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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03002363
Other study ID # STU00203250
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2016
Est. completion date September 1, 2017

Study information

Verified date August 2018
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.

1. 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.

2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Months to 36 Months
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Video Modeling Intervention
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
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.

Locations

Country Name City State
United States Northwestern Clinic for Audiology, Speech, Language, and Learning Evanston Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Parent stress PI developed form regarding parent perception Immediately before and immediately after audiology appointment (same day as appointment)
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