Developmental DysgraphiaNCT02620098
Effectiveness of a Handwriting Intervention
A study testing Size Matters Handwriting Program in people with Developmental Dysgraphia, run by Temple University.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dysgraphia
- What is being tested?
- Size Matters Handwriting Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children not in kindergarten
- Children not receiving IEP or Rtl tier 2 interventions
About this study
Official title: Effectiveness of a Handwriting Intervention With At-Risk Kindergarteners
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.
Read the 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.
- Conditions
- Developmental Dysgraphia
- Being tested
- Size Matters Handwriting Program
- Medical subject headings
- Agraphia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Size Matters Handwriting ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Before and after 30 sessions completed twice a week for 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Developmental DysgraphiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Pfeiffer, Temple University
- Investigators
- Beth Pfeiffer, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620098
- Sponsor's protocol ID
- Hand01
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bradley R, Danielson L, Doolittle J. Response to intervention. J Learn Disabil. 2005 Nov-Dec;38(6):485-6. doi: 10.1177/00222194050380060201.
PubMed 16392688Case-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.
PubMed 22214111Case-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.
PubMed 22742687Case-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.
PubMed 25397764Dunsmuir 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.
PubMed 15296550Feder 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.
PubMed 17376144Howe 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.
PubMed 23245779James 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.
PubMed 25541600Ohl 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.
PubMed 23968788Pfeiffer 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.
PubMed 26460474
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Handwriting Intervention With At-Risk Kindergarteners
- ClinicalTrials.gov ID
- NCT02620098
- Acronym / sponsor ID
- Hand01
- Conditions
- Developmental Dysgraphia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Size Matters Handwriting Program | Experimental | Other: Size Matters Handwriting ProgramAll 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. |
| 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. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Size Matters Handwriting ProgramThe 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. | Other | Size Matters Handwriting Program |
Primary outcome
Change in the Test of Handwriting Skills-Revised (THS-R) after 16 weeks
Time frame: Before and after 30 sessions completed twice a week for 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).
1 secondary outcome
Change in the North Dakota Title I Kindergarten Reading Standards Assessment (Letter Identification Subtest after 16 weeks
Time frame: Before and after 30 sessions completed twice a week for 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 16392688Bradley R, Danielson L, Doolittle J. Response to intervention. J Learn Disabil. 2005 Nov-Dec;38(6):485-6. doi: 10.1177/00222194050380060201.
- Background: PubMed 22214111Case-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.
- Background: PubMed 22742687Case-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.
- Background: PubMed 25397764Case-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.
- Background: PubMed 15296550Dunsmuir 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.
- Background: PubMed 17376144Feder 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.
- Background: PubMed 23245779Howe 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.
- Background: PubMed 25541600James 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.
- Background: PubMed 23968788Ohl 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.
- Background: PubMed 26460474Pfeiffer 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Pfeiffer, PhD principal investigator
Temple University
Questions about this trial
What is this clinical trial studying?
A study testing Size Matters Handwriting Program in people with Developmental Dysgraphia, run by Temple University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Test of Handwriting Skills-Revised (THS-R) after 16 weeks (time frame: Before and after 30 sessions completed twice a week for 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02620098, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.