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N/A Completed N=5,233 Randomized Single-blind Prevention

An Evaluation of an Integrated Approach to Prevention and Early Intervention in the Elementary School Years

Source: ClinicalTrials.gov NCT03132805 ↗
Enrolled (actual)
5,233
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Change in Direct Classroom Observations of Student Behavior Between Pre-test and Post-test, 6 Months After the Pre-test. — 0.42; 0.446; 0.453; 0.004 percentage of intervals observed

Summary

In this study, the investigators propose to examine whether the combination of a universal, elementary school-based preventive intervention with an indicated preventive and treatment intervention would yield greater impact on aggression than the universal preventive intervention alone.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Direct Classroom Observations of Student Behavior Between Pre-test and Post-test, 6 Months After the Pre-test.
0.42; 0.446; 0.453; 0.004; 0.001; 0.001
PRIMARY
Teacher Ratings of Student On-task and Aggressive-disruptive Behavior in the Classroom.
4.18; 4.50; 4.53; 4.98; 5.19; 5.14
SECONDARY
Change in Peer Assessment Inventory Between Pre-test and Post-test, 6 Months After the Pre-test.
0.819; 0.806; 0.816
SECONDARY
Change in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children Between Pre-test and Post-test, 6 Months After the Pre-test.
3.36; 3.36; 3.41
SECONDARY
Change in Teacher Sense of Self Efficacy Scale Between Pre-test and Post-test, 6-months After the Pre-test.
3.56; 4.08; 3.92; 3.82; 4.23; 4.09
SECONDARY
Change in the Maslach Burnout Inventory Between Pre-test and Post-test, 6 Months After the Pre-test.
4.02; 3.10; 3.40

Eligibility Criteria

Inclusion Criteria

  • Students enrolled in kindergarten through second grade classrooms and their teachers.

Exclusion Criteria

  • Students must be enrolled in regular education classrooms.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03132805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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