Enhancing IEPs of Children With ADHD Using Daily Report Cards

• ClinicalTrials.gov Identifier: NCT03747887
• Recruitment Status: Active, not recruiting
• First Posted: November 20, 2018
• Last Update Posted: August 24, 2022
• Sponsor: State University of New York at Buffalo
• Collaborator: Florida International University
• Information provided by (Responsible Party): Gregory Fabiano, State University of New York at Buffalo

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.

Condition or disease	Intervention/treatment	Phase
Attention Deficit Hyperactivity Disorder	Behavioral: Daily Report Card; Other: School as Usual	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 211 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Random assignment to intervention group or business as usual group.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Enhancing IEPs of Children With ADHD Using Daily Report Cards: An Efficacy Trial
• Actual Study Start Date: January 3, 2019
• Estimated Primary Completion Date: June 30, 2023
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: School as Usual; School as usual comparison condition.	Other: School as Usual; The Individualized Education Program will be implemented as usual, with no additional study-related supports.
Experimental: Daily Report Card; A coach will establish a Daily Report Card based on IEP goals and objectives with the parents/teachers of the child in this arm.	Behavioral: Daily Report Card; 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.

Outcome Measures

Primary Outcome Measures :

1. Student Behavior Teacher Response Observation Rule Violations Count [ Time Frame: 5 months ]
   Frequency count of classroom rule violations collected during three, 30-minute observation periods and averaged.

Secondary Outcome Measures :

1. Academic Performance Rating Scale [ Time Frame: 5 months ]
   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
2. IEP Goals/Objectives met [ Time Frame: 5 months ]
   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.
3. Impairment rating scale - teacher version [ Time Frame: 5 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

SUNY at Buffalo

Buffalo, New York, United States, 14214

Sponsors and Collaborators

State University of New York at Buffalo

Florida International University

  Study Documents (Full-Text)

Documents provided by Gregory Fabiano, State University of New York at Buffalo:

Study Protocol and Statistical Analysis Plan  [PDF] October 16, 2018

More Information

• Responsible Party: Gregory Fabiano, Principal Investigator, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT03747887
• Other Study ID Numbers: R324A180175
• First Posted: November 20, 2018
• Last Update Posted: August 24, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: At the completion of the study in 2021.
• Access Criteria: Contact Dr. Fabiano directly at fabiano@buffalo.edu

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders