Thirty Million Words Project: A Feasibility Trial (TMW)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01754077
First received: December 13, 2012
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Parental Language Behaviors
Behavioral: LENA Linguistic Feedback Reports
Behavioral: Home Visiting Educational Session
Behavioral: Childhood Nutrition Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Thirty Million Words Project: A Feasibility Trial

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Behavior Change (16 LENA recordings) [ Time Frame: Baseline (3 Recordings), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22 ] [ Designated as safety issue: No ]
    The LENA provides data for the following categories of adult behaviors: Adult Word Count (AWC), Conversational Turn Count (CTC), and Television Time (TVT).

  • Child Behavior Change - LENA: Quantitative Linguistic Change (16 recordings) [ Time Frame: Baseline (3 weeks pre-intervention), 1 per week for 8 weeks (8 recordings), Week 14, Week 18, Week 22 ] [ Designated as safety issue: No ]
    LENA system provides information on Child Vocalization Count (CVC) and Conversational Turn Count (CTC) in the home environment.


Secondary Outcome Measures:
  • STAR Reading [ Time Frame: Approximately 3 weeks pre-intervention ] [ Designated as safety issue: No ]
    Computerized assessment of parent reading level.

  • Center for Epidemiological Studies Depression Screen, short form (CESD-10) [ Time Frame: Approximately 3 weeks pre-intervention program ] [ Designated as safety issue: Yes ]
    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.

  • Parent Behavior Checklist (PBC) [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention, 4-months post-intervention ] [ Designated as safety issue: No ]
    Validated assessment concerning different types of parenting 'style'

  • Wechsler Abbreviated Scales of Intelligence (WASI) [ Time Frame: Approximately 3 week pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    Parent IQ

  • Child Receptive One Word Picture Vocabulary Test (ROWPVT) [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    Interactive assessment of child's receptive vocabulary

  • Child MacArthur Communicative Development Inventory Short Form (CDI) [ Time Frame: Approximately 3 weeks pre-intervention program; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    Parent self-report of child expressive vocabulary.

  • Achenbach Child Behavior Checklist (CBCL) [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    Parent reported assessment of child problematic behaviors.

  • Bayley Child Development Screener [ Time Frame: Approximately 3 weeks pre-intervention ] [ Designated as safety issue: No ]
    Short screener to assess child's level of development for five categories: cognitive, fine motor, gross motor, expressive, and receptive vocabulary.

  • TMW Questionnaire [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    Novel questionnaire developed for use in the study. Assessed parent level of knowledge concerning child language development.

  • Parental Behavior Change - LENA and Video: Qualitative Changes [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    LENA transcription:Mean length utterance (MLU), type/token, syntactical complexity, gesture. Video: gesture, "responsive parenting" behaviors (e.g. being on child's level)

  • Child Expressive One Word Picture Vocabulary Test (EOWPVT) [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    Interactive assessment that evaluates child's expressive vocabulary.

  • Parent Working Memory Test (Sym-Span) [ Time Frame: Approximately 3 weeks pre-intervention ] [ Designated as safety issue: No ]
    Computer administered assessment of parent working memory.

  • Knowledge of Infant Development Index (KIDI) [ Time Frame: Approximately 3 weeks pre-intervention ] [ Designated as safety issue: No ]
    Questionnaire assessing parent knowledge of infant development

  • Theories of Intelligence (TOI) [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    6 item questionnaire regarding incremental and entity theories of intelligence

  • Parent Stress Index (PSI) short form [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    Parent self-report assessment of stress levels related to parenting

  • Models of Developing Language [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    Parent self report evaluating parent's beliefs about language acquisition.

  • Demographics [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    Questionnaire about family background information and the child's developmental history

  • LENA Developmental Snapshot [ Time Frame: Approximately 3 weeks pre-intervention program; 1 week post-intervention program; 4 months post-intervention program ] [ Designated as safety issue: No ]
    Parent report of child's language development level


Enrollment: 40
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   17 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754077

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Dana L Suskind, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01754077     History of Changes
Other Study ID Numbers: 09-209-B
Study First Received: December 13, 2012
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Language
Behavior change
Intervention
Home visiting
Child language development

ClinicalTrials.gov processed this record on August 20, 2014