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Completed

NCT Number: NCT01753661

Project ASPIRE Efficacy Pilot: Achieving Superior Parental Involvement for Rehabilitative Excellence

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.

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Key information

Conditions

Parental Language Behaviors Behavior Communication Ear Diseases Hearing Disorders Hearing Loss Language Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Linguistic Feedback Report

Behavioral

Throughout the study, parents will complete 16 total LENA recordings. The feedback report will include information on the parent's previous LENA recording(s), including the Adult Word Count (AWC), Conversational Turns (CTC), and TV Time (TVT). Parents in the treatment group will receive feedback reports for the baseline and 10 weekly recordings. Feedback reports will not be offered for the follow-up recordings

Multimedia Education Sessions

Behavioral

Treatment group parents will receive 10 weekly home visit sessions (e.g. the ASPIRE Program) with an interventionist during which time they will review multimedia education modules. The sessions include feedback report review, module discussion, video modeling, and goal setting activities. The education modules provide parents with information on supporting the development of listening and spoken language for children with hearing loss.

Other names: Home Visits

EI-As-Usual

Behavioral

The EI-as-usual condition will parallel the treatment condition. Families in the EI-as-usual condition will continue to receive their usual therapy. They will not participate in Project ASPIRE home visits or receive feedback on their recordings. Families in this group will complete the same assessments as the families in the treatment group.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

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

    Time frame: Approximately 3 weeks pre-intervention

    Validated brief depression screen for the parent. Parents who score above the cut score will be assessed for suicidal ideation and self harm. Appropriate referrals will be made following assessment.

  2. MacArthur Child Development Inventories (CDIs)

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

    Parent self-report of child expressive vocabulary.

  3. Scale of Parental Involvement and Self-Efficacy (SPISE)

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

    Parent self-report that assesses of self-efficacy relating to involvement in children's development.

  4. Early Intervention Parenting Self-Efficacy Scale (EIPSES)

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

    Parent self-report measure of self-efficacy relating to early intervention programs.

  5. ASPIRE Knowledge Questionnaire

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

    Questionnaire developed for use in the trial that assesses parent's knowledge of child development and hearing loss

  6. Demographics

    Time frame: Approximately 3 weeks pre-intervention program

    Questionnaire about family background; child development history; child hearing loss and hearing devices

  7. Parent Stress Index (PSI)

    Time frame: Approximately 3 weeks pre-intervention

    A self-report measure that assesses level of parenting-related stress

  8. Little Ears

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

    Short questionnaire about child's level of listening and language development following cochlear implant or hearing aid activation.

  9. Ages and Stages Questionnaire (ASQ)

    Time frame: Approximately 3 weeks pre-intervention program

    A questionnaire concerning the child's development.

  10. Child Behavior Checklist (CBCL)

    Time frame: Approximately 3 weeks pre-intervention

    Parent report of potentially problematic child behaviors.

  11. Rosetti

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

    Questionnaire assessing child's current language development

  12. Capute Scales

    Time frame: Approximately 3 weeks pre-intervention

    Validated scales of child development.

  13. Theories of Intelligence (TOI)

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

    6-item questionnaire that assesses entity and incremental theories of intelligence.

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

    Time frame: Baseline (2 Visits), Week 10, Week 22

    LENA transcription:MLU, type/token, syntactical complexity, gesture Video: gesture, "responsive parenting"

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Acronym: ASPIRE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 20, 2012
Registry last updated
Jun 3, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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