NCT02620098

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

November 18, 2015

Last Update Submit

November 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Before and after 30 sessions completed twice a week for 16 weeks

Secondary Outcomes (1)

  • Change in the North Dakota Title I Kindergarten Reading Standards Assessment (Letter Identification Subtest after 16 weeks

    Before and after 30 sessions completed twice a week for 16 weeks

Study Arms (2)

Size Matters Handwriting Program

EXPERIMENTAL

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.

Other: Size Matters Handwriting Program

Control

NO INTERVENTION

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.

Interventions

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.

Size Matters Handwriting Program

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Bradley R, Danielson L, Doolittle J. Response to intervention. J Learn Disabil. 2005 Nov-Dec;38(6):485-6. doi: 10.1177/00222194050380060201.

    PMID: 16392688BACKGROUND
  • 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.

    PMID: 22214111BACKGROUND
  • 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.

    PMID: 22742687BACKGROUND
  • 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.

    PMID: 25397764BACKGROUND
  • 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.

    PMID: 15296550BACKGROUND
  • 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.

    PMID: 17376144BACKGROUND
  • 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.

    PMID: 23245779BACKGROUND
  • 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.

    PMID: 25541600BACKGROUND
  • 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.

    PMID: 23968788BACKGROUND
  • 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.

    PMID: 26460474BACKGROUND

MeSH Terms

Conditions

Agraphia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Beth Pfeiffer, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2015

First Posted

December 2, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11