TMW Community-Wide Demonstration Project

NCT04330131 | Withdrawn

• 1 other identifier: 19-1588
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

The TMW Center is launching a community-wide demonstration project in partnership with the Children's Services Council of Palm Beach County, Florida, in which the TMW interventions will be delivered at scale through partners who work with families across health, education, and social service systems. The goal of this partnership is to reach 60% of all families with children age birth through three with at least one TMW intervention over the five-year partnership, with a significant percentage of families receiving more than one intervention. The TMW Center will evaluate the efficacy of the multiple intervention approach in impacting parent knowledge, beliefs, and behavior and child developmental outcomes, and develop an implementation model that can be used in other communities.

Conditions

Language Development

Outcome Measures

Primary Outcomes (4)

• Survey of Parental Expectations and Knowledge (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.

  Up to 3-years of age

• Parental Cognition and Conduct Toward the Infant Scale (PACOTIS)

  A self-report measure of the respondent's perceived impact on their child's development. Scores for each of the 5 items range from 0 ('Not at all what I think') to 10 ('Exactly what I think'). A lower score indicates a better outcome

  Up to 3-years of age

• MacArthur-Bates Communicative Development Inventories-Short Form (MCDI-SF)

  Parent report measure of words that their child understands and says. For a list of words, a parent marks whether a child 'understands', 'understands and says' or 'neither understands nor says.' Each column is tallied and higher counts in the 'understands and says' column indicate better outcomes

  Up to 3-years of age

• StimQ - Reading Subscale

  A questionnaire that is designed to explore the different kinds of activities that primary caregivers engage in with their infant child, preschool child, or toddler and their role in promoting cognitive stimulation for the child. Items 1-4 are scored on a scale of 0-4 based on how often a parent engages in certain behaviors. Items 5-10 are scored as a Yes (1 point) or No (0 points). A higher score indicates a better outcome

  Up to 3-years of age

Study Arms (2)

Treated families

EXPERIMENTAL

The treated families will complete up to 3 interventions: 3Ts - Newborn, 3Ts - Well Baby, and 3Ts - Let's Talk! The ideal progression is that treated families will complete all three interventions. Before completing their first intervention, participants will complete set of baseline surveys measuring their knowledge and beliefs about child development. They will repeat these measures when their child is 6 months, 9 months, 1-, 2-, and 3-years old.

Behavioral: 3Ts - Newborn; Behavioral: 3Ts - Well Baby; Behavioral: 3Ts - Let's Talk!

Comparison Families

NO INTERVENTION

Comparison families will not receive any of the 3Ts interventions but will complete the same surveys as the treatment group at study enrollment and again when their child is 6 months, 9 months, 1-, 2-, and 3-years old.

Interventions

3Ts - Newborn BEHAVIORAL

A video shared with parents/caregivers during a universal screening in hospital mother-baby units. This intervention shares the importance of early talk and interaction with a child to support their early brain development as well as strategies for parents to do so.

Treated families

3Ts - Well Baby BEHAVIORAL

Four videos shared during well child immunization visits at 1-, 2-, 4-, and 6-months in pediatrician offices. This intervention shares the importance of early talk and interaction with a child to support their early brain development as well as strategies for parents to do so.

Treated families

3Ts - Let's Talk! BEHAVIORAL

A series of eight group classes involving education, feedback, and goal setting for parents/caregivers of children age one through three, delivered in a community-based organization. This intervention shares the importance of early talk and interaction with a child to support their early brain development as well as strategies for parents to do so.

Treated families

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be able to understand English or Spanish
• Must be the parent/caregiver of a child in the target range of the intervention (at birth for the 3Ts-Newborn, 0-6 months for 3Ts-Well Baby and 0-3 years for 3Ts-Let's Talk!). For this study, the parent is defined as person with custody of the child.

You may not qualify if:

• Parents under the age of 18 who are not emancipated minors
• Parents who do not have legal custody of their child
• Parents who do not speak enough English or Spanish to receive their educational information in that language.

Sponsors & Collaborators

• University of Chicago: lead
• Childrens Services Council: collaborator
• St. Mary's Medical Center: collaborator
• Soma Medical Center: collaborator
• HomeSafe: collaborator

Study Sites (4)

Soma Medical Center, PA #3-Forest Hill

West Palm Beach, Florida, 33406, United States

Location

St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

Soma Medical Center, PA#4 Military

West Palm Beach, Florida, 33415, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Suskind DL, Leffel KR, Graf E, Hernandez MW, Gunderson EA, Sapolich SG, Suskind E, Leininger L, Goldin-Meadow S, Levine SC. A parent-directed language intervention for children of low socioeconomic status: a randomized controlled pilot study. J Child Lang. 2016 Mar;43(2):366-406. doi: 10.1017/S0305000915000033. Epub 2015 Jun 4.

  PMID: 26041013 BACKGROUND

Related Links

• The homepage for the TMW Center for Early Learning and Public Health

Study Officials

• Dana Suskind, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Treatment group participants will consist of all the families who enroll in the TMW interventions in the hospitals and clinics of the treated community (the target zip codes for intervention delivery). The comparison group will consist of families enrolled from hospitals and pediatric clinics with similar characteristics to the treatment group sites.Then within this comparison group, the researchers will define a sample of comparison families who have similar individual characteristics as the treated families.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 1, 2020
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)