Communication Clinical Trial
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.
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.
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