CompletedNot Applicable

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

United States50 participantsStarted 2021-12-07

Plain-language 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

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes from baseline in the Framing Challenging Behaviors Questionnaire

Timeframe: Baseline, 4 Months and 8 Months

Change from baseline in Job Stress Inventory

Timeframe: Baseline, 4 Months and 8 Months

Change in Language Environment Analysis (LENA)

Timeframe: Baseline, 4 Months and 8 Months

Change from Baseline in CHILD for Home-Based Child Care Observation Tool

Timeframe: Baseline, 4 Months and 8 Months

Change from Baseline in Infant-Toddler Risk of Expulsion assessment

Timeframe: Baseline, 4 Months and 8 Months

Change from baseline in Devereux Early Childhood Assessment for Infants/Toddlers

Timeframe: Baseline, 4 Months and 8 Months

Trial details

NCT IDNCT05132374

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Child Development trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes from baseline in the Framing Challenging Behaviors Questionnaire

Timeframe: Baseline, 4 Months and 8 Months

Change from baseline in Job Stress Inventory

Timeframe: Baseline, 4 Months and 8 Months

Change in Language Environment Analysis (LENA)

Timeframe: Baseline, 4 Months and 8 Months

Change from Baseline in CHILD for Home-Based Child Care Observation Tool

Timeframe: Baseline, 4 Months and 8 Months

Change from Baseline in Infant-Toddler Risk of Expulsion assessment

Timeframe: Baseline, 4 Months and 8 Months

Change from baseline in Devereux Early Childhood Assessment for Infants/Toddlers

Timeframe: Baseline, 4 Months and 8 Months