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

Deafness, Bilateral Clinical Trial

— PEARLS  

Official title:

Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260062
• Other study ID #: 20150457
• Secondary ID: R21DC016265
• Status: Completed
• Phase: N/A
• Start date: April 11, 2016
• Est. completion date: April 2021

Study information

• Verified date: May 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 48 Months

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Deafness, Bilateral

Intervention

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).

Other:
• Standard Care Speech therapy
Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.

Locations

Country	Name	City	State
United States	Don Soffer Clinical Research Building	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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