Condition category
Mental and Behavioural Disorders
Date applied
02/07/2014
Date assigned
04/08/2014
Last edited
24/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study of 200 families with interaction problems with their infants under the age of 2 years in Norway. Video feedback of Infant-Parent Interaction (VIPI) is a method which is widely practiced in primary healthcare in the Scandinavian countries, but no clinical study has been conducted of its effects on parent-child interaction. In this study, we want to compare the effects of VIPI with usual care on parent-child interaction.

Who can participate?
Families who are considered to have interaction problems with their infants who are less than 2 years of age.

What does the study involve?
The families are randomly allocated to one of two groups: VIPI or treatment-as-usual (TAU). Over a period of 2 years three trained research assistants will visit the families in their homes. During the visit, parents will complete questionnaires and will be videotaped when interacting with their infants for 30 minutes in a natural everyday situation like feeding, playing or nappy changing. These videotapes will later be assessed. We will assess the families before VIPI (T1), after VIPI (T2) and 6 months later. The TAU group in this study receives consultations from health nurses, social and child welfare workers, community psychologists, and practitioners.

What are the possible benefits and risks of participating?
For most parents there will expectedly be an immediate direct treatment benefit either from VIPI or TAU. There will be no risk to the participants.

Where is the study run from?
The VIPI study aims to recruit about 200 families from two major cities and six rural areas in Norway.

When is the study starting and how long is it expected to run for?
The study started in January 2011 and will last until December 2015.

Who is funding the study?
National Network of Infant Mental Health, Oslo (Norway).

Who is the main contact?
Professor Turid Suzanne Berg-Nielsen, tsbn@r-bup.no
Dr Magnhild S. Høivik, magnhild.s.hoivik@ntnu.no

Trial website

Contact information

Type

Scientific

Primary contact

Prof Turid Suzanne Berg-Nielsen

ORCID ID

Contact details

RBUP
Postbox 4623 Nydalen
Oslo
0405
Norway
+47 (0) 22586015
tsbn@r-bup.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ISRCTN2014

Study information

Scientific title

A longitudinal randomized controlled trial of the intervention Video-feedback of Infant-Parent Interaction (VIPI) for infants under 2 years of age

Acronym

VIPI

Study hypothesis

It is hypothesized that parents with moderate interaction problems with their infants will profit from the intervention (VIPI) compared to treatment as usual (TAU). Parents with either minor interaction problems or more serious problems will not benefit from VIPI than TAU.
It is hypothesized that maternal depressive symptoms will moderate the effect of VIPI, with more symptoms resulting in less effect.

Ethics approval

Regional Committee of Ethical Research in Mid-Norway, 02/10/2007, ref. 1.2007.2176

Study design

Naturalistic multi-site longitudinal randomized controlled trial with a parallel-group, consecutively randomized single-blinded design with a 1-2-1-2 allocation ratio within each site

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Psychiatry, developmental psychology

Intervention

Participants will be randomly allocated to one of two groups:
1. Video-feedback of Infant-Parent Interaction (VIPI)
2. Treatment as usual (TAU)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

An observational measure with standardized coding of parent-child interaction: The Emotional Availability Scales measured at baseline (T1), after 2 months (T2) and after 8 months (T3).

Secondary outcome measures

Ages & Stages Questionnaire social-emotional measuring parent-reported social-emotional development in infants measured at baseline (T1), after 2 months (T2) and after 8 months (T3).

Overall trial start date

01/01/2011

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Parents of infants under 2 years of age with interaction problems with their infant and sufficient proficiency in Norwegian to fill out questionnaires

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Parents with:
1. Psychosis
2. Developmental delays
3. Ongoing substance abuse problems

Recruitment start date

01/01/2011

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Norway

Trial participating centre

RBUP
Oslo
0405
Norway

Sponsor information

Organisation

National Network of Infant Mental Health (Norway)

Sponsor details

Postboks 4623 Nydalen
Oslo
0405 Oslo
Norway
+47 (0) 22586000
mbh@r-bup.no

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

National Network of Infant Mental Health, Oslo (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25699090

Publication citations

Additional files

Editorial Notes