Typical Preschoolers Who Can Not ZipperNCT04185324
Efficacy of an Intervention to Teach Zippering: A Two-Group Control Study
A study testing Standard zippering vest and Modified zippering vest in people with Typical Preschoolers Who Can Not Zipper, run by Salus University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 42 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Typical Preschoolers Who Can Not Zipper
- What is being tested?
- Standard zippering vest and Modified zippering vest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Child must meet inclusion criteria and be present at school during three researcher visits to the preschool within three consecutive weeks.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Little Joes preschool
Jenkintown, Pennsylvania, 19046
About this study
Official title: 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.
Read the 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.
- Conditions
- Typical Preschoolers Who Can Not Zipper
- Being tested
- Standard zippering vest, Modified zippering vest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard zippering vestBehavioural
Also called Control group
Standard zippering vest used to teach zippering
Modified zippering vestBehavioural
Also called Comparison group
Modified zippering vest used to teach zippering, along with related story
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Modified zippering vest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: all data was collected within three weeks for each child to minimize the impact of typical development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Sep 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typical Preschoolers Who Can Not ZipperStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two cohort
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fern Silverman, EdD, Principal investigator, Salus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185324
- Sponsor's protocol ID
- SalusU
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Visual Cues and Verbal Storytelling in Teaching Preschool Children Zippering
- ClinicalTrials.gov ID
- NCT04185324
- Acronym / sponsor ID
- SalusU
- Conditions
- Typical Preschoolers Who Can Not Zipper
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- two cohort
| Arm | Type | Receives |
|---|---|---|
| Standard zippering vest | Experimental | Behavioral: Standard zippering vestChildren receive three supervised sessions for them to practice engaging and pull up a zipper, using a standard teaching zippering vest. |
| Modified zippering vest | Experimental | Behavioral: Modified zippering vestChildren 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. |
Who may qualify
- Ages
- 42 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Child must meet inclusion criteria and be present at school during three researcher visits to the preschool within three consecutive weeks.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard zippering vestAlso: Control groupStandard zippering vest used to teach zippering | Behavioural | Standard zippering vest |
| Modified zippering vestAlso: Comparison groupModified zippering vest used to teach zippering, along with related story | Behavioural | Modified zippering vest |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Typical Preschoolers Who Can Not Zipper
Recruiting
Assessment of Language Comprehension and Learning in Children Attending Child Psychiatry Services (TICOALA-SOINS)
Typical Development, Typically Developing Children Ages 3 to 6
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fern Silverman, EdD principal investigator
Salus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard zippering vest and Modified zippering vest in people with Typical Preschoolers Who Can Not Zipper, run by Salus University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zippering steps completed (time frame: all data was collected within three weeks for each child to minimize the impact of typical development). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.