Enhancing IEPs of Children With ADHD Using Daily Report Cards
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Report Card
School as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria:
- Current Individualized Education program
- Diagnosis of ADHD
- Enrolled in Grades Kindergarten - 6
Exclusion Criteria:
- IQ < 70
- Home-schooled
- Enrolled in a classroom with another study participant
- Autism spectrum disorder
Sites / Locations
- SUNY at Buffalo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
School as Usual
Daily Report Card
Arm Description
School as usual comparison condition.
A coach will establish a Daily Report Card based on IEP goals and objectives with the parents/teachers of the child in this arm.
Outcomes
Primary Outcome Measures
Student Behavior Teacher Response Observation Rule Violations Count
Frequency count of classroom rule violations collected during three, 30-minute observation periods and averaged.
Secondary Outcome Measures
Academic Performance Rating Scale
Academic Performance Rating Scale sub scales of: Academic Productivity factor (7 items) that relates to work completion and accuracy, independent work, and following directions (coefficient alpha = .94; test-retest reliability over two weeks = .93), and an Academic Success (12 items) factor related to the child's academic achievement, recall, and ability (coefficient alpha = .95; test-retest reliability over two weeks = .91). Items are rated by teachers on a five-point Likert scale, and scores are summed for each of the two factors. Scores range from 5-35 for the Academic Success factor and from 5-60 for the Academic Productivity factor. Higher scores are representative of stronger classroom functioning
IEP Goals/Objectives met
Teacher rating at endpoint of goals/objectives met on an improvement rating scale ranging from very much worse to very much better. Scores across goals/objectives will be averaged for a single overall score, and higher scores indicated greater degrees of goal attainment.
Impairment rating scale - teacher version
Ratings of functional impairment on a 7-point visual analogue scale ranging from 0-6. Lower ratings indicated less impairment in functioning in each domain. Scores across domains will be averaged.
Full Information
NCT ID
NCT03747887
First Posted
November 14, 2018
Last Updated
September 19, 2023
Sponsor
State University of New York at Buffalo
Collaborators
Florida International University
1. Study Identification
Unique Protocol Identification Number
NCT03747887
Brief Title
Enhancing IEPs of Children With ADHD Using Daily Report Cards
Official Title
Enhancing IEPs of Children With ADHD Using Daily Report Cards: An Efficacy Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
Florida International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study are to determine the effectiveness of the daily report card (DRC) approach to supporting children with ADHD in special education in schools compared to a business as usual condition. Children in the study will be randomly assigned to business as usual, or to receive a DRC based on Individualized Education Program goals and objectives, across the school year. All children will have progress carefully monitored across the school year.
Detailed Description
This study will investigate the efficacy of an intervention to enhance the special education supports used for children with ADHD (i.e., the manner in which goals/objectives on the IEP are monitored and addressed; targeting of social/behavioral goals).
The purpose of this proposed study is to provide evidence for the efficacy of using a daily report card intervention (DRC) as a means of linking the child with ADHD's IEP goals and objectives to his/her daily functioning in the classroom environment. A Goal 2 study was recently completed to develop and provide preliminary support for the DRC intervention for this purpose (Fabiano et al., 2010). The proposed investigation will be a multi-site study conducted in elementary schools throughout the Western New York and South Florida area. Participants will be 216 children (grades K-6), who have been diagnosed with ADHD and have an IEP (e.g., Specific Learning Disability, Emotionally Disturbed, Other Health Impaired).
In the proposed study, the efficacy of the DRC as an enhancement to children with ADHD's IEPs will be investigated in an experimental study. Children will be randomly assigned on the individual level to a condition where a behavioral consultant works with the child's teacher(s) to construct a DRC, implement it, and monitor it, or to an IEP only, school as usual (SAU) condition, where teachers will attempt to meet the IEP goals and objectives as they typically would. A DRC is an operationalized list of target behaviors (e.g., "completes reading assignments with 80% accuracy or better," "has no office time outs during the day") that are evaluated each day by the teacher. The DRC is used as a means of providing the child and parent feedback on progress on a daily basis, and it doubles as a mechanism teachers can use to track and monitor the child's behavior and progress on key functional domains. The DRC can be easily linked to IEP goals and objectives, providing a bridge between the IEP and the child's daily functioning in the classroom. Parents will also be taught in parenting meetings how to reward their child at home for successful attainment of DRC goals and how to communicate effectively with their child's teacher.
Measures of key outcomes will include observations of behavior in the classroom conducted by observers naïve to group assignment or study hypotheses, academic performance outcomes, parent and teacher ratings of functioning, and IEP goal attainment. Primary measures of outcome will be analyzed using ANCOVA procedures. Secondary measures will include teacher ratings of ADHD and disruptive behavior/impairment. Additional analyses will investigate moderators (grade level, comorbid aggressive behavior, IEP quality). It is further hypothesized that classroom environment and fidelity of implementation at school/home will mediate outcomes (i.e., classroom climate, the fidelity of teacher monitoring/feedback regarding behavior, consistency of parent-implemented consequences at home).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random assignment to intervention group or business as usual group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)
8. Arms, Groups, and Interventions
Arm Title
School as Usual
Arm Type
Active Comparator
Arm Description
School as usual comparison condition.
Arm Title
Daily Report Card
Arm Type
Experimental
Arm Description
A coach will establish a Daily Report Card based on IEP goals and objectives with the parents/teachers of the child in this arm.
Intervention Type
Behavioral
Intervention Name(s)
Daily Report Card
Intervention Description
Students assigned to the DRC group will have a consultant assigned to the student for the duration of the school year. The consultant will work with the child's primary special education teacher (or regular education teacher if the child spends the majority of his or her day mainstreamed) to establish a DRC over the course of three consultation visits. The How to Establish a Daily Report Card manual contains a standard DRC instruction packet that is provided to teachers to explain the rationale of the DRC, procedures for creating, modifying, and evaluating the DRC, procedures for parents to create home-based rewards for DRC performance, and information on trouble-shooting.
Intervention Type
Other
Intervention Name(s)
School as Usual
Intervention Description
The Individualized Education Program will be implemented as usual, with no additional study-related supports.
Primary Outcome Measure Information:
Title
Student Behavior Teacher Response Observation Rule Violations Count
Description
Frequency count of classroom rule violations collected during three, 30-minute observation periods and averaged.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Academic Performance Rating Scale
Description
Academic Performance Rating Scale sub scales of: Academic Productivity factor (7 items) that relates to work completion and accuracy, independent work, and following directions (coefficient alpha = .94; test-retest reliability over two weeks = .93), and an Academic Success (12 items) factor related to the child's academic achievement, recall, and ability (coefficient alpha = .95; test-retest reliability over two weeks = .91). Items are rated by teachers on a five-point Likert scale, and scores are summed for each of the two factors. Scores range from 5-35 for the Academic Success factor and from 5-60 for the Academic Productivity factor. Higher scores are representative of stronger classroom functioning
Time Frame
5 months
Title
IEP Goals/Objectives met
Description
Teacher rating at endpoint of goals/objectives met on an improvement rating scale ranging from very much worse to very much better. Scores across goals/objectives will be averaged for a single overall score, and higher scores indicated greater degrees of goal attainment.
Time Frame
5 months
Title
Impairment rating scale - teacher version
Description
Ratings of functional impairment on a 7-point visual analogue scale ranging from 0-6. Lower ratings indicated less impairment in functioning in each domain. Scores across domains will be averaged.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current Individualized Education program
Diagnosis of ADHD
Enrolled in Grades Kindergarten - 6
Exclusion Criteria:
IQ < 70
Home-schooled
Enrolled in a classroom with another study participant
Autism spectrum disorder
Facility Information:
Facility Name
SUNY at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
At the completion of the study, an anonymous database will be created and shared as per the data sharing plan constructed as part of the grant.
IPD Sharing Time Frame
At the completion of the study in 2021.
IPD Sharing Access Criteria
Contact Dr. Fabiano directly at fabiano@buffalo.edu
Learn more about this trial
Enhancing IEPs of Children With ADHD Using Daily Report Cards
We'll reach out to this number within 24 hrs