Child DevelopmentNCT05197998
Leveraging Families to Promote Healthy Socio-Emotional Development in Children
A study testing ColorBRAVE in people with Child Development and Parents, run by Tulane University at 1 site in United States.
Trial summary
The objective of this research is to evaluate a mobile app-based intervention for parents of children in K-2nd grade designed that guides them in how to have productive conversations about race with their children. This study will recruit a national sample of parents and their K-2nd grade children. Read more about this study
- Who is it for?
- Ages 5 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Parents, Prosocial and Emotional Well-Being
- What is being tested?
- ColorBRAVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Residence in the US; caregiver age 18 years or older and child age 5-8 years old; ability to read and understand English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tulane University
New Orleans, Louisiana, 70112
David H. Chae, ScD MA, 504-988-1847, dchae@tulane.edu
About this study
The objective of this research is to evaluate a mobile app-based intervention for parents of children in K-2nd grade designed that guides them in how to have productive conversations about race with their children. This study will recruit a national sample of parents and their K-2nd grade children. The impact of the intervention is tested using a wait-list controlled trial design. Outcomes include prosocial behaviors and indicators of emotional well-being.
- Being tested
- ColorBRAVE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColorBRAVEBehavioural
The intervention is a multi-module program delivered via a mobile app for parents of children in K-2nd grade. Each module in the program will take approximately 30 minutes to complete, with lessons facilitated through interactive storytelling, videos, and games.
| Study group | Role | What they receive |
|---|---|---|
| ColorBRAVE | Experimental | The experimental group will be asked to download a multi-module mobile app designed to guide parents and caregivers in having conversations about race with their K-2nd grade children Receives: Behavioral: ColorBRAVE |
| Wait-list Control | Other | The wait-list control group will be placed on the wait-list for the first 6-weeks, the period in which the experimental group will complete the intervention program. Following the 6-week wait-list period they will receive the ColorBRAVE program. Receives: Behavioral: ColorBRAVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Racial Socialization Frequency Scale
Parents will report the frequency with which they engage in racial socialization practices with their K-2nd grade child.
Measured: 0-12 months
Racial Socialization Competency Scale
Parents will report the degree of comfort, skills, and stress in engaging in different processes related to racial socialization with their K-2nd grade child.
Measured: 0-12 months
Cross-race Friendships
Parents will report the race of their K-2nd grade child's 5 closest friends - the number of cross-race friendships will consist of the number of friends that are race discordant to their child.
Measured: 0-12 months
Colorblind Racial Attitudes (CoBRAS) Scale
Color-blind racial attitudes among parents will be assessed using the COBRAS Scale.
Measured: 0-12 months
Child Prosocial Behavior Questionnaire (CPBQ)
Parents will report on the degree to which their K-2nd grade child engages in various prosocial behaviors, including those surrounding helping, sharing, and comforting.
Measured: 0-12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Measures
Parent reports of child socio-emotional well being (e.g., positive peer relationships, depression, anxiety).
Measured: 0-12 months
Prosocial Children Measure
Children (ages 5-8 years old) will be introduced to a child and told scenarios in which that child must choose other children to engage in various activities with, among a group of diverse children. Children will be asked (1) whether they liked or disliked how that child chose the children to participate in the activity with and (2) if there is anything they would like to say to that child about their choice in children.
Measured: 0-12 months
Child Bystander Response Questionnaire
Children will report the frequency with which they engage in different bystander behaviors when they see someone being treated poorly or unfairly due to their race, ethnicity, or cultural background.
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Feb 2027 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Wait-list control design
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University, University of Chicago, University of Illinois Chicago, San Diego State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- David H. Chae, ScD, MA, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197998
- Sponsor's protocol ID
- 5U01HD115257-04
- Other IDs
- 5U01HD115257-04
- Status last verified
- Oct 2026
- First submitted
- 22 Nov 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of key analyses, study documentation and de-identified data will be made available to the research community upon request. Data requests may be submitted to the Project Coordinator and reviewed by the study PI to determine whether there is significant scientific overlap in the research questions and analyses proposed by the outside investigator. Those who submit qualified proposals will be provided with a dataset containing only the variables requested and the associated documentation (e.g., codebooks, description of study protocols, data dictionaries) under a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Families to Promote Healthy Socio-Emotional Development in Children
- ClinicalTrials.gov ID
- NCT05197998
- Acronym / sponsor ID
- 5U01HD115257-04
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Tufts University, University of Chicago, University of Illinois Chicago, San Diego State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Jan 2022 (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 objective of this research is to evaluate a mobile app-based intervention for parents of children in K-2nd grade designed that guides them in how to have productive conversations about race with their children. This study will recruit a national sample of parents and their K-2nd grade children. The impact of the intervention is tested using a wait-list controlled trial design. Outcomes include prosocial behaviors and indicators of emotional well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Wait-list control design
| Arm | Type | Receives |
|---|---|---|
| ColorBRAVE | Experimental | Behavioral: ColorBRAVEThe experimental group will be asked to download a multi-module mobile app designed to guide parents and caregivers in having conversations about race with their K-2nd grade children |
| Wait-list Control | Other | Behavioral: ColorBRAVEThe wait-list control group will be placed on the wait-list for the first 6-weeks, the period in which the experimental group will complete the intervention program. Following the 6-week wait-list period they will receive the ColorBRAVE program. |
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| ColorBRAVEThe intervention is a multi-module program delivered via a mobile app for parents of children in K-2nd grade. Each module in the program will take approximately 30 minutes to complete, with lessons facilitated through interactive storytelling, videos, and games. | Behavioural | ColorBRAVE, Wait-list Control |
Primary outcome
Racial Socialization Frequency Scale
Time frame: 0-12 months
Parents will report the frequency with which they engage in racial socialization practices with their K-2nd grade child.
Racial Socialization Competency Scale
Time frame: 0-12 months
Parents will report the degree of comfort, skills, and stress in engaging in different processes related to racial socialization with their K-2nd grade child.
Cross-race Friendships
Time frame: 0-12 months
Parents will report the race of their K-2nd grade child's 5 closest friends - the number of cross-race friendships will consist of the number of friends that are race discordant to their child.
Colorblind Racial Attitudes (CoBRAS) Scale
Time frame: 0-12 months
Color-blind racial attitudes among parents will be assessed using the COBRAS Scale.
Child Prosocial Behavior Questionnaire (CPBQ)
Time frame: 0-12 months
Parents will report on the degree to which their K-2nd grade child engages in various prosocial behaviors, including those surrounding helping, sharing, and comforting.
Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Measures
Time frame: 0-12 months
Parent reports of child socio-emotional well being (e.g., positive peer relationships, depression, anxiety).
Prosocial Children Measure
Time frame: 0-12 months
Children (ages 5-8 years old) will be introduced to a child and told scenarios in which that child must choose other children to engage in various activities with, among a group of diverse children. Children will be asked (1) whether they liked or disliked how that child chose the children to participate in the activity with and (2) if there is anything they would like to say to that child about their choice in children.
Child Bystander Response Questionnaire
Time frame: 0-12 months
Children will report the frequency with which they engage in different bystander behaviors when they see someone being treated poorly or unfairly due to their race, ethnicity, or cultural background.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. Upon completion of key analyses, study documentation and de-identified data will be made available to the research community upon request. Data requests may be submitted to the Project Coordinator and reviewed by the study PI to determine whether there is significant scientific overlap in the research questions and analyses proposed by the outside investigator. Those who submit qualified proposals will be provided with a dataset containing only the variables requested and the associated documentation (e.g., codebooks, description of study protocols, data dictionaries) under a data sharing agreement.
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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.
David H. Chae, ScD, MA principal investigator
Tulane 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 ColorBRAVE in people with Child Development and Parents, run by Tulane 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?
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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David H. Chae, ScD, MA (504-988-1847, dchae@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Racial Socialization Frequency Scale (time frame: 0-12 months). The study lists 8 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 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.