NCT05189769

Brief Summary

The primary purpose of this project is to test a comprehensive, two-part intervention with ReACT and a recently adapted, Coping Power+ Program. ReACT and PBIS are school-wide universal interventions. Coping Power and Coping Power+ are targeted preventive interventions designed to assist at-risk 7th grade students to improve their coping with interpersonal stressors during middle school. This project will evaluate the effects of the program on teacher, student and parent perceptions of school climate, student behavior, social-emotional competence, disciplinary infractions, and identity for 7th grade students in Coping Power or Coping Power+

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,093

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

May 15, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

6.6 years

First QC Date

November 30, 2021

Last Update Submit

December 11, 2024

Conditions

Keywords

aggressiondiscipline

Outcome Measures

Primary Outcomes (3)

  • National Institute on Drug Abuse Quick Screener: Teacher Report of Reactive and Proactive Behaviors.

    his 6-item screener will be completed on all students in participating classrooms. Higher scores indicate more risk to determine the top 25% of the scoring students who will be considered participants in the CP and CP+ groups. T

    Pre-intervention

  • Behavior Assessment Scale for Children (BASC)-Third Edition Teacher Report Scale Child Form (BASC-3).

    The BASC-3 Teacher Rating Scale has 139 items and takes approximately 15 minutes to complete. Higher scores indicate more risk

    Pre-intervention

  • School Climate

    he Georgia School Climate Survey (GSCS) is a computerized school climate rating scale that was developed as part of the Georgia School Climate Survey Suite (Georgia Department of Education, La Salle, Meyers, 2014).

    Pre-intervention and immediately after intervention concludes

Secondary Outcomes (1)

  • Discipline Incidents.

    immediately after intervention concludes

Study Arms (4)

CP/No REACT

EXPERIMENTAL

Traditional Coping Power for 7th graders, no school wide REACT training

Behavioral: CP no REACT

CP/REACT

EXPERIMENTAL

Traditional Coping Power for 7th graders and school wide REACT training

Behavioral: CP and REACT

CP+/No REACT

EXPERIMENTAL

New, adapted Coping Power for 7th graders intervention with no school wide REACT training

Behavioral: CP+/No REACT

CP+/REACT

EXPERIMENTAL

New, adapted Coping Power for 7th graders, school wide REACT training

Behavioral: CP+ and REACT

Interventions

CP no REACTBEHAVIORAL

Coping Power no REACT

CP/No REACT
CP+/No REACTBEHAVIORAL

CP+ and no REACT

CP+/No REACT
CP+ and REACTBEHAVIORAL

CP+ and REACT

CP+/REACT

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • th grader
  • screened on NIDA screener as in the highest 25 percentile on risk in target school

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jefferson County Public Schools

Birmingham, Alabama, 35226, United States

Location

Huntsville City Schools

Huntsville, Alabama, 35649, United States

Location

MeSH Terms

Conditions

Child BehaviorAggression

Condition Hierarchy (Ancestors)

BehaviorAberrant Motor Behavior in DementiaBehavioral SymptomsSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Design. This project will include a 5-year randomized control trial with four conditions: (a) PBIS and CP (serving as control), (b) SWPBIS+ and CP, (c) SWPBIS and CP+, and (d) SWPBIS+ and CP+.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 2X2 randomized control trial across 2 districts
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI; Professor

Study Record Dates

First Submitted

November 30, 2021

First Posted

January 13, 2022

Study Start

May 15, 2019

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

No plan at this time

Locations