Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04096378
Other study ID # HUM00160402
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 3, 2023
Est. completion date May 5, 2023

Study information

Verified date May 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 5, 2023
Est. primary completion date May 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 99 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Having a relative who is currently an EMBRace staff member. - At least one of the biological parents does not identify as African American.

Study Design


Intervention

Behavioral:
EMBRace Intervention Group
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 Group
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.

Locations

Country Name City State
United States University of Michigan Detroit Center Detroit Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (4)

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: 10.339 — View Citation

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.

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 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 in caregivers at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)
Primary 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 in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)
Primary 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 in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)
Primary 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 in youth and caregivers at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)
Secondary 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 in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)
Secondary 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 in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A