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Completed

NCT Number: NCT03260062

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

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).

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Key information

Conditions

Deafness, Bilateral Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Bilateral Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

12 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Don Soffer Clinical Research Building

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parent-Child Early Approaches to Raising Language Skills

Behavioral

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 therapy

Other

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

Primary outcomes

  1. Change in parental sensitivity

    Time frame: 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 outcomes

  1. Change in use of higher-level versus lower-level language strategies

    Time frame: 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.

  2. Change in parental involvement and self-efficacy

    Time frame: 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.

  3. Change in Auditory Skills

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

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

Registry information

Official study title

Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants

Acronym: PEARLS

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 24, 2017
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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