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Completed

NCT Number: NCT01754077

Thirty Million Words Project: A Feasibility Trial

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.

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Key information

Conditions

Parental Language Behaviors Behavior Communication Language

Age range

17 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LENA Linguistic Feedback Reports

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

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.

Childhood Nutrition Education

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.

Primary outcomes

  1. 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

    The LENA provides data for the following categories of adult behaviors: Adult Word Count (AWC), Conversational Turn Count (CTC), and Television Time (TVT).

  2. 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

    LENA system provides information on Child Vocalization Count (CVC) and Conversational Turn Count (CTC) in the home environment.

Secondary outcomes

  1. STAR Reading

    Time frame: Approximately 3 weeks pre-intervention

    Computerized assessment of parent reading level.

  2. Center for Epidemiological Studies Depression Screen, short form (CESD-10)

    Time frame: Approximately 3 weeks pre-intervention program

    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.

  3. Parent Behavior Checklist (PBC)

    Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention, 4-months post-intervention

    Validated assessment concerning different types of parenting 'style'

  4. Wechsler Abbreviated Scales of Intelligence (WASI)

    Time frame: Approximately 3 week pre-intervention; 1 week post-intervention; 4 months post-intervention

    Parent IQ

  5. Child Receptive One Word Picture Vocabulary Test (ROWPVT)

    Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention

    Interactive assessment of child's receptive vocabulary

  6. Child MacArthur Communicative Development Inventory Short Form (CDI)

    Time frame: Approximately 3 weeks pre-intervention program; 1 week post-intervention; 4 months post-intervention

    Parent self-report of child expressive vocabulary.

  7. Achenbach Child Behavior Checklist (CBCL)

    Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention

    Parent reported assessment of child problematic behaviors.

  8. Bayley Child Development Screener

    Time frame: Approximately 3 weeks pre-intervention

    Short screener to assess child's level of development for five categories: cognitive, fine motor, gross motor, expressive, and receptive vocabulary.

  9. TMW Questionnaire

    Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention

    Novel questionnaire developed for use in the study. Assessed parent level of knowledge concerning child language development.

  10. Parental Behavior Change - LENA and Video: Qualitative Changes

    Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention

    LENA transcription:Mean length utterance (MLU), type/token, syntactical complexity, gesture. Video: gesture, "responsive parenting" behaviors (e.g. being on child's level)

  11. Child Expressive One Word Picture Vocabulary Test (EOWPVT)

    Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention

    Interactive assessment that evaluates child's expressive vocabulary.

  12. Parent Working Memory Test (Sym-Span)

    Time frame: Approximately 3 weeks pre-intervention

    Computer administered assessment of parent working memory.

  13. Knowledge of Infant Development Index (KIDI)

    Time frame: Approximately 3 weeks pre-intervention

    Questionnaire assessing parent knowledge of infant development

  14. Theories of Intelligence (TOI)

    Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention

    6 item questionnaire regarding incremental and entity theories of intelligence

  15. Parent Stress Index (PSI) short form

    Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention

    Parent self-report assessment of stress levels related to parenting

  16. Models of Developing Language

    Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention

    Parent self report evaluating parent's beliefs about language acquisition.

  17. Demographics

    Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention

    Questionnaire about family background information and the child's developmental history

  18. LENA Developmental Snapshot

    Time frame: Approximately 3 weeks pre-intervention program; 1 week post-intervention program; 4 months post-intervention program

    Parent report of child's language development level

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: TMW

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 21, 2012
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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