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The Incredible Years Parents and Babies Program in Denmark

Not Applicable
Completed
Conditions
Parenting
Registration Number
NCT01931917
Lead Sponsor
VIVE - The Danish Center for Social Science Research
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
112
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Parental Stress Scale (PSS)20 weeks post intervention start, child age 18 months
Karitane Parenting Confidence Scale (KPCS)Baseline, 20 weeks post intervention start

The 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.

Secondary Outcome Measures
NameTimeMethod
Cognitive development questionnaire (CDQ)child age 18 months
Being a Mother (BaM13)child age 18 months
Parenting Sense of Competence (PSOC)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
Emotional Availability Scales (EAS) or Care Index20 weeks post intervention start

Video observation task measuring mother-infant attachment and relation

Sense of coherence (SOC13)Baseline
Major Depression Inventory (MDI)Baseline, 20 weeks post intervention start, child age 18 months
Rosenberg self esteem (RSS)20 weeks post intervention start
Mother and baby interaction scale (MABISC)20 weeks post intervention start
Strengths and Difficulties Questionnaire (SDQ)child age 18 months
Parental Reflective Functioning Questionnaire (PRFQ-1) short versionchild age 18 months

Trial Locations

Locations (1)

SFI the Danish National Centre for Social Research

🇩🇰

Copenhagen, Denmark

SFI the Danish National Centre for Social Research
🇩🇰Copenhagen, Denmark

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