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

NCT ID: NCT03260062

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-11
• Study Completion Date: 2021-04-30

Brief Summary

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).

Conditions

Deafness, Bilateral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PEARLS

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

Group Type: EXPERIMENTAL

Parent-Child Early Approaches to Raising Language Skills

Intervention Type: BEHAVIORAL

The PEARLS intervention will teach parents evidence-based language strategies and sensitive parenting (e.g., warmth, respect for autonomy, linguistic stimulation) to promote language development in young deaf children with cochlear implants (CI).

Control

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

Group Type: ACTIVE_COMPARATOR

Standard Care Speech therapy

Intervention Type: OTHER

Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.

Interventions

Parent-Child Early Approaches to Raising Language Skills

The PEARLS intervention will teach parents evidence-based language strategies and sensitive parenting (e.g., warmth, respect for autonomy, linguistic stimulation) to promote language development in young deaf children with cochlear implants (CI).

Intervention Type: BEHAVIORAL

Standard Care Speech therapy

Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 48 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Ivette Cejas

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivette Cejas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Don Soffer Clinical Research Building

Miami, Florida, United States

Countries

United States

Other Identifiers

R21DC016265

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20150457

Identifier Type: -

Identifier Source: org_study_id