Thirty Million Words- Well Baby Initiative

NCT02812017 | Completed

• 1 other identifier: 15-0914
• Study Type: interventional
• Target: 952
• Locations: 1 country
• Sites: 10

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.

Conditions

Behavior; Communication; Language

Keywords

educational intervention; language development; postpartum; parental attachment; achievement gap; language gap; school readiness

Outcome Measures

Primary Outcomes (11)

• 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.

  24 months

• Receptive vocabulary score

  score of Receptive vocabulary

  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.

  24 months

• Patient report

  consistent anticipatory guidance

  24 months

• Stakeholder report

  daily anticipatory guidance

  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.

  24 months

• MacArthur-Bates Communicative Development Inventory (CDI) Vocabulary Checklist: Level 1

  parent report of child's developing abilities in early language

  24 months

• StimQ Cognitive Home Environment

  A standardized, interview-based instrument to measure a family's cognitive home environment.

  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.

  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

  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.

  30 months

Secondary Outcomes (6)

• FLE: Family Life Events Survey of family structure, the household, and the child's caretaker(s)

  18 months

• SDoH: Social Determinants of Health survey

  24 months

• ACE: Adverse Childhood Experiences survey

  24 months

• EPDS: Edinburgh Postnatal Depression Scale (or other standardized depression scale)

  1 month

• ASQ: Ages and Stages Questionnaire

  24 months

Study Arms (3)

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.

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.

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.

Interventions

Thirty Million Words- Well Baby BEHAVIORAL

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.

1 - Intervention

Safety Starts at Home OTHER

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.

2 - Neutral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \) 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).

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (10)

PCC South Family Health Center

Berwyn, Illinois, 60402, United States

Location

Advocate Medical Group

Chicago, Illinois, 60618, United States

Location

Lawndale Christian Health Center

Chicago, Illinois, 60623, United States

Location

University of Chicago Medical Center - Friend Family Health Center

Chicago, Illinois, 60629, United States

Location

Lawndale Christian Health Center - Archer Avenue

Chicago, Illinois, 60632, United States

Location

PCC Salud Family Health Center

Chicago, Illinois, 60639, United States

Location

Advocate Medical Group

Chicago, Illinois, 60640, United States

Location

University of Chicago Medical Center - Friend Family Health Center

Chicago, Illinois, 60640, United States

Location

PCC Austin Family Health Center

Chicago, Illinois, 60644, United States

Location

PCC Lake Street Family Health Center

Oak Park, Illinois, 60302, United States

Location

Related Publications (2)

• 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.

  PMID: 35301018 DERIVED

• List 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.

  PMID: 34599167 DERIVED

Related Links

• Click here for more information about the Thirty Million Words

MeSH Terms

Conditions

Behavior; Communication; Language

Study Officials

• Dana Suskind, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Kristin Leffel, AB

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 23, 2016
• Study Start: June 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

US (10)