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Completed

NCT Number: NCT01931917

The Incredible Years Parents and Babies Program in Denmark

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.

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Key information

Conditions

Parenting

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

SFI the Danish National Centre for Social Research

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incredible Years Parents and Babies Program

Behavioral

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

Usual Care

Behavioral

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

Primary outcomes

  1. Karitane Parenting Confidence Scale (KPCS)

    Time frame: 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.

  2. Parental Stress Scale (PSS)

    Time frame: 20 weeks post intervention start, child age 18 months

Secondary outcomes

  1. Sense of coherence (SOC13)

    Time frame: Baseline

  2. Major Depression Inventory (MDI)

    Time frame: Baseline, 20 weeks post intervention start, child age 18 months

  3. Ages and stages - Social-Emotional (ASQ-SE)

    Time frame: Baseline, 20 weeks post intervention start, child age 18 months

  4. World health organisation well being index (WHO5)

    Time frame: Baseline, 20 weeks post intervention start, child age 18 months

  5. Rosenberg self esteem (RSS)

    Time frame: 20 weeks post intervention start

  6. Emotional Availability Scales (EAS) or Care Index

    Time frame: 20 weeks post intervention start

    Video observation task measuring mother-infant attachment and relation

  7. Mother and baby interaction scale (MABISC)

    Time frame: 20 weeks post intervention start

  8. Strengths and Difficulties Questionnaire (SDQ)

    Time frame: child age 18 months

  9. Cognitive development questionnaire (CDQ)

    Time frame: child age 18 months

  10. Being a Mother (BaM13)

    Time frame: child age 18 months

  11. Parental Reflective Functioning Questionnaire (PRFQ-1) short version

    Time frame: child age 18 months

  12. Parenting Sense of Competence (PSOC)

    Time frame: child age 18 months

Other outcomes

  1. Parent and child health

    Time frame: 20 weeks post intervention start, child age 18 months

    Single items on parent and child health, child temperament, parent life satisfaction, network, economy, interaction with child, child height and weight.

  2. Single items on child temperament

    Time frame: Baseline, 20 weeks post intervention start, child age 18 months

  3. Single items on interaction with child

    Time frame: 20 weeks post intervention start, child age 18 months

Sponsors and collaborators

Lead sponsor

VIVE - The Danish Center for Social Science Research

Other

Collaborators

  • TRYG Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2013
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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