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

Study Overview
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Brief Summary
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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).

Official Title
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Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants

Conditions
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Deafness, Bilateral

Intervention / Treatment
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* Behavioral: Parent-Child Early Approaches to Raising Language Skills
* Other: Standard Care Speech therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEARLS<br>Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention | Behavioral: Parent-Child Early Approaches to Raising Language Skills<br>* 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).<br>|
| Active Comparator: Control<br>Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy | Other: Standard Care Speech therapy<br>* Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implants, language development, parenting intervention, maternal sensitivity, facilitative language techniques