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

Sponsor

University of Miami (Other)

Overall Status

Completed

CT.gov ID

NCT03260062

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)

Enrollment

Location

Arms

59.7

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Deafness, Bilateral	Behavioral: Parent-Child Early Approaches to Raising Language Skills Other: Standard Care Speech therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants

Actual Study Start Date :

Apr 11, 2016

Actual Primary Completion Date :

Apr 1, 2021

Actual Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEARLS Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS 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).
Active Comparator: Control Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy	Other: Standard Care Speech therapy Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.

Arm

Intervention/Treatment

Experimental: PEARLS

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

Active Comparator: Control

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

Other: Standard Care Speech therapy

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

Outcome Measures

Primary Outcome Measures

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

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.
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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 48 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.