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Improving Outcomes Using Technology for Children Who Are DHH

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ClinicalTrials.gov Identifier: NCT02998164
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
This study evaluates the efficacy of using augmentative and alternative communication (AAC) technology for enhancing language development in children who are deaf or hard of hearing. Half of the participants will receive AAC technology with their speech and language therapy and half will continue with their usual care models.

Condition or disease Intervention/treatment Phase
Hearing Loss Language Development Social Behavior Behavioral: augmentative and alternative communication technology Behavioral: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Outcomes Using Augmentative and Alternative Communication for Children Who Are Deaf or Hard of Hearing
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Technology-assisted language intervention
This intervention will incorporate augmentative and alternative communication software delivered on iPads into speech-language therapy
Behavioral: augmentative and alternative communication technology
Active Comparator: usual care
This group will be usual care children are already receiving.
Behavioral: Usual Care
No change to the therapy care received




Primary Outcome Measures :
  1. Syntax [ Time Frame: Change between baseline and 24 weeks ]
    Evaluated using the mean length of utterance in morphemes collected from language samples. Assessing change between baseline and 24 weeks.

  2. semantics [ Time Frame: Change between baseline and 24 weeks ]
    Variety and total number of vocabulary words used collected from language samples.Assessing change between baseline and 24 weeks.

  3. Discourse [ Time Frame: Assessing change between baseline and 24 weeks. ]
    Child's mean turn length in words collected from language samples. Assessing change between baseline and 24 weeks.


Secondary Outcome Measures :
  1. Language standard scores (receptive and expressive) [ Time Frame: Assessing change between baseline and 24 weeks. ]
    Receptive language (what a child understands) and expressive language (what a child says) as measured by standardized language assessment.

  2. Social functioning [ Time Frame: Assessing change between baseline and 24 weeks. ]
    Social functioning as measured by parent-reported assessments or scales



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • documented permanent bilateral hearing loss with severity levels clinically defined in any range (mild to profound);
  • identified with a language gap;
  • currently receiving speech-language therapy.

Exclusion Criteria:

  • primary language other than English
  • significant motor impairments
  • nonverbal IQ <60
  • children with severe communication disorders (i.e. autism spectrum disorders).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998164


Contacts
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Contact: Laura Smith, MPH 513-803-1901 laura.smith1@cchmc.org
Contact: Jareen Meinzen-Derr, PhD 513-636-7789 jareen.meinzen-derr@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jareen Meinzen-Derr, PhD    513-636-7789    jareen.meinzen-derr@cchmc.org   
Contact: Laura Smith, MPH    513-803-1901    laura.smith1@cchmc.org   
Sub-Investigator: Susan Wiley, MD         
Sub-Investigator: Sandra Grether, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Jareen Meinzen-Derr, PhD Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02998164     History of Changes
Other Study ID Numbers: CIN001-Improving Outcomes
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We currently do not have a IPD sharing plan. However, we will have one in place prior to the end of the study

Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms