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Thirty Million Words- Well Baby Initiative (TMW-WB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812017
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Behavior Communication Language Behavioral: Thirty Million Words- Well Baby Other: Safety Starts at Home Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 952 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Thirty Million Words: Well Baby Initiative
Study Start Date : June 2016
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: 1 - Intervention
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.
Behavioral: Thirty Million Words- Well Baby
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.

Placebo Comparator: 2 - Neutral
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.
Other: Safety Starts at Home
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.

No Intervention: 3 - Usual care
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.



Primary Outcome Measures :
  1. 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.

  2. Receptive vocabulary score [ Time Frame: 30 months ]
    score of Receptive vocabulary

  3. 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.

  4. Patient report [ Time Frame: 24 months ]
    consistent anticipatory guidance

  5. Stakeholder report [ Time Frame: 24 months ]
    daily anticipatory guidance

  6. 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.

  7. MacArthur-Bates Communicative Development Inventory (CDI) Vocabulary Checklist: Level 1 [ Time Frame: 24 months ]
    parent report of child's developing abilities in early language

  8. StimQ Cognitive Home Environment [ Time Frame: 24 months ]
    A standardized, interview-based instrument to measure a family's cognitive home environment.

  9. 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.

  10. 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

  11. 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.


Secondary Outcome Measures :
  1. FLE: Family Life Events Survey of family structure, the household, and the child's caretaker(s) [ Time Frame: 18 months ]
    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.

  2. SDoH: Social Determinants of Health survey [ Time Frame: 24 months ]
    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.

  3. ACE: Adverse Childhood Experiences survey [ Time Frame: 24 months ]
    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.

  4. EPDS: Edinburgh Postnatal Depression Scale (or other standardized depression scale) [ Time Frame: 1 month ]
    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.

  5. ASQ: Ages and Stages Questionnaire [ Time Frame: 24 months ]
    The Ages & Stages Questionnaire: Social-Emotional is a series of questions that aims to identify any social or emotional problems in a developing child.

  6. Pearlin Mastery Scale [ Time Frame: 30 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812017


Locations
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United States, Illinois
PCC South Family Health Center
Berwyn, Illinois, United States, 60402
Advocate Medical Group
Chicago, Illinois, United States, 60618
Lawndale Christian Health Center
Chicago, Illinois, United States, 60623
University of Chicago Medical Center - Friend Family Health Center
Chicago, Illinois, United States, 60629
Lawndale Christian Health Center - Archer Avenue
Chicago, Illinois, United States, 60632
PCC Salud Family Health Center
Chicago, Illinois, United States, 60639
Advocate Medical Group
Chicago, Illinois, United States, 60640
University of Chicago Medical Center - Friend Family Health Center
Chicago, Illinois, United States, 60640
PCC Austin Family Health Center
Chicago, Illinois, United States, 60644
PCC Lake Street Family Health Center
Oak Park, Illinois, United States, 60302
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Dana Suskind, MD University of Chicago
Study Chair: Kristin Leffel, AB University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:
Additional Information:
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02812017    
Other Study ID Numbers: 15-0914
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Keywords provided by University of Chicago:
educational intervention
language development
postpartum
parental attachment
achievement gap
language gap
school readiness