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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04185324
Other study ID # SalusU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date January 30, 2020

Study information

Verified date December 2019
Source Salus University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date January 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 42 Months to 60 Months
Eligibility 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 Design


Related Conditions & MeSH terms

  • Typical Preschoolers Who Can Not Zipper

Intervention

Behavioral:
Standard zippering vest
Standard zippering vest used to teach zippering
Modified zippering vest
Modified zippering vest used to teach zippering, along with related story

Locations

Country Name City State
United States Little Joes preschool Jenkintown Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Salus University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Zippering steps completed 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