Attention Deficit Hyperactivity DisorderNCT03747887
Enhancing IEPs of Children With ADHD Using Daily Report Cards
A study testing Daily Report Card and School as Usual in people with Attention Deficit Hyperactivity Disorder, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Daily Report Card and School as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Current Individualized Education program
- Diagnosis of ADHD
- Enrolled in Grades Kindergarten - 6
Who cannot join
- IQ < 70
- Home-schooled
- Enrolled in a classroom with another study participant
- Autism spectrum disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing IEPs of Children With ADHD Using Daily Report Cards: An Efficacy Trial
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.
Read the 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).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Daily Report Card, School as Usual
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Report CardBehavioural
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.
School as UsualOther
The Individualized Education Program will be implemented as usual, with no additional study-related supports.
| Study group | Role | What they receive |
|---|---|---|
| School as Usual | Active comparator | School as usual comparison condition. Receives: Other: School as Usual |
| Daily Report Card | Experimental | A coach will establish a Daily Report Card based on IEP goals and objectives with the parents/teachers of the child in this arm. Receives: Behavioral: Daily Report Card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Behavior Teacher Response Observation Rule Violations Count
Frequency count of classroom rule violations collected during three, 30-minute observation periods and averaged.
Measured: 5 months
Secondary outcomes (3)
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
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start3 Jan 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment to intervention group or business as usual group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Florida International University
- Responsible party
- Principal investigator, Gregory Fabiano, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747887
- Sponsor's protocol ID
- R324A180175
- Status last verified
- Sep 2023
- First submitted
- 14 Nov 2018
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing IEPs of Children With ADHD Using Daily Report Cards: An Efficacy Trial
- ClinicalTrials.gov ID
- NCT03747887
- Acronym / sponsor ID
- R324A180175
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Florida International University
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Random assignment to intervention group or business as usual group.
| Arm | Type | Receives |
|---|---|---|
| School as Usual | Active comparator | Other: School as UsualSchool as usual comparison condition. |
| Daily Report Card | Experimental | Behavioral: Daily Report CardA coach will establish a Daily Report Card based on IEP goals and objectives with the parents/teachers of the child in this arm. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Current Individualized Education program
- Diagnosis of ADHD
- Enrolled in Grades Kindergarten - 6
Key exclusion criteria (4 listed)
- IQ < 70
- Home-schooled
- Enrolled in a classroom with another study participant
- Autism spectrum disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Report CardStudents 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. | Behavioural | Daily Report Card |
| School as UsualThe Individualized Education Program will be implemented as usual, with no additional study-related supports. | Other | School as Usual |
Primary outcome
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.
3 secondary outcomes
Academic Performance Rating Scale
Time frame: 5 months
IEP Goals/Objectives met
Time frame: 5 months
Impairment rating scale - teacher version
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Report Card and School as Usual in people with Attention Deficit Hyperactivity Disorder, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student Behavior Teacher Response Observation Rule Violations Count (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.