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

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

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.

Study Overview

• Status: Completed
• Conditions: Parental Language Behaviors
• Intervention / Treatment: Behavioral: Linguistic Feedback Report; Behavioral: Multimedia Education Sessions; Behavioral: EI-As-Usual

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Linguistic Change	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.	16 recordings total over a 6 month period: Baseline (3 Recordings), Weeks 1-10, Week 14, Week 18, Week 22
Child Behavior Change - LENA: Quantitative	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).	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center for Epidemiological Studies Depression Screen, short form (CESD-10)	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.	Approximately 3 weeks pre-intervention
MacArthur Child Development Inventories (CDIs)	Parent self-report of child expressive vocabulary.	Approximately 3 weeks pre-intervention; 3 months post-intervention
Scale of Parental Involvement and Self-Efficacy (SPISE)	Parent self-report that assesses of self-efficacy relating to involvement in children's development.	Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention
Early Intervention Parenting Self-Efficacy Scale (EIPSES)	Parent self-report measure of self-efficacy relating to early intervention programs.	Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention
ASPIRE Knowledge Questionnaire	Questionnaire developed for use in the trial that assesses parent's knowledge of child development and hearing loss	Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Demographics	Questionnaire about family background; child development history; child hearing loss and hearing devices	Approximately 3 weeks pre-intervention program
Parent Stress Index (PSI)	A self-report measure that assesses level of parenting-related stress	Approximately 3 weeks pre-intervention
Little Ears	Short questionnaire about child's level of listening and language development following cochlear implant or hearing aid activation.	Approximately 3 weeks pre-intervention; 3 months post-intervention
Ages and Stages Questionnaire (ASQ)	A questionnaire concerning the child's development.	Approximately 3 weeks pre-intervention program
Child Behavior Checklist (CBCL)	Parent report of potentially problematic child behaviors.	Approximately 3 weeks pre-intervention
Rosetti	Questionnaire assessing child's current language development	Approximately 3 weeks pre-intervention; 3 months post-intervention
Capute Scales	Validated scales of child development.	Approximately 3 weeks pre-intervention
Theories of Intelligence (TOI)	6-item questionnaire that assesses entity and incremental theories of intelligence.	Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention
Parental Behavior Change - LENA and Video: Qualitative Changes	LENA transcription:MLU, type/token, syntactical complexity, gesture Video: gesture, "responsive parenting"	Baseline (2 Visits), Week 10, Week 22

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (ESTIMATE): December 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2016
• Last Update Submitted That Met QC Criteria: June 2, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Language; Early Intervention; Hearing loss; Behavior change; Home visiting
• Other Study ID Numbers: 12-0125