Child DevelopmentI-T CHILDNCT05132374
The Infant- Toddler Climate of Healthy Interactions for Learning and Development (I-T CHILD)
A study testing I-T CHILD in people with Child Development and Child Behavior, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Child Development, Child Behavior, Social Skills
- What is being tested?
- I-T CHILD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants are excluded if they do not meet all of the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: I-T CHILD: Building Babies' Brains With the Power of Healthy Relationships
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
Read the 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.
- Conditions
- Child Development, Child Behavior, Social Skills, Infant Development
- Being tested
- I-T CHILD
- Keywords
- low-income families, infants, toddlers, child care, home based, child care providers
- Medical subject headings
- Child Behavior, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-T CHILDOther
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Those receiving standard practice early childhood mental health consultation but enhanced with the I-T CHILD as a framework for consultation Receives: Other: I-T CHILD |
| Waitlist-control group | No intervention | Those who receive no intervention until the end of the evaluation period) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in the Framing Challenging Behaviors Questionnaire
a validated self-report questionnaire completed by child care providers that measures how they think about child misbehaviors. It includes 3 statements, on a 10 point scale continuum of two different thoughts or ideas regarding children's challenging behavior. Scores range between 1 to 10 (the mean score of the 3 statements). The continuum represents different ways of looking at children's misbehaviors, with higher scores representing a higher internal locus of control. It take 5 minutes or less to administer.
Measured: Baseline, 4 Months and 8 Months
Change from baseline in Job Stress Inventory
a validated self-report questionnaire completed by child care providers that measures their level of child care provider job stress associated with their perceptions of job demands, job control, and job resources. It includes 22 statements, scored on a Likert 1-5 "How often..." ("Rarely/Never" to "Most of the Time"). The score range is 22- 110.The higher the score, the higher the perceived job stress level. It take 5 minutes or less to administer.
Measured: Baseline, 4 Months and 8 Months
Change in Language Environment Analysis (LENA)
is a language analytic technology used for measuring the amount of language input received by infants and toddlers. The device records the sound environment within hearing range of the child throughout an entire day in the child care program through a vest. The LENA device is collected and connected to computer with LENA software installed. The LENA software processes the audio recordings into data metrics that include the child's exposure to verbal stimulation and number and complexity of child utterances. These metrices constitute the outcome variable in this area. More about LENA technology can be read here: https://www.lena.org/technology/. The child wears the vest for the entire day (8-12 hrs) while at the provider's home based childcare. The LENA system looks at adult word count (AWC); child vocalization count (CVC); and parent-child conversational turns (PCCTs) per hour.
Measured: Baseline, 4 Months and 8 Months
Change from Baseline in CHILD for Home-Based Child Care Observation Tool
an observation measure of home-based child care environments for infants and toddlers adapted from a center-based child care version for preschoolers. It is completed by a trained observer during an approximately 2-hour observational period. Trainees achieve reliability in the course of a 3-day training program. The IT-CHILD is a comprehensive observational assessment of the mental health (or social and emotional) climate of early care and education settings. The measure consists of 28 easily observable items, scored on a 5-point anchored Likert scale ranging from -2 (very undermining) to +2 (very promoting). The score range is then -2 to +2. It takes approximately 2 hours of time to administer (20 minute observations followed by 10 minutes of interpretation and scoring for 4 sessions).
Measured: Baseline, 4 Months and 8 Months
Change from Baseline in Infant-Toddler Risk of Expulsion assessment
a child care provider completed rating scale adapted from the validated Preschool Expulsion Risk Measure. The scale consists of 12 items rated on a 5-point Likert scale ("strongly disagree" to "strongly agree") that have been shown to accurately predict a child care providers intent to expel a child from the child care program. The score range is 1-4 (the mean score for the 12 statements), the higher the score, the higher the risk of expulsion).It take 5 minutes or less to administer.
Measured: Baseline, 4 Months and 8 Months
Change from baseline in Devereux Early Childhood Assessment for Infants/Toddlers
is a validated measure of child development completed by the child care provider that measures an infant's or toddler's child overall development and social-emotional behaviors. It includes 33 statements (infant) or 36 statements (toddler), and is scored on a Likert scale of 0 to 4 ("Never" to "Very Frequently").Two standard scores are provided: percentile scores and T-scores. The T-scores are standard scores that have a set mean of 50 and a standard deviation of 10. T-scores on the DECA are categorized as follows: T-Scores of 60 and above indicate that the child has social and emotional "strengths," T-scores of 41-59 inclusive indicate that the child is showing a "typical" amount of positive behaviors related to social and emotional competence, and T-scores of 40 and below indicate that the child has a "need for instruction". It takes approximately 5- 10 minutes to administer.
Measured: Baseline, 4 Months and 8 Months
Secondary outcomes (5)
Change from baseline in Center for Epidemiological Studies Depression Scale
A standardized and validated self-report screening measure for depressive symptoms measured on Likert scale. The CED-D is one of the most widely used depression screeners for research purposes. The measure asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. It includes 10 statements, with a higher score indicating more reported depression. (two reverse scoring "I felt Happy" and "I felt hopeful about the future"). The possible range of the 10-item scale is 0 to 30, and a cut off score of ten or higher indicates the presence of significant depressive symptoms. It takes approximately 5 or less of time to administer.
Measured: Baseline, 4 Months and 8 Months
Change from baseline in Adverse Childhood Experiences Survey
a standardized and validated self-report measure of events during a person's childhood that create stress and compromise health and mental health during their adult lives. 10 statements (parental divorce, homeless during childhood, etc.) are measured dichotomously (yes or no) based on whether or not they were experienced during childhood by the person completing the self-rating. The more 'yes' is answered, the more adverse childhood experience reported. People have an ACE score of 0 to 10. Each type of trauma counts as one, no matter how many times it occurs. It takes approximately 5 or less of time to administer.
Measured: Baseline, 4 Months and 8 Months
Change from baseline in Brief Resilience Scale
a standardized and validated self-report measure of a person's resiliency or ability to bounce back from stress. It includes 6 statements, and is scored on a Likert scale (1-5, Strongly Disagree to Strongly Agree). To score, one adds the responses varying from 1-5 for all six items giving a range from 6-30. A higher score indicated a higher resiliency. It takes approximately 5 or less of time to administer.
Measured: Baseline, 4 Months and 8 Months
Change from Baseline in Perceived Stress Scale
is a standardized and validated self-report measure of the amount of stress a person is experiencing, using 10 items scored on a 5-point Likert scale 0-4 (Never to Very Often). The PSS is the most widely used scale for measuring the perception of stress. PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. It takes approximately 5 or less of time to administer.
Measured: Baseline, 4 Months and 8 Monthss)
Change from Baseline in Positive and Negative Affect Scales
A validated self-report measure of overall positive and negative affect. It lists 20 adjectives describing positive (10 words) and negative feelings (10 words) (e.g., excited; ashamed) that a person generally feels on a five-point scale (very slightly to extremely). The scoring is the sum of positive feelings (10 words), and a sum of the negative feelings (10 words). Total scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. It takes approximately 5 or less to administer.
Measured: Baseline, 4 Months and 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start7 Dec 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Robinhood Foundation, Adelphi University, Docs for Tots
- Responsible party
- Sponsor
- Investigators
- Chin Reyes, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132374
- Sponsor's protocol ID
- 2000029873
- Acronym
- I-T CHILD
- Status last verified
- Feb 2023
- First submitted
- 12 Nov 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-T CHILD: Building Babies' Brains With the Power of Healthy Relationships
- ClinicalTrials.gov ID
- NCT05132374
- Acronym / sponsor ID
- I-T CHILD / 2000029873
- Conditions
- Child Development, Child Behavior, Social Skills, Infant Development
- Keywords
- low-income families, infants, toddlers, child care, home based, child care providers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Robinhood Foundation, Adelphi University, Docs for Tots
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: I-T CHILDThose receiving standard practice early childhood mental health consultation but enhanced with the I-T CHILD as a framework for consultation |
| Waitlist-control group | No intervention | –Those who receive no intervention until the end of the evaluation period) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Participants are excluded if they do not meet all of the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-T CHILDThis study will evaluate the I-T CHILD's application in early childhood mental health consultation services provided to family/group family child care programs | Other | Treatment Group |
Primary outcome
Changes from baseline in the Framing Challenging Behaviors Questionnaire
Time frame: Baseline, 4 Months and 8 Months
a validated self-report questionnaire completed by child care providers that measures how they think about child misbehaviors. It includes 3 statements, on a 10 point scale continuum of two different thoughts or ideas regarding children's challenging behavior. Scores range between 1 to 10 (the mean score of the 3 statements). The continuum represents different ways of looking at children's misbehaviors, with higher scores representing a higher internal locus of control. It take 5 minutes or less to administer.
Change from baseline in Job Stress Inventory
Time frame: Baseline, 4 Months and 8 Months
a validated self-report questionnaire completed by child care providers that measures their level of child care provider job stress associated with their perceptions of job demands, job control, and job resources. It includes 22 statements, scored on a Likert 1-5 "How often..." ("Rarely/Never" to "Most of the Time"). The score range is 22- 110.The higher the score, the higher the perceived job stress level. It take 5 minutes or less to administer.
Change in Language Environment Analysis (LENA)
Time frame: Baseline, 4 Months and 8 Months
is a language analytic technology used for measuring the amount of language input received by infants and toddlers. The device records the sound environment within hearing range of the child throughout an entire day in the child care program through a vest. The LENA device is collected and connected to computer with LENA software installed. The LENA software processes the audio recordings into data metrics that include the child's exposure to verbal stimulation and number and complexity of child utterances. These metrices constitute the outcome variable in this area. More about LENA technology can be read here: https://www.lena.org/technology/. The child wears the vest for the entire day (8-12 hrs) while at the provider's home based childcare. The LENA system looks at adult word count (AWC); child vocalization count (CVC); and parent-child conversational turns (PCCTs) per hour.
Change from Baseline in CHILD for Home-Based Child Care Observation Tool
Time frame: Baseline, 4 Months and 8 Months
an observation measure of home-based child care environments for infants and toddlers adapted from a center-based child care version for preschoolers. It is completed by a trained observer during an approximately 2-hour observational period. Trainees achieve reliability in the course of a 3-day training program. The IT-CHILD is a comprehensive observational assessment of the mental health (or social and emotional) climate of early care and education settings. The measure consists of 28 easily observable items, scored on a 5-point anchored Likert scale ranging from -2 (very undermining) to +2 (very promoting). The score range is then -2 to +2. It takes approximately 2 hours of time to administer (20 minute observations followed by 10 minutes of interpretation and scoring for 4 sessions).
Change from Baseline in Infant-Toddler Risk of Expulsion assessment
Time frame: Baseline, 4 Months and 8 Months
a child care provider completed rating scale adapted from the validated Preschool Expulsion Risk Measure. The scale consists of 12 items rated on a 5-point Likert scale ("strongly disagree" to "strongly agree") that have been shown to accurately predict a child care providers intent to expel a child from the child care program. The score range is 1-4 (the mean score for the 12 statements), the higher the score, the higher the risk of expulsion).It take 5 minutes or less to administer.
Change from baseline in Devereux Early Childhood Assessment for Infants/Toddlers
Time frame: Baseline, 4 Months and 8 Months
is a validated measure of child development completed by the child care provider that measures an infant's or toddler's child overall development and social-emotional behaviors. It includes 33 statements (infant) or 36 statements (toddler), and is scored on a Likert scale of 0 to 4 ("Never" to "Very Frequently").Two standard scores are provided: percentile scores and T-scores. The T-scores are standard scores that have a set mean of 50 and a standard deviation of 10. T-scores on the DECA are categorized as follows: T-Scores of 60 and above indicate that the child has social and emotional "strengths," T-scores of 41-59 inclusive indicate that the child is showing a "typical" amount of positive behaviors related to social and emotional competence, and T-scores of 40 and below indicate that the child has a "need for instruction". It takes approximately 5- 10 minutes to administer.
5 secondary outcomes
Change from baseline in Center for Epidemiological Studies Depression Scale
Time frame: Baseline, 4 Months and 8 Months
Change from baseline in Adverse Childhood Experiences Survey
Time frame: Baseline, 4 Months and 8 Months
Change from baseline in Brief Resilience Scale
Time frame: Baseline, 4 Months and 8 Months
Change from Baseline in Perceived Stress Scale
Time frame: Baseline, 4 Months and 8 Monthss)
Change from Baseline in Positive and Negative Affect Scales
Time frame: Baseline, 4 Months and 8 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin Reyes, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-T CHILD in people with Child Development and Child Behavior, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in the Framing Challenging Behaviors Questionnaire (time frame: Baseline, 4 Months and 8 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.