N/A
N=5,233
An Evaluation of an Integrated Approach to Prevention and Early Intervention in the Elementary School Years
Aggression
Bottom Line
View on ClinicalTrials.gov: NCT03132805 ↗Enrolled (actual)
5,233
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: 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 percentage of intervals observed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PATHS to PAX (Behavioral); PATHS to PAX and the Incredible Years (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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.
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.