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临床试验/NCT01754077
NCT01754077已完成不适用

Thirty Million Words Project: A Feasibility Trial

University of Chicago2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Behavior Change (16 LENA recordings)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
17 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Low-SES: income proxies and education proxies

排除标准

  • High-SES: income proxies and education proxies
  • developmental delays
  • medical conditions that affect child speech or hearing

结局指标

主要结局

Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Behavior Change (16 LENA recordings)

时间窗: 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).

Child Behavior Change - LENA: Quantitative Linguistic Change (16 recordings)

时间窗: 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.

次要结局

  • STAR Reading(Approximately 3 weeks pre-intervention)
  • Center for Epidemiological Studies Depression Screen, short form (CESD-10)(Approximately 3 weeks pre-intervention program)
  • Parent Behavior Checklist (PBC)(Approximately 3 weeks pre-intervention; 1 week post-intervention, 4-months post-intervention)
  • Wechsler Abbreviated Scales of Intelligence (WASI)(Approximately 3 week pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • Child Receptive One Word Picture Vocabulary Test (ROWPVT)(Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • Child MacArthur Communicative Development Inventory Short Form (CDI)(Approximately 3 weeks pre-intervention program; 1 week post-intervention; 4 months post-intervention)
  • Achenbach Child Behavior Checklist (CBCL)(Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • Bayley Child Development Screener(Approximately 3 weeks pre-intervention)
  • TMW Questionnaire(Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • Parental Behavior Change - LENA and Video: Qualitative Changes(Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • Parent Working Memory Test (Sym-Span)(Approximately 3 weeks pre-intervention)
  • Knowledge of Infant Development Index (KIDI)(Approximately 3 weeks pre-intervention)
  • Theories of Intelligence (TOI)(Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • Child Expressive One Word Picture Vocabulary Test (EOWPVT)(Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • Parent Stress Index (PSI) short form(Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • Models of Developing Language(Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • Demographics(Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • LENA Developmental Snapshot(Approximately 3 weeks pre-intervention program; 1 week post-intervention program; 4 months post-intervention program)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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