BehaviorTMW-WBNCT02812017
Thirty Million Words- Well Baby Initiative
A study testing Thirty Million Words- Well Baby and Safety Starts at Home in people with Behavior and Communication, run by University of Chicago at 10 sites in United States.
Trial summary
The purpose of the proposed study is to determine the efficacy of a multi-media educational curriculum in strengthening the early learning environments of vulnerable children, and positively impacting their language and cognitive development. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Communication, Language
- What is being tested?
- Thirty Million Words- Well Baby and Safety Starts at Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 952 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2016to 31 Dec 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria is as follows: 1) participants (i.e. parents and their children) who live at or below 200% of the federal poverty line, 2) parents at least the age of 18, 3) children younger than 1 month old (at start of study), 4) parents who have legal custody of their child, 5) parents whose child lives with them, 6) parents who are able to commit to the intervention requirements, 7) children who have not experienced any of the following conditions: premature birth (36 weeks or less), cleft lip or cleft palate (and syndromes associated with clefts), Neurocutaneous syndromes (nf1 and 2, tuberous sclerosis, etc), Trisomy, cerebral palsy, history of failing a hearing test, syndromes associated with sensorineural hearing loss (alport, jervell-lange-nielsen, waardenburg, treacher-collins, etc), TORCH infection, Head bleeds or history of intraventricular hemorrhage (IVH), or has had a tracheal intubation, 8) parents who have not earned or are not currently working toward a graduate or professional degree (e.g. M.A., M.S., M.B.A).
Who cannot join
- 1) participants (i.e. parents and their children) who live over 200% of the federal poverty line, 2) parents under the age of 18, 3) children older than 1 month old (at start of study), 4) parents who do not have legal custody of their child, 5) parents whose child does not live with them, 6) parents who are unable to commit to the intervention requirements, 7) foster parents, 8) children who have experienced any of the following conditions: premature birth (36 weeks or less), cleft lip or cleft palate (and syndromes associated with clefts), Neurocutaneous syndromes (nf1 and 2, tuberous sclerosis, etc), Trisomy, cerebral palsy, history of failing a hearing test, syndromes associated with sensorineural hearing loss (alport, jervell-lange-nielsen, waardenburg, treacher-collins, etc), TORCH infection, Head bleeds or history of intraventricular hemorrhage (IVH), or has had a tracheal intubation, 9) parents who have earned or are currently working toward a graduate or professional degree (e.g. M.A., M.S., M.B.A).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
PCC South Family Health Center
Berwyn, Illinois, 60402
Advocate Medical Group
Chicago, Illinois, 60618
Lawndale Christian Health Center
Chicago, Illinois, 60623
University of Chicago Medical Center - Friend Family Health Center
Chicago, Illinois, 60629
Lawndale Christian Health Center - Archer Avenue
Chicago, Illinois, 60632
PCC Salud Family Health Center
Chicago, Illinois, 60639
Advocate Medical Group
Chicago, Illinois, 60640
University of Chicago Medical Center - Friend Family Health Center
Chicago, Illinois, 60640
PCC Austin Family Health Center
Chicago, Illinois, 60644
PCC Lake Street Family Health Center
Oak Park, Illinois, 60302
About this study
Official title: Thirty Million Words: Well Baby Initiative
The purpose of the proposed study is to determine the efficacy of a multi-media educational curriculum in strengthening the early learning environments of vulnerable children, and positively impacting their language and cognitive development. Through evidence-based strategies, the TMW-WB curriculum teaches parents how to harness the power of their words to build their child's brain and impact their child's learning trajectory.
Read the detailed description
Participants will be recruited at Lawndale Christian Health Clinic (LCHC), Advocate Medical Group (AMG), or PCC Community Wellness Centers (PCC) at their first well-baby visit. If the parent and child are eligible for the study, the parents will be asked to give informed consent for the study.
Before the one-month visit, participants will be randomized into the three experiential groups. We will use the website Research Randomizer to generate a randomization table. We will use the service to generate a dummy set of 500 unique unsorted numbers where each unique number is paired with a participant number (1-250, sorted). In an Excel spreadsheet, the first half of the dummy number set) will be assigned evenly to the Treatment condition (arm 1) and the other half will be assigned evenly to the Control conditions (arms 2 or 3). Then, the data in the columns "participant", "condition" and "dummy" will be sorted using the Excel "Sort by" function on the column "dummy". The participant numbers are now unsorted and randomly assigned to either one of the two experimental conditions: Treatment or Control. The treatment group will be randomized again in the same way as explained above to either TMW-Well Baby arm, orthe two control groups Usual Care arm Neutral Video arm. This will allow us to ensure equal sample sizes for all treatment and control conditions. A separate randomization table will be crated in the same way for the Spanish-speaking group.
At the one-month Well Baby visit, participants in the Usual Care arm of the study will receive care as usual. Participants in the Neutral Video arm will watch the first of four short videos (approximately 5-10 minutes) about infant safety. Patients in the TMW-Well Baby arm will watch the Module 1 video intervention. This module present information on child language and cognitive development. Videos will be shown in the waiting room, or during the period after the nurse completes the child's vitals and before the pediatrician sees the patient. Should a video still be running when the pediatrician enters the room, it will be stopped and completed after the pediatrician has left. After the visit, patients in all arms will be asked to complete the Post-Visit survey about their visit, indicating the areas and level of anticipatory guidance they received during their visit, their overall satisfaction levels, and their unmet needs for guidance and requests for more information. At this visit, the health clinic may collect information using a standardized depression scale. This provides information on the covariates parental language ability and depression level. Results from the depression scale will be shared by the patient's pediatrician, both because pediatricians need to administer a depression scale anyway and in an effort to reduce burdens associated with housing the study in the clinic. If the clinic does not administer a depression scale, the Edinburgh Postnatal Depression Scale (EPDS)will be administered by the research staff.
At their two-month Well Baby visit, patients in the TMW-Well Baby arms will watch the Module 2 video intervention , while patients in the Usual Care arm will receive care as usual, and patients in the Neutral Video arm will watch an infant safety video. All measures will be taken in the same way as at the one-month Well Baby visit.
At their four-month Well Baby visit, patients in the TMW-Well Baby arm will watch the Module 3 video intervention , while patients in the Usual Care arm will receive care as usual, and patients in the Neutral Video arm will watch an infant safety video. All measures will be taken in exactly the same way as at the one-month Well Baby visit.
At their six-month Well Baby visit, patients in the TMW-Well Baby arms will watch the Module 4 video intervention, while patients in the Usual Care arm will receive care as usual, and patients in the Neutral Video arm will watch an infant safety video. After the visit, patients in each group will be asked to complete the Post-Visit survey about their appointment. Additional measures will be taken at this visit. The SPEAK will be administered for a second time, the Verbal Comprehension section of the Woodcock-Johnson Test of Cognitive Abilities assessment will be completed, and the participants will be asked to carry out an NCAST PCI teaching task, which is a measure for assessing parent-child interaction via scalable teaching tasks that parents teach their children. Finally, the depression scale results will be shared by the patient's pediatrician, as well as the Ages and Stages Questionnaire (ASQ), if applicable. The Ages and Stages Questionnaire is a screening questionnaire that pinpoints developmental progress in children between the ages of one month to 5 years.
At age seven-months, or about one month after their six-month Well Baby visit, participants will be emailed two follow-up surveys (i.e. the SPEAK and TOPSE surveys). If they complete these surveys within four weeks of receipt, they are eligible for a $10 gift card to be emailed. If the surveys are not completed, participants will not receive the gift-card and will complete these surveys at their next Well-Baby visit.
At their nine-month Well Baby visit, all patients will participate in a second NCAST PCI teaching scale task with their child. At this visit, the MacArthur-Bates Communicative Development Inventories: Words and Gestures Infant form for 8- to 18- month olds (MacArthur-CDI) will be administered. Finally, the depression scale and ASQ results will be shared by the patient's pediatrician, if applicable.
At their twelve-month Well Baby visit, all patients complete the Family Life Events, SPEAK and TOPSE surveys again. Participants will also participate in a third NCAST PCI teaching scale task with their child. The MacArthur-Bates Communicative Development Inventories: Words and Gestures Infant form for 8- to 18- month olds (MacArthur-CDI) will be administered. Finally, any depression scale and ASQ results will be shared by the patient's pediatrician, if applicable.
For participants enrolled on or before 7/31/2016:
At their 18-month Well Baby visit, participants enrolled on or before 7/31/2016 will complete the MacArthur-Bates Communicative Development Inventories Short Form Vocabulary Checklist: Level 1 (MacArthur-CDI) and the SPEAK-R. Finally, any depression scale and ASQ results will be shared by the patient's pediatrician, if applicable.
At their 24-month Well Baby visit, participants enrolled on or before 7/31/2016 will complete the MacArthur-Bates Communicative Development Inventories Short Form Vocabulary Checklist: Level 1 (MacArthur-CDI) and the SPEAK-R. Finally, any depression scale and ASQ results will be shared by the patient's pediatrician, if applicable.
Around age 30-months, participants enrolled on or before 7/31/2016 will be asked to extend their participation in the study to a 30-month home visit and complete the Receptive One-word Picture Vocabulary Test (ROWPVT), Child Behavior Checklist (CBCL), and the Pearlin Mastery Scale.
For participants enrolled between 8/1/2016-1/31/2017:
At their 18-month Well Baby visit, participants enrolled on or before 7/31/2016 will complete the MacArthur-Bates Communicative Development Inventories Short Form Vocabulary Checklist: Level 1 (MacArthur-CDI) and the SPEAK-R. Finally, any depression scale and ASQ results will be shared by the patient's pediatrician, if applicable.
Around age 30-months, participants enrolled between 8/1/2016-1/31/2017, will be asked to extend their participation in the study to a 30-month home visit and participants will complete the Receptive One-word Picture Vocabulary Test (ROWPVT), Child Behavior Checklist (CBCL) , the TOPSE, a survey about seeking advice about child development, and the Pearlin Mastery Scale.
- Conditions
- Behavior, Communication, Language
- Being tested
- Thirty Million Words- Well Baby, Safety Starts at Home
- Keywords
- educational intervention, language development, postpartum, parental attachment, achievement gap, language gap, school readiness
- Medical subject headings
- Behavior, Communication, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thirty Million Words- Well BabyBehavioural
Through evidence-based strategies, the TMW-WB curriculum teaches parents how to harness the power of their words to build their child's brain and impact their child's learning trajectory.
Safety Starts at HomeOther
A portion of the Safety Stars at Home set is shown. Demonstrating proven childproofing techniques and accident-prevention strategies, which unifies safety guidelines and shows caregivers how to take proactive measures at home. Many no- or low-cost safety alternatives are offered.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Intervention | Experimental | The treatment group will complete a demographics questionnaire and the baseline measures before the intervention. Participants will then view the Thirty Million Words-Well Baby intervention, which consists of educational, multimedia modules at the one-, two-, four-, and six-month well baby pediatric visits. The participant will complete survey measures after the one-, two-, four- and six-month visits, as well as over email at seven-months old and in clinic again at the nine-, twelve-, eighteen-, and twenty-four month visits. Receives: Behavioral: Thirty Million Words- Well Baby |
| 2 - Neutral | Placebo comparator | The Neutral Video group will complete a demographics questionnaire and the baseline measures before the intervention. Participants will then view the neutral videos about car safety at the one-, two-, four-, and six-month well baby pediatric visits. The participant will complete survey measures after the one-, two-, four- and six-month visits, as well as over email at seven-months old and in clinic again at the nine-, twelve-, eighteen-, and twenty-four month visits. Receives: Other: Safety Starts at Home |
| 3 - Usual care | No intervention | The treatment group will complete a demographics questionnaire and the baseline measures before the intervention. Participants will receive care as usual at the one-, two-, four-, and six-month well baby pediatric visits. The participant will complete survey measures after the one-, two-, four- and six-month visits, as well as over email at seven-months old and in clinic again at the nine-, twelve-, eighteen-, and twenty-four month visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPEAK
The Survey of Parental Expectations And Knowledge About Language Learning (SPEAK) measures parental knowledge and expectations of how their children learn language at different ages. Some items about beliefs of appropriate age of exposure are rated on a 6-point scale ranging from: 1 "As an infant (0 to 6 moths)" to 6 "In elementary school (6 years and up)" Other items are rated on a 4-point Likert scale ranging from 1 (definitely true), 2 (probably true), 3 (probably not true) to 4 (definitely not true). Scores range from 0 to 71, and scoring of each item is based a criterion scale, with 0 points given to the most incorrect response and 1 additional point given to each progressively more correct response. A higher score correlates to a better outcome and indicates a higher parental knowledge.
Measured: 24 months
Receptive vocabulary score
score of Receptive vocabulary
Measured: 30 months
NCSAT Teaching Scale
Observational data on parent-child interaction. The NCAST Teaching Scale is an assessment for measuring parent-child interaction, and it has 73 variables, which are used to rate caregiver and infant behavior from birth to 36 months. The teaching scale is constructed of 73 item subskills for interaction and marked either yes (1) or no (0) as observed by the clinician during the interaction. The subskills are divided into four subscales for the parent- Sensitivity to Cues, Response to Distress, Social Emotional Growth Fostering, and Cognitive Growth Fostering, and two subscales for the infant-Clarity of Cues and Responsiveness to Caregiver. Summary scores include the total scores for each subscale, the Parent Total Score, Child Total Score, and Parent/Child Total Teaching Score.
Measured: 24 months
Patient report
consistent anticipatory guidance
Measured: 24 months
Stakeholder report
daily anticipatory guidance
Measured: 24 months
TOPSE
Parental self-efficacy measure. The Tool to measure Parenting Self-Efficacy (0-6 months) and can be used to evaluate the effectiveness of parenting programs and identify areas that individual parents may be struggling with. Each statement is scored from 0-10, where 0 equates with "completely disagree," 5 equates with "moderately agree," and 10 equates with "completely agree." Each statement is scored from 0-10 and the total score for each section is a sum of scores. There are 6 sections with 6 questions, including emotion and affection, play and enjoyment, empathy and understanding, pressures, self-acceptance, and learning and knowledge. The booklet comprises of 36 statements in total. The maximum score for each area is 60 and the maximum total score is 360. Higher scores represent a better score.
Measured: 24 months
MacArthur-Bates Communicative Development Inventory (CDI) Vocabulary Checklist: Level 1
parent report of child's developing abilities in early language
Measured: 24 months
StimQ Cognitive Home Environment
A standardized, interview-based instrument to measure a family's cognitive home environment.
Measured: 24 months
TOI: Survey of Theories of Intelligence
Theories of Intelligence (TOI), which assesses parents' theories about children's intelligence. This 8-item questionnaire measures parents beliefs about the malleability of their child's intelligence. Each question is scored on a likert scale of Strongly Disagree (5) to Strongly Agree (0), with a maximum score of 40. A higher score indicates a better outcome, as it indicates that parents believe that their child's intelligence is malleable.
Measured: 18 months
WJ-IV: Woodcock-Johnson IV Test of Cognitive Abilities: Verbal Reasoning Assessment
The Woodcock Johnson (WJ) assesses a child's school readiness. It measures cognitive abilities, scholastic aptitude, and performance in the areas of reading, mathematics, and written language
Measured: 6 months
CBCL: Child Behavior Checklist
A parent-report questionnaire on which the child was rated on various behavioral and emotional problems. The Child Behavioral Checklist is a checklist assessing concerning and/or troublesome behaviors of children. The CBCL contains 100 items and 3 additional lines of optional items scored from 0-2, with 0 meaning "Not True," 1 meaning "Somewhat or Sometimes True," and 2 meaning "Very true or Often True." The maximum score is 306 (range from 0-306), and higher scores correspond to worse behavior or worse outcomes.
Measured: 30 months
Secondary outcomes (6)
FLE: Family Life Events Survey of family structure, the household, and the child's caretaker(s)
Questionnaire detailing the family structure of the household and the child's caregivers. The Family Life Events Survey (FLE) is a 22-item questionnaire asking about time intensive/potentially stressful family related events in a participants life. Each questions is followed by the answer choices yes (1) or no (0). The maximum score on the survey is 22, and higher scores correspond with more stressful, worse outcomes in terms of stress and family life events.
Measured: 18 months
SDoH: Social Determinants of Health survey
A survey about social determinants of health. The Social Determinants of Health Survey (SDoH) asks questions to help assessor better understand social circumstances that may cause hardship and impact health. There are a total of 14 questions answered with a yes (1) or no (0) in 2 parts. Part 1 contains questions 1-8 and has a maximum score of 8 while Part 2 contains questions 9-14 and has a maximum score of 6. The sum, or total score of the two sections has a maximum score of 14, and higher scores compare to worse outcomes.
Measured: 24 months
ACE: Adverse Childhood Experiences survey
A survey about Adverse Childhood Experiences (ACEs), The Adverse Childhood Experiences (ACE) Survey asks about events occurring during a participant's childhood and tests for the degree of adversity during childhood. There are 17 questions, each with answer choices yes (1) or no (0). There are 2 larger subsections, including household dysfunction and abuse. There are 9 questions involving household dysfunction and 8 involving abuse, and the maximum score is 17. A higher score indicates worse outcome.
Measured: 24 months
EPDS: Edinburgh Postnatal Depression Scale (or other standardized depression scale)
standardized depression scale. The Edinburgh Postnatal Depression Scale measures signs and degree of postnatal depression in mothers. There are a total of 10 questions, scored with varying answers from 0-3. There is a maximum score of 30, which corresponds to higher levels of postnatal depressions and worse outcomes.
Measured: 1 month
ASQ: Ages and Stages Questionnaire
The Ages \& Stages Questionnaire: Social-Emotional is a series of questions that aims to identify any social or emotional problems in a developing child.
Measured: 24 months
Pearlin Mastery Scale
The Pearlin Mastery (PM) scale measures the extent to which an individual regards their life chances as being under their personal control rather than fatalistically ruled. The Pearlin Mastery Scale gages how strongly a participant feels that they are able to master and control their lives. There are a total of 7 statements that participants can rate from 1-4 in terms of agreement, where 1 is "Strongly Disagree," 2 is "Disagree," 3 is "Agree," and 4 is "Strongly Agree." The maximum score is 28, and the minimum is 7. A higher score corresponds to higher levels of mastery, or better outcome.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 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
- 952 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 ChicagoKristin Leffel, AB, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812017
- Sponsor's protocol ID
- 15-0914
- Acronym
- TMW-WB
- Status last verified
- Mar 2020
- First submitted
- 22 Jun 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Leung CYY, Trinidad JE, Suskind DL. Video-Based Anticipatory Guidance on Early Cognitive and Language Development in the First 6 Months: A Randomized Controlled Trial. J Pediatr. 2022 Jun;245:227-229.e1. doi: 10.1016/j.jpeds.2022.03.008. Epub 2022 Mar 14.
PubMed 35301018List JA, Pernaudet J, Suskind DL. Shifting parental beliefs about child development to foster parental investments and improve school readiness outcomes. Nat Commun. 2021 Oct 1;12(1):5765. doi: 10.1038/s41467-021-25964-y.
PubMed 34599167
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thirty Million Words: Well Baby Initiative
- ClinicalTrials.gov ID
- NCT02812017
- Acronym / sponsor ID
- TMW-WB / 15-0914
- Conditions
- Behavior, Communication, Language
- Keywords
- educational intervention, language development, postpartum, parental attachment, achievement gap, language gap, school readiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 952 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 23 Jun 2016 (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 study is to determine the efficacy of a multi-media educational curriculum in strengthening the early learning environments of vulnerable children, and positively impacting their language and cognitive development. Through evidence-based strategies, the TMW-WB curriculum teaches parents how to harness the power of their words to build their child's brain and impact their child's learning trajectory.
Detailed description
Participants will be recruited at Lawndale Christian Health Clinic (LCHC), Advocate Medical Group (AMG), or PCC Community Wellness Centers (PCC) at their first well-baby visit. If the parent and child are eligible for the study, the parents will be asked to give informed consent for the study.
Before the one-month visit, participants will be randomized into the three experiential groups. We will use the website Research Randomizer to generate a randomization table. We will use the service to generate a dummy set of 500 unique unsorted numbers where each unique number is paired with a participant number (1-250, sorted). In an Excel spreadsheet, the first half of the dummy number set) will be assigned evenly to the Treatment condition (arm 1) and the other half will be assigned evenly to the Control conditions (arms 2 or 3). Then, the data in the columns "participant", "condition" and "dummy" will be sorted using the Excel "Sort by" function on the column "dummy". The participant numbers are now unsorted and randomly assigned to either one of the two experimental conditions: Treatment or Control. The treatment group will be randomized again in the same way as explained above to either TMW-Well Baby arm, orthe two control groups Usual Care arm Neutral Video arm. This will allow us to ensure equal sample sizes for all treatment and control conditions. A separate randomization table will be crated in the same way for the Spanish-speaking group.
At the one-month Well Baby visit, participants in the Usual Care arm of the study will receive care as usual. Participants in the Neutral Video arm will watch the first of four short videos (approximately 5-10 minutes) about infant safety. Patients in the TMW-Well Baby arm will watch the Module 1 video intervention. This module present information on child language and cognitive development. Videos will be shown in the waiting room, or during the period after the nurse completes the child's vitals and before the pediatrician sees the patient. Should a video still be running when the pediatrician enters the room, it will be stopped and completed after the pediatrician has left. After the visit, patients in all arms will be asked to complete the Post-Visit survey about their visit, indicating the areas and level of anticipatory guidance they received during their visit, their overall satisfaction levels, and their unmet needs for guidance and requests for more information. At this visit, the health clinic may collect information using a standardized depression scale. This provides information on the covariates parental language ability and depression level. Results from the depression scale will be shared by the patient's pediatrician, both because pediatricians need to administer a depression scale anyway and in an effort to reduce burdens associated with housing the study in the clinic. If the clinic does not administer a depression scale, the Edinburgh Postnatal Depression Scale (EPDS)will be administered by the research staff.
At their two-month Well Baby visit, patients in the TMW-Well Baby arms will watch the Module 2 video intervention , while patients in the Usual Care arm will receive care as usual, and patients in the Neutral Video arm will watch an infant safety video. All measures will be taken in the same way as at the one-month Well Baby visit.
At their four-month Well Baby visit, patients in the TMW-Well Baby arm will watch the Module 3 video intervention , while patients in the Usual Care arm will receive care as usual, and patients in the Neutral Video arm will watch an infant safety video. All measures will be taken in exactly the same way as at the one-month Well Baby visit.
At their six-month Well Baby visit, patients in the TMW-Well Baby arms will watch the Module 4 video intervention, while patients in the Usual Care arm will receive care as usual, and patients in the Neutral Video arm will watch an infant safety video. After the visit, patients in each group will be asked to complete the Post-Visit survey about their appointment. Additional measures will be taken at this visit. The SPEAK will be administered for a second time, the Verbal Comprehension section of the Woodcock-Johnson Test of Cognitive Abilities assessment will be completed, and the participants will be asked to carry out an NCAST PCI teaching task, which is a measure for assessing parent-child interaction via scalable teaching tasks that parents teach their children. Finally, the depression scale results will be shared by the patient's pediatrician, as well as the Ages and Stages Questionnaire (ASQ), if applicable. The Ages and Stages Questionnaire is a screening questionnaire that pinpoints developmental progress in children between the ages of one month to 5 years.
At age seven-months, or about one month after their six-month Well Baby visit, participants will be emailed two follow-up surveys (i.e. the SPEAK and TOPSE surveys). If they complete these surveys within four weeks of receipt, they are eligible for a $10 gift card to be emailed. If the surveys are not completed, participants will not receive the gift-card and will complete these surveys at their next Well-Baby visit.
At their nine-month Well Baby visit, all patients will participate in a second NCAST PCI teaching scale task with their child. At this visit, the MacArthur-Bates Communicative Development Inventories: Words and Gestures Infant form for 8- to 18- month olds (MacArthur-CDI) will be administered. Finally, the depression scale and ASQ results will be shared by the patient's pediatrician, if applicable.
At their twelve-month Well Baby visit, all patients complete the Family Life Events, SPEAK and TOPSE surveys again. Participants will also participate in a third NCAST PCI teaching scale task with their child. The MacArthur-Bates Communicative Development Inventories: Words and Gestures Infant form for 8- to 18- month olds (MacArthur-CDI) will be administered. Finally, any depression scale and ASQ results will be shared by the patient's pediatrician, if applicable.
For participants enrolled on or before 7/31/2016:
At their 18-month Well Baby visit, participants enrolled on or before 7/31/2016 will complete the MacArthur-Bates Communicative Development Inventories Short Form Vocabulary Checklist: Level 1 (MacArthur-CDI) and the SPEAK-R. Finally, any depression scale and ASQ results will be shared by the patient's pediatrician, if applicable.
At their 24-month Well Baby visit, participants enrolled on or before 7/31/2016 will complete the MacArthur-Bates Communicative Development Inventories Short Form Vocabulary Checklist: Level 1 (MacArthur-CDI) and the SPEAK-R. Finally, any depression scale and ASQ results will be shared by the patient's pediatrician, if applicable.
Around age 30-months, participants enrolled on or before 7/31/2016 will be asked to extend their participation in the study to a 30-month home visit and complete the Receptive One-word Picture Vocabulary Test (ROWPVT), Child Behavior Checklist (CBCL), and the Pearlin Mastery Scale.
For participants enrolled between 8/1/2016-1/31/2017:
At their 18-month Well Baby visit, participants enrolled on or before 7/31/2016 will complete the MacArthur-Bates Communicative Development Inventories Short Form Vocabulary Checklist: Level 1 (MacArthur-CDI) and the SPEAK-R. Finally, any depression scale and ASQ results will be shared by the patient's pediatrician, if applicable.
Around age 30-months, participants enrolled between 8/1/2016-1/31/2017, will be asked to extend their participation in the study to a 30-month home visit and participants will complete the Receptive One-word Picture Vocabulary Test (ROWPVT), Child Behavior Checklist (CBCL) , the TOPSE, a survey about seeking advice about child development, and the Pearlin Mastery Scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 - Intervention | Experimental | Behavioral: Thirty Million Words- Well BabyThe treatment group will complete a demographics questionnaire and the baseline measures before the intervention. Participants will then view the Thirty Million Words-Well Baby intervention, which consists of educational, multimedia modules at the one-, two-, four-, and six-month well baby pediatric visits. The participant will complete survey measures after the one-, two-, four- and six-month visits, as well as over email at seven-months old and in clinic again at the nine-, twelve-, eighteen-, and twenty-four month visits. |
| 2 - Neutral | Placebo comparator | Other: Safety Starts at HomeThe Neutral Video group will complete a demographics questionnaire and the baseline measures before the intervention. Participants will then view the neutral videos about car safety at the one-, two-, four-, and six-month well baby pediatric visits. The participant will complete survey measures after the one-, two-, four- and six-month visits, as well as over email at seven-months old and in clinic again at the nine-, twelve-, eighteen-, and twenty-four month visits. |
| 3 - Usual care | No intervention | –The treatment group will complete a demographics questionnaire and the baseline measures before the intervention. Participants will receive care as usual at the one-, two-, four-, and six-month well baby pediatric visits. The participant will complete survey measures after the one-, two-, four- and six-month visits, as well as over email at seven-months old and in clinic again at the nine-, twelve-, eighteen-, and twenty-four month visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria is as follows: 1) participants (i.e. parents and their children) who live at or below 200% of the federal poverty line, 2) parents at least the age of 18, 3) children younger than 1 month old (at start of study), 4) parents who have legal custody of their child, 5) parents whose child lives with them, 6) parents who are able to commit to the intervention requirements, 7) children who have not experienced any of the following conditions: premature birth (36 weeks or less), cleft lip or cleft palate (and syndromes associated with clefts), Neurocutaneous syndromes (nf1 and 2, tuberous sclerosis, etc), Trisomy, cerebral palsy, history of failing a hearing test, syndromes associated with sensorineural hearing loss (alport, jervell-lange-nielsen, waardenburg, treacher-collins, etc), TORCH infection, Head bleeds or history of intraventricular hemorrhage (IVH), or has had a tracheal intubation, 8) parents who have not earned or are not currently working toward a graduate or professional degree (e.g. M.A., M.S., M.B.A).
Key exclusion criteria (1 listed)
- 1) participants (i.e. parents and their children) who live over 200% of the federal poverty line, 2) parents under the age of 18, 3) children older than 1 month old (at start of study), 4) parents who do not have legal custody of their child, 5) parents whose child does not live with them, 6) parents who are unable to commit to the intervention requirements, 7) foster parents, 8) children who have experienced any of the following conditions: premature birth (36 weeks or less), cleft lip or cleft palate (and syndromes associated with clefts), Neurocutaneous syndromes (nf1 and 2, tuberous sclerosis, etc), Trisomy, cerebral palsy, history of failing a hearing test, syndromes associated with sensorineural hearing loss (alport, jervell-lange-nielsen, waardenburg, treacher-collins, etc), TORCH infection, Head bleeds or history of intraventricular hemorrhage (IVH), or has had a tracheal intubation, 9) parents who have earned or are currently working toward a graduate or professional degree (e.g. M.A., M.S., M.B.A).
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- Well BabyThrough evidence-based strategies, the TMW-WB curriculum teaches parents how to harness the power of their words to build their child's brain and impact their child's learning trajectory. | Behavioural | 1 - Intervention |
| Safety Starts at HomeA portion of the Safety Stars at Home set is shown. Demonstrating proven childproofing techniques and accident-prevention strategies, which unifies safety guidelines and shows caregivers how to take proactive measures at home. Many no- or low-cost safety alternatives are offered. | Other | 2 - Neutral |
Primary outcome
SPEAK
Time frame: 24 months
The Survey of Parental Expectations And Knowledge About Language Learning (SPEAK) measures parental knowledge and expectations of how their children learn language at different ages. Some items about beliefs of appropriate age of exposure are rated on a 6-point scale ranging from: 1 "As an infant (0 to 6 moths)" to 6 "In elementary school (6 years and up)" Other items are rated on a 4-point Likert scale ranging from 1 (definitely true), 2 (probably true), 3 (probably not true) to 4 (definitely not true). Scores range from 0 to 71, and scoring of each item is based a criterion scale, with 0 points given to the most incorrect response and 1 additional point given to each progressively more correct response. A higher score correlates to a better outcome and indicates a higher parental knowledge.
Receptive vocabulary score
Time frame: 30 months
score of Receptive vocabulary
NCSAT Teaching Scale
Time frame: 24 months
Observational data on parent-child interaction. The NCAST Teaching Scale is an assessment for measuring parent-child interaction, and it has 73 variables, which are used to rate caregiver and infant behavior from birth to 36 months. The teaching scale is constructed of 73 item subskills for interaction and marked either yes (1) or no (0) as observed by the clinician during the interaction. The subskills are divided into four subscales for the parent- Sensitivity to Cues, Response to Distress, Social Emotional Growth Fostering, and Cognitive Growth Fostering, and two subscales for the infant-Clarity of Cues and Responsiveness to Caregiver. Summary scores include the total scores for each subscale, the Parent Total Score, Child Total Score, and Parent/Child Total Teaching Score.
Patient report
Time frame: 24 months
consistent anticipatory guidance
Stakeholder report
Time frame: 24 months
daily anticipatory guidance
TOPSE
Time frame: 24 months
Parental self-efficacy measure. The Tool to measure Parenting Self-Efficacy (0-6 months) and can be used to evaluate the effectiveness of parenting programs and identify areas that individual parents may be struggling with. Each statement is scored from 0-10, where 0 equates with "completely disagree," 5 equates with "moderately agree," and 10 equates with "completely agree." Each statement is scored from 0-10 and the total score for each section is a sum of scores. There are 6 sections with 6 questions, including emotion and affection, play and enjoyment, empathy and understanding, pressures, self-acceptance, and learning and knowledge. The booklet comprises of 36 statements in total. The maximum score for each area is 60 and the maximum total score is 360. Higher scores represent a better score.
MacArthur-Bates Communicative Development Inventory (CDI) Vocabulary Checklist: Level 1
Time frame: 24 months
parent report of child's developing abilities in early language
StimQ Cognitive Home Environment
Time frame: 24 months
A standardized, interview-based instrument to measure a family's cognitive home environment.
TOI: Survey of Theories of Intelligence
Time frame: 18 months
Theories of Intelligence (TOI), which assesses parents' theories about children's intelligence. This 8-item questionnaire measures parents beliefs about the malleability of their child's intelligence. Each question is scored on a likert scale of Strongly Disagree (5) to Strongly Agree (0), with a maximum score of 40. A higher score indicates a better outcome, as it indicates that parents believe that their child's intelligence is malleable.
WJ-IV: Woodcock-Johnson IV Test of Cognitive Abilities: Verbal Reasoning Assessment
Time frame: 6 months
The Woodcock Johnson (WJ) assesses a child's school readiness. It measures cognitive abilities, scholastic aptitude, and performance in the areas of reading, mathematics, and written language
CBCL: Child Behavior Checklist
Time frame: 30 months
A parent-report questionnaire on which the child was rated on various behavioral and emotional problems. The Child Behavioral Checklist is a checklist assessing concerning and/or troublesome behaviors of children. The CBCL contains 100 items and 3 additional lines of optional items scored from 0-2, with 0 meaning "Not True," 1 meaning "Somewhat or Sometimes True," and 2 meaning "Very true or Often True." The maximum score is 306 (range from 0-306), and higher scores correspond to worse behavior or worse outcomes.
6 secondary outcomes
FLE: Family Life Events Survey of family structure, the household, and the child's caretaker(s)
Time frame: 18 months
SDoH: Social Determinants of Health survey
Time frame: 24 months
ACE: Adverse Childhood Experiences survey
Time frame: 24 months
EPDS: Edinburgh Postnatal Depression Scale (or other standardized depression scale)
Time frame: 1 month
ASQ: Ages and Stages Questionnaire
Time frame: 24 months
Pearlin Mastery Scale
Time frame: 30 months
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 24 Mar 2020.
- Derived from this study: PubMed 35301018Leung CYY, Trinidad JE, Suskind DL. Video-Based Anticipatory Guidance on Early Cognitive and Language Development in the First 6 Months: A Randomized Controlled Trial. J Pediatr. 2022 Jun;245:227-229.e1. doi: 10.1016/j.jpeds.2022.03.008. Epub 2022 Mar 14.
- Derived from this study: PubMed 34599167List JA, Pernaudet J, Suskind DL. Shifting parental beliefs about child development to foster parental investments and improve school readiness outcomes. Nat Commun. 2021 Oct 1;12(1):5765. doi: 10.1038/s41467-021-25964-y.
- Click here for more information about the Thirty Million WordsLink provided by the sponsor.
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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
University of Chicago
Kristin Leffel, AB study chair
University of Chicago
10 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- Well Baby and Safety Starts at Home in people with Behavior and Communication, run by University of Chicago at 10 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 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. 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 (time frame: 24 months). The study lists 11 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 NCT02812017, 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 24 Mar 2020.