Pedagogues Promoting Positive Parenting in a Home-visiting Program in At-risk Families: A RCT of VIPP-SD

NCT ID: NCT04805918

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Behavior Problems in Early Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes Assessor: The individual who evaluates the video-based outcome(s) of interest

Study Groups

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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.

Group Type EXPERIMENTAL

VIPP-SD

Intervention Type BEHAVIORAL

Parenting program

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.

Group Type ACTIVE_COMPARATOR

VIPP-SD

Intervention Type BEHAVIORAL

Parenting program

Interventions

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VIPP-SD

Parenting program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Mette Væver

PhD Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mette væver, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Danish VIPP-SD RCT study

Identifier Type: -

Identifier Source: org_study_id

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