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

Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03260062
Acronym
PEARLS
Enrollment
15
Registered
2017-08-24
Start date
2016-04-11
Completion date
2021-04-30
Last updated
2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness, Bilateral

Keywords

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

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).

Interventions

BEHAVIORALParent-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).

OTHERStandard Care Speech therapy

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

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Months to 48 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in parental sensitivityBaseline, Week 10Parent 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

MeasureTime frameDescription
Change in use of higher-level versus lower-level language strategiesBaseline, Week 10Parents 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-efficacyBaseline, Week 10Parent 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 SkillsBaseline, Week 10Children'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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026