examine the effects of the Incredible Years Baby Programme (IY baby) offered as a universal intervention compared to Usual Care (UC) for parents with infants aged 0-12 months.

Detailed description: A randomised controlled effectiveness pilot trial of the Incredible Years Parents and Babies Program (IY baby)offered as a universal intervention in two municipalities in Denmark. 120 families will be randomised to IY Baby (intervention) og Usual Care (UC- control). Families recruited to the study have infants aged 0-4 months old. All first time mothers in one municipality and all mothers in another municipality are recruited. Outcomes are measured at 20 weeks post baseline and when the child is 18 months old. The aim of this trial is to estimate the effectiveness of the IY Baby program on parent and infant well-being, development and relationship and establish parameters for a definitive trial. In addition, the pilot study will also gather information on parent recruitment and participation to inform future research in this area.

Eligibility criteria: Inclusion Criteria:

* Parents with a child aged 0-4 months
* Parents are able to understand Danish at a basic level

Exclusion Criteria:

* Serious physical disability
* serious mental disability
* Child can not be placed in out of home care

Primary outcomes:
measure: Karitane Parenting Confidence Scale (KPCS)
timeFrame: Baseline, 20 weeks post intervention start
measure: Parental Stress Scale (PSS)
timeFrame: 20 weeks post intervention start, child age 18 months
Secondary outcomes:
measure: Sense of coherence (SOC13)
timeFrame: Baseline
measure: Major Depression Inventory (MDI)
timeFrame: Baseline, 20 weeks post intervention start, child age 18 months
measure: Ages and stages - Social-Emotional (ASQ-SE)
timeFrame: Baseline, 20 weeks post intervention start, child age 18 months
measure: World health organisation well being index (WHO5)
timeFrame: Baseline, 20 weeks post intervention start, child age 18 months
measure: Rosenberg self esteem (RSS)
timeFrame: 20 weeks post intervention start
measure: Emotional Availability Scales (EAS) or Care Index
timeFrame: 20 weeks post intervention start
measure: Mother and baby interaction scale (MABISC)
timeFrame: 20 weeks post intervention start
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: child age 18 months
measure: Cognitive development questionnaire (CDQ)
timeFrame: child age 18 months
measure: Being a Mother (BaM13)
timeFrame: child age 18 months
measure: Parental Reflective Functioning Questionnaire (PRFQ-1) short version
timeFrame: child age 18 months
measure: Parenting Sense of Competence (PSOC)
timeFrame: child age 18 months
Other outcomes:
measure: Parent and child health
timeFrame: 20 weeks post intervention start, child age 18 months
measure: Single items on child temperament
timeFrame: Baseline, 20 weeks post intervention start, child age 18 months
measure: Single items on interaction with child
timeFrame: 20 weeks post intervention start, child age 18 months
Locations:
city: Copenhagen
country: Denmark
facility: SFI the Danish National Centre for Social Research
Study officials:
affiliation: VIVE - The Danish Center for Social Science Research
name: Maiken Pontoppidan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pontoppidan M, Thorsager M, Steenhoff T. Parent-child Relationship Outcomes of the Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial. Scand J Child Adolesc Psychiatr Psychol. 2022 Jun 7;10(1):40-52. doi: 10.2478/sjcapp-2022-0004. eCollection 2022 Jan.
citation: Pontoppidan M, Klest SK, Sandoy TM. The Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial. PLoS One. 2016 Dec 14;11(12):e0167592. doi: 10.1371/journal.pone.0167592. eCollection 2016.
citation: Pontoppidan M. 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. Trials. 2015 Sep 2;16:386. doi: 10.1186/s13063-015-0859-y.