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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01753661
Acronym
ASPIRE
Enrollment
41
Registered
2012-12-20
Start date
2012-06-30
Completion date
2015-02-28
Last updated
2016-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parental Language Behaviors

Keywords

Hearing loss, Language, Behavior change, Early Intervention, Home visiting

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.

Interventions

BEHAVIORALLinguistic 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

BEHAVIORALMultimedia 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.

BEHAVIORALEI-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.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Linguistic Change16 recordings total over a 6 month period: Baseline (3 Recordings), Weeks 1-10, Week 14, Week 18, Week 22The 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: Quantitative16 recordings over a 6 month period: Baseline (3 Recordings, approximately 1 per week for 3 weeks), Weeks 1-10, Week 14, Week 18, Week 22The 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

MeasureTime frameDescription
Center for Epidemiological Studies Depression Screen, short form (CESD-10)Approximately 3 weeks pre-interventionValidated 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)Approximately 3 weeks pre-intervention; 3 months post-interventionParent self-report of child expressive vocabulary.
Scale of Parental Involvement and Self-Efficacy (SPISE)Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-interventionParent self-report that assesses of self-efficacy relating to involvement in children's development.
Early Intervention Parenting Self-Efficacy Scale (EIPSES)Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-interventionParent self-report measure of self-efficacy relating to early intervention programs.
ASPIRE Knowledge QuestionnaireApproximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-interventionQuestionnaire developed for use in the trial that assesses parent's knowledge of child development and hearing loss
DemographicsApproximately 3 weeks pre-intervention programQuestionnaire about family background; child development history; child hearing loss and hearing devices
Parent Stress Index (PSI)Approximately 3 weeks pre-interventionA self-report measure that assesses level of parenting-related stress
Little EarsApproximately 3 weeks pre-intervention; 3 months post-interventionShort questionnaire about child's level of listening and language development following cochlear implant or hearing aid activation.
Ages and Stages Questionnaire (ASQ)Approximately 3 weeks pre-intervention programA questionnaire concerning the child's development.
Child Behavior Checklist (CBCL)Approximately 3 weeks pre-interventionParent report of potentially problematic child behaviors.
RosettiApproximately 3 weeks pre-intervention; 3 months post-interventionQuestionnaire assessing child's current language development
Capute ScalesApproximately 3 weeks pre-interventionValidated scales of child development.
Theories of Intelligence (TOI)Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention6-item questionnaire that assesses entity and incremental theories of intelligence.
Parental Behavior Change - LENA and Video: Qualitative ChangesBaseline (2 Visits), Week 10, Week 22LENA transcription:MLU, type/token, syntactical complexity, gesture Video: gesture, responsive parenting

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026