The Incredible Years Parents and Babies Program in Denmark

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931917
• Other study ID #: SFI 2570
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: January 16, 2018
• Start date: August 2013
• Est. completion date: October 2017

Study information

• Verified date: January 2018
• Source: VIVE - The Danish Centre of Applied Social Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parenting

Intervention

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

Locations

Country	Name	City	State
Denmark	SFI the Danish National Centre for Social Research	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
VIVE - The Danish Centre of Applied Social Science	TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

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

External Links

•   Paper - post intervention outcomes
•   Trial protocol