Thirty Million Words Project: A Feasibility Trial (TMW)

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.

Study Overview

• Status: Completed
• Conditions: Parental Language Behaviors
• Intervention / Treatment: Behavioral: LENA Linguistic Feedback Reports; Behavioral: Home Visiting Educational Session; Behavioral: Childhood Nutrition Education

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; 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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Behavior Change (16 LENA recordings)	The LENA provides data for the following categories of adult behaviors: Adult Word Count (AWC), Conversational Turn Count (CTC), and Television Time (TVT).	Baseline (3 Recordings), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22
Child Behavior Change - LENA: Quantitative Linguistic Change (16 recordings)	LENA system provides information on Child Vocalization Count (CVC) and Conversational Turn Count (CTC) in the home environment.	Baseline (3 weeks pre-intervention), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAR Reading	Computerized assessment of parent reading level.	Approximately 3 weeks pre-intervention
Center for Epidemiological Studies Depression Screen, short form (CESD-10)	Validated brief depression screen for parent. Appropriate referrals were made for parents who received a score above the CESD-10 cut score and who experienced suicidal ideation or self harm.	Approximately 3 weeks pre-intervention program
Parent Behavior Checklist (PBC)	Validated assessment concerning different types of parenting 'style'	Approximately 3 weeks pre-intervention; 1 week post-intervention, 4-months post-intervention
Wechsler Abbreviated Scales of Intelligence (WASI)	Parent IQ	Approximately 3 week pre-intervention; 1 week post-intervention; 4 months post-intervention
Child Receptive One Word Picture Vocabulary Test (ROWPVT)	Interactive assessment of child's receptive vocabulary	Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Child MacArthur Communicative Development Inventory Short Form (CDI)	Parent self-report of child expressive vocabulary.	Approximately 3 weeks pre-intervention program; 1 week post-intervention; 4 months post-intervention
Achenbach Child Behavior Checklist (CBCL)	Parent reported assessment of child problematic behaviors.	Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Bayley Child Development Screener	Short screener to assess child's level of development for five categories: cognitive, fine motor, gross motor, expressive, and receptive vocabulary.	Approximately 3 weeks pre-intervention
TMW Questionnaire	Novel questionnaire developed for use in the study. Assessed parent level of knowledge concerning child language development.	Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Parental Behavior Change - LENA and Video: Qualitative Changes	LENA transcription:Mean length utterance (MLU), type/token, syntactical complexity, gesture. Video: gesture, "responsive parenting" behaviors (e.g. being on child's level)	Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Child Expressive One Word Picture Vocabulary Test (EOWPVT)	Interactive assessment that evaluates child's expressive vocabulary.	Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Parent Working Memory Test (Sym-Span)	Computer administered assessment of parent working memory.	Approximately 3 weeks pre-intervention
Knowledge of Infant Development Index (KIDI)	Questionnaire assessing parent knowledge of infant development	Approximately 3 weeks pre-intervention
Theories of Intelligence (TOI)	6 item questionnaire regarding incremental and entity theories of intelligence	Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Parent Stress Index (PSI) short form	Parent self-report assessment of stress levels related to parenting	Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Models of Developing Language	Parent self report evaluating parent's beliefs about language acquisition.	Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Demographics	Questionnaire about family background information and the child's developmental history	Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
LENA Developmental Snapshot	Parent report of child's language development level	Approximately 3 weeks pre-intervention program; 1 week post-intervention program; 4 months post-intervention program

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 21, 2012

Study Record Updates

• Last Update Posted (Estimate): September 5, 2013
• Last Update Submitted That Met QC Criteria: September 4, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Language; Intervention; Behavior change; Home visiting; Child language development
• Other Study ID Numbers: 09-209-B