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

Not Applicable

Completed

• Conditions: Deafness, Bilateral
• Interventions: Behavioral: Parent-Child Early Approaches to Raising Language Skills; Other: Standard Care Speech therapy

• Registration Number: NCT03260062
• Lead Sponsor: 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-04-11
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-24
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEARLS	Parent-Child Early Approaches to Raising Language Skills	Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention
Control	Standard Care Speech therapy	Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy

Primary Outcome Measures

Name	Time	Method
Change in parental sensitivity	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

Name	Time	Method
Change in Auditory Skills	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
Change in parental involvement and self-efficacy	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 use of higher-level versus lower-level language strategies	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.

Trial Locations

Locations (1)

Don Soffer Clinical Research Building; 🇺🇸 Miami, Florida, United States