NCT03975972

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 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

June 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

June 4, 2019

Last Update Submit

October 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reading Achievement

    The reading level of student using the reading assessment that is utilized by the school: Independent Reading Level Assessment Framework (IRLA)

    9 weeks

Secondary Outcomes (1)

  • Literacy Engagement

    9 weeks

Study Arms (2)

Occupational Therapy Based Literacy Intervention

EXPERIMENTAL

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

Standard Classroom Based Literacy Intervention

NO 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.

Interventions

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.

Occupational Therapy Based Literacy Intervention

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (3)

  • Grajo, L.C. & Candler, C. (2014). Children with reading difficulties: how occupational therapy can help. OT Practice, 19(13), 16-17.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 27089292BACKGROUND

Related Links

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Turquessa Francis, Ed.D

    SUNY Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 5, 2019

Study Start

September 2, 2019

Primary Completion

December 13, 2019

Study Completion

December 20, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Individual Participant Data will not be made available to other researchers.

Locations