School Climate and Children's Behavioral Health (Project Access)

February 1, 2019 updated by: Children's Hospital of Philadelphia

Targeting School Climate and Children's Behavioral Health in Urban Schools

The overall purpose of this project is to determine whether school personnel implementing a two-tier School-wide Positive Behavior Support (SWPBS, an evidence based intervention) program for typically developing children as well as children with, or at risk for, externalizing or anxiety disorders can implement the components of the program with the same level of fidelity, integrity and clinical effectiveness when they receive a low level of support (consultation) from their coaches and supervisors as they can with a high level of support (consultation and coaching).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Demonstrating that school personnel can implement evidence based interventions (EBIs) for externalizing and anxiety problems with a high degree of fidelity, integrity and clinical effectiveness could spur more initiatives toward the adoption of EBIs in urban schools, thus further lowering health disparities in these settings. The overall purpose of this project is to determine whether school personnel implementing a two-tier School-wide Positive Behavior Support (SWPBS, an evidence based intervention) program for typically developing children as well as children with, or at risk for, externalizing or anxiety disorders can implement the components of the program with the same level of fidelity, integrity and clinical effectiveness when they receive a low level of support (consultation) from their coaches and supervisors as they can with a high level of support (consultation and coaching). This study will target six schools within the Philadelphia School District (PSD). Within those 6 schools, research participants will consist of students (grades 4-8) and school staff members. The investigators will evaluate 1) the effectiveness of SWPBS with consultation and coaching, as compared to the baseline and to SWPBS with consultation only; in reducing office discipline referrals (ODRs) and improving school climate, and children's grades, diagnostic status, symptom severity and impairment; 2) the effectiveness of the SWPBS with consultation and coaching, as compared to SWPBS with consultation only, in increasing program fidelity and integrity.

Study Type

Interventional

Enrollment (Actual)

437

Phase

  • 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 Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19130
        • The School District of Philadelphia

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

Ages Eligible for Study

8 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All 6 participating schools are included in Tier 1.
  • The inclusion criteria for Tier 2 includes children in grades 3-8, who are referred by a school staff member because of behavioral or emotional difficulties or because they have received 3 or more Office Discipline Referrals. Children who consent to participate in the project.

Exclusion Criteria:

  • There are no exclusion criteria for Tier 1.
  • The exclusion criteria for Tier 2 include any child in grades 3-8 whose family chooses not to consent to screening or participate in the intervention, has Special Education classification of "Intellectual Disability", who is not able to communicate in English, or has a history of psychotic or autistic spectrum disorders.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Internalizing Disorders
Students identified as being at-risk for or meeting criteria for Internalizing Disorders will assigned to this intervention arm. They will receive the FRIENDS for Life intervention. FRIENDS is a group Cognitive Behavioral Therapy (CBT) intervention, based on a theoretical model, which addresses cognitive, physiological and behavioral processes that are seen to interact in the development and perpetuation of excessive anxiety.
Behavioral: Friends for Life
Friends for Life is a group CBT intervention, based on a theoretical model, which addresses cognitive, physiological and behavioral processes that are seen to interact in the development and perpetuation of excessive anxiety.
Other Names:
  • FRIENDS
Active Comparator: Externalizing Disorders
Students identified as being at-risk for or meeting criteria for Externalizing Disorders will be assigned to this intervention arm. They will receive the Coping Power Program (CPP) intervention. CPP is a cognitive-behavioral, multi-component group intervention for elementary and middle school students at risk for externalizing behavior disorders. In addition to anger management, the CPP includes units on goal setting, emotional awareness, relaxation training, social skills training, problem solving, and handling peer pressure.
Behavioral: Coping Power Program
The Coping Power Program CPP is a cognitive-behavioral, multi-component group intervention for elementary and middle school students at risk for externalizing behavior disorders. In addition to anger management, the CPP includes units on goal setting, emotional awareness, relaxation training, social skills training, problem solving, and handling peer pressure.
Other Names:
  • CPP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Support During Implementation
Time Frame: 48 months
To determine whether program fidelity and integrity for Tier 1 (for all students) and Tier 2 (for at risk and high risk students) would differ between schools receiving a high level of support (consultation and coaching) and schools receiving a low level of support (consultation) for program implementers.
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost Benefit Analyses
Time Frame: 48 months
The secondary objectives are to determine the incremental cost-effectiveness of SWPBS HLS (consultation and coaching) versus SWPBS LLS (consultation).
48 months

Collaborators and Investigators

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

Sponsor

Children's Hospital of Philadelphia

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The School District of Philadelphia
Devereux Foundation, Pennsylvania

Investigators

  • Principal Investigator: Ricardo B. Eiraldi, PhD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2013

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

September 5, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 12-009477
  • 5R01HD073430-02 (U.S. NIH Grant/Contract)

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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