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

NCT03260062 | Completed

• 2 other identifiers: 20150457R21DC016265
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

cochlear implants; language development; parenting intervention; maternal sensitivity; facilitative language techniques

Outcome Measures

Primary Outcomes (1)

• Change in parental sensitivity

  Parent sensitivity (warmth, positive regard, respect for child autonomy) will be coded from video-taped parent-child interactions during two play activities. Sensitivity will be coded on a 1 to 7 Likert scale, with higher scores indicating higher sensitivity.

  Baseline, Week 10

Secondary Outcomes (3)

• Change in use of higher-level versus lower-level language strategies

  Baseline, Week 10

• Change in parental involvement and self-efficacy

  Baseline, Week 10

• Change in Auditory Skills

  Baseline, Week 10

Study Arms (2)

PEARLS

EXPERIMENTAL

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

Behavioral: Parent-Child Early Approaches to Raising Language Skills

Control

ACTIVE COMPARATOR

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

Other: Standard Care Speech therapy

Interventions

Parent-Child Early Approaches to Raising Language Skills 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).

PEARLS

Standard Care Speech therapy OTHER

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

Control

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children who are severely to profoundly deaf and a cochlear implant candidate,
• children who are 12 to 48 months,
• English or Spanish as primary language spoken at home,
• families educating their children in spoken language,
• children who pass the cognitive screening, scoring 75 or above on the screening measure

You may not qualify if:

• parents who do not consent to being videotaped,
• 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),
• children with significant syndromes (e.g., CHARGE, autism, cerebral palsy) or severe brain abnormalities,
• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Don Soffer Clinical Research Building

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hearing Loss, Bilateral

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivette Cejas, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 24, 2017
• Study Start: April 11, 2016
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)