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

Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants

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).

Study Overview

• Status: Completed
• Conditions: Deafness, Bilateral
• Intervention / Treatment: Behavioral: Parent-Child Early Approaches to Raising Language Skills; Other: Standard Care Speech therapy

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Don Soffer Clinical Research Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PEARLS; Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention	Behavioral: 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).
ACTIVE_COMPARATOR: Control; Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy	Other: Standard Care Speech therapy; Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in use of higher-level versus lower-level language strategies	Parents use of higher level language strategies (open-ended questions, parallel talk, expansion) during video-taped parent-child interactions will be coded. Parent interactions will be transcribed and the number of specific language strategies will recorded.	Baseline, Week 10
Change in parental involvement and self-efficacy	Parent involved self-efficacy will be measured using the Scale for Parental Involvement and Self-Efficacy (SPISE) for young children with hearing loss. SPISE has a total score ranging from 23 to 161 with the higher score indicating more parent involvement and higher self-efficacy.	Baseline, Week 10
Change in Auditory Skills	Children's auditory skills will be measured using the Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS). IT-MAIS has a total score ranging from 0-40 with the higher score indicating better auditory skills.Auditory Integration Scale (IT-MAIS). Higher scores indicated better auditory skills	Baseline, Week 10

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Ivette Cejas, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2016
• Primary Completion (ACTUAL): April 1, 2021
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (ACTUAL): August 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: language development; cochlear implants; parenting intervention; maternal sensitivity; facilitative language techniques
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Bilateral
• Other Study ID Numbers: 20150457; R21DC016265 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No