NCT03132805: P2P+IY

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

Completed NA Results posted Last updated 2 August 2022

What this trial tests

NA trial testing PATHS to PAX in Aggression in 5,233 participants. Completed in 30 April 2021.

Timeline

1 June 2016

Primary endpoint
30 April 2021

30 April 2021

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	prevention
Enrollment	5,233
Start date	1 June 2016
Primary completion	30 April 2021
Estimated completion	30 April 2021
Sites	1 location across United States

Drugs / interventions tested

• PATHS to PAX
• PATHS to PAX and the Incredible Years

Conditions studied

• Aggression — all drugs for Aggression →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

5 and older, any sex, with Aggression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

On-Task

Group	Value	95% CI
Control	0.42	± 0.03
PATHS to PAX	0.446	± 0.02
PATHS to PAX and the IncredibleYears	0.453	± 0.02

Physical Aggression

Group	Value	95% CI
Control	0.004	± 0.001
PATHS to PAX	0.001	± 0.001
PATHS to PAX and the IncredibleYears	0.001	± 0.001

Teacher Ratings of Student On-task and Aggressive-disruptive Behavior in the Classroom. Primary · 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 outco

Readiness to Learn

Group	Value	95% CI
Control	4.18	± 0.09
PATHS to PAX	4.50	± 0.06
PATHS to PAX and the IncredibleYears	4.53	± 0.09

Authority Acceptance

Group	Value	95% CI
Control	4.98	± 0.06
PATHS to PAX	5.19	± 0.07
PATHS to PAX and the IncredibleYears	5.14	± 0.06

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

Group	Value	95% CI
Control	0.819	± 0.02
PATHS to PAX	0.806	± 0.01
PATHS to PAX and the IncredibleYears	0.816	± 0.02

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. Secondary · 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 c

Group	Value	95% CI
Control	3.36	± 0.04
PATHS to PAX	3.36	± 0.03
PATHS to PAX and the IncredibleYears	3.41	± 0.04

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

Teacher Sense of Social Emotional Learning Self Efficacy

Group	Value	95% CI
Control	3.56	± 0.08
PATHS to PAX	4.08	± 0.09
PATHS to PAX and the IncredibleYears	3.92	± 0.08

Teacher Sense of Behavior Management Self Efficacy

Group	Value	95% CI
Control	3.82	± 0.07
PATHS to PAX	4.23	± 0.07
PATHS to PAX and the IncredibleYears	4.09	± 0.07

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

Group	Value	95% CI
Control	4.02	± 0.19
PATHS to PAX	3.10	± 0.23
PATHS to PAX and the IncredibleYears	3.40	± 0.20

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.