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

NCT03132805 | Completed Results DMC

• 2 other identifiers: DA039869R01DA039869
• Study Type: interventional
• Target: 5,233
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aggression

Outcome Measures

Primary Outcomes (2)

• Change in Direct Classroom Observations of Student Behavior Between Pre-test and Post-test, 6 Months After the Pre-test.

  Classroom observations of student behavior were carried out by independent observers on two occasions, one week apart, at pre- and post-test respectively. The behaviors observed were on-task and physical aggression. Behaviors were observed in 10 second intervals and were recorded as present if they occurred at least once during a 10 second interval. The per interval on-task and physical aggression scores could range from 0-1, with 0 signifying the behavior was not observed and 1 signifying the behavior was observed. The on-task and physical aggression scores used in the analyses were the average score across all of the 10-second intervals the student was observed. (Adapted from Tapp, Wehby \& Ellis, 1995).

  The observations are carried out at pre-test and at post-test, 6 months after the pre-test.

• Teacher Ratings of Student On-task and Aggressive-disruptive Behavior in the Classroom.

  Change in Teacher Observation of Classroom Adaptation between pre-test and post-test, 6 months after the pre-test. Student adaptation to classroom task demands are rated by teachers over the last 3 weeks on a 6-point frequency scale (1 = almost never to 6 = almost always). The domains include authority acceptance and readiness to learn. Authority acceptance items include compliance with classroom rules, and readiness to learn items reflect attentive classroom behaviors (e.g. stays on task). The mean of the teacher ratings across the items making up each of these subscales was used in the outcome analyses. The minimum score for both the authority acceptance and readiness to learn subscales was 1 and maximum score was 6. Higher scores on both subscales reflect greater adaptation.

  The ratings are carried out at pre-test, post-test, 6 months after the pre-test.

Secondary Outcomes (4)

• Change in Peer Assessment Inventory Between Pre-test and Post-test, 6 Months After the Pre-test.

  The peer nomination instrument is administered at pre-test and at post-test, 6 months after the pre-test.

• 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.

  This scale will be administered at pre-test and post-test, 6-months after the pre-test.

• Change in Teacher Sense of Self Efficacy Scale Between Pre-test and Post-test, 6-months After the Pre-test.

  This scale will be administered at pre-test and post-test, 6 months after the pre-test.

• Change in the Maslach Burnout Inventory Between Pre-test and Post-test, 6 Months After the Pre-test.

  This scale will be administered at pre-test and post-test, 6 months after the pre-test.

Study Arms (3)

Control

NO INTERVENTION

Schools which receive no intervention

PATHS to PAX

EXPERIMENTAL

Universal classroom-based preventive intervention designed to reduce aggression.

Behavioral: PATHS to PAX

PATHS to PAX and the IncredibleYears

EXPERIMENTAL

The combination of PATHS to PAX with the Incredible Years child and parent groups.

Behavioral: PATHS to PAX and the Incredible Years

Interventions

PATHS to PAX BEHAVIORAL

A universal classroom-based preventive intervention designed to prevent aggression.

PATHS to PAX

PATHS to PAX and the Incredible Years BEHAVIORAL

A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.

PATHS to PAX and the IncredibleYears

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Students must be enrolled in regular education classrooms.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (6)

• Maslach, C., Jackson, S. E., & Leiter, M. P. (1997). Maslach Burnout Inventory: Third edition. In C. P. Zalaquett & R. J. Wood (Eds.), Evaluating stress: A book of resources (pp. 191-218). Scarecrow Education.

  BACKGROUND

• Tapp, J., Wehby, J., & Ellis, D. (1995). A multiple option observation system for experimental studies: MOOSES. Behavior Research Methods, Instruments & Computers, 27(1), 25-31.

  BACKGROUND

• Harter S, Pike R. The pictorial scale of perceived competence and social acceptance for young children. Child Dev. 1984 Dec;55(6):1969-82.

  PMID: 6525886 BACKGROUND

• Main, S., & Hammond, L. (2008). Best Practice or Most Practiced? Pre-Service Teachers' Beliefs about Effective Behaviour Management Strategies and Reported Self-Efficacy. Australian Journal of Teacher Education, 33, 28-39.

  BACKGROUND

• Werthamer-Larsson L, Kellam S, Wheeler L. Effect of first-grade classroom environment on shy behavior, aggressive behavior, and concentration problems. Am J Community Psychol. 1991 Aug;19(4):585-602. doi: 10.1007/BF00937993.

  PMID: 1755437 BACKGROUND

• Domitrovich CE, Bradshaw CP, Berg JK, Pas ET, Becker KD, Musci R, Embry DD, Ialongo N. How Do School-Based Prevention Programs Impact Teachers? Findings from a Randomized Trial of an Integrated Classroom Management and Social-Emotional Program. Prev Sci. 2016 Apr;17(3):325-37. doi: 10.1007/s11121-015-0618-z.

  PMID: 26749578 BACKGROUND

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Limitations and Caveats

Due to the COVID-19 school related disruptions, we were unable to fully complete the implementation of the interventions for the 4th cohort. We were unable to complete the Classroom Observations of Student Behavior, Peer Assessments, and Perceived Competence of Social Acceptance at post-test in the 4th cohort. The Teacher Observation of Classroom Adaptation scales were completed based on the virtual-learning environment for the one-year follow-up of the 4th cohort of students.

Results Point of Contact

• Title: Nicholas S. Ialongo, Principal Investigator
• Organization: Johns Hopkins University

nialong1@jhu.edu

410-493-1252

Study Officials

• Nicholas Ialongo, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blind to intervention status.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Schools are randomly assigned to 1 of 3 conditions, control, universal classroom-based preventive intervention, and universal classroom-based intervention plus an indicated preventive intervention. Data on student outcomes to be collected at pre- post- and 6 month follow-up. \*Enrollment numbers reflect both students and teachers who agreed to participate in the study.

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 28, 2017
• Study Start: June 1, 2016
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 2, 2022
• Results First Posted: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)