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

Not Applicable

Completed

• Conditions: Parental Language Behaviors
• Interventions: Behavioral: Linguistic Feedback Report; Behavioral: EI-As-Usual; Behavioral: Multimedia Education Sessions

• Registration Number: NCT01753661
• Lead Sponsor: University of Chicago

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Project ASPIRE Treatment Condition	Linguistic Feedback Report	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.
Project ASPIRE Treatment Condition	Multimedia Education Sessions	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.
EI-As-Usual Condition	EI-As-Usual	As an ethical decision, eligible participants may roll over to the experimental group after satisfactory completion of this treatment.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States