PEARLS Intervention (PEARLS)

• ClinicalTrials.gov Identifier: NCT03260062
• Recruitment Status: Recruiting
• First Posted: August 24, 2017
• Last Update Posted: August 6, 2019
• Sponsor: University of Miami
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Information provided by (Responsible Party): Ivette Cejas, University of Miami

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Deafness, Bilateral	Behavioral: Parent-Child Early Approaches to Raising Language Skills; Other: Standard Care Speech therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants
• Actual Study Start Date: April 11, 2016
• Estimated Primary Completion Date: September 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: PEARLS; Parent-Child Early Approaches to Raising Language Skills	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 will receive standard care 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.

Outcome Measures

Primary Outcome Measures :

1. Change in parental sensitivity [ Time Frame: Baseline, Week 10 ]
   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.

Secondary Outcome Measures :

1. Change in use of higher-level versus lower-level language strategies [ Time Frame: Baseline, Week 10 ]
   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.
2. Change in parental involvement and self-efficacy [ Time Frame: Baseline, Week 10 ]
   Parent involved and self-efficacy will be measured using the Scale for Parental Involvement and Self-Efficacy (SPISE) for young children with hearing loss. Higher scores indicate more parent involvement and higher self-efficacy
3. Change in Auditory Skills [ Time Frame: Baseline, Week 10 ]
   Children's auditory skills will be measured using the Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS). Higher scores indicated better auditory skills

Eligibility Criteria

• Ages Eligible for Study: 12 Months to 48 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Ivette Cejas, PhD; 3052439199; icejas@med.miami.edu

Locations

United States, Florida

Don Soffer Clinical Research Building; Recruiting

Miami, Florida, United States, 33136

Contact: Ivette Cejas, PhD 305-243-9199 icejas@med.miami.edu

Principal Investigator: Ivette Cejas, PhD

Sponsors and Collaborators

University of Miami

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

• Principal Investigator: Ivette Cejas, PhD; University of Miami

More Information

• Responsible Party: Ivette Cejas, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03260062 History of Changes
• Other Study ID Numbers: 20150457; R21DC016265 ( U.S. NIH Grant/Contract )
• First Posted: August 24, 2017
• Last Update Posted: August 6, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ivette Cejas, University of Miami:

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

Additional relevant MeSH terms:

Deafness; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms