NCT01941069

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
437

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

5.5 years

First QC Date

September 5, 2013

Last Update Submit

February 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Level of Support During Implementation

    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 Outcomes (1)

  • Cost Benefit Analyses

    48 months

Study Arms (2)

Internalizing Disorders

ACTIVE COMPARATOR

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

Externalizing Disorders

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: FRIENDS
Internalizing Disorders

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.

Also known as: CPP
Externalizing Disorders

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All 6 participating schools are included in Tier 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The School District of Philadelphia

Philadelphia, Pennsylvania, 19130, United States

Location

Related Publications (2)

  • Eiraldi R, Mautone JA, Khanna MS, Power TJ, Orapallo A, Cacia J, Schwartz BS, McCurdy B, Keiffer J, Paidipati C, Kanine R, Abraham M, Tulio S, Swift L, Bressler SN, Cabello B, Jawad AF. Group CBT for Externalizing Disorders in Urban Schools: Effect of Training Strategy on Treatment Fidelity and Child Outcomes. Behav Ther. 2018 Jul;49(4):538-550. doi: 10.1016/j.beth.2018.01.001. Epub 2018 Jan 6.

  • Eiraldi R, McCurdy B, Khanna M, Mautone J, Jawad AF, Power T, Cidav Z, Cacia J, Sugai G. A cluster randomized trial to evaluate external support for the implementation of positive behavioral interventions and supports by school personnel. Implement Sci. 2014 Jan 15;9:12. doi: 10.1186/1748-5908-9-12.

MeSH Terms

Interventions

6-chloro-2-(1-piperazinyl)pyrazine

Study Officials

  • Ricardo B. Eiraldi, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 13, 2013

Study Start

January 1, 2013

Primary Completion

June 30, 2018

Study Completion

December 31, 2018

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations