Increasing Kindergarten Social-Emotional Skills for Positive Long-Term Mental Health

NCT06908330 | Not Yet Recruiting

• 1 other identifier: R34MH138714
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parenting Behavior; Social Emotional Competence; Internalizing Behavior; Externalizing Behavior

Outcome Measures

Primary Outcomes (2)

• Strengths & Difficulties Questionnaire

  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

  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.

Study Arms (2)

SSTRS group

EXPERIMENTAL

These participants will participate in the SSTRS intervention.

Behavioral: Social-emotional Skills for Thriving and Relating at School Program

Services as Usual

NO INTERVENTION

These participants will receive kindergarten programming as usual.

Interventions

Social-emotional Skills for Thriving and Relating at School Program BEHAVIORAL

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.

SSTRS group

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• child entering kindergarten in school that is participiating in the study

You may not qualify if:

• being in a classroom in which the teacher or EA was previously trained in another closely-related treatment protocol

Sponsors & Collaborators

• Oregon Social Learning Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Oregon Social Learning Center

Eugene, Oregon, 97401, United States

Location

Study Officials

• Katherine Pears, Ph.D.

  Oregon Social Learning Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Pears, Ph.D.

CONTACT

5414852711; katherinep@oslc.org

Deena Scheidt

CONTACT

5414852711; deenas@oslc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 3, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available no later than 2027. There is no end date.
• Access Criteria: Access will be granted according to the procedures for accessing data from the NDA.

Locations

US (1)