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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2022-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Child Development Child Behavior Social Skills Infant Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study consists of the following main activities: (1) training and certification of early childhood mental health consultants from various 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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment Group

Those receiving standard practice early childhood mental health consultation but enhanced with the I-T CHILD as a framework for consultation

Group Type EXPERIMENTAL

I-T CHILD

Intervention Type OTHER

This study will evaluate the I-T CHILD's application in early childhood mental health consultation services provided to family/group family child care programs

Waitlist-control group

Those who receive no intervention until the end of the evaluation period)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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I-T CHILD

This study will evaluate the I-T CHILD's application in early childhood mental health consultation services provided to family/group family child care programs

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes