Clinical trial NCT04512157: Supporting Social and Emotional Competence in Preschool Children
Official title: Supporting Social and Emotional Competence in Preschool Children: A Study of the Cultural Adaptation and Effectiveness of Preschool Promoting Alternative THinking Strategies (PsPATHS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children's Social Emotional Competence
Children's Well-being
Keywords: Promoting Alternative Thinking Strategies
Preschool
Children
Sweden
PATHS
Lead sponsor: Stockholm University
Sponsor class: OTHER
Collaborators: name: Göteborg University
name: Tarleton State University
First posted: 2020-08-13
Enrollment: 285
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design used was a cluster randomized controlled intervention trial, with a waitlist comparison group, with pre and post-testing.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Emotional knowledge
timeFrame: 1 year
measure: Emotional awareness
timeFrame: 1 year
measure: Social problem solving
timeFrame: 1 year
measure: Inhibitory control 1
timeFrame: 1 year
measure: Inhibitory control 2
timeFrame: 1 year
measure: Working memory
timeFrame: 1 year
Secondary outcomes:
measure: Prosocial/communication skills
timeFrame: 1 year
measure: Child's Emotional self-regulation
timeFrame: 1 year
measure: Child's Academic skills
timeFrame: 1 year
measure: Prosocial skills
timeFrame: 1 year
measure: Task orientation
timeFrame: 1 year
measure: Social cooperation
timeFrame: 1 year
measure: Social interaction
timeFrame: 1 year
measure: Social independence
timeFrame: 1 year
Other outcomes:
measure: Social withdrawal (internalizing behavior)
timeFrame: 1 year
measure: Anxiety/somatic problems (internalizing behavior)
timeFrame: 1 year
measure: Aggression (externalizing behavior)
timeFrame: 1 year
measure: Inattention
timeFrame: 1 year
measure: Hyperactivity/Impulsivity
timeFrame: 1 year
Locations:
Study officials:
affiliation: Stockholm University
name: Lilianne Eninger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stockholm University
name: Håkan Fischer, Department Head, PhD
role: STUDY_CHAIR
References:
citation: 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.