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Completed

NCT Number: NCT03002363

The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance

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.

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Key information

Age range

18 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Northwestern Clinic for Audiology, Speech, Language, and Learning

Evanston, Illinois, 60208, United States

About this study

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. Another purpose of this study is to determine if pre-exposure to the test setting can increase the compliance on individual test measures. To test the central hypothesis and accomplish the study objective, 2 aims guide the proposed study.

  • Determine the extent to which pre-exposure to expectations and tasks that occur during the audiological evaluation will increase audiological testing compliance. Hypothesis: Children receiving the intervention video, which will model what they will experience during the audiological evaluation, will show greater compliance during the evaluation than children who receive the placebo video.
  • Determine the extent to which enhanced testing compliance will increase the number of test measures obtained during an audiological evaluation. Hypothesis: Children who are more compliant during the audiological evaluation will allow the audiologist to obtain more test measures in a single appointment than the children who are less compliant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • None

Treatment and study plan

Video Modeling Intervention

Behavioral

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.

Placebo Video

Behavioral

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.

Primary outcomes

  1. Compliance to audiology tests (% of audiology tests completed during an audiology session)

    Time frame: Immediately following appointment (same day as appointment)

    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.

Secondary outcomes

  1. Parent stress

    Time frame: Immediately before and immediately after audiology appointment (same day as appointment)

    PI developed form regarding parent perception

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2016
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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