NCT04185324

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

March 31, 2020

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

November 26, 2019

Last Update Submit

March 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Standard zippering vest

EXPERIMENTAL

Children receive three supervised sessions for them to practice engaging and pull up a zipper, using a standard teaching zippering vest.

Behavioral: Standard zippering vest

Modified zippering vest

EXPERIMENTAL

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.

Behavioral: Modified zippering vest

Interventions

Standard zippering vest used to teach zippering

Also known as: Control group
Standard zippering vest

Modified zippering vest used to teach zippering, along with related story

Also known as: Comparison group
Modified zippering vest

Eligibility Criteria

Age42 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Little Joes preschool

Jenkintown, Pennsylvania, 19046, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Fern Silverman, EdD

    Salus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Preschoolers are not aware of whether they receive zippering instruction using a standard teaching zippering vest or the modified one. The parents were not aware which group their child was put in. All children received extra practice with zippering, in both groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 4, 2019

Study Start

September 1, 2019

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

March 31, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations