Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test

Attention Deficit Hyperactivity Disorder Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05489081
• Other study ID #: 22-019825
• Secondary ID: K23MH122577
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder Symptoms
• Hyperkinesis

Intervention

Behavioral:
• Positive Behavior Management Toolkit
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Potential mediators of teacher implementation outcomes	Teacher self-reported measures of potential mediators of teacher implementation outcomes: intentions to use behavioral classroom management interventions, psychological determinants of intentions, and habits regarding 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)
Primary	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 Completely Disagree to Completely Agree). The total score is the average of the 4 item scores.	Endpoint (i.e, at least 8 weeks from resource package receipt)
Primary	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 Completely Disagree to Completely Agree). The total score is the average of the 4 item scores.	Endpoint (i.e, at least 8 weeks from resource package receipt)
Primary	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 Completely Disagree to Completely Agree). The total score is the average of the 4 item scores.	Endpoint (i.e, at least 8 weeks from resource package receipt)
Primary	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)
Primary	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 8-items are rated on a 5-point scale (from Excellent to Problematic).	Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Primary	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 Excellent to Problematic).	Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Primary	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 scale from 1 to 5.	Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Primary	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).	Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Primary	Feasibility of research procedures - Recruitment numbers	Number of teachers and students enrolled in the study	Baseline
Primary	Feasibility of research procedures - Response rate	Proportion of parent- and teacher- report surveys completed across timepoints and conditions out of the number of teachers and students enrolled and randomized	Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)
Primary	Feasibility of research procedures - Retention rate	Proportion 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	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).	Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Secondary	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).	Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Secondary	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).	Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Secondary	Change in Academic Success	Teacher-reported Academic Success subscale score of the Academic Performance rating Scale (APRS). The Academic Success subscale includes 6 items, each rated on a scale from 1 to 5.	Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Secondary	Change in engagement and Disruptive Direct Behavior Ratings	Teacher-reported ratings on the engagement and disruptive behavior domains of Direct Behavior Rating Multi-Item Scales, each of which consist of 5 items on a 6-point scale.	Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)