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PEARLS Intervention (PEARLS)

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ClinicalTrials.gov Identifier: NCT03260062
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Ivette Cejas, University of Miami

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

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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 2019
Estimated Study Completion Date : December 2019


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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260062


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

Locations
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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
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Principal Investigator: Ivette Cejas, PhD University of Miami

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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    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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