BehaviorTMW-NINCT02267265
Pilot Study of Novel Postpartum Educational Video Intervention
A study testing TMW-Newborn Intervention video and Safe Sleep for your Baby (SIDS) educational video in people with Behavior and Communication, run by University of Chicago at 2 sites in United States.
Trial summary
A child's early language environment is pivotal for language development. Disparities in early language environments contribute to the gap in school readiness between poor and more advantaged children. Ultimately this leads to disparities in students' school achievement and economic outcomes. 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
- Behavior, Communication, Language
- What is being tested?
- TMW-Newborn Intervention video and Safe Sleep for your Baby (SIDS) educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 694 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Dec 2016
- 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
- -Postpartum mothers admitted to the mother-baby unit.
Who cannot join
- Mothers of infants who were admitted to the neonatal intensive care unit (NICU).
- Mothers who experienced any serious medical complications during birth.
- Mothers who do not expect to reside in Illinois for the duration of the study (approximately two months).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
The University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: A Randomized Controlled Trial Pilot Study of the Thirty Million Words® Newborn Initiative Intervention, a Novel Postpartum Educational Video
A child's early language environment is pivotal for language development. Disparities in early language environments contribute to the gap in school readiness between poor and more advantaged children. Ultimately this leads to disparities in students' school achievement and economic outcomes. While recent research has highlighted the value of early intervention for children in disadvantaged families, most existing interventions begin too late, reach only a small proportion of children at risk, and do not capitalize on the critical role that parent language plays in a child's educational trajectory. To address this challenge, the investigators propose to develop and evaluate a novel language-based, perinatal public health intervention, Thirty Million Words Newborn Initiative (TMW-NI). It is proposed that new mothers will receive this educational intervention while their babies are undergoing the universal newborn hearing screen. The intervention will use video, animation, and interactive questions to convey the importance of the early language environment and to illustrate strategies parents can use to promote language learning. The investigators will conduct formative research with mothers of low socioeconomic status (low-SES) and with healthcare providers to inform the content and format of the intervention prototype. Also critical for acceptability, the investigators will use an iterative approach to develop the intervention, with review of the work-in-progress by the intended audience. To assess feasibility and initial efficacy, the investigators will conduct a randomized-controlled trial with low-SES mothers during the newborn period. The investigators hypothesize that TMW-NI will positively impact parents' knowledge and beliefs about the role of language input for a child's language development.
- Conditions
- Behavior, Communication, Language
- Being tested
- TMW-Newborn Intervention video, Safe Sleep for your Baby (SIDS) educational video
- Keywords
- educational intervention, language development, universal newborn hearing screening, postpartum, parental attachment, loss to follow-up, hearing loss, achievement gap, language gap, school readiness
- Medical subject headings
- Behavior, Communication, Language, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMW-Newborn Intervention videoOther
This is an educational video intervention developed by the Thirty Million Words® Initiative Lab.
Safe Sleep for your Baby (SIDS) educational videoOther
It is an educational video developed by the National Institute of Child Health and Development (NICHD) promoting the prevention of Sudden Infant Death Syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Treatment intervention | Experimental | The treatment group will complete a demographics questionnaire and the knowledge survey before the intervention. Participants will then view the 10 minute TMW-Newborn Intervention video around the time of the newborn hearing screening. Participants whose newborn does not pass the hearing screen will view an additional 3 minute video detailing the importance of following up for an outpatient re-screening. The participant will complete the knowledge survey again before discharge, and after approximately four to six weeks. Receives: Other: TMW-Newborn Intervention video |
| Control intervention | Active comparator | The control group will complete a demographics questionnaire and knowledge survey. Participants will subsequently view the 10-minute Safe Sleep for your Baby (SIDS) educational video. It is an educational video developed by the National Institute of Child Health and Development (NICHD) promoting the prevention of Sudden Infant Death Syndrome. This will be around the time of the newborn hearing screening. Participants will complete the knowledge survey again before discharge, and after approximately four to six weeks. Receives: Other: Safe Sleep for your Baby (SIDS) educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TMW-NI knowledge survey
Scores on the TMW-NI knowledge will be compared to pre-intervention scores.
Measured: About 24 hours post intervention
Change in TMW-NI knowledge survey
Scores on the TMW-NI knowledge will be compared to pre-intervention scores.
Measured: About 4 weeks post intervention
Secondary outcomes (1)
Loss to follow-up
Measuring change in loss to follow-up statistics for patients that do not pass the universal newborn hearing screening.
Measured: About 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
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 BehaviorStudies 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
- 694 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Opinion Research Center, Northwestern University
- Responsible party
- Sponsor
- Investigators
- Dana Suskind, MD, Principal investigator, The University of Chicago MedicineKristin Leffel, AB, Study chair, The University of Chicago Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267265
- Sponsor's protocol ID
- TMW-NI
- Acronym
- TMW-NI
- Status last verified
- Dec 2017
- First submitted
- 11 Sep 2014
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sowa LE, Thomas JMN, Hundertmark AC, Baroody FM, Suskind DL. Leveraging the universal newborn hearing screen to impact parental knowledge of childhood speech development in low socioeconomic populations: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2021 Jul;146:110763. doi: 10.1016/j.ijporl.2021.110763. Epub 2021 May 11.
PubMed 34000494
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Pilot Study of the Thirty Million Words® Newborn Initiative Intervention, a Novel Postpartum Educational Video
- ClinicalTrials.gov ID
- NCT02267265
- Acronym / sponsor ID
- TMW-NI / TMW-NI
- Conditions
- Behavior, Communication, Language
- Keywords
- educational intervention, language development, universal newborn hearing screening, postpartum, parental attachment, loss to follow-up, hearing loss, achievement gap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 694 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Opinion Research Center, Northwestern University
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Oct 2014 (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.
A child's early language environment is pivotal for language development. Disparities in early language environments contribute to the gap in school readiness between poor and more advantaged children. Ultimately this leads to disparities in students' school achievement and economic outcomes. While recent research has highlighted the value of early intervention for children in disadvantaged families, most existing interventions begin too late, reach only a small proportion of children at risk, and do not capitalize on the critical role that parent language plays in a child's educational trajectory. To address this challenge, the investigators propose to develop and evaluate a novel language-based, perinatal public health intervention, Thirty Million Words Newborn Initiative (TMW-NI). It is proposed that new mothers will receive this educational intervention while their babies are undergoing the universal newborn hearing screen. The intervention will use video, animation, and interactive questions to convey the importance of the early language environment and to illustrate strategies parents can use to promote language learning. The investigators will conduct formative research with mothers of low socioeconomic status (low-SES) and with healthcare providers to inform the content and format of the intervention prototype. Also critical for acceptability, the investigators will use an iterative approach to develop the intervention, with review of the work-in-progress by the intended audience. To assess feasibility and initial efficacy, the investigators will conduct a randomized-controlled trial with low-SES mothers during the newborn period. The investigators hypothesize that TMW-NI will positively impact parents' knowledge and beliefs about the role of language input for a child's language development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment intervention | Experimental | Other: TMW-Newborn Intervention videoThe treatment group will complete a demographics questionnaire and the knowledge survey before the intervention. Participants will then view the 10 minute TMW-Newborn Intervention video around the time of the newborn hearing screening. Participants whose newborn does not pass the hearing screen will view an additional 3 minute video detailing the importance of following up for an outpatient re-screening. The participant will complete the knowledge survey again before discharge, and after approximately four to six weeks. |
| Control intervention | Active comparator | Other: Safe Sleep for your Baby (SIDS) educational videoThe control group will complete a demographics questionnaire and knowledge survey. Participants will subsequently view the 10-minute Safe Sleep for your Baby (SIDS) educational video. It is an educational video developed by the National Institute of Child Health and Development (NICHD) promoting the prevention of Sudden Infant Death Syndrome. This will be around the time of the newborn hearing screening. Participants will complete the knowledge survey again before discharge, and after approximately four to six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Postpartum mothers admitted to the mother-baby unit.
Key exclusion criteria (3 listed)
- Mothers of infants who were admitted to the neonatal intensive care unit (NICU).
- Mothers who experienced any serious medical complications during birth.
- Mothers who do not expect to reside in Illinois for the duration of the study (approximately two months).
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 |
|---|---|---|
| TMW-Newborn Intervention videoThis is an educational video intervention developed by the Thirty Million Words® Initiative Lab. | Other | Treatment intervention |
| Safe Sleep for your Baby (SIDS) educational videoIt is an educational video developed by the National Institute of Child Health and Development (NICHD) promoting the prevention of Sudden Infant Death Syndrome. | Other | Control intervention |
Primary outcome
Change in TMW-NI knowledge survey
Time frame: About 24 hours post intervention
Scores on the TMW-NI knowledge will be compared to pre-intervention scores.
Change in TMW-NI knowledge survey
Time frame: About 4 weeks post intervention
Scores on the TMW-NI knowledge will be compared to pre-intervention scores.
1 secondary outcome
Loss to follow-up
Time frame: About 4 weeks post intervention
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 6 Dec 2017.
- Derived from this study: PubMed 34000494Sowa LE, Thomas JMN, Hundertmark AC, Baroody FM, Suskind DL. Leveraging the universal newborn hearing screen to impact parental knowledge of childhood speech development in low socioeconomic populations: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2021 Jul;146:110763. doi: 10.1016/j.ijporl.2021.110763. Epub 2021 May 11.
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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.
Dana Suskind, MD principal investigator
The University of Chicago Medicine
Kristin Leffel, AB study chair
The University of Chicago Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMW-Newborn Intervention video and Safe Sleep for your Baby (SIDS) educational video in people with Behavior and Communication, run by University of Chicago at 2 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 3 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Change in TMW-NI knowledge survey (time frame: About 24 hours post intervention). 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?
On the ClinicalTrials.gov record for NCT02267265, 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 6 Dec 2017.