Behavior Problems in Early ChildhoodNCT04805918
Pedagogues Promoting Positive Parenting in a Home-visiting Program in At-risk Families: A RCT of VIPP-SD
A study testing VIPP-SD in people with Behavior Problems in Early Childhood, run by University of Copenhagen at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Behavior Problems in Early Childhood
- What is being tested?
- VIPP-SD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen
Copenhagen, 1353
About this study
Official title: 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.
- Conditions
- Behavior Problems in Early Childhood
- Being tested
- VIPP-SD
- Keywords
- Selected early intervention, parental sensitivity and sensitive discipline, child externalizing behavior, pedagogues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIPP-SDBehavioural
Parenting program
| Study group | Role | What they receive |
|---|---|---|
| VIPP-SD (Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline). | Experimental | 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. Receives: Behavioral: VIPP-SD |
| Care as ususl | Active comparator | 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. Receives: Behavioral: VIPP-SD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental attitudes toward sensitivity and sensitive discipline (ATSSD)
Questionnaire regarding parents' attitudes towards parenting (Bakermans-Kranenburg \& Van IJzendoorn, 2003)
Measured: Through study completion, an average of 6 months
Secondary outcomes (9)
Parenting Daily Hassles (PDH)
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).
Measured: Through study completion, an average of 6 months
Parenting Stress
via self-report using Parenting Stress IndexTM, Fourth Edition Short Form (PSI-4-SF;Abidin, 1995)
Measured: Through study completion, an average of 6 months
Parental Mentalizing
self-report using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens, \& Fonagy, 2017).
Measured: Through study completion, an average of 6 months
Family functioning
self-report using the McMaster Family Assessment Device (FAD), the six item version (de Haan et al., 2015)
Measured: Through study completion, an average of 6 months
Parental symptoms of anxiety
Anxiety symptoms will be assessed with GAD-7, which is a 7-item screening questionnaire for generalized anxiety disorder (Spitzer, Kroenke, Williams \& Löwe, 2006).
Measured: Through study completion, an average of 6 months
Parental behavioral sensitivity and sensitive discipline
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.
Measured: Through study completion, an average of 6 months
Child behavior problems
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).
Measured: Through study completion, an average of 6 months
Child socio-emotional development
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).
Measured: Through study completion, an average of 6 months
Parental symptoms of depression
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).
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start15 Mar 2021
- Primary completion28 Feb 2023
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior Problems in Early ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study population will be randomly allocated in the ratio 1:1 to either VIPP-SD or CAU. The randomization is stratified by municipality. A computer-generated list of random numbers is used for the allocation of participants. The allocation list is created using block randomization with block sizes of 10. The allocation sequence is generated by an investigator with no clinical involvement in the project.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Mette Væver, University of Copenhagen
- Investigators
- mette væver, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805918
- Sponsor's protocol ID
- Danish VIPP-SD RCT study
- Status last verified
- May 2026
- First submitted
- 12 Mar 2021
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04805918
- Acronym / sponsor ID
- Danish VIPP-SD RCT study
- Conditions
- Behavior Problems in Early Childhood
- Keywords
- Selected early intervention, parental sensitivity and sensitive discipline, child externalizing behavior, pedagogues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study population will be randomly allocated in the ratio 1:1 to either VIPP-SD or CAU. The randomization is stratified by municipality. A computer-generated list of random numbers is used for the allocation of participants. The allocation list is created using block randomization with block sizes of 10. The allocation sequence is generated by an investigator with no clinical involvement in the project.
| Arm | Type | Receives |
|---|---|---|
| VIPP-SD (Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline). | Experimental | Behavioral: VIPP-SDThe 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. |
| Care as ususl | Active comparator | Behavioral: VIPP-SDThe 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIPP-SDParenting program | Behavioural | Care as ususl, VIPP-SD (Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline). |
Primary outcome
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)
9 secondary outcomes
Parenting Daily Hassles (PDH)
Time frame: Through study completion, an average of 6 months
Parenting Stress
Time frame: Through study completion, an average of 6 months
Parental Mentalizing
Time frame: Through study completion, an average of 6 months
Family functioning
Time frame: Through study completion, an average of 6 months
Parental symptoms of anxiety
Time frame: Through study completion, an average of 6 months
Parental behavioral sensitivity and sensitive discipline
Time frame: Through study completion, an average of 6 months
Child behavior problems
Time frame: Through study completion, an average of 6 months
Child socio-emotional development
Time frame: Through study completion, an average of 6 months
Parental symptoms of depression
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mette væver, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIPP-SD in people with Behavior Problems in Early Childhood, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental attitudes toward sensitivity and sensitive discipline (ATSSD) (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.