Improving Outcomes Using Technology for Children Who Are DHH
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02998164|
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss Language Development Social Behavior||Behavioral: augmentative and alternative communication technology Behavioral: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- Social functioning [ Time Frame: Assessing change between baseline and 24 weeks. ]Social functioning as measured by parent-reported assessments or scales
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
|Contact: Laura Smith, MPHemail@example.com|
|Contact: Jareen Meinzen-Derr, PhDfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Jareen Meinzen-Derr, PhD 513-636-7789 email@example.com|
|Contact: Laura Smith, MPH 513-803-1901 firstname.lastname@example.org|
|Sub-Investigator: Susan Wiley, MD|
|Sub-Investigator: Sandra Grether, PhD|
|Principal Investigator:||Jareen Meinzen-Derr, PhD||Children's Hospital Medical Center, Cincinnati|