- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04512157
Supporting Social and Emotional Competence in Preschool Children (PsPATHS_STK)
August 13, 2020 updated by: Lilianne Eninger, Stockholm University
Supporting Social and Emotional Competence in Preschool Children: A Study of the Cultural Adaptation and Effectiveness of Preschool Promoting Alternative THinking Strategies (PsPATHS)
Social emotional competence is instrumental to children's health and development.
The preschool edition of Promoting Alternative THinking Strategies (PATHS®) intervention was tested in this study.
PATHS® is a universal teacher implemented, and school-based intervention.
In the first years of this study, PATHS® which was originally developed in the United States was adapted for a Swedish preschool context according to a theoretical model for intervention cultural adaptation entitled the Planned Intervention Adaptation (PIA) protocol.
After the cultural adaptation process, a two-wave pre-posttest randomized controlled trial of PsPATHS was conducted with Swedish preschool aged children.
Implementation data were collected and outcome evaluation results are being finalized at the time that this protocol is being submitted in August 2020.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Social emotional competence is instrumental to children's health and development.
The preschool edition of Promoting Alternative THinking Strategies (PATHS®) intervention was tested in this study.
PATHS® is a universal teacher implemented, and school-based intervention that aims to give preschool children a strategically timed boost in social emotional competence.
Specifically, PATHS® encourages the use of interactive techniques to bolster children's ability to self-regulate, increase their adeptness at social cognitive problem solving, as well as to gain insight into their emotions and emotions of others.
In the first years of this study, PATHS® which was originally developed in the United States was adapted for a Swedish preschool context according to a theoretical model for intervention cultural adaptation entitled the Planned Intervention Adaptation (PIA) protocol.
PIA calls for specific small-scale research studies that guide the cultural adaptation of an imported intervention.
After the cultural adaptation process, a two-wave pre-posttest randomized controlled trial of PsPATHS was conducted with Swedish preschool aged children.
The main study, which this protocol documents was a two-wave pre to posttest, cluster randomized controlled trial with multi-method and informant assessment (N = 285 four and five-year-old Swedish children; 145 wait-list control and 140 intervention).
Implementation data were collected and outcome evaluation results are being finalized at the time that this protocol is being submitted in August 2020.
Study Type
Interventional
Enrollment (Actual)
285
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- Preschool level: Public or privately administered preschools with at least one classroom of 4- to 5-year old children, located within one of three selected municipalities in the Stockholm area.
- Individual child level: Children were included if they attended participating preschools, were 4 or 5 years old and had the written consent of their guardians, and if they had a sufficient understanding of Swedish to perform tasks.
Exclusion criteria:
- Preschool level: Types of preschools excluded from study participation were open preschools, parent cooperative run preschools, and family day homes.
- Individual child level: Children were excluded if they did not have a sufficient understanding of Swedish to perform tasks.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PATHS, Intervention preschools
These preschools implement PATHS for one school year
|
PATHS® is a universal teacher implemented, and school-based intervention that aims to give preschool children a strategically timed boost in social emotional competence.
Specifically, PATHS® encourages the use of interactive techniques to bolster children's ability to self-regulate, increase their adeptness at social cognitive problem solving, as well as to gain insight into their emotions and emotions of others.
Other Names:
|
|
No Intervention: Waitlist control preschools
Preschool as usual, which does have some social emotional learning but not PATHS specifically
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional knowledge
Time Frame: 1 year
|
Child task: Emotional knowledge is measured by Assessment of Children's Emotions Skills (ACES; Schultz, et al., 2001) accuracy score.
One point was given for each correct response.
The 10 faces with clear emotional expressions were used for this scale score.
The maximum score was 10, indicating excellent emotional knowledge.
|
1 year
|
|
Emotional awareness
Time Frame: 1 year
|
Child task: Emotional awareness is measured by the Challenging Situations Task (Denham et al., 1994) score called Label Emotional responses (sum score across four situations, with one point given for each correct response).
|
1 year
|
|
Social problem solving
Time Frame: 1 year
|
Child task: Social problem solving is measured by the Challenging Situations Task scores for competent, aggressive, and inept responses.
For each category of response, a maximum of four was possible.
|
1 year
|
|
Inhibitory control 1
Time Frame: 1 year
|
Child task: inhibitory control as measured by number of correct responses on the Knock & Tap task from NEPSY (Korkman et al., 1998).
Possible range of scores was 0 to 30, with high scores indicating good inhibitory control.
|
1 year
|
|
Inhibitory control 2
Time Frame: 1 year
|
Child task: accuracy score on an adapted version of the Day-Night task (Gerstadt et al., 1994).
Possible range of scores was 0 to 48, with high scores indicating good inhibitory control.
|
1 year
|
|
Working memory
Time Frame: 1 year
|
Child task: accuracy score on the Word span task as an index of working memory (Tillman et al., 2008).
The score was calculated as the sum of correctly remembered words in the right order, maximum of 30 points, with high scores indicating good working memory.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prosocial/communication skills
Time Frame: 1 year
|
Teachers rated Prosocial/communication skills using the Social Competence Scale (SCS; Sorensen et al., 2016).
Mean score was calculated, with items rated from 0 to 4. High mean score indicated good skills.
|
1 year
|
|
Child's Emotional self-regulation
Time Frame: 1 year
|
Teachers rated Child's Emotional self-regulation using the Social Competence Scale (SCS; Sorensen et al., 2016).
Mean score was calculated, with items rated from 0 to 4. High mean score indicated good skills.
|
1 year
|
|
Child's Academic skills
Time Frame: 1 year
|
Teachers rated Child's Academic skills using the Social Competence Scale (SCS; Sorensen et al., 2016).
Mean score was calculated, with items rated from 0 to 4. High mean score indicated good skills.
|
1 year
|
|
Prosocial skills
Time Frame: 1 year
|
Observer ratings: Observers rated Prosocial skills of children across two standardized play situations, ratings were seven items from the Prosocial/communication skills subscale of the SCS.
The seven items on this scale were rated on a 5-point Likert scale from 1 (Not At All) to 5 (Very Well).
Mean score was calculated, with a high mean score indicating good skills.
|
1 year
|
|
Task orientation
Time Frame: 1 year
|
Observer ratings: Task orientation of children was rated on a Task Orientation scale (adapted from Smith-Donald et al., 2007).
Interviewers used this scale to rate the child's ability to sustain attention across the performed tasks children.
Interviewers rated nine items on a 5-point Likert scale ranging from 0 (Not True At All) to 4 (Very True).
Mean score was calculated, with a high mean score indicating good skills.
|
1 year
|
|
Social cooperation
Time Frame: 1 year
|
Teacher ratings: Children's social cooperation skills were rated by teachers using the Preschool and Kindergarten Behavior Scale (PKBS; Merrell, 1996).
Likert scale ranging from 0 to 3. Mean score was calculated, with a high mean score indicating good skills.
|
1 year
|
|
Social interaction
Time Frame: 1 year
|
Teacher ratings: Children's social interaction skills were rated by teachers using the Preschool and Kindergarten Behavior Scale (PKBS; Merrell, 1996).
Likert scale ranging from 0 to 3. Mean score was calculated, with a high mean score indicating good skills.
|
1 year
|
|
Social independence
Time Frame: 1 year
|
Teacher ratings: Children's social independence skills were rated by teachers using the Preschool and Kindergarten Behavior Scale (PKBS; Merrell, 1996).
Likert scale ranging from 0 to 3. Mean score was calculated, with a high mean score indicating good skills.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social withdrawal (internalizing behavior)
Time Frame: 1 year
|
Teacher ratings: Social withdrawal using the Preschool and Kindergarten Behavior Scales (PKBS; Merrell, 1996).
Likert scale ranging from 0 to 3. Mean score was calculated, with a high mean score indicating a high level of social withdrawal.
|
1 year
|
|
Anxiety/somatic problems (internalizing behavior)
Time Frame: 1 year
|
Teacher ratings: Anxiety/somatic problems using the Preschool and Kindergarten Behavior Scales (PKBS; Merrell, 1996).
Likert scale ranging from 0 to 3. Mean score was calculated, with a high mean score indicating a high level of anxiety/somatic problems.
|
1 year
|
|
Aggression (externalizing behavior)
Time Frame: 1 year
|
Teacher ratings: Aggression using the Preschool and Kindergarten Behavior Scales (PKBS; Merrell, 1996).
Likert scale ranging from 0 to 3. Mean score was calculated, with a high mean score indicating a high level of aggression.
|
1 year
|
|
Inattention
Time Frame: 1 year
|
Teacher ratings: Inattention using the ADHD Rating Scale - IV (DuPaul, Power, Anastopoulos & Reid, 1998).
Likert scale ranging from 0 to 3. Mean score was calculated, with a high mean score indicating a high level of inattention problems.
|
1 year
|
|
Hyperactivity/Impulsivity
Time Frame: 1 year
|
Teacher ratings: Hyperactivity/Impulsivity using the ADHD Rating Scale - IV (DuPaul, Power, Anastopoulos & Reid, 1998).
Likert scale ranging from 0 to 3. Mean score was calculated, with a high mean score indicating a high level of hyperactivity/impulsivity problems.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lilianne Eninger, PhD, Stockholm University
- Study Chair: Håkan Fischer, Department Head, PhD, Stockholm University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2012
Primary Completion (Actual)
September 30, 2016
Study Completion (Actual)
September 30, 2016
Study Registration Dates
First Submitted
August 4, 2020
First Submitted That Met QC Criteria
August 10, 2020
First Posted (Actual)
August 13, 2020
Study Record Updates
Last Update Posted (Actual)
August 17, 2020
Last Update Submitted That Met QC Criteria
August 13, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 259-2012-71
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
This study's ethical review does not allow for individual participant data to be in a public repository.
Under certain circumstances researchers may be able to access de identified data, see IPD Sharing Access Criteria (below)
IPD Sharing Time Frame
August 2020-August 2023
IPD Sharing Access Criteria
Individual data requests for de-identified (IPD) will be reviewed for qualified researchers (e.g., Ph.D.) who obtain ethical permission under Swedish ethical regulations/laws for secondary data analysis for purposes such as meta-analysis or confirmation of published study results.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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