The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of the current study is to determine if pre-exposure through video modeling will enhance testing compliance in a population of children who are receiving a diagnostic evaluation for Autism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 9, 2016
CompletedFirst Posted
Study publicly available on registry
December 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedAugust 21, 2018
August 1, 2018
1 year
December 9, 2016
August 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compliance to audiology tests (% of audiology tests completed during an audiology session)
Compliance to the following audiology test battery: Otoscopy, Speech Awareness Threshold, Pure Tone Testing, Distortion, Product Otacoustic Emissions, Tympanometry. Compliance is measured as either "yes" or "no" to each of the tests in order to measure how many audiology tests are completed at the visit. The individual test units do not matter for the overall compliance of the visit.
Immediately following appointment (same day as appointment)
Secondary Outcomes (1)
Parent stress
Immediately before and immediately after audiology appointment (same day as appointment)
Study Arms (2)
Video Modeling Intervention
EXPERIMENTALThe intervention group receives a video that is a behavior modeling video that walks through the entire audiological evaluation. It also includes tips for caregivers to practice with their child before the appointment.
Placebo Video
PLACEBO COMPARATORThe other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.
Interventions
Prior to arrival of the audiological evaluation, the child and caregiver will be required to watch one of two videos created by the research personnel. One video, the intervention video, is a behavior modeling video walking through the entire audiological evaluation. It also includes tips for caregivers to practice with their child before the appointment. The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.
The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.
Eligibility Criteria
You may qualify if:
- Child must have chronological age of less than 36 months
- Participation in the Northwestern University Center for Audiology, Speech, Language, and Learning (NUCASLL) Developmental Diagnostic Program (DDP)
- A parent or caregiver who is willing to watch the intervention video, bring the child to/ participate in the audiological evaluation, and fill out a brief survey prior to and following the appointment, and
- Parent must understand English and speak English to their child.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern Clinic for Audiology, Speech, Language, and Learning
Evanston, Illinois, 60208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megan Y Roberts, PhD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 9, 2016
First Posted
December 23, 2016
Study Start
September 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
August 21, 2018
Record last verified: 2018-08