Active — Not RecruitingNot Applicable

Thirty Million Words Home Visiting

United States206 participantsStarted 2014-11

Plain-language 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. The investigators 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, the investigators 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, the investigators 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). Added 2023: an 8th child-assessment, parent/child interaction video session, and parent surveys have been added with the original sample to measure long-term outcomes of children whose parents participated in the home visiting intervention.

Who can participate

Age range

13 Months – 16 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Preschool Language Scale IV (PLS)

Timeframe: Baseline, month 6, month 12, month 18, month 24, month 36, month 48

Peabody Picture Vocabulary Test (PPVT)

Timeframe: Month 24, Month 36, Month 48, Month 96

Language ENvironment Analysis

Timeframe: Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12, Month 18, Month 24, Month 36, Month 48

Parent/Child video sessions

Timeframe: Month 0, Month 6, Month 12, Month 18, Month 24, Month 36, Month 48, Month 96.

Trial details

NCT IDNCT02216032

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-16

View on ClinicalTrials.gov More Language Environments of Children of Low-socioeconomic Status trials