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Racial DiscriminationEMBRaceNCT04096378

EMBRace With Grandparents

A study testing EMBRace Intervention Group and EMBRace Waitlist Group in people with Racial Discrimination and Depression, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Research on racial discrimination (RD) continues to show the debilitating toll on mental and physical health for adolescents throughout their developmental trajectory, particularly for Black Americans. Read more about this study

Who is it for?
Ages 10 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Racial Discrimination, Depression, Anxiety
What is being tested?
EMBRace Intervention Group and EMBRace Waitlist Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
3 Apr 2023to 5 May 2023
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 10 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • The child must be between the ages of 10-14 years.
  • At least one caregiver will be primarily designated to attend sessions.
  • At least one biological parent must identify or be identified as African American.
  • The participant is a resident of the Detroit Metropolitan Area.
  • The participant's primary language is English

Who cannot join

  • Having a relative who is currently an EMBRace staff member.
  • At least one of the biological parents does not identify as African American.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Michigan Detroit Center

    Detroit, Michigan, 48203

Other trials in United States

About this study

Official title: Improving Racial Socialization Competency for Black Caregivers Through a Culturally-Informed Familial Therapeutic Intervention

Research on racial discrimination (RD) continues to show the debilitating toll on mental and physical health for adolescents throughout their developmental trajectory, particularly for Black Americans. While adolescents may employ emotion-focused behaviors (e.g., overeating, etc.) in-the-moment to reduce discriminatory distress, such risk-laden behaviors can result in later disparities in their overall health. While this link has been repeatedly established in the literature, racially-specific protective mechanisms (e.g., racial socialization; RS) have been shown to disrupt the pathway from discrimination to health-related outcomes in adolescents. Although informative, the literature on RS has yet to advance our understanding of ways to improve upon these protective processes in Black families. Thus, the proposed study will further our understanding by aiming to improve RS competency (e.g., skills and efficacy) among African American caregivers and youth (ages 10-14) in Detroit, Michigan through the Engaging, Managing, and Bonding through Race (EMBRace) intervention.

The EMBRace intervention facilitates spaces where Black caregivers strengthen and develop skills to be attentive to their adolescent's racial trauma while also reducing their own stress via racial coping knowledge and RS strategies. Parents and adolescents start each session by engaging in separate therapeutic sessions to process experiences of their Black identity. They will then join together for a family session that focuses on enhancing messages about racial pride, bias preparation, rationales behind promoting distrust, and why not engaging in RS practices may be detrimental to youth. EMBRace sessions will take place at the University of Michigan Detroit Center and community sites, and will be video recorded to improve upon the delivery of therapeutic techniques to the families we serve.

Read the detailed description

Approximately 90% of Black youth report facing or witnessing racial discrimination in their proximal (e.g., classroom) and virtual (e.g., social network) environments. The association between discrimination and negative mental health outcomes (e.g., more severe and higher rates of depression) has been repeatedly established in the literature. Moreover, discrimination impairs the way youth cope, and it is this compromised coping that is associated with negative psychological, academic, and health outcomes. Further, adolescent outcomes may lead to marked health complications and widening disparities in adulthood. Within adolescence, families can have a contributing role in the buffering or exacerbation of coping processes and behaviors to discriminatory experiences. The majority of Black families use racial socialization (RS)-or the verbal and nonverbal communication regarding racial matters-to facilitate coping with race. While RS has been shown to disrupt the trajectory from discrimination to negative psychological outcomes in some respects, it has also contributed to increased youth depressive and anxious symptoms given the wide variety of strategies observed in RS communication. Furthermore, less is known about the impact that grandparents have in the socialization process of their adolescent grandchildren, even though Black grandparents are more likely to rear their grandchildren compared to other races and given current trends. To address these gaps, the emergence of a new RS theory and accompanying clinical intervention seeks to investigate and improve upon this potentially protective cultural process by improving RS competency and enhancing coping processes. The Racial Encounter Coping Appraisal and Socialization Theory (RECAST) postulates that caregivers' explicit and consistent delivery of psychoeducation-informed, skilled, and confident RS practices can reduce caregiver stress and subsequent psychological problems experienced by Black youth via greater coping self-efficacy and coping behaviors. The Engaging, Managing, and Bonding through Race (EMBRace) intervention is the application of RECAST and seeks to improve upon competent RS practices through therapeutic and empirically supported strategies. The use of culturally-relevant theory in clinical treatment is vital to Black youth's coping with specific (i.e., racial) stressors linked to long-term health and wellness outcomes. The empirical investigation of RECAST can also clarify whether aging caregivers (e.g., grandparents) develop the same competencies as other primary caregivers for an intergenerational exploration of RS practices. Thus, the goal of this study is to test the effectiveness of a unique culturally-relevant and family-based intervention developed to enhance RS competencies in Black caregivers and reduce negative psychological outcomes for adolescent children. Building on the preliminary data that I collected during the acceptability pilot testing of the EMBRace intervention in Philadelphia, the proposed study will test the mechanism of caregiver RS competency as a moderator of discrimination, coping self-efficacy, coping, and adolescent psychological outcomes.

The specific aims of the study are to:

  1. improve caregiver RS competency, including a decrease in stress;
  2. improve adolescents' self-reported coping strategies through enhanced coping self-efficacy; and
  3. decrease adolescents' self-reported psychological problems within the EMBRace treatment group.

By posttest and 6-week follow-up, EMBRace families are hypothesized to:

  1. be rated as and rate themselves as more competent in their RS practices, including less stress;
  2. report more satisfactory coping and higher coping self-efficacy scores; and
  3. report less psychological problems relative to pre-test and a control group.

The success of an EMBRace pilot and subsequent clinical trials can lead to its uptake by service agencies and youth-facing organizations to address the pervasive societal problem of racial discrimination for Black youth and families. The reduction of psychological harm in Black families will have a reverberating impact in various systems (e.g., school, health, residential), which can also address the persistent gaps evident in these systems (e.g., achievement, life expectancy, resource). Furthermore, I seek to have a sustainable and long-term research agenda in the improvement of patient health given the community-oriented nature of EMBRace, which partners with families and organizations and trains clinicians for both the improvement of Black family outcomes and the treatment of race-related problems.

Being tested
EMBRace Intervention Group, EMBRace Waitlist Group
Keywords
Racial Socialization, Family Functioning, Stress and Coping
Medical subject headings
Racism, Depression, Anxiety Disorders, Psychological Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMBRace Intervention GroupBehavioural

    The EMBRace intervention will consist of five weekly sessions (weeks 2 - 6) that will be facilitated by EMBRace-trained therapists. Throughout the 8-week intervention, families will be scheduled for 2-hour blocks with sessions being administered to each parent and adolescent for 90 minutes (individually for 30 minutes, 15-minute break, and 45-minutes session with parent and adolescent together). The sessions will cover research-based types of Racial Socialization, including cultural pride, preparation for bias, and attentiveness and balance towards societal racism. Parents and youth will also learn and practice five literacy skills to process and manage the stress of racial encounters including the ability to recognize racial discrimination, accurately appraise the stress of self and others, reduce one's stress, engage instead of avoid, and finally resolve toward healthy outcomes.

  • EMBRace Waitlist GroupBehavioural

    The waitlist group will be asked to complete a pretest and posttest while the treatment group goes through the EMBRace intervention. During this time, the waitlist group will not have any additional requirements and will not be given any form of comparative treatments. Upon the completion of the treatment from the intervention group, the waitlist group will be consented for entry into the intervention arm of the study and will follow the procedures for the intervention group above.

Study groups in NCT04096378
Study groupRoleWhat they receive
EMBRace Intervention GroupExperimentalOver 13 weeks, participants will engage in a pretest (week 1) 5 weekly sessions (weeks 2-6), a posttest (week 7) and a follow-up (week 13). The intervention (Engaging, Managing, and Bonding through Race: EMBRace) seeks to reduce racial trauma for both youth and caregivers and increase family functioning via psychoeducation and therapy.
Receives: Behavioral: EMBRace Intervention Group
EMBRace Waitlist GroupOtherParticipants will wait for thirteen weeks without receiving EMBRace or alternative therapeutic sessions. The waitlist group will subsequently become the intervention group with the opportunity to participate in the EMBRace intervention protocol above.
Receives: Behavioral: EMBRace Waitlist Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Racial Socialization Competency

    Racial Socialization Competency (RaSCS) consists of 28 items that include " teach my child to initiate a conversation about race with peers" and "share my emotions about my positive racial encounters." Participants will answer the following questions based on their experiences within the last year. When they do the following with their children, participants indicate A) how much they think they can; B) how prepared they are; and C) how stressed they are.

    Measured: Measured in caregivers at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)

  2. Change in Adolescent Depression

    The Kutcher Adolescent Depression Scale-6 (KADS-6) is a self-report scale specifically designed to diagnose and assess the severity of adolescent depression. The abbreviated 6-item scale will be used instead of the 16 or 11 item scale. The scales identify as 0-Hardly Ever, 1- Much of the time, 2 most of the time, and 3- All of the time.

    Measured: Measured in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)

  3. Change in Problem Behaviors

    Brief Problems Monitor (BPM), is a 19-item scale designed for parents to better assess their child's Internalizing (INT), Attention Problems (ATT), Externalizing (EXT), and Total Problems (TOT). Scales comprise items from the Child Behavior Checklist for Ages 6-18 (CBCL/6-18), Teacher's Report Form (TRF), and Youth Self-Report (YSR). Statements such as "acts too young/old for his age" are accompanied by a scale of 0 (being not true), 1 (somewhat true) and 2 (very true). The items, scales, and norms are based on decades of research and practical experience, as summarized in the BPM Manual.

    Measured: Measured in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)

  4. Change in Perception of Stress

    The Perceived Stress Scale (PSS) is a psychological instrument for measuring the perception of stress. It is a 10-item Likert-based measure of the degree to which situations in one's life are appraised as stressful. Each of the items on the PSS-10 are rated on a 5-point Likert scale, ranging from 0 (never) to 4 (very often). Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. The PSS was designed for use in community samples with at least a junior high school education. Moreover, the questions are of a general nature and hence are relatively free of content specific to any subpopulation group. The questions in the PSS ask about feelings and thoughts during the last month. In each case, respondents are asked how often.

    Measured: Measured in youth and caregivers at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)

Secondary outcomes (2)
  1. Change in Adolescent Coping Behaviors

    Adolescent Coping Orientation for Problem Experiences (A-COPE) measures adolescent coping behaviors that results from the normal adolescent stress associated with trying to create a balance between being connected to and at the same time independent from one's family. A-COPE is a 54 item self-report questionnaire used to identify coping strategies employed by adolescents. (e.g., When you face difficulties or feel tense, how often do you talk to your mother about what bothers you?) Responses of A-COPE are measured on a 5-point Likert scale (never, hardly, sometimes, often, most of the time).

    Measured: Measured in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)

  2. Change in Adolescent Racial Distress

    The Adolescent Discrimination Distress Index measures distress associated with instances of perceived racial prejudice encountered in educational contexts. It is a 15-item scale, each question asking, "Have you experienced this?" Responses are in dichotomous format with "yes/no" answer options. If answered yes, each question will ask "If you had this experience, did it upset with?" with a Likert response scale of 1-5. 1 (not at all), 2 (slightly), 3 (moderately), 4 (considerably), 5 (extremely).

    Measured: Measured in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2019
  2. Study start3 Apr 2023
  3. Primary completion5 May 2023
  4. Study completion5 May 2023

Resources

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
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04096378
Sponsor's protocol ID
HUM00160402
Acronym
EMBRace
Status last verified
May 2023
First submitted
12 Sep 2019
Last updated
9 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share participants' data with other researchers.

Publications

  • Anderson RE, Stevenson HC. RECASTing racial stress and trauma: Theorizing the healing potential of racial socialization in families. Am Psychol. 2019 Jan;74(1):63-75. doi: 10.1037/amp0000392.

    PubMed 30652900
  • Anderson RE, McKenny MC, Stevenson HC. EMBRace: Developing a Racial Socialization Intervention to Reduce Racial Stress and Enhance Racial Coping among Black Parents and Adolescents. Fam Process. 2019 Mar;58(1):53-67. doi: 10.1111/famp.12412. Epub 2018 Dec 15.

    PubMed 30552778
  • Anderson RE, Jones SCT, Navarro CC, McKenny MC, Mehta TJ, Stevenson HC. Addressing the Mental Health Needs of Black American Youth and Families: A Case Study from the EMBRace Intervention. Int J Environ Res Public Health. 2018 May 2;15(5):898. doi: 10.3390/ijerph15050898.

    PubMed 29724068
  • Anderson RE, McKenny M, Mitchell A, Koku L, Stevenson HC. EMBRacing racial stress and trauma: Preliminary feasibility and coping responses of a racial socialization intervention. Journal of Black Psychology 44(1): 25-46, 2018.

Questions about this trial

What is this clinical trial studying?

A study testing EMBRace Intervention Group and EMBRace Waitlist Group in people with Racial Discrimination and Depression, run by University of Michigan 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 5 inclusion and 2 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 9 May 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?

Change in Racial Socialization Competency (time frame: Measured in caregivers at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)). 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?

On the ClinicalTrials.gov record for NCT04096378, which also lists 4 linked publications.

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 9 May 2023.

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