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

August 20, 2018 updated by: Megan Roberts, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern Clinic for Audiology, Speech, Language, and Learning

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video Modeling Intervention
The 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.
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 Comparator: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately following appointment (same day as appointment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent stress
Time Frame: Immediately before and immediately after audiology appointment (same day as appointment)
PI developed form regarding parent perception
Immediately before and immediately after audiology appointment (same day as appointment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Megan Y Roberts, PhD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

December 9, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimate)

December 23, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU00203250

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism

Clinical Trials on Video Modeling Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe