Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants
| Registry | NCT03260062, acronym PEARLS |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 15 (Actual) |
| Sponsor | University of Miami (Other); collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Conditions | Deafness, Bilateral |
| Interventions | Parent-Child Early Approaches to Raising Language Skills, Standard Care Speech therapy (Behavioral, other) |
| Dates | start 2016-04-11, primary completion 2021-04-01, completion 2021-04-01, first posted 2017-08-24, last updated 2021-05-07 |
| Locations | 1 site in United States |
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All trials for Deafness, Bilateral All trials of Parent-Child Early Approaches to Raising Language Skills All trials of Standard Care Speech therapy
The purpose of this research study is to develop and evaluate a parent training program, which aims to improve language. The study is being conducted to see if teaching parents positive parenting techniques and behavior strategies will improve the rate of language development in children with cochlear implants when compared to standard speech therapy (e.g., auditory-verbal therapy).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PEARLS | Experimental | Behavioral: Parent-Child Early Approaches to Raising Language Skills | Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention |
| Control | Active comparator | Other: Standard Care Speech therapy | Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy |
Sex: All, ages: 12 Months to 48 Months
Inclusion Criteria: 1. children who are severely to profoundly deaf and a cochlear implant candidate, 2. children who are 12 to 48 months, 3. English or Spanish as primary language spoken at home, 4. families educating their children in spoken language, 5. children who pass the cognitive screening, scoring 75 or above on the screening measure Exclusion Criteria: 1. parents who do not consent to being videotaped, 2. children with moderate to severe developmental delays (as assessed using the Battelle Developmental Inventory (BDI-2) 2nd Edition for children ages 0 to 24 months or the Leiter International Performance Scale-Revised), 3. children with significant syndromes (e.g., CHARGE, autism, cerebral palsy) or severe brain abnormalities, 4. families who do not receive their auditory-verbal therapy from University of Miami (UM). Further, children who have already completed the BDI-2 within the past year as part of their Early Steps (Florida Early Intervention) program will not have it re-administered.
| Facility | City | Country | Status |
|---|---|---|---|
| Don Soffer Clinical Research Building | Miami, Florida | United States |
NIH grants: R21DC016265