Language Environments of Children of Low-socioeconomic StatusTMW HV RCTNCT02216032
Thirty Million Words Home Visiting
A study testing TMW Curriculum and Nutrition Curriculum in people with Language Environments of Children of Low-socioeconomic Status, run by University of Chicago at 1 site in United States.
Trial summary
The TMW intervention aims to foster parental behaviors that facilitate children's language emergence at a critical developmental stage, and thus will be implemented at 13-16 months of age. Read more about this study
- Who is it for?
- Ages 13 to 16 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Environments of Children of Low-socioeconomic Status
- What is being tested?
- TMW Curriculum and Nutrition Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 16 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- participants (i.e. parents and their children) who live at or below 250% of the federal poverty line
- paternal education at or below BA/BS
- parents with children between the ages of 13-16 months old
Who cannot join
- participants (i.e. parents and their children) who live over 200% of the federal poverty line
- parents under the age of 18
- children younger than 13 months old or older than 16 months old (at start of study)
- parents who do not have legal custody of their child
- parents whose child does not live with them
- parents who are not with their child at least two full days per week
Show all 11Show fewer
- parents who are unable to commit to the intervention requirements
- foster parents
- children with significant cognitive or physical impairments (specifically Autism Spectrum Disorder, Epilepsy, Cerebral Palsy, hearing impairment, Down Syndrome and blindness)
- parents who have earned or are currently working toward a graduate or professional degree (e.g. M.A., M.S., M.B.A)
- parents who speak less than 80% English to their children.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thirty Million Words® Initiative at the University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: Thirty Million Words Home Visiting: A Longitudinal RCT
The TMW intervention aims to foster parental behaviors that facilitate children's language emergence at a critical developmental stage, and thus will be implemented at 13-16 months of age. The investigators hypothesize that the primary effects of the TMW Intervention will significantly 1) improve low-SES parents' understanding of the importance of parent language in a child's development, 2) increase parents' linguistic interaction, responsiveness, and overall engagement with their children, and 3) increase children's language output, as measured through LENA (child vocalization count, conversational turn count), coded video interaction (number of types, tokens and utterances for both children and adults), audio recordings from The Three T's application during the video sessions, and a battery of assessments targeting linguistic and cognitive development. Furthermore, the investigators hypothesize that increased parental interaction will result in 4) an improvement in children's socioemotional development as assessed by the Social Emotional Ages and Stages Questionnaire (ASQ-SE). Finally, the investigators hypothesize that these socioemotional and linguistic gains through early development, along with sustained increased parental engagement, will be expressed in 5) increased child school readiness upon kindergarten entry as assessed by Woodcock-Johnson Psycho-Educational Battery (WJ).
Added 2023: an 8th child-assessment, parent/child interaction video session, and parent surveys have been added with the original sample to measure long-term outcomes of children whose parents participated in the home visiting intervention.
Read the detailed description
During the Recruitment Phase, a TMW research assistant (RA) will recruit participants for the study. If interested in joining the study, participants will complete the Preliminary Enrollment Consent. From this point forward, all study activities will take place in the participant's home. To follow the completion of the Preliminary Enrollment Consent, participants will be asked to complete a series of baseline measurements over a four-week time period. RAs will facilitate the collection of these measures. Following satisfactory completion of the baseline measures, participants will move on to the Enrollment Phase at which point they will complete the Enrollment Consent. At this point, participants will be randomized into either one of two conditions (The Treatment group received an educational curriculum on language development and the Control group receives an educational curriculum on the role of nutrition in development) as part of a matched pair. Pairs will be matched by 1) age of the child and 2) averaged conversational turn counts from the 3 baseline LENA recordings. Assignment to Control or Treatment of each member of a pair is decided through a coin flip. Additionally, participants will complete Video 1, administered by an RA. During this and all subsequent Videos, audio recordings will be taken using both the LENA and the Three T's App. Following the Enrollment Phase, participants will move on to the Intervention Phase. During the Intervention Phase, participants will first complete Assessment 1. A staff member of Thirty Million Words will conduct this and all subsequent assessments. Following Assessment 1, participants will receive 12 bi-weekly home visits over a six-month period from trained TMW Home Visitors. During the home visits, Home Visitors will deliver two different curricula to the respective groups. The Treatment group will receive the TMW Curriculum. The Control group will receive the alternative Nutrition Curriculum, which provides information about the importance of healthy nutrition for child development, strategies for healthy eating, and meal preparation. In addition to receiving the home visits, participants will also complete LENA recordings on a bi-weekly basis, alternating weeks with the home visiting schedule. Participants in both the Control and the Treatment condition will receive text messages to remind them to complete their LENA recording on the day that they had previously scheduled. For the Treatment group only, a text message reminder for a specific goal will be sent as well. This will help parents be mindful of their goals at the time that they plan to achieve them by reminding parents to engage linguistically with their children. This text reminder portion of the study will piggy-back on the goal setting portions in which the parent will set specific, personalized goals. Reminders of these goals will be sent to their phones at a day and time that parents choose. Both the Treatment and Control participants will be given the option to opt out of the text messaging if they do not wish to receive these messages. Following the Intervention Phase, participants will move on to the 42-month Follow-up Phase. Throughout this phase, participants will complete Videos 2-7 with an RA, Assessments 2-7 with a TMW assessor, LENA recordings 16-21, and four curricula supplementation 'Boosters,' delivered by an RA. This marks the final phase of involving participants. After study completion, Dr. Suskind or her research team will contact participants regarding theirs and their child's participation in further research studies. A separate IRB protocol will be submitted at that time.
Transcription Service Feasibility Pilot Study
The purpose of this pilot study is to assess the feasibility of using a transcription service to transcribe Video Session recordings compared to using University of Chicago research personnel. Up to 10 already enrolled participants will be asked to participate in a pilot study to assess the feasibility of using a transcription service to transcribe participant Video Session recordings. Each participant in the pilot study will receive an addendum to the study consent document and discuss the addendum with a member of the research team prior to their study video sessions being sent to third-party transcription services to conduct a feasibility study.
A Business Associate and Service Agreement is being processed between the University and the transcription service to ensure University approved security measures are in place to transcribe participant video sessions. No videos will be sent to the transcription service until the Business Associate and Service Agreement is approved.
Added 2023: when the children in the original sample turn 9-10 years old, parents are contacted with the opportunity to complete an additional study time point, to evaluate their child's outcomes as they've reached 3rd - 4th grade. Participants sign an addendum to the enrollment consent in order to participate. Trained assessors meet with the child to conduct measures of language, cognitive, and math skills ("Assessment 8"). Additionally, the assessor records a parent-child interaction completing an age-appropriate task ("Video Session 8"). Finally, the parent completes a series of surveys measuring knowledge about child development, parental inputs, and child behaviors
- Being tested
- TMW Curriculum, Nutrition Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMW CurriculumOther
Nutrition CurriculumOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | We will deliver the TMW Curriculum to 106 Treatment families. The TMW Curriculum is comprised of 1) 12 educational modules, 2) animations and videos of real parent-child interactions to teach parents about the science behind child brain development, and model strategies for improving parents' child-directed speech, 3) video modeling and collaborative goal setting, and 4) quantitative linguistic feedback from Language ENvironment Analysis (LENA) recordings. Receives: Other: TMW Curriculum |
| Control Group | Other | We will deliver a Nutrition Curriculum to 100 Control families. The Nutrition Curriculum provides information about the importance of healthy nutrition for child development, strategies for healthy eating, and meal preparation. Receives: Other: Nutrition Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preschool Language Scale IV (PLS)
The PLS is used as a measure of a child's receptive vocabulary, and is used in this study to evaluate a child's language development from baseline to Month 48. It is a direct to child assessment administered by a trained assessor. Raw score values range from 0 to 65, with a higher score indicating higher receptive vocabulary skills.
Measured: Baseline, month 6, month 12, month 18, month 24, month 36, month 48
Peabody Picture Vocabulary Test (PPVT)
The PPVT is a measure of a child's receptive vocabulary, and is used in this study to evaluate a child's language development from Month 24 to Month 48 and as a measure of school readiness upon kindergarten entry. It is additionally used to evaluate language development at Month 96. It is a direct to child assessment administered by a trained assessor. Raw score values range from 0 to 175, with a higher score indicating higher receptive vocabulary skills. It is a direct to child assessment administered by a trained assessor. This assessment is a primary outcome measure at Months 24, 36, and 48 and secondary at month 96.
Measured: Month 24, Month 36, Month 48, Month 96
Language ENvironment Analysis
LENA is a recording device that is worn by the child to provide metrics of conversational turn counts, adult word counts, and child vocalizations. LENA is used in this study as a quantitative measure of parent child interaction and to measure change from baseline in child oral language development and production to month 48.
Measured: Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12, Month 18, Month 24, Month 36, Month 48
Parent/Child video sessions
Observational coding is used to characterize quality of interactions between parent and child during recorded free-play and book sharing activities. This outcome is primary at months 0-48 and secondary at Month 96.
Measured: Month 0, Month 6, Month 12, Month 18, Month 24, Month 36, Month 48, Month 96.
Secondary outcomes (4)
Woodcock Johnson (WJ-IV).
The WJ-IV is a measure of a child's achievement and cognitive abilities. It is used in this study as a measure of school readiness at kindergarten entry and skills in mid-elementary school. It is a direct to child assessment administered by a trained assessor. A higher score on this assessment indicates greater skills.
Measured: Month 48, Month 96
NIH toolbox Cognition Battery
The NIH toolbox Cognition Battery assesses a child's executive function skills, including inhibitory control and working memory. It is a direct to child assessment completed by the child using an iPad. A higher score on this assessment indicates greater executive function skills relative to other children of the same age. This additional outcome measure was added in 2023 with the addition of an 8th study assessment.
Measured: Month 96
Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)
The ASQ:SE is a screening tool designed to capture concerns about a child's social-emotional development. It is a parent report measure used in this study as a measure of school readiness upon kindergarten entry. Score values range from 0 to 360, with a higher value indicating that a child's social-emotional development may not be at an age-appropriate level.
Measured: Month 6, Month 24, Month 36, Month 48
Give-a-number task (Give-N)
The Give-N task is a measure of a child's understanding of number words. It is a direct to child assessment, administered by a trained assessor used in this study as a measure of school readiness upon kindergarten entry. Scores range from 0-6, with a higher score indicated that a child has a greater comprehension of number words.
Measured: Month 36, Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startNov 2014
- Primary completion16 Jan 2022
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Language Environments of Children of Low-socioeconomic StatusStudies 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
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Suskind, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216032
- Sponsor's protocol ID
- 14-0895
- Acronym
- TMW HV RCT
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2014
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Suskind, D., Leffel, K. R., Hernandez, M. W., Sapolich, S. G., Suskind, E., Kirkham, E., & Meehan, P. (2013) An exploratory study of "Quantitative Linguistic Feedback": Effect of LENA Feedback on Adult Language Production. Communication Disorders Quarterly. 34(4) 199-209. Doi: 10.1177/1525740112473146
LoRe D, Leung CYY, Brenner L, Suskind DL. Parent-directed intervention in promoting knowledge of pediatric nutrition and healthy lifestyle among low-SES families with toddlers: A randomized controlled trial. Child Care Health Dev. 2019 Jul;45(4):518-522. doi: 10.1111/cch.12682. Epub 2019 May 27.
PubMed 31050026
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thirty Million Words Home Visiting: A Longitudinal RCT
- ClinicalTrials.gov ID
- NCT02216032
- Acronym / sponsor ID
- TMW HV RCT / 14-0895
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 16 Jan 2022 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Aug 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.
The TMW intervention aims to foster parental behaviors that facilitate children's language emergence at a critical developmental stage, and thus will be implemented at 13-16 months of age. The investigators hypothesize that the primary effects of the TMW Intervention will significantly 1) improve low-SES parents' understanding of the importance of parent language in a child's development, 2) increase parents' linguistic interaction, responsiveness, and overall engagement with their children, and 3) increase children's language output, as measured through LENA (child vocalization count, conversational turn count), coded video interaction (number of types, tokens and utterances for both children and adults), audio recordings from The Three T's application during the video sessions, and a battery of assessments targeting linguistic and cognitive development. Furthermore, the investigators hypothesize that increased parental interaction will result in 4) an improvement in children's socioemotional development as assessed by the Social Emotional Ages and Stages Questionnaire (ASQ-SE). Finally, the investigators hypothesize that these socioemotional and linguistic gains through early development, along with sustained increased parental engagement, will be expressed in 5) increased child school readiness upon kindergarten entry as assessed by Woodcock-Johnson Psycho-Educational Battery (WJ).
Added 2023: an 8th child-assessment, parent/child interaction video session, and parent surveys have been added with the original sample to measure long-term outcomes of children whose parents participated in the home visiting intervention.
Detailed description
During the Recruitment Phase, a TMW research assistant (RA) will recruit participants for the study. If interested in joining the study, participants will complete the Preliminary Enrollment Consent. From this point forward, all study activities will take place in the participant's home. To follow the completion of the Preliminary Enrollment Consent, participants will be asked to complete a series of baseline measurements over a four-week time period. RAs will facilitate the collection of these measures. Following satisfactory completion of the baseline measures, participants will move on to the Enrollment Phase at which point they will complete the Enrollment Consent. At this point, participants will be randomized into either one of two conditions (The Treatment group received an educational curriculum on language development and the Control group receives an educational curriculum on the role of nutrition in development) as part of a matched pair. Pairs will be matched by 1) age of the child and 2) averaged conversational turn counts from the 3 baseline LENA recordings. Assignment to Control or Treatment of each member of a pair is decided through a coin flip. Additionally, participants will complete Video 1, administered by an RA. During this and all subsequent Videos, audio recordings will be taken using both the LENA and the Three T's App. Following the Enrollment Phase, participants will move on to the Intervention Phase. During the Intervention Phase, participants will first complete Assessment 1. A staff member of Thirty Million Words will conduct this and all subsequent assessments. Following Assessment 1, participants will receive 12 bi-weekly home visits over a six-month period from trained TMW Home Visitors. During the home visits, Home Visitors will deliver two different curricula to the respective groups. The Treatment group will receive the TMW Curriculum. The Control group will receive the alternative Nutrition Curriculum, which provides information about the importance of healthy nutrition for child development, strategies for healthy eating, and meal preparation. In addition to receiving the home visits, participants will also complete LENA recordings on a bi-weekly basis, alternating weeks with the home visiting schedule. Participants in both the Control and the Treatment condition will receive text messages to remind them to complete their LENA recording on the day that they had previously scheduled. For the Treatment group only, a text message reminder for a specific goal will be sent as well. This will help parents be mindful of their goals at the time that they plan to achieve them by reminding parents to engage linguistically with their children. This text reminder portion of the study will piggy-back on the goal setting portions in which the parent will set specific, personalized goals. Reminders of these goals will be sent to their phones at a day and time that parents choose. Both the Treatment and Control participants will be given the option to opt out of the text messaging if they do not wish to receive these messages. Following the Intervention Phase, participants will move on to the 42-month Follow-up Phase. Throughout this phase, participants will complete Videos 2-7 with an RA, Assessments 2-7 with a TMW assessor, LENA recordings 16-21, and four curricula supplementation 'Boosters,' delivered by an RA. This marks the final phase of involving participants. After study completion, Dr. Suskind or her research team will contact participants regarding theirs and their child's participation in further research studies. A separate IRB protocol will be submitted at that time.
Transcription Service Feasibility Pilot Study
The purpose of this pilot study is to assess the feasibility of using a transcription service to transcribe Video Session recordings compared to using University of Chicago research personnel. Up to 10 already enrolled participants will be asked to participate in a pilot study to assess the feasibility of using a transcription service to transcribe participant Video Session recordings. Each participant in the pilot study will receive an addendum to the study consent document and discuss the addendum with a member of the research team prior to their study video sessions being sent to third-party transcription services to conduct a feasibility study.
A Business Associate and Service Agreement is being processed between the University and the transcription service to ensure University approved security measures are in place to transcribe participant video sessions. No videos will be sent to the transcription service until the Business Associate and Service Agreement is approved.
Added 2023: when the children in the original sample turn 9-10 years old, parents are contacted with the opportunity to complete an additional study time point, to evaluate their child's outcomes as they've reached 3rd - 4th grade. Participants sign an addendum to the enrollment consent in order to participate. Trained assessors meet with the child to conduct measures of language, cognitive, and math skills ("Assessment 8"). Additionally, the assessor records a parent-child interaction completing an age-appropriate task ("Video Session 8"). Finally, the parent completes a series of surveys measuring knowledge about child development, parental inputs, and child behaviors
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: TMW CurriculumWe will deliver the TMW Curriculum to 106 Treatment families. The TMW Curriculum is comprised of 1) 12 educational modules, 2) animations and videos of real parent-child interactions to teach parents about the science behind child brain development, and model strategies for improving parents' child-directed speech, 3) video modeling and collaborative goal setting, and 4) quantitative linguistic feedback from Language ENvironment Analysis (LENA) recordings. |
| Control Group | Other | Other: Nutrition CurriculumWe will deliver a Nutrition Curriculum to 100 Control families. The Nutrition Curriculum provides information about the importance of healthy nutrition for child development, strategies for healthy eating, and meal preparation. |
Who may qualify
- Ages
- 13 to 16 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- participants (i.e. parents and their children) who live at or below 250% of the federal poverty line
- paternal education at or below BA/BS
- parents with children between the ages of 13-16 months old
Key exclusion criteria (11 listed)
- participants (i.e. parents and their children) who live over 200% of the federal poverty line
- parents under the age of 18
- children younger than 13 months old or older than 16 months old (at start of study)
- parents who do not have legal custody of their child
- parents whose child does not live with them
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 Curriculum | Other | Treatment Group |
| Nutrition Curriculum | Other | Control Group |
Primary outcome
Preschool Language Scale IV (PLS)
Time frame: Baseline, month 6, month 12, month 18, month 24, month 36, month 48
The PLS is used as a measure of a child's receptive vocabulary, and is used in this study to evaluate a child's language development from baseline to Month 48. It is a direct to child assessment administered by a trained assessor. Raw score values range from 0 to 65, with a higher score indicating higher receptive vocabulary skills.
Peabody Picture Vocabulary Test (PPVT)
Time frame: Month 24, Month 36, Month 48, Month 96
The PPVT is a measure of a child's receptive vocabulary, and is used in this study to evaluate a child's language development from Month 24 to Month 48 and as a measure of school readiness upon kindergarten entry. It is additionally used to evaluate language development at Month 96. It is a direct to child assessment administered by a trained assessor. Raw score values range from 0 to 175, with a higher score indicating higher receptive vocabulary skills. It is a direct to child assessment administered by a trained assessor. This assessment is a primary outcome measure at Months 24, 36, and 48 and secondary at month 96.
Language ENvironment Analysis
Time frame: Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12, Month 18, Month 24, Month 36, Month 48
LENA is a recording device that is worn by the child to provide metrics of conversational turn counts, adult word counts, and child vocalizations. LENA is used in this study as a quantitative measure of parent child interaction and to measure change from baseline in child oral language development and production to month 48.
Parent/Child video sessions
Time frame: Month 0, Month 6, Month 12, Month 18, Month 24, Month 36, Month 48, Month 96.
Observational coding is used to characterize quality of interactions between parent and child during recorded free-play and book sharing activities. This outcome is primary at months 0-48 and secondary at Month 96.
4 secondary outcomes
Woodcock Johnson (WJ-IV).
Time frame: Month 48, Month 96
NIH toolbox Cognition Battery
Time frame: Month 96
Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)
Time frame: Month 6, Month 24, Month 36, Month 48
Give-a-number task (Give-N)
Time frame: Month 36, Month 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- BackgroundSuskind, D., Leffel, K. R., Hernandez, M. W., Sapolich, S. G., Suskind, E., Kirkham, E., & Meehan, P. (2013) An exploratory study of "Quantitative Linguistic Feedback": Effect of LENA Feedback on Adult Language Production. Communication Disorders Quarterly. 34(4) 199-209. Doi: 10.1177/1525740112473146
- Derived from this study: PubMed 31050026LoRe D, Leung CYY, Brenner L, Suskind DL. Parent-directed intervention in promoting knowledge of pediatric nutrition and healthy lifestyle among low-SES families with toddlers: A randomized controlled trial. Child Care Health Dev. 2019 Jul;45(4):518-522. doi: 10.1111/cch.12682. Epub 2019 May 27.
- Click here for more information about the Thirty Million WordsLink provided by the sponsor.
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
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 TMW Curriculum and Nutrition Curriculum in people with Language Environments of Children of Low-socioeconomic Status, 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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Preschool Language Scale IV (PLS) (time frame: Baseline, month 6, month 12, month 18, month 24, month 36, month 48). The study lists 4 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 NCT02216032, which also lists 2 linked publications.
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 8 Apr 2026.