The Incredible Years Parents and Babies Program in Denmark

NCT ID: NCT01931917

Last Updated: 2018-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-10-31

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.

Conditions

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Parenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Incredible Years Parents and Babies Program

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type BEHAVIORAL

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TRYG Foundation

OTHER

Sponsor Role collaborator

VIVE - The Danish Center for Social Science Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maiken Pontoppidan

Role: PRINCIPAL_INVESTIGATOR

VIVE - The Danish Center for Social Science Research

Locations

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SFI the Danish National Centre for Social Research

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Pontoppidan M, Thorsager M, Steenhoff T. Parent-child Relationship Outcomes of the Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial. Scand J Child Adolesc Psychiatr Psychol. 2022 Jun 7;10(1):40-52. doi: 10.2478/sjcapp-2022-0004. eCollection 2022 Jan.

Reference Type DERIVED
PMID: 35799975 (View on PubMed)

Pontoppidan M, Klest SK, Sandoy TM. The Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial. PLoS One. 2016 Dec 14;11(12):e0167592. doi: 10.1371/journal.pone.0167592. eCollection 2016.

Reference Type DERIVED
PMID: 27974857 (View on PubMed)

Pontoppidan M. The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial. Trials. 2015 Sep 2;16:386. doi: 10.1186/s13063-015-0859-y.

Reference Type DERIVED
PMID: 26329163 (View on PubMed)

Related Links

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Other Identifiers

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SFI 2570

Identifier Type: -

Identifier Source: org_study_id

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