PEARLS Intervention (PEARLS)
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|ClinicalTrials.gov Identifier: NCT03260062|
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Deafness, Bilateral||Behavioral: Parent-Child Early Approaches to Raising Language Skills Other: Standard Care Speech therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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 :||April 11, 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Parent-Child Early Approaches to Raising Language Skills
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 will receive standard care 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.
- 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.
- 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.
- Change in parental involvement and self-efficacy [ Time Frame: Baseline, Week 10 ]Parent involved and self-efficacy will be measured using the Scale for Parental Involvement and Self-Efficacy (SPISE) for young children with hearing loss. Higher scores indicate more parent involvement and higher self-efficacy
- 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). Higher scores indicated better auditory skills
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260062
|Contact: Ivette Cejas, PhDfirstname.lastname@example.org|
|United States, Florida|
|Don Soffer Clinical Research Building||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Ivette Cejas, PhD 305-243-9199 email@example.com|
|Principal Investigator: Ivette Cejas, PhD|
|Principal Investigator:||Ivette Cejas, PhD||University of Miami|