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The Incredible Years Parents and Babies Program in Denmark

A Randomised Controlled Pilot Trial of The Incredible Years Parents and Babies Program in Denmark

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01931917
Enrollment
112
Registered
2013-08-30
Start date
2013-08-31
Completion date
2017-10-31
Last updated
2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenting

Keywords

Prevention, Parenting, Infants, Family programs, Early intervention

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.

Interventions

BEHAVIORALIncredible Years Parents and Babies Program

4-5 home visits by health visitor IY parents and babies program 8 sessions Group of mothers Health visitor station Extra visits by health visitor if needed

BEHAVIORALUsual Care

4-5 home visits by health visitor Group of mothers Health visitor station Extra visits by health visitor if needed

Sponsors

TRYG Foundation
CollaboratorOTHER
VIVE - The Danish Center for Social Science Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Karitane Parenting Confidence Scale (KPCS)Baseline, 20 weeks post intervention startThe KPCS measures perceived parenting self-efficacy (PPSE) in parents of children aged 0-12 months. High PPSE has been shown to act as a buffer against factors that can compromise a child's development, such as parental depression, anxiety, stress and relationship difficulties, and is associated with actual parenting competence and positive child outcomes The KPCS is a short self-report instrument. It was developed in Australia primarily for health professionals experienced in working with parentcraft and psychosocial issues of early parenthood, including Maternal, Child and Family Health Nurses, and allied health and medical professionals.
Parental Stress Scale (PSS)20 weeks post intervention start, child age 18 months

Secondary

MeasureTime frameDescription
Major Depression Inventory (MDI)Baseline, 20 weeks post intervention start, child age 18 months
Ages and stages - Social-Emotional (ASQ-SE)Baseline, 20 weeks post intervention start, child age 18 months
World health organisation well being index (WHO5)Baseline, 20 weeks post intervention start, child age 18 months
Rosenberg self esteem (RSS)20 weeks post intervention start
Emotional Availability Scales (EAS) or Care Index20 weeks post intervention startVideo observation task measuring mother-infant attachment and relation
Sense of coherence (SOC13)Baseline
Being a Mother (BaM13)child age 18 months
Parental Reflective Functioning Questionnaire (PRFQ-1) short versionchild age 18 months
Parenting Sense of Competence (PSOC)child age 18 months
Mother and baby interaction scale (MABISC)20 weeks post intervention start
Strengths and Difficulties Questionnaire (SDQ)child age 18 months
Cognitive development questionnaire (CDQ)child age 18 months

Other

MeasureTime frameDescription
Parent and child health20 weeks post intervention start, child age 18 monthsSingle items on parent and child health, child temperament, parent life satisfaction, network, economy, interaction with child, child height and weight.
Single items on interaction with child20 weeks post intervention start, child age 18 months
Single items on child temperamentBaseline, 20 weeks post intervention start, child age 18 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026