Parental Language BehaviorsASPIRENCT01753661
Project ASPIRE Efficacy Pilot: Achieving Superior Parental Involvement for Rehabilitative Excellence
A study testing Linguistic Feedback Report, Multimedia Education Sessions and EI-As-Usual in people with Parental Language Behaviors, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Parental Language Behaviors
- What is being tested?
- Linguistic Feedback Report, Multimedia Education Sessions and EI-As-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Linguistic Feedback Report, Multimedia Education Sessions, EI-As-Usual
- Keywords
- Hearing loss, Language, Behavior change, Early Intervention, Home visiting
- Medical subject headings
- Hearing Loss, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linguistic Feedback ReportBehavioural
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 SessionsBehavioural
Also called Home Visits
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-UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Project ASPIRE Treatment Condition | Experimental | 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. Receives: Behavioral: Linguistic Feedback Report; Behavioral: Multimedia Education Sessions |
| EI-As-Usual Condition | Active comparator | As an ethical decision, eligible participants may roll over to the experimental group after satisfactory completion of this treatment. Receives: Behavioral: EI-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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 (14)
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.
Measured: Approximately 3 weeks pre-intervention
MacArthur Child Development Inventories (CDIs)
Parent self-report of child expressive vocabulary.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Approximately 3 weeks pre-intervention program
Parent Stress Index (PSI)
A self-report measure that assesses level of parenting-related stress
Measured: 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.
Measured: Approximately 3 weeks pre-intervention; 3 months post-intervention
Ages and Stages Questionnaire (ASQ)
A questionnaire concerning the child's development.
Measured: Approximately 3 weeks pre-intervention program
Child Behavior Checklist (CBCL)
Parent report of potentially problematic child behaviors.
Measured: Approximately 3 weeks pre-intervention
Rosetti
Questionnaire assessing child's current language development
Measured: Approximately 3 weeks pre-intervention; 3 months post-intervention
Capute Scales
Validated scales of child development.
Measured: Approximately 3 weeks pre-intervention
Theories of Intelligence (TOI)
6-item questionnaire that assesses entity and incremental theories of intelligence.
Measured: 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"
Measured: Baseline (2 Visits), Week 10, Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parental Language BehaviorsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana L Suskind, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753661
- Sponsor's protocol ID
- 12-0125
- Acronym
- ASPIRE
- Status last verified
- Jun 2016
- First submitted
- 17 Dec 2012
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parent-Directed, Multimedia Early Intervention Tool to Improve Outcomes in Underserved Children Who Are Deaf or Hard-of-Hearing
- ClinicalTrials.gov ID
- NCT01753661
- Acronym / sponsor ID
- ASPIRE / 12-0125
- Conditions
- Parental Language Behaviors
- Keywords
- Hearing loss, Language, Behavior change, Early Intervention, Home visiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project ASPIRE Treatment Condition | Experimental | Behavioral: Linguistic Feedback Report, Behavioral: Multimedia Education SessionsThe 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 | Active comparator | Behavioral: EI-As-UsualAs an ethical decision, eligible participants may roll over to the experimental group after satisfactory completion of this treatment. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linguistic Feedback ReportThroughout 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 | Behavioural | Project ASPIRE Treatment Condition |
| Multimedia Education SessionsAlso: Home VisitsTreatment 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. | Behavioural | Project ASPIRE Treatment Condition |
| EI-As-UsualThe 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. | Behavioural | EI-As-Usual Condition |
Primary outcome
Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Linguistic Change
Time frame: 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.
Child Behavior Change - LENA: Quantitative
Time frame: 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).
14 secondary outcomes
Center for Epidemiological Studies Depression Screen, short form (CESD-10)
Time frame: Approximately 3 weeks pre-intervention
MacArthur Child Development Inventories (CDIs)
Time frame: Approximately 3 weeks pre-intervention; 3 months post-intervention
Scale of Parental Involvement and Self-Efficacy (SPISE)
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention
Early Intervention Parenting Self-Efficacy Scale (EIPSES)
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention
ASPIRE Knowledge Questionnaire
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 4 months post-intervention
Demographics
Time frame: Approximately 3 weeks pre-intervention program
Parent Stress Index (PSI)
Time frame: Approximately 3 weeks pre-intervention
Little Ears
Time frame: Approximately 3 weeks pre-intervention; 3 months post-intervention
Ages and Stages Questionnaire (ASQ)
Time frame: Approximately 3 weeks pre-intervention program
Child Behavior Checklist (CBCL)
Time frame: Approximately 3 weeks pre-intervention
Rosetti
Time frame: Approximately 3 weeks pre-intervention; 3 months post-intervention
Capute Scales
Time frame: Approximately 3 weeks pre-intervention
Theories of Intelligence (TOI)
Time frame: Approximately 3 weeks pre-intervention; 1 week post-intervention; 3 months post-intervention
Parental Behavior Change - LENA and Video: Qualitative Changes
Time frame: Baseline (2 Visits), Week 10, Week 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
Related trials for Parental Language Behaviors
Not yet recruiting
Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism
Autism Spectrum Disorder (ASD), Autism
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Recruiting
Neural Prediction to Enhance Language
Bilateral Sensorineural Hearing Loss, Speech and Language Development Delay Due to Hearing Loss
Enrolling by invitationPhase 2
Long-Term Outcomes of Early Communication Intervention for Deaf/Hard of Hearing Toddlers
Hearing Loss, Bilateral
Recruiting
Combined Oral Motor Stimulation and Language on Preterm Infant Feeding
Language Delay, Language Development
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana L Suskind, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linguistic Feedback Report, Multimedia Education Sessions and EI-As-Usual in people with Parental Language Behaviors, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Behavior Change - Language ENvironment Analysis (LENA): Quantitative Linguistic Change (time frame: 16 recordings total over a 6 month period: Baseline (3 Recordings), Weeks 1-10, Week 14, Week 18, Week 22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.