NCT04512157

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

4.5 years

First QC Date

August 4, 2020

Last Update Submit

August 13, 2020

Conditions

Keywords

Promoting Alternative Thinking StrategiesPreschoolChildrenSwedenPATHS

Outcome Measures

Primary Outcomes (6)

  • Emotional knowledge

    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

    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

    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

    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

    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

    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 Outcomes (8)

  • Prosocial/communication skills

    1 year

  • Child's Emotional self-regulation

    1 year

  • Child's Academic skills

    1 year

  • Prosocial skills

    1 year

  • Task orientation

    1 year

  • +3 more secondary outcomes

Other Outcomes (5)

  • Social withdrawal (internalizing behavior)

    1 year

  • Anxiety/somatic problems (internalizing behavior)

    1 year

  • Aggression (externalizing behavior)

    1 year

  • +2 more other outcomes

Study Arms (2)

PATHS, Intervention preschools

EXPERIMENTAL

These preschools implement PATHS for one school year

Behavioral: Promoting Alternative Thinking Strategies (PATHS), Preschool Edition

Waitlist control preschools

NO INTERVENTION

Preschool as usual, which does have some social emotional learning but not PATHS specifically

Interventions

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.

Also known as: PATHS
PATHS, Intervention preschools

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Eninger L, Ferrer-Wreder L, Eichas K, Olsson TM, Hau HG, Allodi MW, Smedler AC, Sedem M, Gull IC, Herkner B. A Cluster Randomized Trial of Promoting Alternative Thinking Strategies (PATHS(R)) With Swedish Preschool Children. Front Psychol. 2021 Jul 13;12:695288. doi: 10.3389/fpsyg.2021.695288. eCollection 2021.

Study Officials

  • Lilianne Eninger, PhD

    Stockholm University

    PRINCIPAL INVESTIGATOR
  • Håkan Fischer, Department Head, PhD

    Stockholm University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There was no masking after random assignment of recruited schools to condition (intervention or waitlist control condition).
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The design used was a cluster randomized controlled intervention trial, with a waitlist comparison group, with pre and post-testing.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Psychology, Senior lecturer

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 13, 2020

Study Start

April 1, 2012

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

August 17, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

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)

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
August 2020-August 2023
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.