Language DevelopmentNCT03366831
Newborn Implementation
A study testing Thirty Million Words Initiative Newborn Intervention in people with Language Development, run by University of Chicago at 3 sites in United States.
Trial summary
The purpose of the proposed research is to perform testing of the Thirty Million Words Newborn Initiative (TMW-NI) with the primary goal of evaluating various implementation methods. The investigators hypothesize that the TMW-Newborn intervention will: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Language Development
- What is being tested?
- Thirty Million Words Initiative Newborn Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,701 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Apr 2017to 6 Nov 2019
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New mothers at Sacred Heart Hospital, University of Chicago Medical Center, and Baptist Hospital-Pensacola.
Who cannot join
- Individuals that do not have a live birth at Sacred Heart Hospital, University of Chicago Medical Center, or Baptist Hospital-Pensacola or do not receive the UNHS at one of these locations will not be eligible for this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
TMW Center for Early Learning + Public Health at the University of Chicago Medicine
Chicago, Illinois, 60637
Sacred Heart Hospital
Pensacola, Florida, 19141
Baptist Hospital
Pensacola, Florida, 32501
About this study
Official title: Thirty Million Words Initiative Newborn Implementation Trial
The purpose of the proposed research is to perform testing of the Thirty Million Words Newborn Initiative (TMW-NI) with the primary goal of evaluating various implementation methods.
The investigators hypothesize that the TMW-Newborn intervention will:
Read more
- Significantly impact parent knowledge regarding the importance of universal newborn hearing screen (UNHS) follow-up
- Significantly impact parent knowledge of child development Additionally,the investigators hypothesize that:
- The 7-minute version of the video with questions interspersed will most significantly improve parent knowledge of child development
- There will be no significant differences in effectiveness of the Spanish and English versions of the TMW-Newborn intervention
The hypotheses rely on the existing research data supporting the idea that parental understanding and beliefs will alter parental behavior, and consequently, that increased parental linguistic input will impact child cognitive development.
Read the detailed description
The investigators propose to perform a randomized implementation trial to evaluate the efficacy of various implementation methods of the TMW-Newborn educational intervention. The study will be conducted in temporal proximity to the administration of the universal newborn hearing screen.
After routine delivery, postpartum mothers are admitted to the mother-baby unit for 48-72 hours. A hearing screening technician of the Sacred Heart Hospital will deliver the tablet that houses the intervention to every mother whose child is receiving the hearing screening. The technician will give each mother a tablet set up to the HIPAA Compliant TMW-Newborn Web Platform that houses the randomization tool, the welcome video, the tablet based consent passage, the surveys, and the educational intervention videos. First, the participant will watch the welcome video and complete the tablet based consent. Then, the participant will be randomized into one of four conditions: 15 minute version of the TMW-Newborn intervention video without questions interspersed, the 15 minute version of the TMW-Newborn intervention video with questions interspersed, the 7 minute version of the TMW-Newborn intervention video without questions interspersed, or the 7 minute version of the TMW-Newborn intervention video with questions interspersed.
After randomization, the participant will be brought to the screen with the SPEAK III to complete. Then, they will answer a few non-identifying demographics questions. These surveys takes approximately 10 minutes to complete will be followed by either a 15-minute or 7-minute video.
After watching their assigned video, all participants will repeat the SPEAK questionnaire for a second time. Then, the hearing screener will pick up the tablet from the participant. No identifying information is being collected within the TMW-Newborn web platform, and the hearing screening technicians will not be able to see or access any of the participants' responses.
After all surveys are complete, the hearing screening technician will pick up the tablet from the participant and answer any remaining questions.
This study protocol will only be used at Sacred Heart Hospital, Baptist Hospital, and University of Chicago Hospital.
- Conditions
- Language Development
- Being tested
- Thirty Million Words Initiative Newborn Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thirty Million Words Initiative Newborn InterventionBehavioural
The Thirty Million Words Initiative Newborn Intervention (TMW-Newborn) is a public health effort aimed at increasing awareness about the importance of a child's early language environment in his or her first years of life. This one-time educational intervention will be impacting maternal awareness and knowledge about the importance of children's early language environment, between ages 0 and 3.
| Study group | Role | What they receive |
|---|---|---|
| 15 minute version without questions | Active comparator | 15 minute version of the TMW-Newborn intervention video without questions interspersed Receives: Behavioral: Thirty Million Words Initiative Newborn Intervention |
| 15 minute version with questions | Active comparator | 15 minute version of the TMW-Newborn intervention video with questions interspersed Receives: Behavioral: Thirty Million Words Initiative Newborn Intervention |
| 7 minute version without questions | Active comparator | 7 minute version of the TMW-Newborn intervention video without questions interspersed Receives: Behavioral: Thirty Million Words Initiative Newborn Intervention |
| 7 minute version with questions | Active comparator | 7 minute version of the TMW-Newborn intervention video with questions interspersed. Receives: Behavioral: Thirty Million Words Initiative Newborn Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPEAK Survey (Baby Subscales)
measures an individuals expectations and knowledge about child development
Measured: 48-72 after routine delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start10 Apr 2017
- Primary completion6 Nov 2019
- Study completion6 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Language DevelopmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,701 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366831
- Sponsor's protocol ID
- 17-0329
- Status last verified
- May 2023
- First submitted
- 4 Dec 2017
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Publications
Suskind DL, Leung CYY, Webber RJ, Hundertmark AC, Leffel KR, Fuenmayor Rivas IE, Grobman WA. Educating Parents About Infant Language Development: A Randomized Controlled Trial. Clin Pediatr (Phila). 2018 Jul;57(8):945-953. doi: 10.1177/0009922817737079. Epub 2017 Oct 26.
PubMed 29073768
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thirty Million Words Initiative Newborn Implementation Trial
- ClinicalTrials.gov ID
- NCT03366831
- Acronym / sponsor ID
- 17-0329
- Conditions
- Language Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,701 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 8 Dec 2017 (actual)
- 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 research is to perform testing of the Thirty Million Words Newborn Initiative (TMW-NI) with the primary goal of evaluating various implementation methods.
The investigators hypothesize that the TMW-Newborn intervention will:
- Significantly impact parent knowledge regarding the importance of universal newborn hearing screen (UNHS) follow-up
- Significantly impact parent knowledge of child development Additionally,the investigators hypothesize that:
- The 7-minute version of the video with questions interspersed will most significantly improve parent knowledge of child development
- There will be no significant differences in effectiveness of the Spanish and English versions of the TMW-Newborn intervention
The hypotheses rely on the existing research data supporting the idea that parental understanding and beliefs will alter parental behavior, and consequently, that increased parental linguistic input will impact child cognitive development.
Detailed description
The investigators propose to perform a randomized implementation trial to evaluate the efficacy of various implementation methods of the TMW-Newborn educational intervention. The study will be conducted in temporal proximity to the administration of the universal newborn hearing screen.
After routine delivery, postpartum mothers are admitted to the mother-baby unit for 48-72 hours. A hearing screening technician of the Sacred Heart Hospital will deliver the tablet that houses the intervention to every mother whose child is receiving the hearing screening. The technician will give each mother a tablet set up to the HIPAA Compliant TMW-Newborn Web Platform that houses the randomization tool, the welcome video, the tablet based consent passage, the surveys, and the educational intervention videos. First, the participant will watch the welcome video and complete the tablet based consent. Then, the participant will be randomized into one of four conditions: 15 minute version of the TMW-Newborn intervention video without questions interspersed, the 15 minute version of the TMW-Newborn intervention video with questions interspersed, the 7 minute version of the TMW-Newborn intervention video without questions interspersed, or the 7 minute version of the TMW-Newborn intervention video with questions interspersed.
After randomization, the participant will be brought to the screen with the SPEAK III to complete. Then, they will answer a few non-identifying demographics questions. These surveys takes approximately 10 minutes to complete will be followed by either a 15-minute or 7-minute video.
After watching their assigned video, all participants will repeat the SPEAK questionnaire for a second time. Then, the hearing screener will pick up the tablet from the participant. No identifying information is being collected within the TMW-Newborn web platform, and the hearing screening technicians will not be able to see or access any of the participants' responses.
After all surveys are complete, the hearing screening technician will pick up the tablet from the participant and answer any remaining questions.
This study protocol will only be used at Sacred Heart Hospital, Baptist Hospital, and University of Chicago Hospital.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 15 minute version without questions | Active comparator | Behavioral: Thirty Million Words Initiative Newborn Intervention15 minute version of the TMW-Newborn intervention video without questions interspersed |
| 15 minute version with questions | Active comparator | Behavioral: Thirty Million Words Initiative Newborn Intervention15 minute version of the TMW-Newborn intervention video with questions interspersed |
| 7 minute version without questions | Active comparator | Behavioral: Thirty Million Words Initiative Newborn Intervention7 minute version of the TMW-Newborn intervention video without questions interspersed |
| 7 minute version with questions | Active comparator | Behavioral: Thirty Million Words Initiative Newborn Intervention7 minute version of the TMW-Newborn intervention video with questions interspersed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New mothers at Sacred Heart Hospital, University of Chicago Medical Center, and Baptist Hospital-Pensacola.
Key exclusion criteria (1 listed)
- Individuals that do not have a live birth at Sacred Heart Hospital, University of Chicago Medical Center, or Baptist Hospital-Pensacola or do not receive the UNHS at one of these locations will not be eligible for this study.
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 |
|---|---|---|
| Thirty Million Words Initiative Newborn InterventionThe Thirty Million Words Initiative Newborn Intervention (TMW-Newborn) is a public health effort aimed at increasing awareness about the importance of a child's early language environment in his or her first years of life. This one-time educational intervention will be impacting maternal awareness and knowledge about the importance of children's early language environment, between ages 0 and 3. | Behavioural | 15 minute version with questions, 15 minute version without questions, 7 minute version with questions, 7 minute version without questions |
Primary outcome
SPEAK Survey (Baby Subscales)
Time frame: 48-72 after routine delivery
measures an individuals expectations and knowledge about child development
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 10 May 2023.
- Background: PubMed 29073768Suskind DL, Leung CYY, Webber RJ, Hundertmark AC, Leffel KR, Fuenmayor Rivas IE, Grobman WA. Educating Parents About Infant Language Development: A Randomized Controlled Trial. Clin Pediatr (Phila). 2018 Jul;57(8):945-953. doi: 10.1177/0009922817737079. Epub 2017 Oct 26.
- Click here for more information about the Thirty Million WordsLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thirty Million Words Initiative Newborn Intervention in people with Language Development, run by University of Chicago at 3 sites 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 1 inclusion and 1 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
SPEAK Survey (Baby Subscales) (time frame: 48-72 after routine delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03366831, which also lists 1 linked publication.
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 10 May 2023.