Children's Social Emotional CompetencePsPATHS_STKNCT04512157
Supporting Social and Emotional Competence in Preschool Children
A study testing Promoting Alternative Thinking Strategies (PATHS), Preschool Edition in people with Children's Social Emotional Competence and Children's Well-being, run by Stockholm University.
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. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Children's Social Emotional Competence, Children's Well-being
- What is being tested?
- Promoting Alternative Thinking Strategies (PATHS), Preschool Edition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2012to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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)
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.
Read the 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.
- Being tested
- Promoting Alternative Thinking Strategies (PATHS), Preschool Edition
- Keywords
- Promoting Alternative Thinking Strategies, Preschool, Children, Sweden, PATHS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Alternative Thinking Strategies (PATHS), Preschool EditionBehavioural
Also called PATHS
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.
| Study group | Role | What they receive |
|---|---|---|
| PATHS, Intervention preschools | Experimental | These preschools implement PATHS for one school year Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (8)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Apr 2012
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children's Social Emotional CompetenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design used was a cluster randomized controlled intervention trial, with a waitlist comparison group, with pre and post-testing.
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University, Tarleton State University
- Responsible party
- Principal investigator, Lilianne Eninger, Stockholm University
- Investigators
- Lilianne Eninger, PhD, Principal investigator, Stockholm UniversityHåkan Fischer, Department Head, PhD, Study chair, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512157
- Sponsor's protocol ID
- 259-2012-71
- Acronym
- PsPATHS_STK
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Publications
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.
PubMed 34326800
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04512157
- Acronym / sponsor ID
- PsPATHS_STK / 259-2012-71
- Keywords
- Promoting Alternative Thinking Strategies, Preschool, Children, Sweden, PATHS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Collaborators
- Göteborg University, Tarleton State University
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The design used was a cluster randomized controlled intervention trial, with a waitlist comparison group, with pre and post-testing.
| Arm | Type | Receives |
|---|---|---|
| PATHS, Intervention preschools | Experimental | Behavioral: Promoting Alternative Thinking Strategies (PATHS), Preschool EditionThese preschools implement PATHS for one school year |
| Waitlist control preschools | No intervention | –Preschool as usual, which does have some social emotional learning but not PATHS specifically |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting Alternative Thinking Strategies (PATHS), Preschool EditionAlso: PATHSPATHS® 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. | Behavioural | PATHS, Intervention preschools |
Primary outcome
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.
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).
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.
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.
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.
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.
8 secondary outcomes
Prosocial/communication skills
Time frame: 1 year
Child's Emotional self-regulation
Time frame: 1 year
Child's Academic skills
Time frame: 1 year
Prosocial skills
Time frame: 1 year
Task orientation
Time frame: 1 year
Social cooperation
Time frame: 1 year
Social interaction
Time frame: 1 year
Social independence
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Derived from this study: PubMed 34326800Eninger 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.
- Individual participant dataSharing planned: Yes. 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)
Related trials for Children's Social Emotional Competence
Recruiting
SAGA for Toddlers. Supporting Children's Linguistic and Socio-Emotional Development in Early Childhood Education and Care
Social Emotional Competence, Language Development
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilianne Eninger, PhD principal investigator
Stockholm University
Håkan Fischer, Department Head, PhD study chair
Stockholm University
Questions about this trial
What is this clinical trial studying?
A study testing Promoting Alternative Thinking Strategies (PATHS), Preschool Edition in people with Children's Social Emotional Competence and Children's Well-being, run by Stockholm University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional knowledge (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.