NCT01931917

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4.2 years

First QC Date

August 27, 2013

Last Update Submit

January 16, 2018

Conditions

Parenting

Keywords

PreventionParentingInfantsFamily programsEarly intervention

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Other Outcomes (3)

  • Parent and child health

    20 weeks post intervention start, child age 18 months

  • Single items on child temperament

    Baseline, 20 weeks post intervention start, child age 18 months

  • Single items on interaction with child

    20 weeks post intervention start, child age 18 months

Study Arms (2)

IY Parents and Babies Program

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Incredible Years Parents and Babies ProgramBEHAVIORAL

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

IY Parents and Babies Program
Usual CareBEHAVIORAL

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

Usual Care

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents with a child aged 0-4 months
  • Parents are able to understand Danish at a basic level

You may not qualify if:

  • Serious physical disability
  • serious mental disability
  • Child can not be placed in out of home care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SFI the Danish National Centre for Social Research

Copenhagen, 2100, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 35799975DERIVED

  • 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.

    PMID: 27974857DERIVED

  • 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.

    PMID: 26329163DERIVED

Related Links

Study Officials

  • Maiken Pontoppidan

    VIVE - The Danish Center for Social Science Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 30, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

DK(1)