- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06908330
Increasing Kindergarten Social-Emotional Skills for Positive Long-Term Mental Health
Increasing Kindergarten Social-Emotional Skills for Positive Long-Term Mental Health: A Pilot Test of the Strengthening Social-Emotional Skills for Relating and Thriving at School (SSTRS) Program
The goal of this clinical trial is to learn if the Social-emotional Skills for Thriving and Relating at School (SSTRS) Program can help children entering kindergarten and their families. The main questions it aims to answer are: 1) Do children who participate in SSTRS have better social-emotional skills and mental health? and 2) Do parents who participate in SSTRS have more positive parenting skills and involvement in their children's learning?
Researchers will compare the SSTRS Program to the regular kindergarten curriculum without SSTRS to see if being in SSTRS helps children to have better mental health and parents to have better parenting skills.
Kindergarteners will have daily SSTRS lessons in their kindergarten classes for 8 weeks.
Their parents will watch videos and attend group meetings with other parents and answer questions about their own and their children's behaviors and mental health
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katherine Pears, Ph.D.
- Phone Number: 5414852711
- Email: katherinep@oslc.org
Study Contact Backup
- Name: Deena Scheidt
- Phone Number: 5414852711
- Email: deenas@oslc.org
Study Locations
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Oregon
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Eugene, Oregon, United States, 97401
- Oregon Social Learning Center
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Contact:
- Katherine Pears, Ph.D.
- Phone Number: 5414852711
- Email: katherinep@oslc.org
-
Contact:
- Deena Scheidt
- Phone Number: 5414852711
- Email: deenas@oslc.org
-
Contact:
- Katherine Pears, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- child entering kindergarten in school that is participiating in the study
Exclusion Criteria:
- being in a classroom in which the teacher or EA was previously trained in another closely-related treatment protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SSTRS group
These participants will participate in the SSTRS intervention.
|
The SSTRS Program is a developmentally-tailored, school-based preventive intervention focusing on children and their parents at the critical transition to kindergarten to prevent deficits in children's social-emotional skills-which are known transdiagnostic risk factors for a range of mental health problems.
Children receive SSTRS programming during their regular school day for eight weeks at the beginning of the school year.
Parents receive SSTRS programming via informational videos and virtual parenting groups during the same time period.
|
|
No Intervention: Services as Usual
These participants will receive kindergarten programming as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths & Difficulties Questionnaire
Time Frame: Parents will complete the measure at baseline, 2 months post-baseline at the end of the intervention and 9 months post-baseline. Teachers will complete the measure at 9 months post-baseline.
|
Parent and teacher report on the 25-item measure yields five subscales: Emotional Symptoms Scale (scores range 0-10, high scores indicate more problems), Conduct Problems Scale (scores range 0-10, high scores indicate more problems), Hyperactivity Scale (scores range 0-10, high scores indicate more problems) , Peer Problems Scale (scores range 0-10, high scores indicate more problems), and Prosocial Scale (scores range 0-10, high scores indicate better social skills).
A Total Difficulties Score can also be derived by summing all of the scales except the Prosocial Scale resulting in a score raniging from 0 to 40 with higher scores denoting greater difficulties.
|
Parents will complete the measure at baseline, 2 months post-baseline at the end of the intervention and 9 months post-baseline. Teachers will complete the measure at 9 months post-baseline.
|
|
Office discipline referrals
Time Frame: These will be collected at 9 months post-baseline.
|
These are records of referrals for serious behaviors within the school setting.
They are administartive records.
|
These will be collected at 9 months post-baseline.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine Pears, Ph.D., Oregon Social Learning Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R34MH138714 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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