Thirty Million Words Home Visiting: A Longitudinal RCT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Thirty Million Words Home Visiting: A Longitudinal RCT

Conditions
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Language Environments of Children of Low-socioeconomic Status

Intervention / Treatment
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* Other: TMW Curriculum
* Other: Nutrition Curriculum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants (i.e. parents and their children) who live at or below 250% of the federal poverty line paternal education at or below BA/BS parents with children between the ages of 13-16 months old Exclusion Criteria: participants (i.e. parents and their children) who live over 200% of the federal poverty line parents under the age of 18 children younger than 13 months old or older than 16 months old (at start of study) parents who do not have legal custody of their child parents whose child does not live with them parents who are not with their child at least two full days per week parents who are unable to commit to the intervention requirements foster parents children with significant cognitive or physical impairments (specifically Autism Spectrum Disorder, Epilepsy, Cerebral Palsy, hearing impairment, Down Syndrome and blindness) parents who have earned or are currently working toward a graduate or professional degree (e.g. M.A., M.S., M.B.A) parents who speak less than 80% English to their children.

Ages Eligible for Study
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Minimum Age: 13 Months
Maximum Age: 16 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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. | Other: TMW Curriculum<br> <br> |
| Other: Control Group<br>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. | Other: Nutrition Curriculum<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in child oral language development at month 48 | 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. | Baseline, 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child school readiness upon kindergarten entry | 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. | 4 years |