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临床试验/NCT01753661
NCT01753661已完成不适用

A Parent-Directed, Multimedia Early Intervention Tool to Improve Outcomes in Underserved Children Who Are Deaf or Hard-of-Hearing

University of Chicago2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2012年6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
41
试验地点
2
主要终点
Child Behavior Change - LENA: Quantitative

研究概览

简要总结

The purpose of the proposed exploratory research protocol is to investigate the feasibility and efficacy of Project ASPIRE, a parent-directed intervention aiming to increase parental skills and enrich children's early language environments and ultimately improve child outcomes in children with hearing loss from low-income backgrounds.

详细描述

We will test the curriculum's efficacy in increasing parental knowledge and skills with a pilot study funded by a U.S. Department of Education Institute for Education Sciences Goal 2 grant. We hypothesize that parents who complete the ASPIRE curriculum with an Early Intervention therapist will demonstrate enhanced understanding of their child's listening and language needs. This deeper understanding will support behavior changes that improve the language-learning environment through increased parental engagement and linguistic input. Knowledge increase and changes to the language environment will be apparent in comparative pre- vs. post-intervention assessment scores. In addition, child outcomes will demonstrate improved listening and spoken language trajectories.

To encourage behavior change and help parents track their progress, the curriculum will be coupled with "linguistic feedback" gathered by the Language Environment Analysis (LENA) recorders and software. With linguistic feedback, EI therapists and parents will be able to track the family's progress through skill building and set goals for behavior change. This feedback and goal setting will allow parents to translate their knowledge into behavior changes that enrich their child's early language environment.

研究设计

研究类型
Interventional
分配方式
Non 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
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Child is under 4.5 years old
  • Child uses at least one amplification device (hearing aid, cochlear implant, BAHA)
  • Child has adequate amplification (at least 30 db in one ear)
  • Parent speaks conversational English
  • Family's communication choice includes spoken language
  • Family is considered low-SES according to income and education proxies

排除标准

  • Child is younger than 6 months of age
  • Parent does not speak conversational English
  • Child is over 4.5 years of age
  • Family is considered high-SES according to income and education proxies

结局指标

主要结局

Child Behavior Change - LENA: Quantitative

时间窗: 16 recordings over a 6 month period: Baseline (3 Recordings, approximately 1 per week for 3 weeks), Weeks 1-10, Week 14, Week 18, Week 22

The LENA system provides information about child language behaviors in addition to adult language behaviors, including data for Child Vocalization Count (CVC) and Conversational Turn Count (CTC).

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

时间窗: 16 recordings total over a 6 month period: Baseline (3 Recordings), Weeks 1-10, Week 14, Week 18, Week 22

The Language Environment Analysis (LENA) system records the home audio environment of children with a recorder and processes the recording information with specialized computer software. Processed recordings provide information for researchers on the following adult language-related behaviors: Adult Word Count (AWC), Conversational Turn Count (CTC), Television Time (TVT), and Background Noise.

次要结局

  • Parent Stress Index (PSI)(Approximately 3 weeks pre-intervention)
  • Scale of Parental Involvement and Self-Efficacy (SPISE)(Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention)
  • Early Intervention Parenting Self-Efficacy Scale (EIPSES)(Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention)
  • Child Behavior Checklist (CBCL)(Approximately 3 weeks pre-intervention)
  • Demographics(Approximately 3 weeks pre-intervention program)
  • Rosetti(Approximately 3 weeks pre-intervention; 3 months post-intervention)
  • Theories of Intelligence (TOI)(Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention)
  • Center for Epidemiological Studies Depression Screen, short form (CESD-10)(Approximately 3 weeks pre-intervention)
  • MacArthur Child Development Inventories (CDIs)(Approximately 3 weeks pre-intervention; 3 months post-intervention)
  • Little Ears(Approximately 3 weeks pre-intervention; 3 months post-intervention)
  • Parental Behavior Change - LENA and Video: Qualitative Changes(Baseline (2 Visits), Week 10, Week 22)
  • ASPIRE Knowledge Questionnaire(Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention)
  • Ages and Stages Questionnaire (ASQ)(Approximately 3 weeks pre-intervention program)
  • Capute Scales(Approximately 3 weeks pre-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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