Clinical trial NCT05489081: Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test
Official title: Promoting Implementation of Behavioral Classroom Interventions for Children With ADHD in Urban Schools: A Pilot Test, Aim 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-08-05
Enrollment: 57
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participating teachers, and the students nested within their classroom, are randomized to one of two conditions: implementation strategy resource package or support as usual.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Feasibility of Intervention Measure
timeFrame: Endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Endpoint (i.e, at least 8 weeks from resource package receipt)
measure: 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)
measure: Change in caregiver-reported Child Functional Impairment
timeFrame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Change in teacher-reported Child Functional Impairment
timeFrame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Change in Academic Productivity
timeFrame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Change in Student-Teacher Relationship
timeFrame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Feasibility of research procedures - Recruitment numbers
timeFrame: Baseline
measure: Feasibility of research procedures - Response rate
timeFrame: Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Feasibility of research procedures - Retention rate
timeFrame: 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:
measure: Change in Homework Performance
timeFrame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Change in caregiver-reported ADHD Symptoms
timeFrame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Change in teacher-reported ADHD Symptoms
timeFrame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Change in Academic Success
timeFrame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
measure: Change in engagement and Disruptive Direct Behavior Ratings
timeFrame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Other outcomes:
measure: Potential mediators of teacher implementation outcomes
timeFrame: Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia/University of Pennsylvania Perelman School of Medicine
name: Gwendolyn M Lawson, PhD
role: PRINCIPAL_INVESTIGATOR
References: