Depressive SymptomsOTAATNCT05454293
One Talk at a Time: A Racial-ethnic Socialization Intervention for Diverse Families
A study testing One Talk at a Time: Race and One Talk at a Time: General in people with Depressive Symptoms and Anxiety Disorders and Symptoms, run by University of North Carolina, Greensboro at 1 site in United States.
Trial summary
This study is a randomized effectiveness trial that tests the online delivery of a video-based intervention (One Talk at a Time (OTAAT)) relative to a control group over a one-year span. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety Disorders and Symptoms, Behavioral Symptoms
- What is being tested?
- One Talk at a Time: Race and One Talk at a Time: General
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 30 Jun 2025
- 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
- Parent of a child between the ages of 11 and 13
- Parental race/ethnicity either of East Asian, African American, Latinx (Central American) background
- Both parents are from the same pan-ethnic group
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina Greensboro
Greensboro, North Carolina, 27401
Gabriela Livas-Stein, PhD, 336-256-0041, glstein@uncg.edu
Gabriela Livas Stein, PhD
About this study
Official title: One Talk at a Time: A Racial-ethnic Socialization Intervention for Diverse Families to Reduce Psychosocial Inequalities
This study is a randomized effectiveness trial that tests the online delivery of a video-based intervention (One Talk at a Time (OTAAT)) relative to a control group over a one-year span. Hypotheses include: 1.) The OTAAT intervention will increase parental motivation to engage in racial-ethnic socialization (RES) conversations, their skills and confidence in having these conversations, and the frequency and quality of these conservations; 2.) The OTAAT intervention will increase youth reports of their coping with discrimination, perceived efficacy in coping with discrimination in the future, ethnic-racial identity, and youth mental and academic outcomes; 3.) Greater parental discrimination and youth discrimination will moderate links between OTAAT intervention and parental ethnic-racial motivation + competency as well as youth ethnic-racial identity, coping, and psychosocial outcomes.
Read the detailed description
This study will employ a mixed methods longitudinal randomized control trial design. All parents and youth will be assessed at four time points (Baseline, 3-month, 6-month, and 12-month) using surveys. Investigators will also use an observational racial-ethnic socialization (RES) task at 3-months to complement self-report data where parents and youth will have taped RES conversations.
Investiagtors will collect data with two balanced cohorts (Cohort 1 and Cohort 2). Parent-youth dyads (N=312) will be recruited through community-based organizations and diverse, public middle schools to reach a representative population of each racial-ethnic group. Specific recruitment procedures are included below.
Once an identified parent-youth dyad is recruited into the study, parents and youth will complete separate Qualtrics baseline surveys online. Parents will then receive either the intervention or the control materials via email or text within 2 weeks (and be given a month to start intervention). OTAAT consists of 11 videos (3-5 minutes each) that include didactic modules and social modeling. The total intervention takes approximately 1.5-2 hours to complete online, and parents can move through the videos at their own pace. The control condition will receive web-based communication materials onsite, including communication videos. Subsequent research follow-ups will occur at 3-months, 6-months, and 12-months with both parents and youth via Qualtrics.
After the initial intervention, parents will receive 6 additional OTAAT contacts via text messages/newsletters that will be spread out across the year with contacts at 1, 2, 4, 5, 8, and 10 months after the initial intervention. These contacts will include a short survey assessing the use of Ready, Set, Talk skills and setting times for having RES conversations. Parents in the control condition will similarly receive text messages/newsletters at the same time points.
At 3-month follow-up, parents and youth will also complete a video-recorded RES observational task via a virtual platform or in-person depending on family preference. During the observational task, parents and their children will be asked to spend five minutes discussing four discrimination encounters. During these conversations, parents will be asked to talk to their child about race and culture as they would at home in a natural manner. The task will take approximately 25-30 minutes to complete.
- Conditions
- Depressive Symptoms, Anxiety Disorders and Symptoms, Behavioral Symptoms, Ethnic-Racial Socialization
- Being tested
- One Talk at a Time: Race, One Talk at a Time: General
- Keywords
- Ethnic-racial socialization, Race, Ethnicity, Discrimination, Diverse families, Cultural socialization, Preparation for bias, Culture, Parent-Child communication
- Medical subject headings
- Depression, Anxiety Disorders, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Talk at a Time: RaceOther
This intervention consists of short videos that include didactic modules and social modeling for having conversations with children about race, ethnicity, culture, and discrimination. The total intervention takes approximately 1.5-2 hours to complete online, and parents can move through the videos at their own pace.
One Talk at a Time: GeneralOther
This intervention consists of short videos that include modules and handouts with tips for parent-child communication strategies for navigating difficult topics, such as dating and current events.
| Study group | Role | What they receive |
|---|---|---|
| OTAAT | Experimental | This group will receive the One Talk at a Time curriculum. Receives: Other: One Talk at a Time: Race |
| Parent-Child Communication | Active comparator | This group will receive a curriculum focused on tips and strategies for navigating difficult topics with one's children such as current events and dating. Receives: Other: One Talk at a Time: General |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Motivation (Parent-reported)
The study will use an adapted version of the Motivation to Change measure (Miller \& Johnson, 2008) to assess parental motivation to engage in racial-ethnic socialization with their children.
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Parental Skill (Parent-reported)
The study will use the Racial Socialization Competency Scale (RaSCS; Anderson et al., 2019) to measure parental-perceived skill in delivering racial-ethnic socialization messages
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Parental Confidence (Parent-reported)
The study will use a recently developed scale (under review) that assesses how confident parents feel delivering racial-ethnic socialization messages
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Coping with Discrimination (Youth-reported) Youth Coping with Discrimination
Youth's use of coping strategies will be measured using the Discrimination Coping Strategies Scale (Umaña-Taylor et al., 2008)
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Secondary outcomes (7)
Cultural Socialization Frequency (Parent and youth report)
Frequency of cultural socialization messages will be measured using the cultural socialization subscale of the Ethnic-Racial Socialization Scale (Hughes \& Chen, 1997). The measure will be adapted to measure frequency over the last 3 months rather than year.
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Preparation for Bias Frequency (Parent and youth report)
Frequency of preparation for bias messages will be measured using the preparation for bias subscale of the Ethnic-Racial Socialization Scale (Hughes \& Chen, 1997). The measure will be adapted to measure frequency over the last 3 months rather than year.
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Cultural Socialization Quality
Quality of cultural socialization messages will be assessed during observational coding of parent-child discussions around scenarios describing experiences of discrimination. Coding will be based on Smith Bynum et al.'s (2016) scale.
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Preparation for Bias Quality
Quality of preparation for bias messages will be assessed during observational coding of parent-child discussions around scenarios describing experiences of discrimination. Coding will be based on Smith Bynum et al.'s (2016) scale.
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Youth Self-Esteem (Youth and parent report)
Youth's self-esteem will be assessed using the Rosenberg (1979) measure
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Youth Depressive symptoms (Youth and parent report)
Youth's current depressive symptoms will be measured using the PROMIS Pediatric Short-Form of Depressive Symptoms (Irwin et al., 2010)
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Youth Anxiety symptoms (Youth and parent report)
Youth's current anxiety symptoms will be measured using the PROMIS Pediatric Short-Form of Anxiety Symptoms (Irwin et al., 2010)
Measured: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start24 Aug 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Stein, University of Texas at Austin
- Investigators
- Gabriela Livas Stein, PhD, Principal investigator, University of Texas at AustinStephanie Coard, PhD, Principal investigator, University of North Carolina, GreensboroLisa Kiang, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454293
- Sponsor's protocol ID
- 202064
- Acronym
- OTAAT
- Status last verified
- Dec 2023
- First submitted
- 7 Jul 2022
- Last updated
- 12 Dec 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Talk at a Time: A Racial-ethnic Socialization Intervention for Diverse Families to Reduce Psychosocial Inequalities
- ClinicalTrials.gov ID
- NCT05454293
- Acronym / sponsor ID
- OTAAT / 202064
- Conditions
- Depressive Symptoms, Anxiety Disorders and Symptoms, Behavioral Symptoms, Ethnic-Racial Socialization
- Keywords
- Ethnic-racial socialization, Race, Ethnicity, Discrimination, Diverse families, Cultural socialization, Preparation for bias, Culture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Jul 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.
This study is a randomized effectiveness trial that tests the online delivery of a video-based intervention (One Talk at a Time (OTAAT)) relative to a control group over a one-year span. Hypotheses include: 1.) The OTAAT intervention will increase parental motivation to engage in racial-ethnic socialization (RES) conversations, their skills and confidence in having these conversations, and the frequency and quality of these conservations; 2.) The OTAAT intervention will increase youth reports of their coping with discrimination, perceived efficacy in coping with discrimination in the future, ethnic-racial identity, and youth mental and academic outcomes; 3.) Greater parental discrimination and youth discrimination will moderate links between OTAAT intervention and parental ethnic-racial motivation + competency as well as youth ethnic-racial identity, coping, and psychosocial outcomes.
Detailed description
This study will employ a mixed methods longitudinal randomized control trial design. All parents and youth will be assessed at four time points (Baseline, 3-month, 6-month, and 12-month) using surveys. Investigators will also use an observational racial-ethnic socialization (RES) task at 3-months to complement self-report data where parents and youth will have taped RES conversations.
Investiagtors will collect data with two balanced cohorts (Cohort 1 and Cohort 2). Parent-youth dyads (N=312) will be recruited through community-based organizations and diverse, public middle schools to reach a representative population of each racial-ethnic group. Specific recruitment procedures are included below.
Once an identified parent-youth dyad is recruited into the study, parents and youth will complete separate Qualtrics baseline surveys online. Parents will then receive either the intervention or the control materials via email or text within 2 weeks (and be given a month to start intervention). OTAAT consists of 11 videos (3-5 minutes each) that include didactic modules and social modeling. The total intervention takes approximately 1.5-2 hours to complete online, and parents can move through the videos at their own pace. The control condition will receive web-based communication materials onsite, including communication videos. Subsequent research follow-ups will occur at 3-months, 6-months, and 12-months with both parents and youth via Qualtrics.
After the initial intervention, parents will receive 6 additional OTAAT contacts via text messages/newsletters that will be spread out across the year with contacts at 1, 2, 4, 5, 8, and 10 months after the initial intervention. These contacts will include a short survey assessing the use of Ready, Set, Talk skills and setting times for having RES conversations. Parents in the control condition will similarly receive text messages/newsletters at the same time points.
At 3-month follow-up, parents and youth will also complete a video-recorded RES observational task via a virtual platform or in-person depending on family preference. During the observational task, parents and their children will be asked to spend five minutes discussing four discrimination encounters. During these conversations, parents will be asked to talk to their child about race and culture as they would at home in a natural manner. The task will take approximately 25-30 minutes to complete.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTAAT | Experimental | Other: One Talk at a Time: RaceThis group will receive the One Talk at a Time curriculum. |
| Parent-Child Communication | Active comparator | Other: One Talk at a Time: GeneralThis group will receive a curriculum focused on tips and strategies for navigating difficult topics with one's children such as current events and dating. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parent of a child between the ages of 11 and 13
- Parental race/ethnicity either of East Asian, African American, Latinx (Central American) background
- Both parents are from the same pan-ethnic group
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| One Talk at a Time: RaceThis intervention consists of short videos that include didactic modules and social modeling for having conversations with children about race, ethnicity, culture, and discrimination. The total intervention takes approximately 1.5-2 hours to complete online, and parents can move through the videos at their own pace. | Other | OTAAT |
| One Talk at a Time: GeneralThis intervention consists of short videos that include modules and handouts with tips for parent-child communication strategies for navigating difficult topics, such as dating and current events. | Other | Parent-Child Communication |
Primary outcome
Parental Motivation (Parent-reported)
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
The study will use an adapted version of the Motivation to Change measure (Miller \& Johnson, 2008) to assess parental motivation to engage in racial-ethnic socialization with their children.
Parental Skill (Parent-reported)
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
The study will use the Racial Socialization Competency Scale (RaSCS; Anderson et al., 2019) to measure parental-perceived skill in delivering racial-ethnic socialization messages
Parental Confidence (Parent-reported)
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
The study will use a recently developed scale (under review) that assesses how confident parents feel delivering racial-ethnic socialization messages
Coping with Discrimination (Youth-reported) Youth Coping with Discrimination
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Youth's use of coping strategies will be measured using the Discrimination Coping Strategies Scale (Umaña-Taylor et al., 2008)
7 secondary outcomes
Cultural Socialization Frequency (Parent and youth report)
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Preparation for Bias Frequency (Parent and youth report)
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Cultural Socialization Quality
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Preparation for Bias Quality
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Youth Self-Esteem (Youth and parent report)
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Youth Depressive symptoms (Youth and parent report)
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Youth Anxiety symptoms (Youth and parent report)
Time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 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.
Gabriela Livas Stein, PhD principal investigator
University of Texas at Austin
Stephanie Coard, PhD principal investigator
University of North Carolina, Greensboro
Lisa Kiang, PhD principal investigator
Wake Forest 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 One Talk at a Time: Race and One Talk at a Time: General in people with Depressive Symptoms and Anxiety Disorders and Symptoms, run by University of North Carolina, Greensboro 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 3 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: status not confirmed, as of the sponsor's last update on 12 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Livas Stein, PhD ((336) 256-0041, glstein@uncg.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Motivation (Parent-reported) (time frame: Baseline, 3-month after intervention, 6-months after intervention, and 12-months after intervention). The study lists 4 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 12 Dec 2023.