The Incredible Years Parents and Babies Program in Denmark

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parenting

Intervention / Treatment
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* Behavioral: Incredible Years Parents and Babies Program
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IY Parents and Babies Program<br>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<br>* 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<br>|
| Active Comparator: Usual Care<br>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<br>* 4-5 home visits by health visitor Group of mothers Health visitor station Extra visits by health visitor if needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karitane Parenting Confidence Scale (KPCS) | 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) |  | 20 weeks post intervention start, child age 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sense of coherence (SOC13) |  | Baseline | 
| 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 Index | Video observation task measuring mother-infant attachment and relation | 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 | 
| Cognitive development questionnaire (CDQ) |  | child age 18 months | 
| Being a Mother (BaM13) |  | child age 18 months | 
| Parental Reflective Functioning Questionnaire (PRFQ-1) short version |  | child age 18 months | 
| Parenting Sense of Competence (PSOC) |  | child age 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Parenting, Infants, Family programs, Early intervention