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

NCT04805918 | Unknown

• 1 other identifier: Danish VIPP-SD RCT study
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavior Problems in Early Childhood

Keywords

Selected early intervention; parental sensitivity and sensitive discipline; child externalizing behavior; pedagogues

Outcome Measures

Primary Outcomes (1)

• Parental attitudes toward sensitivity and sensitive discipline (ATSSD)

  Questionnaire regarding parents' attitudes towards parenting (Bakermans-Kranenburg \& Van IJzendoorn, 2003)

  Through study completion, an average of 6 months

Secondary Outcomes (9)

• Parenting Daily Hassles (PDH)

  Through study completion, an average of 6 months

• Parenting Stress

  Through study completion, an average of 6 months

• Parental Mentalizing

  Through study completion, an average of 6 months

• Family functioning

  Through study completion, an average of 6 months

• Parental symptoms of anxiety

  Through study completion, an average of 6 months

Study Arms (2)

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.

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.

Behavioral: VIPP-SD

Interventions

VIPP-SD BEHAVIORAL

Parenting program

Care as ususl; VIPP-SD (Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline).

Eligibility Criteria

• Age: 2 Years - 6 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• University of Aarhus: collaborator

Study Sites (1)

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

Copenhagen, 1353, Denmark

Location

Study Officials

• mette væver, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor: The individual who evaluates the video-based outcome(s) of interest
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 18, 2021
• Study Start: March 15, 2021
• Primary Completion: February 28, 2023
• Study Completion: December 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)