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Completed

NCT Number: NCT04805918

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

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, 1353, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIPP-SD

Behavioral

Parenting program

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. 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)

  3. 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).

  4. 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)

  5. 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).

  6. 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.

  7. 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).

  8. 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).

  9. 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).

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • University of Aarhus

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Mar 18, 2021
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.