Examining the Efficacy of the PRAISE With Coaching Program

July 21, 2026 updated by: Children's Hospital of Philadelphia

Examining the Efficacy of the PRAISE With Coaching Program in Reducing Peer Aggression and Bullying

The PReventing Aggression In Schools Everyday (PRAISE) Program has evidence of impact when run by research staff. PRAISE was adapted using community-based participatory research to a coaching model whereby school-staff are trained to facilitate the program and receive ongoing coaching from research staff. The overall objective is to demonstrate the efficacy of the adapted PRAISE program when facilitated by in-school staff.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRAISE is an aggression and bullying prevention program that includes curriculum to help 3rd through 5th graders learn skills to identify feelings, use calming-down strategies, interpret others' intentions accurately, and consider choices when responding to conflict. PRAISE also has lessons on increasing empathy and perspective-taking, and empowering students to be positive bystanders.

Using a randomized control trial of at least 8 elementary schools (3rd-5th grade) we will examine 2 aims:

Aim 1: Examine the efficacy of PRAISE at reducing students' peer aggression and bullying and improving social problem-solving skills, positive bystander behaviors, and self-efficacy for non-violence.

Aim 2. Examine the moderating role of implementation and student- and facilitator-related factors on the main outcomes of interest.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1008

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146-2305
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
          • Phone Number: 267-426-9286

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Student Inclusion Criteria:

  • Enrolled in one of the participating school sites
  • In a 3rd-5th grade classroom participating in the study

Staff Inclusion Criteria:

  • Employed by one of the participating school sites
  • Teach and/or provide services to students in 3rd-5th grade

Students Exclusion Criteria:

  • Do not speak English
  • Special education students not integrated in a regular education classroom
  • Student not in Grades 3-5 at the participating school sites

Teacher Exclusion Criteria:

  • Do not speak English
  • Do not teach/provide services with 3rd-5th grade students at the participating school sites

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Comparison Schools
These schools do not receive the PRAISE intervention. These schools can have their standard aggression and bullying practices such as community meeting, restorative circles, Second Step program, and the Olweus program. We will measure what classrooms in the comparison condition are doing, but we will not intervene.
Experimental: Intervention Schools
These schools will receive the PRAISE program which includes training and coaching from the research team.
Behavioral: Universal, classroom-based, Bullying and Aggression Prevention Program
PRAISE is a universal, classroom-based aggression and bullying prevention program that addresses all forms (physical, verbal, relational, cyber), with a strong focus on the relational and reactive behaviors. All emotional and social skills taught focus on applying and practicing the skills within peer relationships. This program has gone through iterative development and adaptations using a community-based participatory approach whereby the elementary students and staff were active partners with researchers in refining the program. Specific attention was paid to ensuring that the program is feasible for schools to implement and sustain while also being relevant and relatable for students from a variety of backgrounds and school communities (e.g., under-resourced, higher levels of community violence). This updated PRAISE includes ~14 sessions (amounts can vary by grade) and training and coaching for school-based facilitators of the program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knowledge of Social Information Processing
Time Frame: At baseline and post intervention, approximately 8 months.
Student self-report of social information processing knowledge will be gathered using the Knowledge of Anger Problem Solving measure (9 items) where items are scored a 1 if correct and 0 if incorrect and summed (Range: 0-9), higher scores reflect better social information processing
At baseline and post intervention, approximately 8 months.
Hostile Attributions
Time Frame: At baseline and post intervention, approximately 8 months.
Student self-report of hostile attributions will be assessed using the Cartoon-Based Hostile Attributional Bias measure, with 2 relational vignettes and 2 physical vignettes, with one question asking whether a behavior was intentional or unintentional. Each vignette has a range of 0 (no bias) to 4 (strong bias). Scores on the 2 items per vignette type (relational, physical) are summed where higher scores reflect a worse outcome.
At baseline and post intervention, approximately 8 months.
Reactive/proactive Aggression
Time Frame: At baseline and post intervention, approximately 8 months.
Measured via student self-report using items drawn from the Peer Conflict Scale -Youth Version measure, the proactive relational (6 items) and reactive relational (6 items) and overt (5 items). Items, with a range of 1-Not at all true to 4-Definitely true, will be averaged per scale. Higher scores indicate more proactive relational, reactive relational and reactive overt aggression.
At baseline and post intervention, approximately 8 months.
Cyberbullying
Time Frame: At baseline and post intervention, approximately 8 months.
Student Self-report on items drawn from the European Cyberbullying Intervention Project Questionnaire will assess two scales: cyberbullying perpetration (7 items) and victimization (7 items) with answers ranging from 1-Never to 5-A few times a week. Items will be averaged such that higher score is more perpetration or victimization experiences.
At baseline and post intervention, approximately 8 months.
Bystander Behaviors
Time Frame: At baseline and post intervention, approximately 8 months.
Self-report of positive bystander behaviors will be assessed using 5 items drawn from the Maryland Safe and Supportive Schools (MDS3) Climate Survey with answers ranging from 1-Never to 5-All the time. Items are averaged with higher scores indicating more use of positive bystander behaviors.
At baseline and post intervention, approximately 8 months.
Relational and Overt Aggression
Time Frame: At baseline and post intervention, approximately 8 months.
Using teacher report on each child in their classroom, the Children's Social Behavior Questionnaire will assess a child's relational (7 items) and overt (4 items) aggression with a range of 1-Never true to 5-Almost always true. Items are averaged per scale with higher scores indicating more relational or overt aggression.
At baseline and post intervention, approximately 8 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-efficacy for Non-Violence
Time Frame: At baseline and post intervention, approximately 8 months.
Student self-report of their use of non-aggressive or violent responses when in a conflict with a peer will be assessed using 9 items drawn from the measure developed for the Multisite Violence Prevention Project with a range of 1-Not at to 4-Very confident. Items are averaged with higher scores reflecting more conference in their ability to not use violent or aggressive responses.
At baseline and post intervention, approximately 8 months.
Bullying Perpetration
Time Frame: At baseline and post intervention, approximately 8 months.
Bullying will be assessed using the Behavior Based Bullying measure (9 items; Range: 1- Never to 4- or more times per month), items are averaged where higher scores means more bullying perpetration.
At baseline and post intervention, approximately 8 months.
Empathy
Time Frame: At baseline and post intervention, approximately 8 months.
Student self-report of cognitive empathy using the perspective taking scale of the Interpersonal Reactivity Index (6 items; Range: 1-Never to 5-All the Time). Items are averaged where higher scores indicated more empathy.
At baseline and post intervention, approximately 8 months.
Peer Bullying-Victimization
Time Frame: At baseline and post intervention, approximately 8 months.
Student self-report of victimization by peers using the Social Experience Questionnaire (SEQ; 10 items, Range: 1-Never to 5-All the time). Items are averaged with higher scores indicated more peer bullying-victimization experiences.
At baseline and post intervention, approximately 8 months.
Academic Engagement
Time Frame: At baseline and post intervention, approximately 8 months.
Teacher report on each child in their classroom will be used to assess academic engagement using the Academic Competence Evaluation Scale (8 items; Range: 1-Never to 5-Almost Always). Items are averaged with higher scores reflecting more engagement.
At baseline and post intervention, approximately 8 months.
Student-teacher Relationship
Time Frame: At baseline and post intervention, approximately 8 months.
Teacher report on each child in their classroom of their perceived relationships (closeness and conflict) using the Closeness (5 items) and Conflict (5 items) drawn from the Student Teacher Relationship Scales (STRS; Range: 1-Definitely doesn't apply to 5-Definitely applies). Items per scale are averaged such that higher scores indicated more closeness or conflict between teacher and student.
At baseline and post intervention, approximately 8 months.
Class Climate
Time Frame: At baseline and post intervention, approximately 8 months.
Student self-report of their perception of the class academic and social climate using 6 items drawn from the Maryland Safe and Supportive Schools (MDS3) Climate Survey with a range from 1-Strongly Agree to 4-Strongly Disagree. Items are averaged such that higher scores indicate a more positive classroom climate.
At baseline and post intervention, approximately 8 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Philadelphia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The School District of Philadelphia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tracy E Waasdorp, PhD MSEd, Children's Hospital of Philadelphia
  • Principal Investigator: Brooke S Paskewich, Psy.D, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-022385
  • 1R49CE003566-01-00 (Other Grant/Funding Number: CDC)
  • 1R49CE003566-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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