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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 1353
        • Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: VIPP-SD
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.
Behavioral: VIPP-SD
Parenting program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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