Clinical trial NCT03132805: An Evaluation of an Integrated Approach to Prevention and Early Intervention in the Elementary School Years
Official title: An Evaluation of an Integrated Approach to Prevention and Early Intervention in the Elementary School Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aggression
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-04-28
Enrollment: 5233
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: PREVENTION

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.

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,

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Students must be enrolled in regular education classrooms.

Primary outcomes:
measure: Change in Direct Classroom Observations of Student Behavior Between Pre-test and Post-test, 6 Months After the Pre-test.
timeFrame: The observations are carried out at pre-test and at post-test, 6 months after the pre-test.
measure: Teacher Ratings of Student On-task and Aggressive-disruptive Behavior in the Classroom.
timeFrame: The ratings are carried out at pre-test, post-test, 6 months after the pre-test.
Secondary outcomes:
measure: Change in Peer Assessment Inventory Between Pre-test and Post-test, 6 Months After the Pre-test.
timeFrame: The peer nomination instrument is administered at pre-test and at post-test, 6 months after the pre-test.
measure: 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.
timeFrame: This scale will be administered at pre-test and post-test, 6-months after the pre-test.
measure: Change in Teacher Sense of Self Efficacy Scale Between Pre-test and Post-test, 6-months After the Pre-test.
timeFrame: This scale will be administered at pre-test and post-test, 6 months after the pre-test.
measure: Change in the Maslach Burnout Inventory Between Pre-test and Post-test, 6 Months After the Pre-test.
timeFrame: This scale will be administered at pre-test and post-test, 6 months after the pre-test.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Nicholas Ialongo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Harter S, Pike R. The pictorial scale of perceived competence and social acceptance for young children. Child Dev. 1984 Dec;55(6):1969-82.
citation: 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.
citation: 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.
citation: 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.