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Clinical Trials/NCT05489081
NCT05489081
Completed
Not Applicable

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

Children's Hospital of Philadelphia1 site in 1 country53 target enrollmentSeptember 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder Symptoms
Sponsor
Children's Hospital of Philadelphia
Enrollment
53
Locations
1
Primary Endpoint
Feasibility of Intervention Measure
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2022
End Date
June 18, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A K-5 teacher at a participating school within the School District of Philadelphia
  • Teach at a participating school
  • Informed consent
  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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).

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).

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).

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).

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).

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).

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.

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

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.

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).

Feasibility of Research Procedures - Recruitment Numbers

Time Frame: Baseline

Number of teachers and students enrolled in the study

Secondary Outcomes

  • Change in Teacher-reported ADHD Symptoms(Baseline, endpoint (i.e, at least 8 weeks from resource package receipt))
  • Change in Disruptive Direct Behavior Ratings(Baseline, endpoint (i.e, at least 8 weeks from resource package receipt))
  • Change in Homework Performance(Baseline, endpoint (i.e, at least 8 weeks from resource package receipt))
  • Change in Caregiver-reported ADHD Symptoms(Baseline, endpoint (i.e, at least 8 weeks from resource package receipt))
  • Change in Academic Success(Baseline, endpoint (i.e, at least 8 weeks from resource package receipt))

Study Sites (1)

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