A randomized controlled trial of the intervention Video-feedback of Infant-Parent Interaction (VIPI) for infants under 2 years of age
| ISRCTN | ISRCTN99793905 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99793905 |
| Secondary identifying numbers | ISRCTN2014 |
- Submission date
- 02/07/2014
- Registration date
- 04/08/2014
- Last edited
- 04/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
RBUP
Postbox 4623 Nydalen
Oslo
0405
Norway
| Phone | +47 (0) 22586015 |
|---|---|
| tsbn@r-bup.no |
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A longitudinal randomized controlled trial of the intervention Video-feedback of Infant-Parent Interaction (VIPI) for infants under 2 years of age |
| Study acronym | VIPI |
| Study objectives | 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(s) | Regional Committee of Ethical Research in Mid-Norway, 02/10/2007, ref. 1.2007.2176 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2011 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 112 |
| Key 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 |
| Key exclusion criteria | Parents with: 1. Psychosis 2. Developmental delays 3. Ongoing substance abuse problems |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Norway
Study participating centre
0405
Norway
Sponsor information
Other
Postboks 4623 Nydalen
Oslo
0405 Oslo
Norway
| Phone | +47 (0) 22586000 |
|---|---|
| mbh@r-bup.no |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | video feedback of infant-parent interaction (VIPI) results | 12/02/2015 | Yes | No | |
| Results article | 1-year interactional results | 18/06/2018 | 23/04/2019 | Yes | No |
| Results article | Results in a low- to moderate-risk sample | 14/09/2023 | 04/10/2023 | Yes | No |
Editorial Notes
04/10/2023: Publication reference added.
23/04/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment has been added from the results publication.
