Supporting Social and Emotional Competence in Preschool Children (NCT04512157) | Clinical Trial Compass
CompletedNot Applicable
Supporting Social and Emotional Competence in Preschool Children
285 participantsStarted 2012-04-01
Plain-language 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.
Who can participate
Age range
4 Years – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.