P2P+IY: An Evaluation of an Integrated Approach to Prevention and Early Intervention in the Elementary School Years

• Sponsor: Johns Hopkins Bloomberg School of Public Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03132805
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 5,233
• Location: 1
• Arms: 3
• Actual Duration (Months): 58.9
• Patients Per Site Per Month: 88.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aggression	Behavioral: PATHS to PAX; Behavioral: PATHS to PAX and the Incredible Years	N/A

Detailed Description

Aggressive behavior in the elementary school years is a strong indicator of antisocial behavior, drug abuse and low educational and occupational attainment in adolescence and young adulthood. The Good Behavior Game (GBG) and Promoting Alternative Thinking Strategies (PATHS) represent two of a handful of universal, elementary school, preventive interventions which have been shown in large scale, randomized controlled trials to have an immediate and beneficial impact on aggression. Promoting Alternative Thinking Strategies seeks to accomplish reductions in aggressive behavior via teacher led instruction aimed at facilitating emotion regulation and social problem-solving, whereas the Good Behavior Game provides teachers with an efficient means of reducing aggressive behavior using social learning principles within a game-like context. Importantly, however, the effects of the Good Behavior Game on aggressive behavior proved modest in the first and second generation Johns Hopkins University Preventive Intervention Research Center randomized field trials. This has been the case for Promoting Alternative Thinking Strategies as well. The investigators recently completed a 27-school, randomized controlled trial examining whether the combination of these interventions, which the investigators refer to as PATHS to PAX, would yield significantly greater impact on aggressive behavior than the Good Behavior Game alone. The rationale for expecting greater impact was that the use of the Good Behavior Game should result in reductions in aggressive behavior, which should then facilitate the acquisition of the emotion regulation and social problem-solving skills taught in Promoting Alternative Thinking Strategies. PATHS to PAX did result in a modestly greater reduction in aggressive behavior than the Good Behavior Game alone at 1-year post-test. Yet, the most aggressive students still failed to sufficiently benefit from the PATHS to PAX intervention. Accordingly, in this application, the investigators propose to examine whether the addition of the Incredible Years (IY), an evidence-based preventive and treatment intervention aimed at reducing aggressive behavior, to PATHS to PAX would yield greater impact on these behaviors than the PATHS to PAX intervention alone. The investigators also propose to examine whether the combination of the PATHS to PAX plus the Incredible Years results in increased frequency of implementation of the PATHS to PAX intervention. It is hypothesized that relative to teachers in the PATHS to PAX alone condition, teachers in the PATHS to PAX plus Incredible Years condition will perceive PATHS to PAX as more efficacious and will therefore be more likely to implement it. Four cohorts of 12 schools each will be recruited with schools randomly assigned to 1 of 3 intervention conditions: 1) Control; 2) PATHS to PAX; or 3) PATHS to PAX plus the Incredible Years. Assessments of student outcomes will be carried out at pre-test and post-test in the fall and spring of the initial school year for each cohort and at a 6-month and 1-year follow-up. Teacher outcomes in terms of classroom behavior management self-efficacy, perceptions of the efficacy of PATHS to PAX, and teacher burn out will be assessed at 4-time points during the initial year for each cohort. Assessment of teacher implementation of PATHS to PAX will be carried out on a daily basis throughout the intervention year. Aims 1 and 2 represent the primary goals of this application, whereas Aims 3 and 4 represent secondary, or exploratory, aims:

1. To evaluate, utilizing a group randomized design, whether the combination of PATHS to PAX plus Incredible Years child and parent groups yields greater reductions in aggressive behavior than PATHS to PAX alone.

2. To examine whether the frequency of PATHS to PAX intervention implementation (i.e., number of times and minutes the Good Behavior Game is played per day and Promoting Alternative Thinking Strategies lessons taught per week) will be greater in the PATHS to PAX plus Incredible Years condition.

3. To explore whether any evidence of differential benefits in terms of student outcomes between the PATHS to PAX versus PATHS to PAX plus Incredible Years conditions at post-test are a function of differences in PATHS to PAX implementation (e.g., number of Promoting Alternative Thinking Strategies lessons administered and the number of Good Behavior Games played and the duration of the games played). In addition, the investigators will explore whether any differences in implementation across the two intervention conditions is mediated by differences in teacher behavior management self-efficacy, perceived efficacy of PATHS to PAX in improving student behavior, and teacher burn out at post-test.

4. To explore the moderating effects of teacher, parent and student characteristics on intervention outcomes by expanding the models used for Aims 1 & 2 to include interactions between those characteristics and study condition,

Study Design

• Study Type: Interventional
• Actual Enrollment: 5233 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome assessors are blind to intervention status.
• Primary Purpose: Prevention
• Official Title: An Evaluation of an Integrated Approach to Prevention and Early Intervention in the Elementary School Years
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Apr 30, 2021
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Schools which receive no intervention
Experimental: PATHS to PAX Universal classroom-based preventive intervention designed to reduce aggression.	Behavioral: PATHS to PAX; A universal classroom-based preventive intervention designed to prevent aggression.
Experimental: PATHS to PAX and the IncredibleYears The combination of PATHS to PAX with the Incredible Years child and parent groups.	Behavioral: PATHS to PAX and the Incredible Years; A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.

Outcome Measures

Primary Outcome Measures

1. Change in Direct Classroom Observations of Student Behavior Between Pre-test and Post-test, 6 Months After the Pre-test. [The observations are carried out at pre-test and at 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).

2. Teacher Ratings of Student On-task and Aggressive-disruptive Behavior in the Classroom. [The ratings are carried out at pre-test, post-test, 6 months after the pre-test.]

   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.

Secondary Outcome Measures

1. 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.]

   Students are asked to nominate fellow students in terms of who they like, play with, and perceive as friends. Individual students were read aloud the names of the other students in the classroom. The student being interviewed was asked if they knew the named student. The student was then asked whether the peer nomination descriptors fit the named student (Do you like [student]?, Do you play with [student]?, and Is (s)he one of your best friends?). The student's summary score reflected the mean percentage of nominations received across the 3 items. A higher percentage reflects a student received a greater number of nominations from classmates.

2. 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.]

   The Change in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children assesses the student's perceived competence in the domains of peer acceptance. Items on this instrument present two pictorial alternatives, one of a child displaying high competence in the social acceptance domain and one that depicts less competence. Students were asked which pictorial plate was most like him/her. After making that decision, the student is then asked if the chosen picture is "really true for me" and "sort of true for me." Each item is scored on a 4-point scale, 4 would be the most competent and 1 would designate the least competent. The mean of the items was used in the outcome analyses.

3. 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.]

   This scale assesses teacher sense of self-efficacy in the instructional and classroom behavior management domains. We assessed two distinct dimensions of teachers' perceived self-efficacy that reflect skills uniquely associated with the strategies included in the two interventions. The Behavior Management Self-Efficacy Scale (Main and Hammond 2008) included 14 items regarding classroom behavior management (e.g., I am able to use a variety of behavior management techniques; α= 0.92). The Social-Emotional Learning Efficacy Scale (Domitrovich, et al., 2016) included 8 items which focused on teachers' perceived efficacy to promote social-emotional skills in students (e.g., I am able to teach children to show empathy and compassion for each other; α= 0.91). For each scale, item responses were on a 5-point Likert-type scale and were averaged. For both subscales the minimum score was 1 and maximum was 5, with higher scores indicating greater efficacy.

4. 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.]

   The Maslach Burnout Inventory assesses how frequently teachers experience feelings of burnout in the work place. Teachers completed the Maslach Burnout Inventory (MBI;Maslach et al. 1997) at pretest and post-test. One scale was used in the analyses: emotional exhaustion (9 items, e.g., I feel used up at the end of the workday, α=0.94). Responses were rated on a 7-point scale from never to every day with higher scores indicating greater emotional exhaustion (i.e., greater burnout). For this subscale, the minimum score was 1 and maximum score was 7. Therefore, low scores on emotional exhaustion were desired.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Students must be enrolled in regular education classrooms.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Nicholas Ialongo, PhD, Johns Hopkins Bloomberg School of Public Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 4, 2017

More Information

Publications

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

• Responsible Party: Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT03132805
• Other Study ID Numbers: DA039869; R01DA039869
• First Posted: Apr 28, 2017
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aggression

Study Results

Participant Flow

Pre-assignment Detail

In accordance with our original protocol, we successfully recruited 48 schools over the four cohorts, which were subsequently randomized to one of three conditions. Randomization occurred at the school level and not at the teacher or student level within school. A total of 4,923 students with parental consent to participate were enrolled over the four cohorts from the 48 participating schools. A total of 310 teachers were also enrolled over the four cohorts from the 48 participating schools.

Arm/Group Title	Control	PATHS to PAX	PATHS to PAX and the IncredibleYears
Arm/Group Description	Schools which receive no intervention	Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	The combination of PATHS to PAX with the Incredible Years child and parent groups. PATHS to PAX and the Incredible Years: A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.
Period Title: Overall Study
STARTED	1629	1792	1812
Students	1527	1694	1702
Teachers	102	98	110
Baseline Data Collection (Students)	1442	1603	1617
Post-test Data Collection (Students)	1395	1564	1609
Baseline Data Collection (Teachers)	102	91	99
Post-test Data Collection (Teachers)	92	87	90
COMPLETED	1487	1651	1699
NOT COMPLETED	142	141	113

Baseline Characteristics

Arm/Group Title	Control	PATHS to PAX	PATHS to PAX and the IncredibleYears	Total
Arm/Group Description	Schools which receive no intervention	Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	The combination of PATHS to PAX with the Incredible Years child and parent groups. PATHS to PAX and the Incredible Years: A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.	Total of all reporting groups
Overall Participants	1544	1694	1716	4954
Age (Count of Participants)
<=18 years	1442 93.4%	1603 94.6%	1617 94.2%	4662 94.1%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	102 6.6%	91 5.4%	99 5.8%	292 5.9%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	725 47%	820 48.4%	847 49.4%	2392 48.3%
Male	717 46.4%	783 46.2%	770 44.9%	2270 45.8%
Female	92 6%	86 5.1%	92 5.4%	270 5.5%
Male	10 0.6%	5 0.3%	7 0.4%	22 0.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	155 10%	165 9.7%	42 2.4%	362 7.3%
Not Hispanic or Latino	1287 83.4%	1438 84.9%	1575 91.8%	4300 86.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Hispanic or Latino	2 0.1%	2 0.1%	2 0.1%	6 0.1%
Not Hispanic or Latino	100 6.5%	89 5.3%	97 5.7%	286 5.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	7 0.5%	25 1.5%	10 0.6%	42 0.8%
Asian	12 0.8%	11 0.6%	14 0.8%	37 0.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1208 78.2%	1341 79.2%	1469 85.6%	4018 81.1%
White	215 13.9%	226 13.3%	124 7.2%	565 11.4%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	3 0.2%	4 0.2%	1 0.1%	8 0.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	58 3.8%	41 2.4%	47 2.7%	146 2.9%
White	34 2.2%	38 2.2%	46 2.7%	118 2.4%
More than one race	2 0.1%	2 0.1%	2 0.1%	6 0.1%
Unknown or Not Reported	5 0.3%	6 0.4%	3 0.2%	14 0.3%
Region of Enrollment (Participants - Students & Teachers) [Number]
United States	1544 100%	1694 100%	1716 100%	4954 100%
Teacher Observation of Child Adaptation- Revised (TOCA-R) (units on a scale) [Mean (Standard Deviation) ]
Readiness to Learn	4.115 (1.381)	4.290 (1.336)	4.193 (1.363)	4.202 (1.361)
Authority Acceptance	5.074 (1.104)	5.300 (0.9506)	5.217 (1.021)	5.201 (1.028)
Independent Classroom Observations of Student Behavior (percentage of intervals observed) [Mean (Standard Deviation) ]
On-Task	0.4921 (0.2690)	0.5172 (0.2476)	0.5379 (0.2783)	0.5166 (0.2657)
Physical Aggression	0.0021 (0.0124)	0.0015 (0.0096)	0.0020 (0.0115)	0.0019 (0.0112)
Peer Assessment Inventory (percentage of nominations received) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of nominations received]	0.812 (0.187)	0.816 (0.173)	0.816 (0.170)	0.815 (0.177)
The Pictorial Scale of Perceived Competence and Acceptance For Young Children (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.352 (0.591)	3.305 (0.614)	3.328 (0.591)	3.328 (0.599)
The Behavior Management Self-Efficacy Scale & The Social-Emotional Learning Efficacy Scale (units on a scale) [Mean (Standard Deviation) ]
Behavior Management Self-Efficacy Scale	3.80 (0.54)	3.89 (0.55)	3.83 (0.57)	3.84 (0.55)
Social-Emotional Learning Efficacy Scale	3.57 (0.62)	3.76 (0.53)	3.65 (0.59)	3.66 (0.59)
The Maslach Burnout Inventory (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.64 (1.58)	3.62 (1.49)	3.90 (1.47)	3.72 (1.51)

Outcome Measures

1. Primary Outcome

Title	Change in Direct Classroom Observations of Student Behavior Between Pre-test and Post-test, 6 Months After the Pre-test.
Description	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).
Time Frame	The observations are carried out at pre-test and at post-test, 6 months after the pre-test.

Outcome Measure Data

Analysis Population Description

Students enrolled within participating schools with parental consent to participate in the trial who were observed at baseline and at post-test.

Arm/Group Title	Control	PATHS to PAX	PATHS to PAX and the IncredibleYears
Arm/Group Description	Schools which receive no intervention	Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	The combination of PATHS to PAX with the Incredible Years child and parent groups. PATHS to PAX and the Incredible Years: A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.
Measure Participants	763	891	1129
On-Task	0.42 (0.03)	0.446 (0.02)	0.453 (0.02)
Physical Aggression	0.004 (0.001)	0.001 (0.001)	0.001 (0.001)

2. Primary Outcome

Title	Teacher Ratings of Student On-task and Aggressive-disruptive Behavior in the Classroom.
Description	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.
Time Frame	The ratings are carried out at pre-test, post-test, 6 months after the pre-test.

Outcome Measure Data

Analysis Population Description

Students enrolled in participating schools with parental consent to participate in the trial who were teacher rated at baseline and post-test.

Arm/Group Title	Control	PATHS to PAX	PATHS to PAX and the IncredibleYears
Arm/Group Description	Schools which receive no intervention	Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	The combination of PATHS to PAX with the Incredible Years child and parent groups. PATHS to PAX and the Incredible Years: A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.
Measure Participants	1316	1474	1531
Readiness to Learn	4.18 (0.09)	4.50 (0.06)	4.53 (0.09)
Authority Acceptance	4.98 (0.06)	5.19 (0.07)	5.14 (0.06)

3. Secondary Outcome

Title	Change in Peer Assessment Inventory Between Pre-test and Post-test, 6 Months After the Pre-test.
Description	Students are asked to nominate fellow students in terms of who they like, play with, and perceive as friends. Individual students were read aloud the names of the other students in the classroom. The student being interviewed was asked if they knew the named student. The student was then asked whether the peer nomination descriptors fit the named student (Do you like [student]?, Do you play with [student]?, and Is (s)he one of your best friends?). The student's summary score reflected the mean percentage of nominations received across the 3 items. A higher percentage reflects a student received a greater number of nominations from classmates.
Time Frame	The peer nomination instrument is administered at pre-test and at post-test, 6 months after the pre-test.

Outcome Measure Data

Analysis Population Description

Students enrolled within participating schools with parental consent to participate in the trial who were interviewed at baseline and at post-test.

Arm/Group Title	Control	PATHS to PAX	PATHS to PAX and the IncredibleYears
Arm/Group Description	Schools which receive no intervention	Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	The combination of PATHS to PAX with the Incredible Years child and parent groups. PATHS to PAX and the Incredible Years: A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.
Measure Participants	847	918	1065
Mean (Standard Error) [percentage of nominations received]	0.819 (0.02)	0.806 (0.01)	0.816 (0.02)

4. Secondary Outcome

Title	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.
Description	The Change in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children assesses the student's perceived competence in the domains of peer acceptance. Items on this instrument present two pictorial alternatives, one of a child displaying high competence in the social acceptance domain and one that depicts less competence. Students were asked which pictorial plate was most like him/her. After making that decision, the student is then asked if the chosen picture is "really true for me" and "sort of true for me." Each item is scored on a 4-point scale, 4 would be the most competent and 1 would designate the least competent. The mean of the items was used in the outcome analyses.
Time Frame	This scale will be administered at pre-test and post-test, 6-months after the pre-test.

Outcome Measure Data

Analysis Population Description

Students enrolled in participating schools with parental consent to participate in the trial who were interviewed at baseline and post-test.

Arm/Group Title	Control	PATHS to PAX	PATHS to PAX and the IncredibleYears
Arm/Group Description	Schools which receive no intervention	Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	The combination of PATHS to PAX with the Incredible Years child and parent groups. PATHS to PAX and the Incredible Years: A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.
Measure Participants	847	918	1065
Mean (Standard Error) [score on a scale]	3.36 (0.04)	3.36 (0.03)	3.41 (0.04)

5. Secondary Outcome

Title	Change in Teacher Sense of Self Efficacy Scale Between Pre-test and Post-test, 6-months After the Pre-test.
Description	This scale assesses teacher sense of self-efficacy in the instructional and classroom behavior management domains. We assessed two distinct dimensions of teachers' perceived self-efficacy that reflect skills uniquely associated with the strategies included in the two interventions. The Behavior Management Self-Efficacy Scale (Main and Hammond 2008) included 14 items regarding classroom behavior management (e.g., I am able to use a variety of behavior management techniques; α= 0.92). The Social-Emotional Learning Efficacy Scale (Domitrovich, et al., 2016) included 8 items which focused on teachers' perceived efficacy to promote social-emotional skills in students (e.g., I am able to teach children to show empathy and compassion for each other; α= 0.91). For each scale, item responses were on a 5-point Likert-type scale and were averaged. For both subscales the minimum score was 1 and maximum was 5, with higher scores indicating greater efficacy.
Time Frame	This scale will be administered at pre-test and post-test, 6 months after the pre-test.

Outcome Measure Data

Analysis Population Description

Consenting teachers assigned to Kindergarten - second grade in participating trial schools who were assessed at baseline and post-test.

Arm/Group Title	Control	PATHS to PAX	PATHS to PAX and the IncredibleYears
Arm/Group Description	Schools which receive no intervention	Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	The combination of PATHS to PAX with the Incredible Years child and parent groups. PATHS to PAX and the Incredible Years: A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.
Measure Participants	91	87	90
Teacher Sense of Social Emotional Learning Self Efficacy	3.56 (0.08)	4.08 (0.09)	3.92 (0.08)
Teacher Sense of Behavior Management Self Efficacy	3.82 (0.07)	4.23 (0.07)	4.09 (0.07)

6. Secondary Outcome

Title	Change in the Maslach Burnout Inventory Between Pre-test and Post-test, 6 Months After the Pre-test.
Description	The Maslach Burnout Inventory assesses how frequently teachers experience feelings of burnout in the work place. Teachers completed the Maslach Burnout Inventory (MBI;Maslach et al. 1997) at pretest and post-test. One scale was used in the analyses: emotional exhaustion (9 items, e.g., I feel used up at the end of the workday, α=0.94). Responses were rated on a 7-point scale from never to every day with higher scores indicating greater emotional exhaustion (i.e., greater burnout). For this subscale, the minimum score was 1 and maximum score was 7. Therefore, low scores on emotional exhaustion were desired.
Time Frame	This scale will be administered at pre-test and post-test, 6 months after the pre-test.

Outcome Measure Data

Analysis Population Description

Consenting teachers assigned to Kindergarten - second grade in participating trial schools who were assessed at baseline and post-test.

Arm/Group Title	Control	PATHS to PAX	PATHS to PAX and the IncredibleYears
Arm/Group Description	Schools which receive no intervention	Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	The combination of PATHS to PAX with the Incredible Years child and parent groups. PATHS to PAX and the Incredible Years: A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.
Measure Participants	91	87	90
Mean (Standard Error) [score on a scale]	4.02 (0.19)	3.10 (0.23)	3.40 (0.20)

Adverse Events

Time Frame	Over the four year intervention implementation phase of the trial.
Adverse Event Reporting Description	No difference
Arm/Group Title	Control		PATHS to PAX		PATHS to PAX and the IncredibleYears
Arm/Group Description	Schools which receive no intervention		Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.		The combination of PATHS to PAX with the Incredible Years child and parent groups. PATHS to PAX and the Incredible Years: A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.
All Cause Mortality
	Control		PATHS to PAX		PATHS to PAX and the IncredibleYears
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1629 (0%)		0/1792 (0%)		0/1812 (0%)
Serious Adverse Events
	Control		PATHS to PAX		PATHS to PAX and the IncredibleYears
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1629 (0%)		0/1792 (0%)		0/1812 (0%)
Other (Not Including Serious) Adverse Events
	Control		PATHS to PAX		PATHS to PAX and the IncredibleYears
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1629 (0%)		0/1792 (0%)		0/1812 (0%)

Limitations/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.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.