- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04185324
Efficacy of an Intervention to Teach Zippering: A Two-Group Control Study
Effectiveness of Visual Cues and Verbal Storytelling in Teaching Preschool Children Zippering
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose: This pilot study compares the efficacy of a standard teaching zippering vest presented with general verbal prompts to a modified teaching zippering vest presented with a related story and vocabulary in the acquisition of zippering skills among typically developing preschoolers. Institutional Review Board approval and parent consent was obtained.
Design: An experimental two group pre-post test design was used. Setting: Research occurred in a local preschool. Participants: Participants were recruited from fifty 3.6-to 4.11-year-old preschoolers.
Intervention: Eligible children received 3 zippering practice sessions with either a standard zippering vest (control group) or a modified vest with added visual and language cues (comparison group).
The treatment protocol for both cohorts of participants was administered over a three-week time period to minimize the impact of normal development.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Jenkintown, Pennsylvania, United States, 19046
- Little Joes preschool
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Child must be typically developing as assessed by the Developmental Assessment of Young Children 2 (DAYC-2) developmental screening.
Child must be between 42 and 60 months of age. Child must be unable to zip by a) parent report and b) three observed attempts to zipper -
Exclusion Criteria:
Child must meet inclusion criteria and be present at school during three researcher visits to the preschool within three consecutive weeks.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Standard zippering vest
Children receive three supervised sessions for them to practice engaging and pull up a zipper, using a standard teaching zippering vest.
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Standard zippering vest used to teach zippering
Other Names:
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EXPERIMENTAL: Modified zippering vest
Children receive three sessions of specially designed zippering instruction using a modified zippering vest, where they can practice engaging and pulling up a zipper after being read a related story.
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Modified zippering vest used to teach zippering, along with related story
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Zippering steps completed
Time Frame: all data was collected within three weeks for each child to minimize the impact of typical development
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The task of engaging and pulling up a zipper was broken down to 7 steps.
By examining video data, the number of zippering steps completed was analyzed for each zippering trial.
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all data was collected within three weeks for each child to minimize the impact of typical development
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fern Silverman, EdD, Salus University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SalusU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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