Clinical trial NCT03975972: Occupational Therapy-based Literacy Intervention and Classroom Based Literacy Intervention
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Literacy
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 52
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reading Achievement
timeFrame: 9 weeks
Secondary outcomes:
measure: Literacy Engagement
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: SUNY Buffalo
name: Turquessa Francis, Ed.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grajo, L.C. & Candler, C. (2014). Children with reading difficulties: how occupational therapy can help. OT Practice, 19(13), 16-17.
citation: 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.
citation: Grajo LC, Candler C, Bowyer P, Schultz S, Thomson J, Fong K. Determining the Internal Validity of the Inventory of Reading Occupations: An Assessment Tool of Children's Reading Participation. Am J Occup Ther. 2016 May-Jun;70(3):7003220010p1-9. doi: 10.5014/ajot.2016.017582.