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

University of Miami15 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Deafness, Bilateral

Interventions

Parent-Child Early Approaches to Raising Language SkillsBEHAVIORAL

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).

Standard Care Speech therapyOTHER

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 48 Months

Medical Language ↔ Plain English

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.

Locations (1)

Don Soffer Clinical Research Building

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 10

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: Baseline, Week 10

Data from ClinicalTrials.gov

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