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Clinical Trial Summary

The purpose of the study is to train New York-based early childhood mental health consultants (ECMHCs) who will apply the Infant-Toddler Climate of Healthy Interactions for Learning and Development (I-T CHILD) tool as part of their standard practice. The study will evaluate I-T CHILD-informed early childhood mental health consultation in 100 New York State-licensed family day care and group family day care programs serving infants and toddlers in lower-income neighborhoods


Clinical Trial Description

The overarching goal of the project is to provide New York City with the first strengths-based, equity-oriented, culturally responsive, and cost-efficient suite of measurement and caregiver-oriented tools designed to boost healthy brain development by both assessing and strengthening the quality of caregiver-infant/toddler relationships. The primary goal of the study is to evaluate the effectiveness of the I-T CHILD-informed ECMHC on the caregiver beliefs and teaching practices. The secondary goal is to assess whether changes in caregiver beliefs and teaching practices are associated with children's developmental outcomes. This project is Phase 2 (RCT) of an earlier proof-of-concept of the I-T CHILD (Phase 1). Phase 2 evaluates the I-T CHILD's application in early childhood mental health consultation services provided to family/group family child care programs. Phase 2 consists of the following main activities: (1) training and certification of early childhood mental health consultants from various NY-based agencies on the I-T CHILD Tool; (2) random assignment of child care providers into treatment (those receiving standard practice early childhood mental health consultation but enhanced with the I-T CHILD as a framework for consultation) and waitlist-control groups (no intervention until the end of the evaluation period); (3) provision of I-T CHILD resources to child care providers (user-friendly tips on how to strengthen their relationships with children and families); and (4) data collection (pre-test, post-test, 3-month follow-up). Data to be collected will include caregiver self-report surveys, caregiver ratings of children, observations (live or remote, depending on COVID-19 guidelines), and amount of language used in the program using LENA technology. Additionally, qualitative data will be collected from consenting participants through phone (or Zoom) interviews, depending on participant preferences. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05132374
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date December 7, 2021
Completion date December 31, 2022

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