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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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16 October 2023 |
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Main ID: |
ISRCTN99793905 |
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Date of registration:
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04/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomized controlled trial of the intervention Video-feedback of Infant-Parent Interaction (VIPI) for infants under 2 years of age
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Scientific title:
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A longitudinal randomized controlled trial of the intervention Video-feedback of Infant-Parent Interaction (VIPI) for infants under 2 years of age |
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Date of first enrolment:
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01/01/2011 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN99793905 |
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Study type:
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Interventional |
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Study design:
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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 (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Norway
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Contacts
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Name:
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Turid Suzanne
Berg-Nielsen |
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Address:
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RBUP
Postbox 4623 Nydalen
0405
Oslo
Norway |
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Telephone:
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+47 (0) 22586015 |
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Email:
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tsbn@r-bup.no |
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: Parents with:
1. Psychosis
2. Developmental delays
3. Ongoing substance abuse problems
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psychiatry, developmental psychology
Mental and Behavioural Disorders
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Intervention(s)
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Participants will be randomly allocated to one of two groups:
1. Video-feedback of Infant-Parent Interaction (VIPI)
2. Treatment as usual (TAU)
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Primary Outcome(s)
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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).
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Secondary Outcome(s)
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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).
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Secondary ID(s)
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ISRCTN2014
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Source(s) of Monetary Support
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National Network of Infant Mental Health, Oslo (Norway)
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; Regional Committee of Ethical Research in Mid-Norway, 02/10/2007, ref. 1.2007.2176
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2015 |
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URL:
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