An interventional study of Parent-Child Early Approaches to Raising Language Skills and Standard Care Speech therapy in Deafness, Bilateral, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 12 Months to 48 Months. Per ClinicalTrials.gov, last updated 2021-05-07.
Sponsored by University of Miami · Not applicable, Interventional, and Supportive care
Among 29 studies in Hearing Loss, Bilateral with a site in United States — 11 open to participants now, 13 under way, 1 of them phase 3. Hearing Loss, Bilateral · United States.
Among the 29 studies in Hearing Loss, Bilateral with a site in United States, this one is the 19th largest by enrollment of the 24 interventional ones, is the only one that started in 2016, is one of 19 with no phase, and was the 7th registered.
55 studies on the registry are indexed under Hearing Loss, Bilateral; 17 are open to participants now.
This study's enrollment of 15 is below the median of 30 across 42 interventional studies indexed under Hearing Loss, Bilateral.
Browse Hearing Loss, Bilateral studies →11 of the 29 studies in Hearing Loss, Bilateral with a site in United States are open now, in 5 countries. Each count lists the studies.
Of the 12 Hearing Loss, Bilateral studies recruiting now, 7 (58%) set no upper age limit and 3 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 12 Months to 48 Months · all sexes · no healthy volunteers.
The full table on the hub →29 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2016.
Median enrollment 34 across the 24 interventional studies, 67 across the 5 observational. Of the 16 that completed or were terminated, 12 (75%) have results posted.
11 of 29 have an industry lead sponsor. The 10 most frequent:
University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
University of Miami has 1 study filed under Hearing Loss, Bilateral — fewer than ten, so there is no comparison to draw.
4 of the studies in Hearing Loss, Bilateral with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06860022Vanderbilt UniversitySentence Shaping - DHH | 2026-11 |
| NCT04707885Ohio State UniversityClinical Utility of Residual Hearing in the Cochlear Implant Ear | 2026-12-31 |
| NCT07081542AdventHealthComparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants | 2027-01-31 |
| NCT06864273University of Alabama, TuscaloosaAssessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies | 2027-08-31 |
Among the 29 studies in Hearing Loss, Bilateral with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention
Behavioral: Parent-Child Early Approaches to Raising Language Skills
Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy
Other: Standard Care Speech therapy
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).
Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2016 to primary completion in Apr 2021, 60 months.
Of 27 interventional studies with no phase under Hearing Loss, Bilateral, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 60. This study's 60 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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