CompletedNot Applicable

Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test

United States53 participantsStarted 2022-09-20

Plain-language 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.

Who can participate

Age range

4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of Intervention Measure

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

Acceptability of Intervention Measure (AIM)

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

Intervention Appropriateness Measure (IAM)

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

Change in Observed Teacher Use of Behavioral Classroom Management Interventions

Timeframe: 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

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

Change in Teacher-reported Child Functional Impairment

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

Trial details

NCT IDNCT05489081

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-18

Results submitted2025-05-27

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder Symptoms trials

Plain-language summary

Who can participate

Age range

4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility of Intervention Measure

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

Acceptability of Intervention Measure (AIM)

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

Intervention Appropriateness Measure (IAM)

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

Change in Observed Teacher Use of Behavioral Classroom Management Interventions

Timeframe: 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

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

Change in Teacher-reported Child Functional Impairment

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