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.
Added 2023: when the children in the original sample turn 9-10 years old, parents are contacted with the opportunity to complete an additional study time point, to evaluate their child's outcomes as they've reached 3rd - 4th grade. Participants sign an addendum to the enrollment consent in order to participate. Trained assessors meet with the child to conduct measures of language, cognitive, and math skills ("Assessment 8"). Additionally, the assessor records a parent-child interaction completing an age-appropriate task ("Video Session 8"). Finally, the parent completes a series of surveys measuring knowledge about child development, parental inputs, and child behaviors
