Parent-Child Early Approaches to Raising Language Skills (PEARLS) Intervention (PEARLS)
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|ClinicalTrials.gov Identifier: NCT03260062|
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : November 3, 2020
|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 :||April 2021|
|Estimated Study Completion Date :||July 2021|
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.
- 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 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 [ 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260062
|Contact: Ivette Cejas, PhDemail@example.com|
|United States, Florida|
|Don Soffer Clinical Research Building||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Ivette Cejas, PhD 305-243-9199 firstname.lastname@example.org|
|Principal Investigator: Ivette Cejas, PhD|
|Principal Investigator:||Ivette Cejas, PhD||University of Miami|