Efficacy of an Intervention to Teach Zippering: A Two-Group Control Study

March 29, 2020 updated by: Salus University

Effectiveness of Visual Cues and Verbal Storytelling in Teaching Preschool Children Zippering

Preschoolers are assigned to a control group or a comparison group to examine the efficacy of a new intervention to teach the skill of engaging and pulling up a zipper.

Study Overview

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

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Little Joes preschool

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Standard zippering vest used to teach zippering
Other Names:
  • Control group
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.
Modified zippering vest used to teach zippering, along with related story
Other Names:
  • Comparison group

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
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.
all data was collected within three weeks for each child to minimize the impact of typical development

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fern Silverman, EdD, Salus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ACTUAL)

January 30, 2020

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (ACTUAL)

December 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 29, 2020

Last Verified

December 1, 2019

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Typical Preschoolers Who Can Not Zipper

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