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Effectiveness of a Handwriting Intervention

Primary Purpose

Developmental Dysgraphia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Size Matters Handwriting Program
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Dysgraphia

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers
  • Inclusion Criteria:

    • Kindergartners receiving educational support in the form of IEP and/or RtI tier 2 interventions
    • Must be in a support classroom where services are delivered
  • Exclusion Criteria:

    • Children not in kindergarten
    • Children not receiving IEP or Rtl tier 2 interventions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Size Matters Handwriting Program

    Control

    Arm Description

    All participants were receiving educational support in the form of IEP and/or RtI tier 2 interventions, and were participating in a support classroom where those services where being delivered. The intervention group consisted of 23 kindergarten students comprising all students in two kindergarten support classrooms, one in each of two neighboring schools. All students in the group received the Size Matters Handwriting Program.

    All participants were receiving educational support in the form of IEP and/or RtI tier 2 interventions, and were participating in a support classroom where those services where being delivered. The control group consisted of 12 kindergarteners comprising all students in a kindergarten support classroom at a third school. They received no additional interventions.

    Outcomes

    Primary Outcome Measures

    Change in the Test of Handwriting Skills-Revised (THS-R) after 16 weeks
    A standardized assessment of handwriting which can be administered to students ages six to 18 (Milone, 2007). There are ten subtests which include writing letters and numbers from memory, writing letters, numbers and words from dictation, copying letters, copying words, copying short sentences, and writing short words from dictation (Milone, 2007).

    Secondary Outcome Measures

    Change in the North Dakota Title I Kindergarten Reading Standards Assessment (Letter Identification Subtest after 16 weeks
    The North Dakota Kindergarten Reading Standards Assessment is aligned with North Dakota State Standards and consists of a number of subtests including: letter identification, word recognition, concepts about print, and sentence dictation. The assessment was designed as a tool for teachers and educational in selecting Title I students or assessing student achievement.

    Full Information

    First Posted
    November 18, 2015
    Last Updated
    November 30, 2015
    Sponsor
    Temple University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02620098
    Brief Title
    Effectiveness of a Handwriting Intervention
    Official Title
    Effectiveness of a Handwriting Intervention With At-Risk Kindergarteners
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Temple University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study was to examine the effectiveness of an occupational therapy led handwriting intervention for special education and at-risk kindergarten students.
    Detailed Description
    In spite of the increased use of computers and tablets by children of younger and younger ages, handwriting remains an important skill for school success and continues to be a critical skill for elementary school students to acquire. Beginning writers still do most of their composing by hand, and difficulties with handwriting can have far-reaching effects on a child's self esteem and academic success. This study examined the effectiveness of an occupational therapy led handwriting intervention for special education and at-risk kindergarten students. There is a tremendous need for studies examining the outcomes of handwriting instruction provided to the at-risk population, in order to determine whether outcomes are similar to those seen in the typically developing population. There is also a need for studies that examine outcomes in "real world" settings, in addition to those settings manipulated for experimental research. Such studies may not be as "clean" as those in classic experimental research, however it is imperative to examine outcomes in the settings that are occurring in today's schools. At-risk children are increasingly being provided intensive interventions under an RtI model, and children receiving special education services are increasingly being integrated into less restrictive settings, thus creating classroom environments with a wide variety of students needs. The purpose of this study was to examine the outcomes of a handwriting intervention, the Size Matters Handwriting Program (SMHP), provided to kindergarten children currently receiving IEP or RtI interventions. This study attempted to answer the following research questions: Will at-risk kindergarteners (those children receiving IEP or RtI support) participating in a 16 week, occupational therapy led handwriting SMHP intervention group demonstrate significantly greater improvements in handwriting legibility than children who do not receive the intervention? Will at-risk kindergarteners, participating in a SMHP handwriting intervention, make significantly greater gains in the pre-reading skills of letter-name recognition and letter-sound recall, than students who do not receive the intervention? The study incorporated a two group pre and post-test design. Both groups consisted of kindergarten students receiving IEP and/or RtI support. An occupational therapist provided biweekly group handwriting instruction using the Size Matters Handwriting Program to students in the intervention group (n = 23), while the control group (n=12) received the standard handwriting instruction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Developmental Dysgraphia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Size Matters Handwriting Program
    Arm Type
    Experimental
    Arm Description
    All participants were receiving educational support in the form of IEP and/or RtI tier 2 interventions, and were participating in a support classroom where those services where being delivered. The intervention group consisted of 23 kindergarten students comprising all students in two kindergarten support classrooms, one in each of two neighboring schools. All students in the group received the Size Matters Handwriting Program.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    All participants were receiving educational support in the form of IEP and/or RtI tier 2 interventions, and were participating in a support classroom where those services where being delivered. The control group consisted of 12 kindergarteners comprising all students in a kindergarten support classroom at a third school. They received no additional interventions.
    Intervention Type
    Other
    Intervention Name(s)
    Size Matters Handwriting Program
    Intervention Description
    The Size Matters Handwriting Program (Moskowitz, 2009) (SMHP) program incorporates principles grounded in motor learning theory, cognitive theory, and motivation theory. Children learn the importance of letter size by learning size 1 (capital and tall letters), size 2 (small letters) and size 3 letters (those that dive below the baseline) at different stages (Moskowitz, 2009). The intervention group received a total of 30 sessions of the SMHP, completed twice weekly over a 16 week period. Sessions lasted 30 minutes, and were led by an occupational therapist with training in the Size Matters Handwriting Program. All interventions were provided within the existing support classrooms. Each child had their own SMHP workbook.
    Primary Outcome Measure Information:
    Title
    Change in the Test of Handwriting Skills-Revised (THS-R) after 16 weeks
    Description
    A standardized assessment of handwriting which can be administered to students ages six to 18 (Milone, 2007). There are ten subtests which include writing letters and numbers from memory, writing letters, numbers and words from dictation, copying letters, copying words, copying short sentences, and writing short words from dictation (Milone, 2007).
    Time Frame
    Before and after 30 sessions completed twice a week for 16 weeks
    Secondary Outcome Measure Information:
    Title
    Change in the North Dakota Title I Kindergarten Reading Standards Assessment (Letter Identification Subtest after 16 weeks
    Description
    The North Dakota Kindergarten Reading Standards Assessment is aligned with North Dakota State Standards and consists of a number of subtests including: letter identification, word recognition, concepts about print, and sentence dictation. The assessment was designed as a tool for teachers and educational in selecting Title I students or assessing student achievement.
    Time Frame
    Before and after 30 sessions completed twice a week for 16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Kindergartners receiving educational support in the form of IEP and/or RtI tier 2 interventions Must be in a support classroom where services are delivered Exclusion Criteria: Children not in kindergarten Children not receiving IEP or Rtl tier 2 interventions
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Beth Pfeiffer, PhD
    Organizational Affiliation
    Temple University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16392688
    Citation
    Bradley R, Danielson L, Doolittle J. Response to intervention. J Learn Disabil. 2005 Nov-Dec;38(6):485-6. doi: 10.1177/00222194050380060201.
    Results Reference
    background
    PubMed Identifier
    22214111
    Citation
    Case-Smith J, Holland T, Bishop B. Effectiveness of an integrated handwriting program for first-grade students: a pilot study. Am J Occup Ther. 2011 Nov-Dec;65(6):670-8. doi: 10.5014/ajot.2011.000984.
    Results Reference
    background
    PubMed Identifier
    22742687
    Citation
    Case-Smith J, Holland T, Lane A, White S. Effect of a coteaching handwriting program for first graders: one-group pretest-posttest design. Am J Occup Ther. 2012 Jul-Aug;66(4):396-405. doi: 10.5014/ajot.2012.004333.
    Results Reference
    background
    PubMed Identifier
    25397764
    Citation
    Case-Smith J, Weaver L, Holland T. Effects of a classroom-embedded occupational therapist-teacher handwriting program for first-grade students. Am J Occup Ther. 2014 Nov-Dec;68(6):690-8. doi: 10.5014/ajot.2014.011585.
    Results Reference
    background
    PubMed Identifier
    15296550
    Citation
    Dunsmuir S, Blatchford P. Predictors of writing competence in 4- to 7-year-old children. Br J Educ Psychol. 2004 Sep;74(Pt 3):461-83. doi: 10.1348/0007099041552323.
    Results Reference
    background
    PubMed Identifier
    17376144
    Citation
    Feder KP, Majnemer A. Handwriting development, competency, and intervention. Dev Med Child Neurol. 2007 Apr;49(4):312-7. doi: 10.1111/j.1469-8749.2007.00312.x.
    Results Reference
    background
    PubMed Identifier
    23245779
    Citation
    Howe TH, Roston KL, Sheu CF, Hinojosa J. Assessing handwriting intervention effectiveness in elementary school students: a two-group controlled study. Am J Occup Ther. 2013 Jan-Feb;67(1):19-26. doi: 10.5014/ajot.2013.005470.
    Results Reference
    background
    PubMed Identifier
    25541600
    Citation
    James KH, Engelhardt L. The effects of handwriting experience on functional brain development in pre-literate children. Trends Neurosci Educ. 2012 Dec;1(1):32-42. doi: 10.1016/j.tine.2012.08.001.
    Results Reference
    background
    PubMed Identifier
    23968788
    Citation
    Ohl AM, Graze H, Weber K, Kenny S, Salvatore C, Wagreich S. Effectiveness of a 10-week tier-1 response to intervention program in improving fine motor and visual-motor skills in general education kindergarten students. Am J Occup Ther. 2013 Sep-Oct;67(5):507-14. doi: 10.5014/ajot.2013.008110.
    Results Reference
    background
    PubMed Identifier
    26460474
    Citation
    Pfeiffer B, Rai G, Murray T, Brusilovskiy E. Effectiveness of the Size Matters Handwriting Program. OTJR (Thorofare N J). 2015 Apr;35(2):110-9. doi: 10.1177/1539449215573004.
    Results Reference
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    Effectiveness of a Handwriting Intervention

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