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Thirty Million Words Project: A Feasibility Trial

NCT ID: NCT01754077

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-09-30

Brief Summary

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The purpose of the proposed research is to evaluate the Thirty Million Words (TMW) Intervention through a randomized, controlled pilot study. The primary goal of the intervention is to enrich the early language learning environment of children from low-socioeconomic status (SES) backgrounds by targeting parent skills that relate to adult word input and conversational turn taking. The investigators hypothesize that receiving the TMW intervention will result in changes in parent behaviors.

Detailed Description

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The investigators propose to administer the TMW intervention to a small group of parents from low SES backgrounds in the Chicago area, assessing outcomes for caregivers at specific time intervals after administration. An audio environment recording device, the Language ENvironment Analysis recorder (LENA), will be used to gather information about the child's home language environment. The treatment group will receive feedback from some of these home audio recordings to motivate behavior change. A comparison between measurements from baseline recordings (without linguistic feedback given) and recordings during the intervention program (with linguistic feedback given) will be used to evaluate changes in caregiver linguistic behavior. In addition to the report information, parents will also be provided with strategies for enriching the child's language environment, including advice on book reading and narration. A control arm will receive a brief nutrition intervention and complete the same number of recordings as the treatment group. The control group will complete the same assessment schedule as the treatment group. Assessment data will aid in evaluating the effects of the TMW intervention.

This pilot work is a critical step in understanding the language environment provided by parents of low-SES, the effectiveness of objective feedback, and the potential for change and improvement in parental behavior. After establishing a baseline of parent-child communication levels, LENA recordings will be performed at regular intervals to provide essential feedback and motivation for parents to continually optimize the language environment they provide for their children.

Conditions

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Parental Language Behaviors

Keywords

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Language Behavior change Intervention Home visiting Child language development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Thirty Million Words Project

The participants in the intervention group receive the LENA linguistic feedback reports intervention and the home visiting educational session intervention. Participants in this arm complete the same assessments as participants in the control group.

Group Type EXPERIMENTAL

LENA Linguistic Feedback Reports

Intervention Type BEHAVIORAL

LENA feedback reports show hourly/daily estimates for AWC/CTC and TV/electronic media. The feedback reports will include data obtained from LENA home audio recordings that the families complete. Feedback reports are only given to parents for 8 weekly recordings. The parent does not receive a feedback report for the baseline recordings or the follow-up recordings.

Home Visiting Educational Session

Intervention Type BEHAVIORAL

A research assistant visited the homes of the participants to discuss strategies, skills, and barriers related to enriching children's language environments. The visits included a multi-media educational module, video modeling exercise, goal setting, and linguistic feedback report review. There were 8 weekly home visits in the intervention program.

Control Group

The control group receives the Childhood Nutrition Education intervention. Participants in this group completed the same assessments as the treatment group. Following participation in the control group, eligible families were offered the opportunity to continue into the experimental group.

Group Type OTHER

Childhood Nutrition Education

Intervention Type BEHAVIORAL

The childhood nutrition education intervention is a brief home-visiting intervention during which parents receive information on nutrition from a research assistant. The intervention mirrored the experimental group's educational intervention and decreased the likelihood of differences between groups being the result of attentional effects. This intervention is received by the control group.

Interventions

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LENA Linguistic Feedback Reports

LENA feedback reports show hourly/daily estimates for AWC/CTC and TV/electronic media. The feedback reports will include data obtained from LENA home audio recordings that the families complete. Feedback reports are only given to parents for 8 weekly recordings. The parent does not receive a feedback report for the baseline recordings or the follow-up recordings.

Intervention Type BEHAVIORAL

Home Visiting Educational Session

A research assistant visited the homes of the participants to discuss strategies, skills, and barriers related to enriching children's language environments. The visits included a multi-media educational module, video modeling exercise, goal setting, and linguistic feedback report review. There were 8 weekly home visits in the intervention program.

Intervention Type BEHAVIORAL

Childhood Nutrition Education

The childhood nutrition education intervention is a brief home-visiting intervention during which parents receive information on nutrition from a research assistant. The intervention mirrored the experimental group's educational intervention and decreased the likelihood of differences between groups being the result of attentional effects. This intervention is received by the control group.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Low-SES: income proxies and education proxies

Exclusion Criteria

* High-SES: income proxies and education proxies
* developmental delays
* medical conditions that affect child speech or hearing
Minimum Eligible Age

17 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dana L Suskind, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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09-209-B

Identifier Type: -

Identifier Source: org_study_id