Clinical trial NCT04805918: Pedagogues Promoting Positive Parenting in a Home-visiting Program in At-risk Families: A RCT of VIPP-SD
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Behavior Problems in Early Childhood
Keywords: Selected early intervention
parental sensitivity and sensitive discipline
child externalizing behavior
pedagogues
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2021-03-18
Enrollment: 130
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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). 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.


Eligibility criteria: 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

Primary outcomes:
measure: Parental attitudes toward sensitivity and sensitive discipline (ATSSD)
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Parenting Daily Hassles (PDH)
timeFrame: Through study completion, an average of 6 months
measure: Parenting Stress
timeFrame: Through study completion, an average of 6 months
measure: Parental Mentalizing
timeFrame: Through study completion, an average of 6 months
measure: Family functioning
timeFrame: Through study completion, an average of 6 months
measure: Parental symptoms of anxiety
timeFrame: Through study completion, an average of 6 months
measure: Parental behavioral sensitivity and sensitive discipline
timeFrame: Through study completion, an average of 6 months
measure: Child behavior problems
timeFrame: Through study completion, an average of 6 months
measure: Child socio-emotional development
timeFrame: Through study completion, an average of 6 months
measure: Parental symptoms of depression
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: mette væver, PhD
role: PRINCIPAL_INVESTIGATOR
References: