<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03260062</url>
  </required_header>
  <id_info>
    <org_study_id>20150457</org_study_id>
    <secondary_id>R21DC016265</secondary_id>
    <nct_id>NCT03260062</nct_id>
  </id_info>
  <brief_title>Parent-Child Early Approaches to Raising Language Skills (PEARLS) Intervention</brief_title>
  <acronym>PEARLS</acronym>
  <official_title>Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to develop and evaluate a parent training program,&#xD;
      which aims to improve language. The study is being conducted to see if teaching parents&#xD;
      positive parenting techniques and behavior strategies will improve the rate of language&#xD;
      development in children with cochlear implants when compared to standard speech therapy&#xD;
      (e.g., auditory-verbal therapy).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2016</start_date>
  <completion_date type="Actual">April 2021</completion_date>
  <primary_completion_date type="Actual">April 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in parental sensitivity</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in use of higher-level versus lower-level language strategies</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parental involvement and self-efficacy</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Auditory Skills</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Deafness, Bilateral</condition>
  <arm_group>
    <arm_group_label>PEARLS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent-Child Early Approaches to Raising Language Skills</intervention_name>
    <description>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).</description>
    <arm_group_label>PEARLS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care Speech therapy</intervention_name>
    <description>Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. children who are severely to profoundly deaf and a cochlear implant candidate,&#xD;
&#xD;
          2. children who are 12 to 48 months,&#xD;
&#xD;
          3. English or Spanish as primary language spoken at home,&#xD;
&#xD;
          4. families educating their children in spoken language,&#xD;
&#xD;
          5. children who pass the cognitive screening, scoring 75 or above on the screening&#xD;
             measure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. parents who do not consent to being videotaped,&#xD;
&#xD;
          2. children with moderate to severe developmental delays (as assessed using the Battelle&#xD;
             Developmental Inventory (BDI-2) 2nd Edition for children ages 0 to 24 months or the&#xD;
             Leiter International Performance Scale-Revised),&#xD;
&#xD;
          3. children with significant syndromes (e.g., CHARGE, autism, cerebral palsy) or severe&#xD;
             brain abnormalities,&#xD;
&#xD;
          4. families who do not receive their auditory-verbal therapy from University of Miami&#xD;
             (UM). Further, children who have already completed the BDI-2 within the past year as&#xD;
             part of their Early Steps (Florida Early Intervention) program will not have it&#xD;
             re-administered.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>48 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ivette Cejas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Don Soffer Clinical Research Building</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Ivette Cejas</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>cochlear implants</keyword>
  <keyword>language development</keyword>
  <keyword>parenting intervention</keyword>
  <keyword>maternal sensitivity</keyword>
  <keyword>facilitative language techniques</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Bilateral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03260062
org study id: 20150457
secondary id: R21DC016265
nct id: NCT03260062
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in parental sensitivity
time frame: Baseline, Week 10
description: 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.
measure: Change in use of higher-level versus lower-level language strategies
time frame: Baseline, Week 10
description: 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.
measure: Change in parental involvement and self-efficacy
time frame: Baseline, Week 10
description: 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.
measure: Change in Auditory Skills
time frame: Baseline, Week 10
description: 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
arm group label: PEARLS
arm group type: Experimental
description: Participants in this arm will receive 10 1-hour weekly sessions of the PEARLS intervention
arm group label: Control
arm group type: Active Comparator
description: Participants in this arm will receive 10 1-hour weekly sessions of the standard of care LSL Speech Therapy
intervention type: Behavioral
intervention name: Parent-Child Early Approaches to Raising Language Skills
description: 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).
arm group label: PEARLS
intervention type: Other
intervention name: Standard Care Speech therapy
description: Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.
arm group label: Control
criteria: 
gender: All
minimum age: 12 Months
maximum age: 48 Months
healthy volunteers: No
last name: Ivette Cejas, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Ivette Cejas
investigator title: Associate Professor
mesh term: Deafness
mesh term: Hearing Loss, Bilateral
sharing ipd: No