Trial Outcomes & Findings for An Evaluation of an Integrated Approach to Prevention and Early Intervention in the Elementary School Years (NCT NCT03132805)

Last Updated: 2022-08-02

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

5233 participants

Primary outcome timeframe

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

Results posted on

2022-08-02

Participant Flow

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.

Unit of analysis: Schools

Participant milestones

Participant milestones
Measure	Control Schools which receive no intervention	PATHS to PAX Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	PATHS to PAX and the IncredibleYears 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.
Overall Study STARTED	1629 16	1792 16	1812 16
Overall Study Students	1527 16	1694 16	1702 16
Overall Study Teachers	102 16	98 16	110 16
Overall Study Baseline Data Collection (Students)	1442 16	1603 16	1617 16
Overall Study Post-test Data Collection (Students)	1395 16	1564 16	1609 16
Overall Study Baseline Data Collection (Teachers)	102 16	91 16	99 16
Overall Study Post-test Data Collection (Teachers)	92 16	87 16	90 16
Overall Study COMPLETED	1487 16	1651 16	1699 16
Overall Study NOT COMPLETED	142 0	141 0	113 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Schools which receive no intervention	PATHS to PAX Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	PATHS to PAX and the IncredibleYears 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.
Overall Study Lost to Follow-up	142	141	113

Baseline Characteristics

Baseline characteristics of enrolled students and enrolled teachers are represented on different rows.

Baseline characteristics by cohort

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Control n=763 Participants Schools which receive no intervention	PATHS to PAX n=891 Participants Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	PATHS to PAX and the IncredibleYears n=1129 Participants 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.
Change in Direct Classroom Observations of Student Behavior Between Pre-test and Post-test, 6 Months After the Pre-test. On-Task	0.42 percentage of intervals observed Standard Error 0.03	0.446 percentage of intervals observed Standard Error 0.02	0.453 percentage of intervals observed Standard Error 0.02
Change in Direct Classroom Observations of Student Behavior Between Pre-test and Post-test, 6 Months After the Pre-test. Physical Aggression	0.004 percentage of intervals observed Standard Error 0.001	0.001 percentage of intervals observed Standard Error 0.001	0.001 percentage of intervals observed Standard Error 0.001

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Control n=1316 Participants Schools which receive no intervention	PATHS to PAX n=1474 Participants Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	PATHS to PAX and the IncredibleYears n=1531 Participants 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.
Teacher Ratings of Student On-task and Aggressive-disruptive Behavior in the Classroom. Readiness to Learn	4.18 score on a scale Standard Error 0.09	4.50 score on a scale Standard Error 0.06	4.53 score on a scale Standard Error 0.09
Teacher Ratings of Student On-task and Aggressive-disruptive Behavior in the Classroom. Authority Acceptance	4.98 score on a scale Standard Error 0.06	5.19 score on a scale Standard Error 0.07	5.14 score on a scale Standard Error 0.06

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Control n=847 Participants Schools which receive no intervention	PATHS to PAX n=918 Participants Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	PATHS to PAX and the IncredibleYears n=1065 Participants 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.
Change in Peer Assessment Inventory Between Pre-test and Post-test, 6 Months After the Pre-test.	0.819 percentage of nominations received Standard Error 0.02	0.806 percentage of nominations received Standard Error 0.01	0.816 percentage of nominations received Standard Error 0.02

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Control n=847 Participants Schools which receive no intervention	PATHS to PAX n=918 Participants Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	PATHS to PAX and the IncredibleYears n=1065 Participants 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.
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 score on a scale Standard Error 0.04	3.36 score on a scale Standard Error 0.03	3.41 score on a scale Standard Error 0.04

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Control n=91 Participants Schools which receive no intervention	PATHS to PAX n=87 Participants Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	PATHS to PAX and the IncredibleYears n=90 Participants 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.
Change in Teacher Sense of Self Efficacy Scale Between Pre-test and Post-test, 6-months After the Pre-test. Teacher Sense of Social Emotional Learning Self Efficacy	3.56 score on a scale Standard Error 0.08	4.08 score on a scale Standard Error 0.09	3.92 score on a scale Standard Error 0.08
Change in Teacher Sense of Self Efficacy Scale Between Pre-test and Post-test, 6-months After the Pre-test. Teacher Sense of Behavior Management Self Efficacy	3.82 score on a scale Standard Error 0.07	4.23 score on a scale Standard Error 0.07	4.09 score on a scale Standard Error 0.07

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Control n=91 Participants Schools which receive no intervention	PATHS to PAX n=87 Participants Universal classroom-based preventive intervention designed to reduce aggression. PATHS to PAX: A universal classroom-based preventive intervention designed to prevent aggression.	PATHS to PAX and the IncredibleYears n=90 Participants 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.
Change in the Maslach Burnout Inventory Between Pre-test and Post-test, 6 Months After the Pre-test.	4.02 score on a scale Standard Error 0.19	3.10 score on a scale Standard Error 0.23	3.40 score on a scale Standard Error 0.20

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PATHS to PAX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PATHS to PAX and the IncredibleYears

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicholas S. Ialongo, Principal Investigator

Johns Hopkins University

Phone: 410-493-1252

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place