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

NCT ID: NCT04185324

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Typical Preschoolers Who Can Not Zipper

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two cohort
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard zippering vest

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

Group Type EXPERIMENTAL

Standard zippering vest

Intervention Type BEHAVIORAL

Standard zippering vest used to teach zippering

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.

Group Type EXPERIMENTAL

Modified zippering vest

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard zippering vest

Standard zippering vest used to teach zippering

Intervention Type BEHAVIORAL

Modified zippering vest

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control group Comparison group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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 -


\-
Minimum Eligible Age

42 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Salus University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fern Silverman, EdD

Role: PRINCIPAL_INVESTIGATOR

Salus University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Little Joes preschool

Jenkintown, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SalusU

Identifier Type: -

Identifier Source: org_study_id