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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03747887
Other study ID # R324A180175
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2019
Est. completion date June 30, 2023

Study information

Verified date September 2023
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 211
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 14 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder

Intervention

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.
Other:
School as Usual
The Individualized Education Program will be implemented as usual, with no additional study-related supports.

Locations

Country Name City State
United States SUNY at Buffalo Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
State University of New York at Buffalo Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Student Behavior Teacher Response Observation Rule Violations Count Frequency count of classroom rule violations collected during three, 30-minute observation periods and averaged. 5 months
Secondary 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 5 months
Secondary 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. 5 months
Secondary 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. 5 months
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