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Clinical Trials/NCT01753661
NCT01753661
Completed
N/A

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

University of Chicago1 site in 1 country41 target enrollmentJune 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parental Language Behaviors
Sponsor
University of Chicago
Enrollment
41
Locations
1
Primary Endpoint
Child Behavior Change - LENA: Quantitative
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
February 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Child Behavior Change - LENA: Quantitative

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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