Thirty Million Words Home Visiting: A Longitudinal RCT
Condition: Language Environments of Children of Low-socioeconomic Status
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): TMW Curriculum; Nutrition Curriculum
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other