Clinical trial NCT05132374: The Infant- Toddler Climate of Healthy Interactions for Learning and Development (I-T CHILD)
Official title: I-T CHILD: Building Babies' Brains With the Power of Healthy Relationships
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Child Behavior
Social Skills
Infant Development
Keywords: low-income families
infants
toddlers
child care
home based
child care providers
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Robinhood Foundation
name: Adelphi University
name: Docs for Tots
First posted: 2021-11-24
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline in the Framing Challenging Behaviors Questionnaire
timeFrame: Baseline, 4 Months and 8 Months
measure: Change from baseline in Job Stress Inventory
timeFrame: Baseline, 4 Months and 8 Months
measure: Change in Language Environment Analysis (LENA)
timeFrame: Baseline, 4 Months and 8 Months
measure: Change from Baseline in CHILD for Home-Based Child Care Observation Tool
timeFrame: Baseline, 4 Months and 8 Months
measure: Change from Baseline in Infant-Toddler Risk of Expulsion assessment
timeFrame: Baseline, 4 Months and 8 Months
measure: Change from baseline in Devereux Early Childhood Assessment for Infants/Toddlers
timeFrame: Baseline, 4 Months and 8 Months
Secondary outcomes:
measure: Change from baseline in Center for Epidemiological Studies Depression Scale
timeFrame: Baseline, 4 Months and 8 Months
measure: Change from baseline in Adverse Childhood Experiences Survey
timeFrame: Baseline, 4 Months and 8 Months
measure: Change from baseline in Brief Resilience Scale
timeFrame: Baseline, 4 Months and 8 Months
measure: Change from Baseline in Perceived Stress Scale
timeFrame: Baseline, 4 Months and 8 Monthss)
measure: Change from Baseline in Positive and Negative Affect Scales
timeFrame: Baseline, 4 Months and 8 Months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Child care site name
state: Connecticut
Study officials:
affiliation: Yale University
name: Chin Reyes, PhD
role: PRINCIPAL_INVESTIGATOR
References: