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

Primary Purpose

Deafness, Bilateral

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent-Child Early Approaches to Raising Language Skills
Standard Care Speech therapy
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Deafness, Bilateral focused on measuring cochlear implants, language development, parenting intervention, maternal sensitivity, facilitative language techniques

Eligibility Criteria

12 Months - 48 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Don Soffer Clinical Research Building

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEARLS

Control

Arm Description

Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention

Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
August 17, 2017
Last Updated
May 6, 2021
Sponsor
University of Miami
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT03260062
Brief Title
Parent-Child Early Approaches to Raising Language Skills (PEARLS) Intervention
Acronym
PEARLS
Official Title
Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2016 (Actual)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Bilateral
Keywords
cochlear implants, language development, parenting intervention, maternal sensitivity, facilitative language techniques

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEARLS
Arm Type
Experimental
Arm Description
Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy
Intervention Type
Behavioral
Intervention Name(s)
Parent-Child Early Approaches to Raising Language Skills
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Standard Care Speech therapy
Intervention Description
Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.
Primary Outcome Measure Information:
Title
Change in parental sensitivity
Description
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.
Time Frame
Baseline, Week 10
Secondary Outcome Measure Information:
Title
Change in use of higher-level versus lower-level language strategies
Description
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.
Time Frame
Baseline, Week 10
Title
Change in parental involvement and self-efficacy
Description
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.
Time Frame
Baseline, Week 10
Title
Change in Auditory Skills
Description
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
Time Frame
Baseline, Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivette Cejas, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Don Soffer Clinical Research Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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