Clinical trial NCT01753661: Project ASPIRE Efficacy Pilot: Achieving Superior Parental Involvement for Rehabilitative Excellence
Official title: A Parent-Directed, Multimedia Early Intervention Tool to Improve Outcomes in Underserved Children Who Are Deaf or Hard-of-Hearing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parental Language Behaviors
Keywords: Hearing loss
Language
Behavior change
Early Intervention
Home visiting
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 41
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Linguistic Change
timeFrame: 16 recordings total over a 6 month period: Baseline (3 Recordings), Weeks 1-10, Week 14, Week 18, Week 22
measure: Child Behavior Change - LENA: Quantitative
timeFrame: 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 outcomes:
measure: Center for Epidemiological Studies Depression Screen, short form (CESD-10)
timeFrame: Approximately 3 weeks pre-intervention
measure: MacArthur Child Development Inventories (CDIs)
timeFrame: Approximately 3 weeks pre-intervention; 3 months post-intervention
measure: Scale of Parental Involvement and Self-Efficacy (SPISE)
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention
measure: Early Intervention Parenting Self-Efficacy Scale (EIPSES)
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention
measure: ASPIRE Knowledge Questionnaire
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
measure: Demographics
timeFrame: Approximately 3 weeks pre-intervention program
measure: Parent Stress Index (PSI)
timeFrame: Approximately 3 weeks pre-intervention
measure: Little Ears
timeFrame: Approximately 3 weeks pre-intervention; 3 months post-intervention
measure: Ages and Stages Questionnaire (ASQ)
timeFrame: Approximately 3 weeks pre-intervention program
measure: Child Behavior Checklist (CBCL)
timeFrame: Approximately 3 weeks pre-intervention
measure: Rosetti
timeFrame: Approximately 3 weeks pre-intervention; 3 months post-intervention
measure: Capute Scales
timeFrame: Approximately 3 weeks pre-intervention
measure: Theories of Intelligence (TOI)
timeFrame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention
measure: Parental Behavior Change - LENA and Video: Qualitative Changes
timeFrame: Baseline (2 Visits), Week 10, Week 22
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Dana L Suskind, MD
role: PRINCIPAL_INVESTIGATOR
References: