An Evaluation of an Integrated Approach to Prevention and Early Intervention in the Elementary School Years
Phase: NA
Conditions: Aggression
Sponsor: Johns Hopkins Bloomberg School of Public Health

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Study Protocol and Statistical Analysis Plan 
 
Official Title: 
 
An Evaluation of an Integrated Approach to Prevention and Early Intervention  
in the Elementary School Years 
 
ClinicalTrials.gov ID: NCT03132805 
 
PI Name:  Nicholas Ialongo 
 
 
Note: There were no amendments for changes in the trial design submitted or approved by the Johns 
Hopkins Bloomberg School of Public Health Institutional Review Board after the initial release of the 
ClinicalTrials.Gov protocol on 04/04/2017. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Description 
 
Rationale: 
There is considerable evidence from long-term longitudinal studies that aggressive/disruptive behavior as 
early as entrance into elementary school predicts later antisocial behavior, violence, substance abuse and 
low educational and occupational attainment10,11,12,13,14. In response to that evidence, our Advanced Center 
for Intervention and Services Research (ACISR), the Johns Hopkins Prevention Intervention Research 
Center (JHU PIRC), has carried out a series of large scale randomized trials of promising school-based 
universal preventive interventions targeting aggressive/disruptive behavior in elementary school. Each trial 
has built on the findings of the previous trial in accord with the prevention research cycle as elaborated in 
the Institute of Medicine Report on Reducing Risks for Mental Disorders15. Although we have found 
beneficial proximal and distal intervention effects10,12,16, our results point to the need for integrating our 
universal interventions with evidence-based indicated and early treatment interventions to reduce the 
number of non-responders and to increase the magnitude of intervention effects. We briefly elaborate 
below the history of our trials and the findings that formed the basis for this trial.   
 
The 1st Generation JHU PIRC Field Trial. Our 1st generation trial involved the evaluation of two, first 
grade, universal, preventive interventions in collaboration with the Baltimore City Public Schools (BCPSS). 
Our use of the term “universal preventive intervention” reflects the fact that we intervened with an entire 
population of first grade school children15. This 1st generation trial was fielded in 19 Baltimore City schools 
with two consecutive cohorts of first graders in the 1985-86 and 1986-87 school years.  Two theory-based 
preventive interventions were evaluated, which were exclusively based in the classroom and did not 
directly involve families.  One intervention, the Good Behavior Game17 (GBG), was aimed at 
aggressive/disruptive and off-task behavior, whereas the other intervention, Mastery Learning18,19(ML), 
targeted poor school achievement.   
 
The results of this 1st generation JHU PIRC field trial yielded evidence that the proximal targets of 
aggressive/disruptive behavior and poor achievement were malleable20,21, and that change in the proximal 
targets was associated with change in the distal outcomes in middle school22 and in early adulthood10,11,12 . 
In terms of the immediate impacts, the GBG resulted in significant—albeit modest--reductions relative to 
controls in aggressive/disruptive and off task behavior based on independent observations21 by the end of 
first grade, whereas Mastery Learning resulted in significant but modest improvement in standardized 
reading achievement20. Dolan et al.20 also reported significant beneficial impact of the GBG in terms of 
teacher ratings and peer nominations of aggressive/disruptive behavior in 1st grade.  The GBG appeared 
to have its greatest proximal impact among boys manifesting mild to moderate elevations in 
aggressive/disruptive behavior at pre-test in the fall of first grade20.  With respect to longer term impact, 
Kellam and colleagues reported significant and beneficial impact of the GBG on antisocial behavior, violent 
crime, substance abuse/dependence, and high-risk sexual behavior at ages 19-2010,11,12.  Consistent with 
the variation seen in the immediate impact of the GBG in Dolan et al.20, the greatest effects were found for 
males with mild to moderate elevations in pre-test levels of aggressive/disruptive behavior in 1st grade.    
 
The 2nd Generation JHU PIRC Field Trial. Although promising, we were not satisfied with the magnitude 
of the effects of the 1st generation interventions on students’ behavior and learning. Subsequently, we 
fielded our 2nd generation of JHU PIRC preventive interventions9. We first created an intervention condition 
wherein we combined the GBG with an academic intervention. The decision to combine the GBG with an 
academic intervention reflected the fact that in our 1st generation field trial the GBG had modest proximal 
impact on achievement, whereas Mastery Learning had an impact on early achievement, but had only a 
modest to moderate crossover, or indirect, effect on aggressive/disruptive behavior. Each intervention thus 
appeared to be specific to its own proximal target. Consequently, if we were to reduce early 
aggressive/disruptive behavior and improve academic achievement, both academic achievement and 
aggressive/disruptive and off-task behavior needed to be targeted in a single intervention condition.   
 
In addition to combining the GBG with an academic intervention in our 2nd generation intervention trials, we 
also developed and fielded a universal, family-school partnership (FSP) intervention to contrast with the 
combination of the GBG and an academic intervention. Like the combination of the GBG with an academic 
intervention, the proximal targets of the FSP intervention were poor achievement and aggressive/disruptive 
and off-task behavior. The FSP intervention included a series of 9 workshops led by teachers and school 
mental health professionals, respectively, over the school year that focused on improving parent child 

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behavior management practices and support for their child’s academic performance. The decision to add a 
family-based component was consistent with existing theory and the considerable empirical evidence of the 
important influences that families exert on their children's academic success23,24 and social development25, 
along with the benefits of strong parent-teacher partnerships and parent involvement26 on children’s 
behavior and achievement.  
 
The design of the 2nd generation JHU PIRC trial featured 3 first grade classrooms within each of 9 
Baltimore City elementary schools. The three 1st grade classrooms in each of the nine elementary schools 
were randomly assigned to one of the two intervention conditions or to a control condition.  In addition, 
children within each of the schools were randomly assigned to classrooms.  We found significant proximal 
(elementary school)9,16, intermediate (middle school)3,16, and longer term (high school/early adulthood) 
intervention impacts on aggressive-disruptive behavior/conduct problems16 and academic outcomes3,9,27.  
Both Ialongo et al.3 and Petras et al.16 provided evidence suggesting that the intermediate3 and longer 
term16 intervention impact on aggressive/disruptive behavior/conduct problems was in part a function of the 
proximal impact of the interventions on aggressive-disruptive behavior in early elementary school and on 
the parent-child relationship in terms of lower levels of parent rejection in late childhood/early adolescence3.   
 
To summarize, both the immediate9 and longer-term results of the 2nd generation JHU PIRC trial16,27 
supported our hypothesis that the combination of the GBG with an academic intervention would yield 
greater impact in terms of effect size on academic achievement than that seen in the 1st generation trials, 
wherein the GBG and Mastery Learning were examined separately20.  However, we did not see greater 
impact on aggressive-disruptive behavior as a result of our combining the GBG with an academic 
intervention. The family-school partnership did yield significant immediate benefits in terms of 
aggressive/disruptive behavior and academic achievement, but the breadth of the effects and their size 
were smaller than for the combination of the GBG and the academic intervention3,9.   
 
The 3rd Generation JHU PIRC Field Trial: The Combination of the GBG & PATHS.  Given the 
combination of the GBG with an academic intervention did not yield greater improvement in 
aggressive/disruptive behavior than that seen in the 1st generation trial of the GBG alone, a seemingly 
logical next step would have been to combine the GBG + academic intervention condition with the FSP 
intervention, given the latter did have an impact on aggressive/disruptive behavior—albeit modest. But the 
costs and logistics involved in mounting a universal family-school partnership intervention proved daunting.   
 
Consequently, we submitted a successful grant application to the Institute of Education Sciences (IES) in 
2007, wherein we proposed to combine the GBG with a second and complimentary, evidenced-based, 
universal preventive intervention: PATHS. There are a number of reasons why we expected additive, if not 
synergistic effects, as a result of combining the two interventions. First, the efficacy of PATHS in terms of 
reducing aggressive/disruptive behavior and increasing prosocial behavior, social competence, inhibitory 
control and verbal fluency in the elementary school years had been demonstrated in a series of 
randomized controlled studies  (CPPRG)28,29,30,31. Second, PATHS seeks to accomplish reductions in 
aggressive/disruptive behavior via teacher led instruction aimed at facilitating emotion regulation, self-
control, social problem-solving, and conflict resolution skills32,33, whereas the GBG is based on social 
learning principles and provides teachers with an efficient means of managing student 
aggressive/disruptive and off-task behavior via reinforcement of the inhibition of these behaviors within a 
game-like context. The GBG, by increasing attention to task and reducing disruptive behavior in the 
classroom, may facilitate the acquisition of the emotion regulation, self-control, social problem-solving, and 
conflict resolution skills taught in PATHS. Third, the social learning based GBG may increase the likelihood 
that students’ newly acquired skills would be appropriately prompted and reinforced by teachers. 
Consequently, the PATHS skills would be better learned and more frequently employed. Fourth, the 
increased teacher and child success, as a result of combining PATHS and the GBG, should minimize 
teacher and child discouragement and subsequent failure to participate or comply fully with the intervention 
regimens.  
 
Our IES funded trial of the GBG+PATHS--or as we refer to it from hereon as PATHS to PAX--featured a 
group-randomized design, wherein 27-schools (grades K-5) were assigned to one or 3 conditions: 1) 
Comparison/Control; 2) GBG Alone; or 3) PATHS to PAX (GBG+PATHS). Approximately, 300 teachers 
and 5,000+ students participated in the trial and provided data, which included classroom observations and 
teacher ratings of student behavior at pre- and post-test over a 1-year period. The evidence from this group 
randomized trial, which was completed in 2012, suggested that PATHS to PAX resulted only in modest 
improvement over the GBG Alone in terms of aggressive/disruptive behavior and teacher outcomes (e.g., 
perceived behavior management self-efficacy)34.     

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The Need for Research on the Combination of Evidence-based Universal, Indicated and Treatment 
Interventions. The relatively modest improvements found for PATHS to PAX (GBG+PATHS) over the 
GBG Alone served in part as the impetus for our testing the nesting of indicated and treatment 
interventions within our universal intervention: PATHS to PAX. Also moving us to evaluate such an 
integration was that despite evidence of long-term benefits of the GBG in terms of the reduction of 
antisocial behavior and drug use10,12 in our 1st and 2nd generation JHU PIRC trials, closer analyses of these 
data suggest that about half of those children in the highest trajectory of aggressive/disruptive behavior 
from grades 1-7 demonstrated no GBG impact in the short or long term11. In addition, based on individual 
interview, focus group, and questionnaire data from our PATHS to PAX trial, the primary reason teachers 
gave for not implementing PATHS to PAX was because it did not prove helpful with their most 
aggressive/disruptive students. This was consistent with Han & Weiss’ model35 of the factors influencing 
teacher implementation of evidence-based interventions in school settings. More specifically, Han & 
Weiss35 argue that teacher perception of the effectiveness of an intervention is a central factor in their level 
of its implementation. Relatedly, data from our PATHS to PAX trial suggested that the greater the number 
of highly aggressive/disruptive children in a PATHS to PAX classroom at baseline, the lower the level of 
teacher implementation of the GBG and PATHS.   
 
Our rationale for expecting an added benefit from the combination of PATHS to PAX with an indicated and 
treatment intervention was that the latter interventions were more likely to be effective with the non-
responders to PATH to PAX. These non-responders typically represent the most aggressive/disruptive 
students in the classroom. We also hypothesized that the improvement in the behavior of the non-
responders via the indicated or treatment intervention would increase teacher perception of the 
effectiveness of PATHS to PAX, which would lead to increased PATHS to PAX implementation. This 
increased implementation should then result in improved student outcomes overall, not just for the non-
responders.    
 
Our choice for an indicated and treatment intervention was the Incredible Years36,37,38,39,40. The Incredible 
Years (IY) has been evaluated in multiple randomized controlled trials as a preventive41 and 
treatment37,38,39,42,43 intervention. IY has been found to be efficacious in reducing aggressive/disruptive 
behavior in the home and school over the short37,38,39,41,42,43 and long term38,44,45. In addition, Webster-
Stratton and colleagues report effects for the IY child component alone37,42,46 —the importance of which is 
highlighted by the relatively modest to moderate parent participation rates often found among urban and 
economically distressed populations9. 
 
We also believed that there was a strong conceptual rationale for combining these three interventions. 
First, all three interventions share a common focus on facilitating the development of the child’s capacity to 
self-regulate. Second, all 3 attempt to achieve that goal through the use of social cognitive learning theory 
principles to varying degrees. Third, the content of small group Dina and PATHS emanates from a common 
theory of socioemotional development 6,7.   
 
 Study Design 
 
Overview of the Research Setting, Design, and Procedures for the Trial. The trial was conducted in the 
Baltimore City Public Schools (BCPS) which serves a predominantly African American population--84% of which 
are eligible for free or reduced lunch. We carried out a school-based, group-randomized trial (GRT) to determine 
whether the PATHS to PAX + Incredible Years arm yielded superior student and teacher outcomes, relative to the 
PATHS to PAX Alone arm. We also tested whether the PATHS to PAX + Incredible Years and the PATHS to PAX 
Alone arms both yielded superior student and teacher outcomes relative to the control arm. These comparisons 
with the control arm were only carried out to insure that in the case of no significant differences between the two 
active intervention arms the reason was not because both interventions failed to yield superior outcomes relative 
to the control arm. A GRT was required given randomization occured at the level of the school. Four consecutive 
cohorts of 12 elementary schools for a total of 48 schools were randomly assigned to 1 of 3 conditions: 1) Control; 
2) GBG+PATHS Alone; or 3) GBG+PATHS+IY. We confined the study to K-2 teachers given evidence from our 
most recent trial that the GBG is most effective in K-2.  
 
We also recruited approximately ~ 25 K-2 students per school assigned to the GBG+PATHS+IY condition for 
participation in the IY child and parent groups across the four cohorts. Students were selected for inclusion in 
the IY intervention based on teacher completion of a checklist version of the Oppositional Defiant and Conduct 
Disorder modules of the teacher version of the Computerized-Diagnostic Interview Schedule for Children IV (C-

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DISC IV). Those students who were sub-syndromal (falling just below the threshold number of 
symptoms/behaviors to meet DSM-IV diagnostic criteria for Oppositional Defiant or Conduct Disorder) and those 
who met diagnostic criteria for one or both of these disorders were recruited for inclusion in the IY groups. 
Randomization. The 12 schools making up each cohort were rank ordered based on school characteristics 
obtained from prior year archival records, including % Black, % free or reduced lunch, % males, % disciplinary 
removals, % receiving special education, number of students, and mean levels of standardized achievement 
scores. Schools adjacent in rank were grouped into triads, or sets of 3. Schools were then randomized to the 3 
conditions from within these matched sets of 3. Timing of the Assessments. Classroom observations of student 
behavior, peer nominations, and child perceptions of peer acceptance were gathered in the fall (October) and 
spring (May) of the first year for each cohort, whereas teacher ratings of student behavior were gathered in the fall 
(October) and spring (May) of the first year for each cohort and at 1-year follow-up in Year 2 for each cohort.     
 
Statistical Analysis Plan 
 
Aims 1 & 2. Outcome Analyses. Trials Aims 1 and 2 were centered on testing whether the PATHS to PAX + 
Incredible Years arm yielded superior student and teacher outcomes relative to the PATHS to PAX Alone arm.  
We also tested whether the PATHS to PAX + Incredible Years and the PATHS to PAX Alone arms both yielded 
superior student and teacher outcomes relative to the control arm. These comparisons with the control arm were 
only carried out to insure that in the case of no significant differences between the two active intervention arms 
the reason was not because both interventions failed to yield superior outcomes relative to the control arm. The 
General Linear Mixed Model was employed given teachers were nested within schools and students nested within 
teachers and repeated observations nested in both. The General Linear Mixed Model it is appropriate when there 
are multiple sources of random variation and all sources are distributed Gaussian. Murray and colleagues report 
that even in the case of violations of the Gaussian distribution assumption, the General Linear Mixed Model 
provides the same Type 1 error protection as the Generalized Linear Mixed Model47,48.   
Importantly, Aims 1 & 2 outcomes included pre-test-post-test only (e.g., classroom observations, peer 
nominations, and teacher reported self-efficacy and burn out), pre-test, post-test and 12-month follow-up (e.g., 
teacher reports of student behavior). General Linear Mixed model analysis of covariance was used in the case of 
the pre-test-post-test, and pre-test and 1-year follow-up outcomes. In addition to intervention status, the baseline 
level of the outcome variable was included as a covariate. School was treated as a random effect. Given all the 
comparisons between conditions were planned and directional, no correction was made for the experiment-wise 
level of error since such a correction would have only been appropriate in the case of exploratory analyses.  
Results reported in the Outcome Measures section include the adjusted post-test means and standard errors for 
the planned comparisons between the 2 intervention arms and between the intervention and control arms. 
 
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