Parent-Child Early Approaches to Raising Language Skills (PEARLS) Intervention

University of Miami

Status: Completed

Conditions: Deafness, Bilateral

Treatments: Behavioral: Parent-Child Early Approaches to Raising Language Skills; Other: Standard Care Speech therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03260062

20150457

R21DC016265 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 15 patients

Sex: All

Ages: 12 to 48 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

PEARLS

Experimental group

Description:

Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention

Treatment:

Behavioral: Parent-Child Early Approaches to Raising Language Skills

Control

Active Comparator group

Description:

Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy

Treatment:

Other: Standard Care Speech therapy