Parent-Child Early Approaches to Raising Language Skills (PEARLS) Intervention (PEARLS)
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ClinicalTrials.gov Identifier: NCT03260062 |
Recruitment Status :
Recruiting
First Posted : August 24, 2017
Last Update Posted : November 3, 2020
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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 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 : | April 2021 |
Estimated Study Completion Date : | July 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: PEARLS
Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention
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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
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Other: Standard Care Speech therapy
Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss. |
- 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.
- 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.
- Change in parental involvement and self-efficacy [ Time Frame: Baseline, Week 10 ]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.
- 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). 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

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Ages Eligible for Study: | 12 Months to 48 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

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
Contact: Ivette Cejas, PhD | 3052439199 | icejas@med.miami.edu |
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 |
Principal Investigator: | Ivette Cejas, PhD | University of Miami |
Responsible Party: | Ivette Cejas, Associate Professor, University of Miami |
ClinicalTrials.gov Identifier: | NCT03260062 |
Other Study ID Numbers: |
20150457 R21DC016265 ( U.S. NIH Grant/Contract ) |
First Posted: | August 24, 2017 Key Record Dates |
Last Update Posted: | November 3, 2020 |
Last Verified: | November 2020 |
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 |
cochlear implants language development parenting intervention maternal sensitivity facilitative language techniques |
Deafness Hearing Loss Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |