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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04512157
Other study ID # 259-2012-71
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2012
Est. completion date September 30, 2016

Study information

Verified date August 2020
Source Stockholm University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 285
Est. completion date September 30, 2016
Est. primary completion date September 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 5 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Stockholm University Göteborg University, Tarleton State University

Outcome

Type Measure Description Time frame Safety issue
Other Social withdrawal (internalizing behavior) 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
Other Anxiety/somatic problems (internalizing behavior) 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
Other Aggression (externalizing behavior) 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
Other Inattention 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
Other Hyperactivity/Impulsivity 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Prosocial/communication skills 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
Secondary Child's Emotional self-regulation 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
Secondary Child's Academic skills 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
Secondary Prosocial skills 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
Secondary Task orientation 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
Secondary Social cooperation 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
Secondary Social interaction 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
Secondary Social independence 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