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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01753661
First received: December 17, 2012
Last updated: September 4, 2013
Last verified: December 2012
  Purpose

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 Intervention
Parental Language Behaviors
Behavioral: Linguistic Feedback Report
Behavioral: Multimedia Education Sessions
Behavioral: EI-As-Usual

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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:
  • Center for Epidemiological Studies Depression Screen, short form (CESD-10) [ Time Frame: Approximately 3 weeks pre-intervention ] [ Designated as safety issue: Yes ]
    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.

  • MacArthur Child Development Inventories (CDIs) [ Time Frame: Approximately 3 weeks pre-intervention; 3 months post-intervention ] [ Designated as safety issue: No ]
    Parent self-report of child expressive vocabulary.

  • Scale of Parental Involvement and Self-Efficacy (SPISE) [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention ] [ Designated as safety issue: No ]
    Parent self-report that assesses of self-efficacy relating to involvement in children's development.

  • Early Intervention Parenting Self-Efficacy Scale (EIPSES) [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention ] [ Designated as safety issue: No ]
    Parent self-report measure of self-efficacy relating to early intervention programs.

  • ASPIRE Knowledge Questionnaire [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention ] [ Designated as safety issue: No ]
    Questionnaire developed for use in the trial that assesses parent's knowledge of child development and hearing loss

  • Demographics [ Time Frame: Approximately 3 weeks pre-intervention program ] [ Designated as safety issue: No ]
    Questionnaire about family background; child development history; child hearing loss and hearing devices

  • Parent Stress Index (PSI) [ Time Frame: Approximately 3 weeks pre-intervention ] [ Designated as safety issue: No ]
    A self-report measure that assesses level of parenting-related stress

  • Little Ears [ Time Frame: Approximately 3 weeks pre-intervention; 3 months post-intervention ] [ Designated as safety issue: No ]
    Short questionnaire about child's level of listening and language development following cochlear implant or hearing aid activation.

  • Ages and Stages Questionnaire (ASQ) [ Time Frame: Approximately 3 weeks pre-intervention program ] [ Designated as safety issue: No ]
    A questionnaire concerning the child's development.

  • Child Behavior Checklist (CBCL) [ Time Frame: Approximately 3 weeks pre-intervention ] [ Designated as safety issue: No ]
    Parent report of potentially problematic child behaviors.

  • Rosetti [ Time Frame: Approximately 3 weeks pre-intervention; 3 months post-intervention ] [ Designated as safety issue: No ]
    Questionnaire assessing child's current language development

  • Capute Scales [ Time Frame: Approximately 3 weeks pre-intervention ] [ Designated as safety issue: No ]
    Validated scales of child development.

  • Theories of Intelligence (TOI) [ Time Frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention ] [ Designated as safety issue: No ]
    6-item questionnaire that assesses entity and incremental theories of intelligence.

  • Parental Behavior Change - LENA and Video: Qualitative Changes [ Time Frame: Baseline (2 Visits), Week 10, Week 22 ] [ Designated as safety issue: No ]
    LENA transcription:MLU, type/token, syntactical complexity, gesture Video: gesture, "responsive parenting"


Estimated Enrollment: 32
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753661

Contacts
Contact: Dana L Suskind, MD 773-834-9169 dsuskind@surgery.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Dana L Suskind, MD    773-834-9169    dsuskind@surgery.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Dana L Suskind, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01753661     History of Changes
Other Study ID Numbers: 12-0125
Study First Received: December 17, 2012
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014