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

Primary Purpose

Behavior Problems in Early Childhood

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
VIPP-SD
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Behavior Problems in Early Childhood focused on measuring Selected early intervention, parental sensitivity and sensitive discipline, child externalizing behavior, pedagogues

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Care as ususl

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Parental attitudes toward sensitivity and sensitive discipline (ATSSD)
Questionnaire regarding parents' attitudes towards parenting (Bakermans-Kranenburg & Van IJzendoorn, 2003)

Secondary Outcome Measures

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).
Parenting Stress
via self-report using Parenting Stress IndexTM, Fourth Edition Short Form (PSI-4-SF;Abidin, 1995)
Parental Mentalizing
self-report using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens, & Fonagy, 2017).
Family functioning
self-report using the McMaster Family Assessment Device (FAD), the six item version (de Haan et al., 2015)
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).
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.
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).
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).
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).

Full Information

First Posted
March 12, 2021
Last Updated
November 1, 2022
Sponsor
University of Copenhagen
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT04805918
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problems in Early Childhood
Keywords
Selected early intervention, parental sensitivity and sensitive discipline, child externalizing behavior, pedagogues

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Outcomes Assessor: The individual who evaluates the video-based outcome(s) of interest
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VIPP-SD (Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline).
Arm Type
Experimental
Arm Description
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.
Arm Title
Care as ususl
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
VIPP-SD
Intervention Description
Parenting program
Primary Outcome Measure Information:
Title
Parental attitudes toward sensitivity and sensitive discipline (ATSSD)
Description
Questionnaire regarding parents' attitudes towards parenting (Bakermans-Kranenburg & Van IJzendoorn, 2003)
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Parenting Daily Hassles (PDH)
Description
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).
Time Frame
Through study completion, an average of 6 months
Title
Parenting Stress
Description
via self-report using Parenting Stress IndexTM, Fourth Edition Short Form (PSI-4-SF;Abidin, 1995)
Time Frame
Through study completion, an average of 6 months
Title
Parental Mentalizing
Description
self-report using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens, & Fonagy, 2017).
Time Frame
Through study completion, an average of 6 months
Title
Family functioning
Description
self-report using the McMaster Family Assessment Device (FAD), the six item version (de Haan et al., 2015)
Time Frame
Through study completion, an average of 6 months
Title
Parental symptoms of anxiety
Description
Anxiety symptoms will be assessed with GAD-7, which is a 7-item screening questionnaire for generalized anxiety disorder (Spitzer, Kroenke, Williams & Löwe, 2006).
Time Frame
Through study completion, an average of 6 months
Title
Parental behavioral sensitivity and sensitive discipline
Description
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.
Time Frame
Through study completion, an average of 6 months
Title
Child behavior problems
Description
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).
Time Frame
Through study completion, an average of 6 months
Title
Child socio-emotional development
Description
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).
Time Frame
Through study completion, an average of 6 months
Title
Parental symptoms of depression
Description
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).
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mette væver, PhD
Phone
+45 35324906
Email
mette.vaever@psy.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Tine Steenhoff, PhD
Phone
+45 35 33 43 95
Email
tine.steenhoff@psy.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mette væver, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
1353
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette S. Væver, PhD
Phone
+45 35324906
Email
mette.vaever@psy.ku.dk
First Name & Middle Initial & Last Name & Degree
Tine E. Steenhoff, PhD
Phone
+45 35330528
Email
Tine.steenhoff@psy.ku.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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