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Completed

NCT Number: NCT05489081

Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Symptoms Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Impulsive Behavior Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Implementation Strategy Resource Package, Support School Success - Teacher Version (SSS-T)

Primary outcomes

  1. Feasibility of Intervention Measure

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

    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).

  2. Acceptability of Intervention Measure (AIM)

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

    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).

  3. Intervention Appropriateness Measure (IAM)

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

    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).

  4. Change in Observed Teacher Use of Behavioral Classroom Management Interventions

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

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

  5. Change in Caregiver-reported Child Functional Impairment

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

    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).

  6. Change in Teacher-reported Child Functional Impairment

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

    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).

  7. Change in Academic Productivity

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

    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).

  8. Change in Student-Teacher Relationship

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

    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).

  9. Feasibility of Research Procedures - Recruitment Numbers

    Time frame: Baseline

    Number of teachers and students enrolled in the study

  10. Feasibility of Research Procedures - Response Rate

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

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

  11. Feasibility of Research Procedures - Retention Rate

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

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

Secondary outcomes

  1. Change in Homework Performance

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

    Caregiver-reported student self-regulation factor on the Homework Performance Questionnaire - Parent Version for students in grades 1-5. The self-regulation factor consists of 9 items, each rated on a 4-point scale (0 = rarely/never, 1 = some of the time, 2 = most of the time, 3 = always/almost always). Four items are reverse scored, and then the self-regulation factor score is computed as the average of the 9 item scores (possible range: 0 through 3, where 3 is the best possible outcome).

  2. Change in Caregiver-reported ADHD Symptoms

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

    Caregiver-reported inattention and hyperactivity/impulsivity symptom scores on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version, which consists of 18 items, rated on a 4-point scale (from 0 = Never to 3 = Very Often). The total score is calculated as the average of the 18 item scores (possible range: 0 through 3, where 0 is the best possible outcome).

  3. Change in Teacher-reported ADHD Symptoms

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

    Teacher-reported inattention and hyperactivity/impulsivity symptom scores on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version, which consists of 18 items, rated on a 4-point scale (from 0 = Never to 3 = Very Often). The total score is calculated as the average of the 18 item scores (possible range: 0 through 3, where 0 is the best possible outcome).

  4. Change in Academic Success

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

    Teacher-reported Academic Success subscale score of the Academic Performance rating Scale (APRS). The Academic Success subscale includes 7 items, each rated on a 5-point Likert scale from 1 to 5. One item is reverse scored, and the total score is computed as the average of the 7 items (possible range: 1 through 5, where 5 is the best possible outcome).

  5. Change in Disruptive Direct Behavior Ratings

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

    Teacher-reported ratings on the disruptive behavior domain of Direct Behavior Rating Multi-Item Scales, which consist of 5 items on a 6-point scale (from 0 = "not a problem" to 6 = "serious problem"). The total score is computed as the average of the 5 items (possible range: 0 through 6, where 0 is the best possible outcome).

Other outcomes

  1. Potential Mediators of Teacher Implementation Outcomes

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

    Teacher self-reported measures of habits regarding their use of behavior-specific praise. This consists of 12 items on a 5-point Likert scale (from 1 = "strongly disagree" to 5 = "strongly agree"). The total score is the average of the 12 item scores (possible range: 1 through 5, where 5 is the best possible outcome).

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Promoting Implementation of Behavioral Classroom Interventions for Children With ADHD in Urban Schools: A Pilot Test, Aim 3

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2022
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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