<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/NCT02216032</url>
  </required_header>
  <id_info>
    <org_study_id>14-0895</org_study_id>
    <nct_id>NCT02216032</nct_id>
  </id_info>
  <brief_title>Thirty Million Words Home Visiting: A Longitudinal RCT</brief_title>
  <acronym>TMW HV RCT</acronym>
  <official_title>Thirty Million Words Home Visiting: A Longitudinal RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The TMW intervention aims to foster parental behaviors that facilitate children's language&#xD;
      emergence at a critical developmental stage, and thus will be implemented at 13-16 months of&#xD;
      age. We hypothesize that the primary effects of the TMW Intervention will significantly 1)&#xD;
      improve low-SES parents' understanding of the importance of parent language in a child's&#xD;
      development, 2) increase parents' linguistic interaction, responsiveness, and overall&#xD;
      engagement with their children, and 3) increase children's language output, as measured&#xD;
      through LENA (child vocalization count, conversational turn count), coded video interaction&#xD;
      (number of types, tokens and utterances for both children and adults), audio recordings from&#xD;
      The Three T's application during the video sessions, and a battery of assessments targeting&#xD;
      linguistic and cognitive development. Furthermore, we hypothesize that increased parental&#xD;
      interaction will result in 4) an improvement in children's socioemotional development as&#xD;
      assessed by the Social Emotional Ages and Stages Questionnaire (ASQ-SE). Finally, we&#xD;
      hypothesize that these socioemotional and linguistic gains through early development, along&#xD;
      with sustained increased parental engagement, will be expressed in 5) increased child school&#xD;
      readiness upon kindergarten entry as assessed by Woodcock-Johnson Psycho-Educational Battery&#xD;
      (WJ).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the Recruitment Phase, a TMW research assistant (RA) will recruit participants for the&#xD;
      study. If interested in joining the study, participants will complete the Preliminary&#xD;
      Enrollment Consent. From this point forward, all study activities will take place in the&#xD;
      participant's home. To follow the completion of the Preliminary Enrollment Consent,&#xD;
      participants will be asked to complete a series of baseline measurements over a four-week&#xD;
      time period. RAs will facilitate the collection of these measures. Following satisfactory&#xD;
      completion of the baseline measures, participants will move on to the Enrollment Phase at&#xD;
      which point they will complete the Enrollment Consent. At this point participants will be&#xD;
      randomized into either one of two conditions (The Treatment group received an educational&#xD;
      curriculum on language development and the Control group receives an educational curriculum&#xD;
      on the role of nutrition in development) as part of a matched pair. Pairs will be matched by&#xD;
      1) age of the child and 2) averaged conversational turn counts from the 3 baseline LENA&#xD;
      recordings. Assignment to Control or Treatment of each member of a pair is decided through a&#xD;
      coin flip. Additionally, participants will complete Video 1, administered by an RA. During&#xD;
      this and all subsequent Videos, audio recordings will be taken using both the LENA and the&#xD;
      Three T's App. Following the Enrollment Phase, participants will move on to the Intervention&#xD;
      Phase. During the Intervention Phase, participants will first complete Assessment 1. A staff&#xD;
      member of Thirty Million Words will conduct this and all subsequent assessments. Following&#xD;
      Assessment 1, participants will receive 12 bi-weekly home visits over a six-month period from&#xD;
      trained TMW Home Visitors. During the home visits, Home Visitors will deliver two different&#xD;
      curricula to the respective groups. The Treatment group will receive the TMW Curriculum. The&#xD;
      Control group will receive the alternative Nutrition Curriculum, which provides information&#xD;
      about the importance of healthy nutrition for child development, strategies for healthy&#xD;
      eating, and meal preparation. In addition to receiving the home visits, participants will&#xD;
      also complete LENA recordings on a bi-weekly basis, alternating weeks with the home visiting&#xD;
      schedule. Participants in both the Control and the Treatment condition will receive text&#xD;
      messages to remind them to complete their LENA recording on the day that they had previously&#xD;
      scheduled. For the Treatment group only, a text message reminder for a specific goal will be&#xD;
      sent as well. This will help parents be mindful of their goals at the time that they plan to&#xD;
      achieve them by reminding parents to engage linguistically with their children. This text&#xD;
      reminder portion of the study will piggy-back on the goal setting portions in which the&#xD;
      parent will set specific, personalized goals. Reminders of these goals will be sent to their&#xD;
      phones at a day and time that parents choose. Both the Treatment and Control participants&#xD;
      will be given the option to opt out of the text messaging if they do not wish to receive&#xD;
      these messages. Following the Intervention Phase, participants will move on to the 42-month&#xD;
      Follow-up Phase. Throughout this phase, participants will complete Videos 2-7 with an RA,&#xD;
      Assessments 2-7 with a TMW assessor, LENA recordings 16-21, and four curricula&#xD;
      supplementation 'Boosters,' delivered by an RA. This marks the final phase of involving&#xD;
      participants. After study completion, Dr. Suskind or her research team will contact&#xD;
      participants regarding theirs and their child's participation in further research studies. A&#xD;
      separate IRB protocol will be submitted at that time.&#xD;
&#xD;
      Transcription Service Feasibility Pilot Study&#xD;
&#xD;
      The purpose of this pilot study is to assess the feasibility of using a transcription service&#xD;
      to transcribe Video Session recordings compared to using University of Chicago research&#xD;
      personnel. Up to 10 already enrolled participants will be asked to participate in a pilot&#xD;
      study to assess the feasibility of using a transcription service to transcribe participant&#xD;
      Video Session recordings. Each participant in the pilot study will receive an addendum to the&#xD;
      study consent document and discuss the addendum with a member of the research team prior to&#xD;
      their study video sessions being sent to third-party transcription services to conduct a&#xD;
      feasibility study.&#xD;
&#xD;
      A Business Associate and Service Agreement is being processed between the University and the&#xD;
      transcription service to ensure University approved security measures are in place to&#xD;
      transcribe participant video sessions. No videos will be sent to the transcription service&#xD;
      until the Business Associate and Service Agreement is approved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">January 16, 2022</completion_date>
  <primary_completion_date type="Actual">January 16, 2022</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in child oral language development at month 48</measure>
    <time_frame>Baseline, 48 months</time_frame>
    <description>Using quantitative techniques such as LENA audio recordings and transcripts of parent/child interaction during video sessions, the change in a child's language production will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child school readiness upon kindergarten entry</measure>
    <time_frame>4 years</time_frame>
    <description>We hypothesize that these socioemotional and linguistic gains through early development, along with sustained increased parental engagement, will be expressed in increased child school readiness upon kindergarten entry.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">206</enrollment>
  <condition>Language Environments of Children of Low-socioeconomic Status</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will deliver the TMW Curriculum to 106 Treatment families. The TMW Curriculum is comprised of 1) 12 educational modules, 2) animations and videos of real parent-child interactions to teach parents about the science behind child brain development, and model strategies for improving parents' child-directed speech, 3) video modeling and collaborative goal setting, and 4) quantitative linguistic feedback from Language ENvironment Analysis (LENA) recordings.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>We will deliver a Nutrition Curriculum to 100 Control families. The Nutrition Curriculum provides information about the importance of healthy nutrition for child development, strategies for healthy eating, and meal preparation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TMW Curriculum</intervention_name>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition Curriculum</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants (i.e. parents and their children) who live at or below 250% of the&#xD;
             federal poverty line&#xD;
&#xD;
          -  paternal education at or below BA/BS&#xD;
&#xD;
          -  parents with children between the ages of 13-16 months old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participants (i.e. parents and their children) who live over 200% of the federal&#xD;
             poverty line&#xD;
&#xD;
          -  parents under the age of 18&#xD;
&#xD;
          -  children younger than 13 months old or older than 16 months old (at start of study)&#xD;
&#xD;
          -  parents who do not have legal custody of their child&#xD;
&#xD;
          -  parents whose child does not live with them&#xD;
&#xD;
          -  parents who are not with their child at least two full days per week&#xD;
&#xD;
          -  parents who are unable to commit to the intervention requirements&#xD;
&#xD;
          -  foster parents&#xD;
&#xD;
          -  children with significant cognitive or physical impairments (specifically Autism&#xD;
             Spectrum Disorder, Epilepsy, Cerebral Palsy, hearing impairment, Down Syndrome and&#xD;
             blindness)&#xD;
&#xD;
          -  parents who have earned or are currently working toward a graduate or professional&#xD;
             degree (e.g. M.A., M.S., M.B.A)&#xD;
&#xD;
          -  parents who speak less than 80% English to their children.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Months</minimum_age>
    <maximum_age>16 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dana Suskind, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thirty Million Words® Initiative at the University of Chicago Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://tmwcenter.uchicago.edu/</url>
    <description>Click here for more information about the Thirty Million Words</description>
  </link>
  <reference>
    <citation>Suskind, D., Leffel, K. R., Hernandez, M. W., Sapolich, S. G., Suskind, E., Kirkham, E., &amp; Meehan, P. (2013) An exploratory study of &quot;Quantitative Linguistic Feedback&quot;: Effect of LENA Feedback on Adult Language Production. Communication Disorders Quarterly. 34(4) 199-209. Doi: 10.1177/1525740112473146</citation>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 8, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT02216032/Prot_SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02216032
org study id: 14-0895
nct id: NCT02216032
lead sponsor: 
has dmc: No
The TMW intervention aims to foster parental behaviors that facilitate children's language
      emergence at a critical developmental stage, and thus will be implemented at 13-16 months of
      age. We hypothesize that the primary effects of the TMW Intervention will significantly 1)
      improve low-SES parents' understanding of the importance of parent language in a child's
      development, 2) increase parents' linguistic interaction, responsiveness, and overall
      engagement with their children, and 3) increase children's language output, as measured
      through LENA (child vocalization count, conversational turn count), coded video interaction
      (number of types, tokens and utterances for both children and adults), audio recordings from
      The Three T's application during the video sessions, and a battery of assessments targeting
      linguistic and cognitive development. Furthermore, we hypothesize that increased parental
      interaction will result in 4) an improvement in children's socioemotional development as
      assessed by the Social Emotional Ages and Stages Questionnaire (ASQ-SE). Finally, we
      hypothesize that these socioemotional and linguistic gains through early development, along
      with sustained increased parental engagement, will be expressed in 5) increased child school
      readiness upon kindergarten entry as assessed by Woodcock-Johnson Psycho-Educational Battery
      (WJ).
During the Recruitment Phase, a TMW research assistant (RA) will recruit participants for the
      study. If interested in joining the study, participants will complete the Preliminary
      Enrollment Consent. From this point forward, all study activities will take place in the
      participant's home. To follow the completion of the Preliminary Enrollment Consent,
      participants will be asked to complete a series of baseline measurements over a four-week
      time period. RAs will facilitate the collection of these measures. Following satisfactory
      completion of the baseline measures, participants will move on to the Enrollment Phase at
      which point they will complete the Enrollment Consent. At this point participants will be
      randomized into either one of two conditions (The Treatment group received an educational
      curriculum on language development and the Control group receives an educational curriculum
      on the role of nutrition in development) as part of a matched pair. Pairs will be matched by
      1) age of the child and 2) averaged conversational turn counts from the 3 baseline LENA
      recordings. Assignment to Control or Treatment of each member of a pair is decided through a
      coin flip. Additionally, participants will complete Video 1, administered by an RA. During
      this and all subsequent Videos, audio recordings will be taken using both the LENA and the
      Three T's App. Following the Enrollment Phase, participants will move on to the Intervention
      Phase. During the Intervention Phase, participants will first complete Assessment 1. A staff
      member of Thirty Million Words will conduct this and all subsequent assessments. Following
      Assessment 1, participants will receive 12 bi-weekly home visits over a six-month period from
      trained TMW Home Visitors. During the home visits, Home Visitors will deliver two different
      curricula to the respective groups. The Treatment group will receive the TMW Curriculum. The
      Control group will receive the alternative Nutrition Curriculum, which provides information
      about the importance of healthy nutrition for child development, strategies for healthy
      eating, and meal preparation. In addition to receiving the home visits, participants will
      also complete LENA recordings on a bi-weekly basis, alternating weeks with the home visiting
      schedule. Participants in both the Control and the Treatment condition will receive text
      messages to remind them to complete their LENA recording on the day that they had previously
      scheduled. For the Treatment group only, a text message reminder for a specific goal will be
      sent as well. This will help parents be mindful of their goals at the time that they plan to
      achieve them by reminding parents to engage linguistically with their children. This text
      reminder portion of the study will piggy-back on the goal setting portions in which the
      parent will set specific, personalized goals. Reminders of these goals will be sent to their
      phones at a day and time that parents choose. Both the Treatment and Control participants
      will be given the option to opt out of the text messaging if they do not wish to receive
      these messages. Following the Intervention Phase, participants will move on to the 42-month
      Follow-up Phase. Throughout this phase, participants will complete Videos 2-7 with an RA,
      Assessments 2-7 with a TMW assessor, LENA recordings 16-21, and four curricula
      supplementation 'Boosters,' delivered by an RA. This marks the final phase of involving
      participants. After study completion, Dr. Suskind or her research team will contact
      participants regarding theirs and their child's participation in further research studies. A
      separate IRB protocol will be submitted at that time.

      Transcription Service Feasibility Pilot Study

      The purpose of this pilot study is to assess the feasibility of using a transcription service
      to transcribe Video Session recordings compared to using University of Chicago research
      personnel. Up to 10 already enrolled participants will be asked to participate in a pilot
      study to assess the feasibility of using a transcription service to transcribe participant
      Video Session recordings. Each participant in the pilot study will receive an addendum to the
      study consent document and discuss the addendum with a member of the research team prior to
      their study video sessions being sent to third-party transcription services to conduct a
      feasibility study.

      A Business Associate and Service Agreement is being processed between the University and the
      transcription service to ensure University approved security measures are in place to
      transcribe participant video sessions. No videos will be sent to the transcription service
      until the Business Associate and Service Agreement is approved.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change from baseline in child oral language development at month 48
time frame: Baseline, 48 months
description: Using quantitative techniques such as LENA audio recordings and transcripts of parent/child interaction during video sessions, the change in a child's language production will be measured.
measure: Child school readiness upon kindergarten entry
time frame: 4 years
description: We hypothesize that these socioemotional and linguistic gains through early development, along with sustained increased parental engagement, will be expressed in increased child school readiness upon kindergarten entry.
arm group label: Treatment Group
arm group type: Experimental
description: We will deliver the TMW Curriculum to 106 Treatment families. The TMW Curriculum is comprised of 1) 12 educational modules, 2) animations and videos of real parent-child interactions to teach parents about the science behind child brain development, and model strategies for improving parents' child-directed speech, 3) video modeling and collaborative goal setting, and 4) quantitative linguistic feedback from Language ENvironment Analysis (LENA) recordings.
arm group label: Control Group
arm group type: Other
description: We will deliver a Nutrition Curriculum to 100 Control families. The Nutrition Curriculum provides information about the importance of healthy nutrition for child development, strategies for healthy eating, and meal preparation.
intervention type: Other
intervention name: TMW Curriculum
arm group label: Treatment Group
intervention type: Other
intervention name: Nutrition Curriculum
arm group label: Control Group
criteria: 
gender: All
minimum age: 13 Months
maximum age: 16 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Dana Suskind, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
url: https://tmwcenter.uchicago.edu/
description: Click here for more information about the Thirty Million Words
citation: Suskind, D., Leffel, K. R., Hernandez, M. W., Sapolich, S. G., Suskind, E., Kirkham, E., & Meehan, P. (2013) An exploratory study of "Quantitative Linguistic Feedback": Effect of LENA Feedback on Adult Language Production. Communication Disorders Quarterly. 34(4) 199-209. Doi: 10.1177/1525740112473146
responsible party type: Sponsor
provided document: 