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

NCT ID: NCT01753661

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-02-28

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.

Conditions

Parental Language Behaviors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Linguistic Feedback Report

Intervention Type: 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

Intervention Type: 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.

EI-As-Usual Condition

As an ethical decision, eligible participants may roll over to the experimental group after satisfactory completion of this treatment.

Group Type: ACTIVE_COMPARATOR

EI-As-Usual

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Home Visits

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

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana L Suskind, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

12-0125

Identifier Type: -

Identifier Source: org_study_id