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| ID | Type | Description | Link |
|---|---|---|---|
| R21DC016265 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEARLS | Experimental | Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention |
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| Control | Active Comparator | Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivette Cejas, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Don Soffer Clinical Research Building | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Standard Care Speech therapy | Other | Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss. |
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| 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. | 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 | Baseline, Week 10 |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |