The Incredible Years Parents and Babies Program in Denmark

January 16, 2018 updated by: VIVE - The Danish Center for Social Science Research

A Randomised Controlled Pilot Trial of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • SFI the Danish National Centre for Social Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IY Parents and Babies Program
In the Incredible Years Parents and Babies Program, parents learn how to help their babies feel loved, safe, and secure. They learn how to encourage their babies' physical and language development. The parenting group format fosters peer support networks and shared learning. Trained Incredible Years facilitators use video clips of real-life situational vignettes to support the training and stimulate parenting group discussions and practice exercises with their babies. The program is group based with 6-8 mothers and partners attending 8 2 hour sessions with their babies.
Behavioral: Incredible 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
Active Comparator: Usual Care
Usual care consists of the elements that are being offered to all mothers in the participating municipalities which is 5 home visits by health visitors, a mothers group, a health nurse station and extra visits if needed.
Behavioral: Usual Care
4-5 home visits by health visitor Group of mothers Health visitor station Extra visits by health visitor if needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 20 weeks post intervention start
Parental Stress Scale (PSS)
Time Frame: 20 weeks post intervention start, child age 18 months
20 weeks post intervention start, child age 18 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 weeks post intervention start, child age 18 months
Single items on child temperament
Time Frame: Baseline, 20 weeks post intervention start, child age 18 months
Baseline, 20 weeks post intervention start, child age 18 months
Single items on interaction with child
Time Frame: 20 weeks post intervention start, child age 18 months
20 weeks post intervention start, child age 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVE - The Danish Center for Social Science Research

Collaborators

TRYG Foundation

Investigators

  • Principal Investigator: Maiken Pontoppidan, VIVE - The Danish Center for Social Science Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SFI 2570

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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