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EMBRace With Grandparents (EMBRace)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096378
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Riana Anderson, University of Michigan

Brief 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.


Condition or disease Intervention/treatment Phase
Racial Discrimination Depression Anxiety Stress Trauma, Psychological Behavioral: EMBRace Intervention Group Behavioral: EMBRace Waitlist Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Racial Socialization Competency for Black Caregivers Through a Culturally-Informed Familial Therapeutic Intervention
Estimated Study Start Date : September 17, 2020
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : February 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: EMBRace Intervention Group
Over 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.
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
Participants 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in Racial Socialization Competency [ Time Frame: Measured in caregivers at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13) ]
    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.

  2. Change in Adolescent Depression [ Time Frame: Measured in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13) ]
    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.

  3. Change in Problem Behaviors [ Time Frame: Measured in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13) ]
    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.

  4. Change in Perception of Stress [ Time Frame: Measured in youth and caregivers at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13) ]
    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.


Secondary Outcome Measures :
  1. Change in Adolescent Coping Behaviors [ Time Frame: Measured in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13) ]
    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).

  2. Change in Adolescent Racial Distress [ Time Frame: Measured in youth at pretest (week 1), Posttest (week 7), and 6 week follow-up (week 13) ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096378


Contacts
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Contact: Kamilah Davis-Wilson, MHA 734-936-3750 TheEMBRaceProgram@gmail.com
Contact: Kyle Nisbeth, MPH knisbeth@umich.edu

Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Riana E Anderson, PhD University of Michigan
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Riana Anderson, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04096378    
Other Study ID Numbers: HUM00160402
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share participants' data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riana Anderson, University of Michigan:
Racial Socialization
Family Functioning
Stress and Coping
Additional relevant MeSH terms:
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Psychological Trauma
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders