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The Infant- Toddler Climate of Healthy Interactions for Learning and Development (I-T CHILD)

Yale University logo

Yale University

Status

Completed

Conditions

Child Development
Child Behavior
Social Skills
Infant Development

Treatments

Other: I-T CHILD

Study type

Interventional

Funder types

Other

Identifiers

NCT05132374
2000029873

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Be operating a legal and licensed home-based child care program serving infants and toddlers

    o The program must serve at least one infant or one toddler, as the study and funding are centered around infants and toddlers.

  • Agree to participate in a 3-month course of early childhood mental health consultation (ECMHC) provided by a trained ECMHC consultant beginning in about one month, if randomized to the treatment condition

  • Agree to participate in data collection activities

    • Be able to respond to surveys either completed online via Yale Qualtrics surveys (home-based child care providers regularly submit licensing and child care subsidy forms online, so this should not be a challenge for legally-operating licensed child care providers), or by phone with a trained data collector.
    • Open to having blinded raters to observe the program.

Exclusion criteria

  • Participants are excluded if they do not meet all of the inclusion criteria.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Treatment Group
Experimental group
Description:
Those receiving standard practice early childhood mental health consultation but enhanced with the I-T CHILD as a framework for consultation
Treatment:
Other: I-T CHILD
Waitlist-control group
No Intervention group
Description:
Those who receive no intervention until the end of the evaluation period)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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