An interventional study of Positive Behavior Management Toolkit in Attention Deficit Hyperactivity Disorder Symptoms, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Health services research
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.
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.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's enrollment of 53 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Teachers:
Children:
Parents/Legal Guardians:
Caregivers:
Exclusion Criteria:
Children:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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)
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
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)
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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
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)
Change in Homework Performance
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).
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Caregiver-reported ADHD Symptoms
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).
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Teacher-reported ADHD Symptoms
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).
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Academic Success
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).
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Disruptive Direct Behavior Ratings
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).
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Potential Mediators of Teacher Implementation Outcomes
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).
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Teachers were recruited from participating schools, and children were recruited from participating classrooms after teachers enrolled.
| Milestone | Implementation Resource Package Group | Control Group |
|---|---|---|
| Started | 28 | 25 |
| Teachers | 11 | 9 |
| Students | 17 | 16 |
| Completed | 28 | 22 |
| Not completed | 0 | 3 |
| Withdrew: Student left classroom | 0 | 1 |
| Withdrew: Teacher left school | 0 | 2 |
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).
| score on a scale | Implementation Resource Package Group | Control Group |
|---|---|---|
| Feasibility of Intervention Measure | 4.52 ± .47 | — |
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).
| score on a scale | Implementation Resource Package Group | Control Group |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | 4.54 ± .51 | — |
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).
| score on a scale | Implementation Resource Package Group | Control Group |
|---|---|---|
| Intervention Appropriateness Measure (IAM) | 4.48 ± .56 | — |
A member of the study will conduct classroom observations to measure fidelity of teacher use of the behavioral classroom management interventions.
| events per hour | Implementation Resource Package Group | Control Group |
|---|---|---|
| Change in Observed Teacher Use of Behavioral Classroom Management Interventions | 5.8 ± 11.0 | -.07 ± 1.9 |
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).
| change score | Implementation Resource Package Group | Control Group |
|---|---|---|
| Change in Caregiver-reported Child Functional Impairment | -.16 ± .48 | .09 ± .62 |
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).
| change score | Implementation Resource Package Group | Control Group |
|---|---|---|
| Change in Teacher-reported Child Functional Impairment | -.22 ± .48 | -.29 ± .61 |
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).
| change score | Implementation Resource Package Group | Control Group |
|---|---|---|
| Change in Academic Productivity | .20 ± .38 | .17 ± .44 |
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).
| change score | Implementation Resource Package Group | Control Group |
|---|---|---|
| Change in Student-Teacher Relationship | .46 ± .62 | .48 ± .81 |
Number of teachers and students enrolled in the study
| Participants | Implementation Resource Package Group | Control Group |
|---|---|---|
| Teachers | 11 | 9 |
| Students | 17 | 16 |
Percentage of parent- and teacher- report surveys completed across timepoints and conditions out of the number of students enrolled and randomized.
| percentage of surveys received | Implementation Resource Package Group | Control Group |
|---|---|---|
| Feasibility of Research Procedures - Response Rate | 94.1 | 90.6 |
Percentage of participants who do not withdraw out of the number of enrolled and randomized teachers and students across conditions
| percentage of participants | Implementation Resource Package Group | Control Group |
|---|---|---|
| Feasibility of Research Procedures - Retention Rate | 100 | 88 |
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).
| change score | Implementation Resource Package Group | Control Group |
|---|---|---|
| Change in Homework Performance | .037 ± .49 | .029 ± .51 |
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).
| change score | Implementation Resource Package Group | Control Group |
|---|---|---|
| Change in Caregiver-reported ADHD Symptoms | -.04 ± .49 | .02 ± .35 |
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).
| change score | Implementation Resource Package Group | Control Group |
|---|---|---|
| Change in Teacher-reported ADHD Symptoms | -.16 ± .36 | -.15 ± .60 |
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).
| change score | Implementation Resource Package Group | Control Group |
|---|---|---|
| Change in Academic Success | .27 ± .41 | .17 ± .42 |
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).
| change score | Implementation Resource Package Group | Control Group |
|---|---|---|
| Change in Disruptive Direct Behavior Ratings | -.90 ± .87 | -.37 ± 1.63 |
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).
| change score | Implementation Resource Package Group | Control Group |
|---|---|---|
| Potential Mediators of Teacher Implementation Outcomes | .53 ± .53 | .34 ± .46 |
Collected over Adverse events were monitored by the study team throughout each participating teacher and child's participation, which lasted for approximately 12-15 weeks from enrollment to endpoint data collection.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implementation Resource Package Group | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Control Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
53 participants (20 teachers, 33 children) were randomly assigned to either the intervention group or the control group following consent and baseline data collection. The number shown in each group reflect unique participants (both teachers and children). The overall number of baseline participants reflect the total number of teachers and children in each arm (i.e., 11 teachers and 17 children in the Implementation Resource Package Group and 9 teachers and 16 children in the control group).
| Age, Categorical(Participants) | Implementation Resource Package Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 9 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Implementation Resource Package Group | Control Group | Total |
|---|---|---|---|
| Mean | 9.2 ± 1.6 | 9.3 ± 1.8 | 9.3 ± 1.7 |
| Sex/Gender, Customized(Participants) | Implementation Resource Package Group | Control Group | Total |
|---|---|---|---|
| Male | 11 | 10 | 21 |
| Female | 5 | 5 | 10 |
| Unknown | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | Implementation Resource Package Group | Control Group | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Implementation Resource Package Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 11 | 9 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Implementation Resource Package Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 4 | 8 |
| Not Hispanic or Latino | 12 | 11 | 23 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Implementation Resource Package Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 4 | 9 |
| White | 4 | 5 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Implementation Resource Package Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 12 | 22 |
| White | 4 | 1 | 5 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 3 | 4 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Attention Deficit Disorder with Hyperactivity →
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