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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01753661
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : June 3, 2016
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Parental Language Behaviors Behavioral: Linguistic Feedback Report Behavioral: Multimedia Education Sessions Behavioral: EI-As-Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Parent-Directed, Multimedia Early Intervention Tool to Improve Outcomes in Underserved Children Who Are Deaf or Hard-of-Hearing
Study Start Date : June 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Project ASPIRE Treatment Condition
The Project ASPIRE Treatment condition will receive the Project ASPIRE intervention program which includes the linguistic feedback reports and the multimedia education sessions. This group will complete the same assessments as the control group.
Behavioral: Linguistic Feedback Report
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

Behavioral: Multimedia Education Sessions
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 Name: Home Visits

Active Comparator: EI-As-Usual Condition
As an ethical decision, eligible participants may roll over to the experimental group after satisfactory completion of this treatment.
Behavioral: EI-As-Usual
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 Outcome Measures :
  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 Outcome Measures :
  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"

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01753661

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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Dana L Suskind, MD University of Chicago

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Responsible Party: University of Chicago Identifier: NCT01753661     History of Changes
Other Study ID Numbers: 12-0125
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016

Keywords provided by University of Chicago:
Hearing loss
Behavior change
Early Intervention
Home visiting