NCT03747887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

4.5 years

First QC Date

November 14, 2018

Last Update Submit

September 19, 2023

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Academic Performance Rating Scale

    5 months

  • IEP Goals/Objectives met

    5 months

  • Impairment rating scale - teacher version

    5 months

Study Arms (2)

School as Usual

ACTIVE COMPARATOR

School as usual comparison condition.

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.

Behavioral: Daily Report Card

Interventions

Daily Report CardBEHAVIORAL

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.

Daily Report Card
School as UsualOTHER

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

School as Usual

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Current Individualized Education program
  • Diagnosis of ADHD
  • Enrolled in Grades Kindergarten - 6

You may not qualify if:

  • IQ \< 70
  • Home-schooled
  • Enrolled in a classroom with another study participant
  • Autism spectrum disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Schools

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Random assignment to intervention group or business as usual group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 20, 2018

Study Start

January 3, 2019

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
At the completion of the study in 2021.
Access Criteria
Contact Dr. Fabiano directly at fabiano@buffalo.edu

Locations

US(1)