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Behavioral Intervention
Vocal-Social Reinforcement for Infant Speech Learning With Hearing Loss
N/A
Recruiting
Led By Sarah W Bottjer, Ph.D.
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Infants ca. 7-16 months of age at study onset
Be younger than 18 years old
Must not have
Infants who are not exposed to English or Spanish in the home
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 16 months and/or 6 months after initial visit
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how social factors influence how infants aged 7-18 months learn speech, with a focus on how those with hearing loss can benefit from extra reinforcement.
Who is the study for?
This study is for infants about 7-18 months old with either typical hearing or sensorineural hearing loss. They must have at least one parent who speaks English or Spanish and can participate in the study. Infants not exposed to these languages, or without a participating parent, cannot join.
What is being tested?
The trial examines how social interactions affect speech learning in infants. It involves parents playing with their child and saying nonsense words, which are then played back to the infant to see if it influences vocal learning.
What are the potential side effects?
Since this study focuses on social interaction and vocal exercises rather than medical interventions, there are no direct side effects associated with traditional clinical trials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 7 and 16 months old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My infant is not exposed to English or Spanish at home.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at 16 months and/or 6 months after initial visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 16 months and/or 6 months after initial visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Vocal Codes During Study Visit
Secondary study objectives
Change in Vocal Codes Between Visits
MacArthur Communicative Development Inventory
Perception
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Parents are instructed to say nonsense words in response to infant babbles with a conserved phonological form as infant plays.
Group II: ControlActive Control1 Intervention
Parents are instructed to say nonsense words at random times with a conserved phonological form as infant plays.
Find a Location
Who is running the clinical trial?
Cornell UniversityOTHER
171 Previous Clinical Trials
14,088,662 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
354 Previous Clinical Trials
181,612 Total Patients Enrolled
15 Trials studying Speech
1,931 Patients Enrolled for Speech
University of Southern CaliforniaLead Sponsor
945 Previous Clinical Trials
1,604,585 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is under 24 months old and needs a follow-up visit.Infants with normal hearing, hearing loss, or hearing loss improved with a hearing aid or cochlear implant can participate.I have a parent at home who speaks English or Spanish and can join the study.My infant is not exposed to English or Spanish at home.My child is between 7 and 16 months old.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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