Thirty Million Words Home Visiting

NCT02216032 | Active Not Recruiting

• 1 other identifier: 14-0895
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Language Environments of Children of Low-socioeconomic Status

Outcome Measures

Primary Outcomes (4)

• Preschool Language Scale IV (PLS)

  The PLS is used as a measure of a child's receptive vocabulary, and is used in this study to evaluate a child's language development from baseline to Month 48. It is a direct to child assessment administered by a trained assessor. Raw score values range from 0 to 65, with a higher score indicating higher receptive vocabulary skills.

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

• Peabody Picture Vocabulary Test (PPVT)

  The PPVT is a measure of a child's receptive vocabulary, and is used in this study to evaluate a child's language development from Month 24 to Month 48 and as a measure of school readiness upon kindergarten entry. It is additionally used to evaluate language development at Month 96. It is a direct to child assessment administered by a trained assessor. Raw score values range from 0 to 175, with a higher score indicating higher receptive vocabulary skills. It is a direct to child assessment administered by a trained assessor. This assessment is a primary outcome measure at Months 24, 36, and 48 and secondary at month 96.

  Month 24, Month 36, Month 48, Month 96

• Language ENvironment Analysis

  LENA is a recording device that is worn by the child to provide metrics of conversational turn counts, adult word counts, and child vocalizations. LENA is used in this study as a quantitative measure of parent child interaction and to measure change from baseline in child oral language development and production to month 48.

  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

  Observational coding is used to characterize quality of interactions between parent and child during recorded free-play and book sharing activities. This outcome is primary at months 0-48 and secondary at Month 96.

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

Secondary Outcomes (4)

• Woodcock Johnson (WJ-IV).

  Month 48, Month 96

• NIH toolbox Cognition Battery

  Month 96

• Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)

  Month 6, Month 24, Month 36, Month 48

• Give-a-number task (Give-N)

  Month 36, Month 48

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

OTHER

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

Interventions

TMW Curriculum OTHER

Treatment Group

Nutrition Curriculum OTHER

Control Group

Eligibility Criteria

• Age: 13 Months - 16 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

Thirty Million Words® Initiative at the University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• 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

  BACKGROUND

• LoRe D, Leung CYY, Brenner L, Suskind DL. Parent-directed intervention in promoting knowledge of pediatric nutrition and healthy lifestyle among low-SES families with toddlers: A randomized controlled trial. Child Care Health Dev. 2019 Jul;45(4):518-522. doi: 10.1111/cch.12682. Epub 2019 May 27.

  PMID: 31050026 DERIVED

Related Links

• Click here for more information about the Thirty Million Words

Study Officials

• Dana Suskind, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 13, 2014
• Study Start: November 1, 2014
• Primary Completion: January 16, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)