Thirty Million Words Project: A Feasibility Trial (TMW)

The University of Chicago

Status: Completed

Conditions: Parental Language Behaviors

Treatments: Behavioral: Home Visiting Educational Session; Behavioral: Childhood Nutrition Education; Behavioral: LENA Linguistic Feedback Reports

Study type: Interventional

Funder types: Other

Identifiers

NCT01754077

09-209-B

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 17 to 36 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Thirty Million Words Project

Experimental group

Description:

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.

Treatment:

Behavioral: LENA Linguistic Feedback Reports

Behavioral: Home Visiting Educational Session

Control Group

Other group

Description:

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.

Treatment:

Behavioral: Childhood Nutrition Education