Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test

NCT05489081 | Completed Results

• 2 other identifiers: 22-019825K23MH122577
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder Symptoms

Keywords

Attention Deficit Hyperactivity Disorder; Positive Behavior Management; Positive Behavioral Interventions and Supports; Behavioral Classroom Management; Inattentive; Hyperactive; Impulsive

Outcome Measures

Primary Outcomes (11)

• Feasibility of Intervention Measure

  Teacher-reported total score on the Feasibility of Intervention Measure (FIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).

  Endpoint (i.e, at least 8 weeks from resource package receipt)

• Acceptability of Intervention Measure (AIM)

  Teacher-reported total score on the Acceptability of Intervention Measure (AIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).

  Endpoint (i.e, at least 8 weeks from resource package receipt)

• Intervention Appropriateness Measure (IAM)

  Teacher-reported total score on the Intervention Appropriateness Measure (IAM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).

  Endpoint (i.e, at least 8 weeks from resource package receipt)

• Change in Observed Teacher Use of Behavioral Classroom Management Interventions

  A member of the study will conduct classroom observations to measure fidelity of teacher use of the behavioral classroom management interventions.

  Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)

• Change in Caregiver-reported Child Functional Impairment

  Caregiver-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version; These 7 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 7 item scores (possible range: 1 through 5, where 1 is the best possible outcome).

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

• Change in Teacher-reported Child Functional Impairment

  Teacher-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version; These 8 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 8 item scores (possible range: 1 through 5, where 5 is the best possible outcome).

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

• Change in Academic Productivity

  Teacher-reported Academic Productivity subscale score of the Academic Performance Rating Scale (APRS). The Academic Productivity subscale includes 12 items, each rated on a 5-point Likert scale from 1 to 5. Four items are reverse scored, and the total score is computed as the average of the 12 items (possible range: 1 through 5, where 5 is the best possible outcome).

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

• Change in Student-Teacher Relationship

  Teacher-reported total score on the Student-Teacher Relationship Scale - Short form, which consists of 15 items, rated on a 5-point scale (from 1 = Definitely does not apply to 5 = Definitely applies). Eight items are reverse score, and then the total score is computed as the average of the 15 item scores (possible range: 1 through 5, where 5 is the best possible outcome).

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

• Feasibility of Research Procedures - Recruitment Numbers

  Number of teachers and students enrolled in the study

  Baseline

• Feasibility of Research Procedures - Response Rate

  Percentage of parent- and teacher- report surveys completed across timepoints and conditions out of the number of students enrolled and randomized.

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

• Feasibility of Research Procedures - Retention Rate

  Percentage of participants who do not withdraw out of the number of enrolled and randomized teachers and students across conditions

  Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)

Secondary Outcomes (5)

• Change in Homework Performance

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

• Change in Caregiver-reported ADHD Symptoms

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

• Change in Teacher-reported ADHD Symptoms

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

• Change in Academic Success

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

• Change in Disruptive Direct Behavior Ratings

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

Other Outcomes (1)

• Potential Mediators of Teacher Implementation Outcomes

  Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)

Study Arms (2)

Implementation Resource Package Group

EXPERIMENTAL

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.

Behavioral: Positive Behavior Management Toolkit

Control Group

NO INTERVENTION

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.

Interventions

Positive Behavior Management Toolkit 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.

Also known as: Implementation Strategy Resource Package, Support School Success - Teacher Version (SSS-T)

Implementation Resource Package Group

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (1)

• 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.

  PMID: 37626422 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm; Impulsive Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Gwendolyn Lawson
• Organization: Children's Hospital of Philadelphia

lawsong@chop.edu

2674266612

Study Officials

• Gwendolyn M Lawson, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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

Model Details: Participating teachers, and the students nested within their classroom, are randomized to one of two conditions: implementation strategy resource package or support as usual.

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 5, 2022
• Study Start: September 20, 2022
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Locations

US (1)