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Occupational Therapy-based Literacy Intervention and Classroom Based Literacy Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03975972
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Information provided by (Responsible Party):
State University of New York at Buffalo

Brief Summary:
The purpose of this study is to determine the impact of a literacy focused occupational therapy intervention program versus standard classroom-based reading intervention on reading engagement and reading achievement in elementary school-aged children with emotional disturbances.

Condition or disease Intervention/treatment Phase
Literacy Other: Occupational Therapy Based Literacy Intervention Not Applicable

Detailed Description:

The elementary school will assist with recruitment by sending recruitment packets home to parents/legal guardian of children to consent to participation in the study. Interested families will return the signed consent form to the researchers in a sealed envelope. These signed consent forms will be collected from the school by the researchers. For children where a consent was provided by a parent or legal guardian, an assent form will be completed by the child for the child to also consent to participating the study, a requirement to ensure that the child has a choice in partaking in the study.

Once all consents have been received, all consenting student participants will be placed in either a control group or intervention group based on the students' classroom teacher. Both the control group and intervention group will be assessed using the Inventory of Reading Occupations(IRO) to determine their access to reading materials and their perceived proficiency with the reading tasks. Both the control group and intervention group's reading level will be obtained from the classroom teacher using the results of the Independent Reading Level Assessment® Framework (IRLA) from the beginning of the school year.

The intervention group will be provided with a 12-question survey to determine reading interest to guide the 9-week literacy intervention plan and ensure that the literacy intervention plan is in line with the IRLA reading Program. The control group will receive literacy instruction as proposed by the IRLA reading program and will not receive a specific occupation-based literacy intervention plan. Both the control and intervention group will have the principal investigator and student researchers available to provide one-on-one support during literacy instruction, with the intervention group receiving a specific literacy intervention plan while the control group continues with the literacy instructional material provided within the IRLA assessment framework. At the end of 9-weeks, the control group and intervention group will be re-administered the Inventory of Reading Occupations(IRO) and an updated reading achievement will be obtained from teacher from the student's scores on the Independent Reading Level Assessment® Framework (IRLA) at the end of the 9-week intervention period. The control group and intervention group's IRO and IRLA scores will be analyzed to find out the differences between the groups in reading interest, perceived reading proficiency and reading achievement. The researchers will be available by phone or email throughout the entirety of the study should questions arise about the intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Differences in Reading Achievement When Using Occupational-therapy Based Strategies Versus Standard Classroom-based Reading Intervention for Elementary School Children—a Pilot Study.
Estimated Study Start Date : September 2, 2019
Estimated Primary Completion Date : December 13, 2019
Estimated Study Completion Date : December 20, 2019

Arm Intervention/treatment
Experimental: Occupational Therapy Based Literacy Intervention
For the intervention group, the results from the Inventory of Reading Occupations will be utilized to determine a prescriptive weekly intervention for each participant in the intervention group that will be provided to teachers based on student interest and literacy need. For the intervention group, each participant will be provided with a list of 12 questions that will be used to inform the intervention plan based on the interests of each participant within the intervention group. Collectively, the information from the 12 questions and the results of the Inventory of Reading Occupations will be used to determine a 9-week intervention plan for each participant within the intervention group. The researchers will work with the subjects twice per week, 30 minutes per session in the classroom using the prescriptive intervention that was determined from the assessments utilized.
Other: Occupational Therapy Based Literacy Intervention
Use of an occupational therapy-based literacy intervention that utilizes student interest to guide a prescriptive literacy intervention. Addressing reading as an occupation and making the necessary modifications to the literacy task to allows for increased engagement in the task. Increased engagement in literacy tasks, allows for opportunities to work on literacy deficit areas to address proficiency with reading ability.

No Intervention: Standard Classroom Based Literacy Intervention
The control group will receive the standard reading instruction provided within the school. With the control group, the researchers will provide occupational therapy support to classroom teachers. But, will provide this support using the materials that are standardly provided within the classroom for literacy instruction. The researchers will provide support to the classroom teachers to students in the control group twice per week for 30 mintues per session in the classroom.

Primary Outcome Measures :
  1. Reading Achievement [ Time Frame: 9 weeks ]
    The reading level of student using the reading assessment that is utilized by the school: Independent Reading Level Assessment Framework (IRLA)

Secondary Outcome Measures :
  1. Literacy Engagement [ Time Frame: 9 weeks ]
    The amount of methods that the students using to access text, literacy tasks that the student engages in and the student's perceived proficiency with methods of accessing text. The Inventory of Reading Occupations (IRO) will be used to determine these three areas.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Participants must be in grades 1-5 .
  • Participants must be between the ages of 5-13 years of age: (the age is capped at a higher level due to the population this school serves where students may repeat a grade. So, the student may be older than most elementary aged children, but from a literacy perspective, they are functioning below their peers).
  • Participants must be at least one grade level below peers in reading using assessment that is utilized in school.
  • Participants must be able to speak English

Exclusion Criteria:

  • Students who are unable to speak or read English due to assessments being in English
  • Students who fall outside of the age criterion listed above
  • Students that are on grade level with reading

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03975972

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Contact: Turquessa Francis, Ed.D 7168296291

Sponsors and Collaborators
State University of New York at Buffalo
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Principal Investigator: Turquessa Francis, Ed.D SUNY Buffalo
Additional Information:
Grajo, L.C. & Candler, C. (2014). Children with reading difficulties: how occupational therapy can help. OT Practice, 19(13), 16-17.
Grajo, L.C. & Candler, C. (2016). An occupation and participation approach to reading intervention (OPARI) part I: defining reading as an occupation. Journal of Occupational Therapy, Schools, & Early Intervention, 9(1), 74-85.

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Responsible Party: State University of New York at Buffalo Identifier: NCT03975972    
Other Study ID Numbers: Study00003591
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be made available to other researchers.

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