Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test

NCT ID: NCT05489081

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2024-06-18

Brief Summary

The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Participating teachers will be randomized to receive the resource package or support as usual and the research team will examine, a) teacher implementation of behavioral classroom interventions and b) mental health outcomes for enrolled children.

Detailed Description

Schools are an accessible and ecologically valid setting for children with hyperactivity, inattentive, or impulsive behaviors to receive evidence-based interventions to reduce symptoms and improve functioning. Behavioral classroom management interventions are well-established treatments for elementary-school age children with, but they can often be challenging for teachers to use. It is therefore important to develop and test implementation strategies in promoting teachers' use of behavioral classroom management interventions and in improving child outcomes. The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Participating teachers will be randomized to receive the resource package or support as usual and the research team will examine, a) teacher implementation of behavioral classroom interventions and b) mental health outcomes for enrolled children.

Conditions

Attention Deficit Hyperactivity Disorder Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Implementation Resource Package Group

Teachers in this group will receive an implementation support package and receive support in using it within their classroom management practice. Also within the intervention group (experimental), will be students nested in the classrooms of the teachers that are assigned to the intervention group.

Group Type: EXPERIMENTAL

Positive Behavior Management Toolkit

Intervention Type: BEHAVIORAL

The Positive Behavior Management Toolkit, or the implementation strategy resource package, is a set of resources provided to teachers in the intervention group that aims to support their use of positive behavior management practices in the classroom, particularly with students with hyperactive, inattentive, or impulsive behaviors.

Control Group

Within the control group (no intervention), teachers in this group will not receive the implementation support package nor extra support during the study period. They will continue to receive implementation support as usual. Also within the control group (no intervention) will be students nested in the classrooms of the teachers that are assigned to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Positive Behavior Management Toolkit

The Positive Behavior Management Toolkit, or the implementation strategy resource package, is a set of resources provided to teachers in the intervention group that aims to support their use of positive behavior management practices in the classroom, particularly with students with hyperactive, inattentive, or impulsive behaviors.

Intervention Type: BEHAVIORAL

Other Intervention Names

Implementation Strategy Resource Package; Support School Success - Teacher Version (SSS-T)

Eligibility Criteria

Inclusion Criteria

Teachers:

• A K-5 teacher at a participating school within the School District of Philadelphia
• Teach at a participating school
• Informed consent

Children:

• Is in a K-5 class of a participating teacher
• Nominated for participation by the participating teacher
• Identified by their participating teacher as displaying impairment related to inattention, hyperactivity or impulsivity
• Informed consent and assent if appropriate

Parents/Legal Guardians:

• Parent or legal guardian of child
• Identifies as familiar enough with the child to fill out measures about the child
• Has mental capacity to provide consent for the participation of child in the study and for their own participation in the study

Caregivers:

• Has been referred by the legal guardian as the primary caregiver that can more accurately complete the measures about the child
• Has mental capacity to provide consent for the participation of child in the study and for their own participation in the study

Exclusion Criteria

Children:

• Special education classification of 'intellectual disability'
• Primary presenting concern of psychotic or autism spectrum disorders
• Presents as in acute risk of harm to self or others, such that participation in the study is clinically inappropriate because they warrant more intensive intervention

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gwendolyn M Lawson, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia/University of Pennsylvania Perelman School of Medicine

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

Lawson GM, Owens JS, Mandell DS, Tavlin S, Rufe S, Lyon AR, Eiraldi R, Power TJ. Implementation resources to support teachers' use of behavioral classroom interventions: protocol of a randomized pilot trial. Pilot Feasibility Stud. 2023 Aug 25;9(1):151. doi: 10.1186/s40814-023-01381-4.

Reference Type: DERIVED

PMID: 37626422 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23MH122577

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-019825

Identifier Type: -

Identifier Source: org_study_id