- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805918
Pedagogues Promoting Positive Parenting in a Home-visiting Program in At-risk Families: A RCT of VIPP-SD
May 21, 2026 updated by: Mette Væver, University of Copenhagen
An Ounce of Prevention is Worth a Pound of Cure: A Randomised Controlled Trial of Pedagogues Promoting Positive Parenting in a Home-visiting Program in At-risk Families
Supportive parenting is a strong predictor of positive outcomes for children, and harsh parenting is a risk factor for child development, especially for the child developing externalizing problems (overactive, oppositional, and aggressive behavior).
Externalizing problems in preschoolers are predictive of a variety of problems in later childhood.
Thus, parents are key targets for change in preventive programs with children at risk for developing externalizing problems.
More than 95% of 2-6 year old Danish children spend an average of 7.5 hours, 5 days a week in a daycare setting, thus pedagogues are key frontline staff in the promotion of parental abilities and early childhood mental health.
However, a recent Danish study shows that pedagogues experience a need for systematic skills and methods for intervening in families with a child at risk.
Attachment-based programs enhancing parental sensitivity and parental sensitive discipline show promising results.
This efficacy study examines the Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD)delivered by 22 VIPP-SD trained pedagogues at home-visits to 120 families with a child (1-6 years) identified to be at risk.
Pedagogues are supervised by four VIPP municipality psychologists, thus promoting the cross-disciplinary collaboration.
The results will point to future identification of families that may (and may not) profit from a pedagogue delivered VIPP-SD intervention, as well as to revise the intervention in order to maximizing its effect, i.e. point to changes to tailor intervention to the particular needs of different families in a Danish context.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Copenhagen, Denmark, 1353
- Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 6 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Child 2-6 year old
- Parent must be more than 18 years old
- Parent must speak and understand Danish
- Family must live in the municipalities of Frederiksberg or Roskilde - and having no intentions of moving out of the municipality before after the intervention has ended
- Parent can attend other treatment initiatives
- Child must attend a daycare center in one of the two municipalities
- Child must be at risk of developing externalizing behavior, i.e. showing signs of overactive, oppositional, and aggressive behavior.
Exclusion criteria
- Sexual or physical abuse by parent
- Parental drug or alcohol abuse
- Child diagnosis of autism
- Child is not considered at risk of developing externalizing behavior problems, but may have other problems, such as delayed language or motordevelopment etc
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VIPP-SD (Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline).
The VIPP-SD includes seven sessions of 1½-2 hours each with an 2-4 weeks interval VIPP-SD is delivered by a VIPP-SD trained pedagogue and takes place in the family home and the targeted parent and child are videotaped during daily interactions.
The intervener studies the video and prepares feedback.
During the sessions, the intervener and parent review the video together and the intervener provides their feedback according to the VIPP-SD protocol.
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Parenting program
|
|
Active Comparator: Care as ususl
The existing standard practices for parents of 2-6 year old children identified to be at risk for developing externalizing problems in the participating municipalities will be the active control condition.
These vary in content and duration in the municipalities.
Likewise, CAU may change during the project period.
The exact content and duration of CAU interventions as well as participants' adherence to treatment will be described as precisely as possible.
|
Parenting program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental attitudes toward sensitivity and sensitive discipline (ATSSD)
Time Frame: Through study completion, an average of 6 months
|
Questionnaire regarding parents' attitudes towards parenting (Bakermans-Kranenburg & Van IJzendoorn, 2003)
|
Through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting Daily Hassles (PDH)
Time Frame: Through study completion, an average of 6 months
|
Parenting Daily Hassles scale where parents are asked to rate 20 minor parenting stresses that often occur in families with small children (Crnic & Greenberg, 1990).
|
Through study completion, an average of 6 months
|
|
Parenting Stress
Time Frame: Through study completion, an average of 6 months
|
via self-report using Parenting Stress IndexTM, Fourth Edition Short Form (PSI-4-SF;Abidin, 1995)
|
Through study completion, an average of 6 months
|
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Parental Mentalizing
Time Frame: Through study completion, an average of 6 months
|
self-report using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens, & Fonagy, 2017).
|
Through study completion, an average of 6 months
|
|
Family functioning
Time Frame: Through study completion, an average of 6 months
|
self-report using the McMaster Family Assessment Device (FAD), the six item version (de Haan et al., 2015)
|
Through study completion, an average of 6 months
|
|
Parental symptoms of anxiety
Time Frame: Through study completion, an average of 6 months
|
Anxiety symptoms will be assessed with GAD-7, which is a 7-item screening questionnaire for generalized anxiety disorder (Spitzer, Kroenke, Williams & Löwe, 2006).
|
Through study completion, an average of 6 months
|
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Parental behavioral sensitivity and sensitive discipline
Time Frame: Through study completion, an average of 6 months
|
Parental sensitivity will be coded from video recordings of parent-child free play. Coding will be conducted using Coding Interactive Behavior (CIB) (Feldman, 1998). Parental sensitive discipline will be coded from video recordings of a "don't touch task" and a "clean-up task". Coding procedure will be based on guidelines from Kuczynski et al., 1987 and Van der Mark et al., 2002. |
Through study completion, an average of 6 months
|
|
Child behavior problems
Time Frame: Through study completion, an average of 6 months
|
This is measured using the Strengths and Difficulties questionnaire (SDQ), which is completed by both parents and pedagogues (Goodman, 1997; Danish version by Niclasen et al., 2012).
|
Through study completion, an average of 6 months
|
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Child socio-emotional development
Time Frame: Through study completion, an average of 6 months
|
Child socio-emotional development is assessed via parental report using the Ages & Stages Questionnaires®: Social-Emotional, Second Edition (ASQ®:SE-2) (Squires, Bricker, & Twombly, 2015).
|
Through study completion, an average of 6 months
|
|
Parental symptoms of depression
Time Frame: Through study completion, an average of 6 months
|
Depression symptoms will be assessed with PHQ-9, which is a 9-item questionnaire to monitor the severity of depression symptoms (Kroenke, Sptizer & Williams, 2001).
|
Through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mette Væver, Phd, University of Copenhagen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2021
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
March 12, 2021
First Submitted That Met QC Criteria
March 16, 2021
First Posted (Actual)
March 18, 2021
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Danish VIPP-SD RCT study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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