Deafness, BilateralPEARLSNCT03260062
Parent-Child Early Approaches to Raising Language Skills (PEARLS) Intervention
A study testing Parent-Child Early Approaches to Raising Language Skills in people with Deafness, Bilateral, run by University of Miami at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 48 months
- Conditions the study is for
- Deafness, Bilateral
- What is being tested?
- Parent-Child Early Approaches to Raising Language Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2016to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Don Soffer Clinical Research Building
Miami, Florida, 33136
About this study
Official title: Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants
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).
- Conditions
- Deafness, Bilateral
- Being tested
- Parent-Child Early Approaches to Raising Language Skills, Standard Care Speech therapy
- Keywords
- cochlear implants, language development, parenting intervention, maternal sensitivity, facilitative language techniques
- Medical subject headings
- Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Early Approaches to Raising Language SkillsBehavioural
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 therapyOther
Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.
| Study group | Role | What they receive |
|---|---|---|
| PEARLS | Experimental | Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention Receives: Behavioral: Parent-Child Early Approaches to Raising Language Skills |
| Control | Active comparator | Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy Receives: Other: Standard Care Speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 10
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Baseline, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start11 Apr 2016
- Primary completionApr 2021
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deafness, BilateralStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Ivette Cejas, University of Miami
- Investigators
- Ivette Cejas, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260062
- Sponsor's protocol ID
- 20150457
- Other IDs
- R21DC016265
- Acronym
- PEARLS
- Status last verified
- May 2021
- First submitted
- 17 Aug 2017
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants
- ClinicalTrials.gov ID
- NCT03260062
- Acronym / sponsor ID
- PEARLS / 20150457
- Conditions
- Deafness, Bilateral
- Keywords
- cochlear implants, language development, parenting intervention, maternal sensitivity, facilitative language techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEARLS | Experimental | Behavioral: Parent-Child Early Approaches to Raising Language SkillsParticipants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention |
| Control | Active comparator | Other: Standard Care Speech therapyParticipants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-Child Early Approaches to Raising Language SkillsThe 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). | Behavioural | PEARLS |
| Standard Care Speech therapyFamilies will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss. | Other | Control |
Primary outcome
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.
3 secondary outcomes
Change in use of higher-level versus lower-level language strategies
Time frame: Baseline, Week 10
Change in parental involvement and self-efficacy
Time frame: Baseline, Week 10
Change in Auditory Skills
Time frame: Baseline, Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivette Cejas, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Child Early Approaches to Raising Language Skills in people with Deafness, Bilateral, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parental sensitivity (time frame: Baseline, Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.