Adapting substance use treatment for black adolescents in the US legal system: protocol for a mixed-method, exploratory, feasibility and acceptability study using the eight-step ADAPT-ITT framework

Abstract

Introduction

This community-led research study protocol emphasises placing black youth impacted by the legal system, their families and their communities at the forefront of substance use treatment development research and decision-making. The study, the Cultural Adaptation of a Substance Use Treatment (CAST) Project, challenges traditional top-down approaches to treatment creation, advocating for a grassroots model that centres community knowledge, values and active participation.

Methods and analysis

The CAST project is a US-based mixed-methods study with an exploratory design that examines the impact of racial discrimination on substance use in black youth impacted by the legal system. The study participants are black youth impacted by the legal system (N=15), parents of black youth impacted by the legal system (N=10) and community members who serve black youth (N=10) (total N=35 study participants). Study participants from each group (youth, parents and community members) will participate in three separate focus groups, respectively, to provide feedback on the culturally responsive content needed to best support black youth impacted by the legal system around substance use and mental health. The eight-step Assess, Decision, Adaptation, Production, Topical Expert, Integration, Training, Testing framework will be used as a guide to inform adaptations to the Motivational Enhancement Therapy and Cognitive Behavioural Therapy (MET/CBT12) for black youth impacted by the legal system. Once the cultural adaptation process has been completed, the study will conclude with an open feasibility and accessibility trial of the culturally adapted MET/CBT12 manual. The primary outcomes of this study are the feasibility and acceptability of the culturally adapted manual, measured by treatment attendance and participant feedback. Secondary outcomes include reductions in substance use and discrimination distress, and improvements in mental health symptoms.

Ethics and dissemination

This study was approved by the Institutional Review Board (IRB) at the University of California, San Francisco (IRB Protocol Number: 23-40126). All study procedures will be conducted in accordance with the ethical standards outlined by the institutional review board. The results from this study will be shared through peer-reviewed publications, academic conferences, community forums and policy briefs to support broader implementation of culturally adapted adolescent substance use interventions that address discrimination-related stress and substance use among black individuals impacted by the legal system.

Trial registration number

NCT06003725.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This study is grounded in robust evidence-based frameworks (Motivational Enhancement Therapy and Cognitive Behavioural Therapy and Assess, Decision, Adaptation, Production, Topical Expert, Integration, Training, Testing), which are effective in reducing adolescent substance use and cost-effective in adapting evidence-based interventions, respectively.

• There are anticipated barriers around scalability and sustainability, as treatment programmes rarely deliver substance use treatment in clinical settings according to race.

• This study will not conduct a cost-analysis to better understand how a culturally adapted programme could be successfully delivered in existing billing structures due to budget limitations.

• This is an early-phase feasibility design with a small sample size, making it difficult to detect meaningful clinical change.

• There is a heavy reliance on self-reported substance use and discrimination experiences in this study, which could lead to social desirability bias.

Introduction

Anti-Blackness, or anti-black racism, refers to the unique, systemic and historically rooted nature of racism directed at black people, distinct from the broader forms of racism faced by other marginalised groups.¹ The pervasive impact of anti-black racism within the legal system perpetuates a cycle of marginalisation, disproportionately ensnaring black youth and compounding the challenges they face, including heightened risks of substance use and barriers to equitable treatment.² Anti-black racism experienced by black youth has been linked to several negative outcomes including internalising symptoms (eg, depression and anxiety)2,5 and externalising behaviours (eg, aggression and substance use).^{6 7} Racism experienced by black youth, including treatment by law enforcement, has been widely documented.^{8 9} Black boys are more likely to have encounters with law enforcement due to racial profiling, school disciplinary policies that disproportionately target them and over-policing in predominantly black communities than their white peers,10,12 and these interactions are more likely to include interpersonal violence and use of excessive force by officers, with negative outcomes.13,15 In addition to these experiences, black youth impacted by the legal system (YILS) have also likely witnessed numerous examples of fatal shootings of unarmed black teenage boys, often by white police officers and private citizens.^{8 9} Research suggests that because anti-black racism is persistent and pervasive, racial trauma and vicarious trauma are likely to play a role in perpetuating substance use in black youth.^{16 17} Black YILS using substances are more vulnerable to poor educational outcomes, behaviour problems and depressive symptoms^{18 19}; have a higher likelihood of entering the adult criminal punishment system; and experience harsher policing practices and sentencing for drug-related crimes.²⁰ Studies show that black YILS are also less likely to be diverted to substance use treatment programmes,²¹ and for black YILS that have engaged in substance use treatment, studies suggest that Black youth often report less satisfaction with treatment and a lack of cultural sensitivity.²² Studies also suggest ethnic and racial differences in treatment engagement and retention for black youth regarding substance use treatment^{18 19 23 24} compared with their white peers.

Psychosocial interventions remain the primary modality of adolescent substance use treatment.^{25 26} Evidence-based substance use interventions for adolescents include family-based therapies, Cognitive Behavioural Therapy (CBT) and multicomponent interventions, such as the combination of Motivational Enhancement (MET)/Motivational Interviewing (MI) and CBT.²⁵ One multicomponent intervention, MET/CBT12, has demonstrated effectiveness in reducing youth cannabis and alcohol use across different youth populations, including YILS.²⁷ Moreover, MET/CBT12 is more feasible and cost-effective than leading family-based therapies (eg, multidimensional family therapy),²⁷ promoting accessibility for youth without stable family support and costing significantly less per person in recovery at the end of treatment.^{27 28} While MET/CBT12 is effective in reducing cannabis and alcohol use among YILS, research has documented several unique risk factors for substance use experienced by black YILS that are not addressed by MET/CBT12. Documented links between experiences of anti-black racism and increased substance use among black YILS highlight the need for an effective intervention that addresses substance use, racial trauma and discrimination distress.²⁹ To date, no known adolescent substance use treatment directly addresses the increased likelihood of substance use due to experiences of anti-black racism or explicitly presents tools on how to reduce substance use and cope with discrimination distress in healthy ways. In response to this critical need, culturally adapting evidence-based interventions is necessary to address the unique needs and experiences of populations for whom the MET/CBT12 intervention was not originally designed.³⁰

The cultural adaptation process will be conducted using the Assess, Decision, Adaptation, Production, Topical Expert, Integration, Training, Testing (ADAPT-ITT) model, a pragmatic framework consisting of eight sequential phases that aid in informing the modifications for existing evidence-based interventions.³¹ The ADAPT-ITT framework has been used in previous studies to adapt evidence-based HIV prevention programmes.32,34 Each phase of this model provides implementation strategies through a grassroots approach to ensure that the cultural adaptation process, the culturally adapted manual, and its delivery incorporate the voices of black YILS, parents and community members and align with the specific cultural needs of black YILS. This paper outlines the study protocol for a National Institute on Drug Abuse study (K23DA057412 (PI: Bryant)), also known as the CAST (Cultural Adaptation of Substance Use Treatment) project, that aims to culturally adapt MET/CBT12, using a community-led approach that prioritises the essential voices of black YILS, black parents and black community members. The study employs mixed methods with an exploratory design, resulting in an open trial for testing feasibility and acceptability. The exploratory design will be facilitated sequentially (qualitative→quantitative) with special attention to incorporating themes and input from individuals with lived experiences. CAST emphasises and values the voices and experiences of each study participant because the community for which this intervention is being culturally adapted is highly impacted by the negative sequelae of adolescent substance use, and therefore stands to benefit from the co-design, implementation and dissemination of this programme.

Study aims and hypothesis

The three primary aims of this prospective study are:

1. Use ADAPT-ITT phases 1–4 to culturally adapt the Cannabis Youth Treatment (CYT) programme for black justice-involved youth by incorporating feedback from youth, caregivers and community members to develop a draft adapted intervention.

2. Use ADAPT-ITT phases 5–7 to refine the culturally adapted CYT manual through expert review, integrate feedback and train the principal investigator (PI) to deliver the adapted intervention.

3. Use ADAPT-ITT phase 8 to pilot the culturally adapted CYT manual with 30 black YILS to assess feasibility and acceptability.

Our secondary aim is to evaluate treatment retention and preliminary changes in substance use, substance-related problems, any improvements in mental health symptoms and discrimination distress.

Our primary hypothesis is that youth receiving the culturally adapted CYT intervention will complete at least 75% of sessions and demonstrate a reduction in alcohol and other drugs (AOD), AOD-related problems and discrimination distress.

Methods and analysis

Theoretical framework

The theoretical framework of this study is grounded in the Stress-Coping Theory, which suggests that an individual adopts coping strategies to manage unpleasant emotions caused by stress, even if this solution is temporary.^{35 36} Compared with white people, black individuals experience more periods of high stress due to instances of structural racism, discrimination and adverse social determinants of health.^{37 38} This theory posits that black youth are more likely to engage in substance use in an attempt to escape, avoid or minimise unpleasant or aversive emotional experiences related to discrimination or racism.³⁶ Previous studies support the applicability of the Stress-Coping Theory to explain increased substance use in response to negative life experiences or stressors (eg, anti-black racism or discrimination).^{36 39 40} This study will test the Stress-Coping Theory by examining if substance use is reduced in black YILS when healthier coping skills are introduced and available to address discrimination distress.

Settings

This study will be conducted in collaboration with a network of community-based organisations, youth-serving agencies and juvenile probation offices located in Contra Costa and Alameda counties, California. Both counties are racially and economically diverse urban areas disproportionately impacted by youth criminalisation and health inequities. Aligned with community-engaged research principles, recruitment, data collection and pilot implementation will occur in trusted, youth-centred community spaces co-selected with feedback from black YILS, black parents and black community members to ensure cultural relevance, safety and accessibility.

Recruitment setting

Study participants will be recruited through established partnerships with local community probation offices, diversion programmes and youth development organisations. Flyers, presentations and direct referrals from probation officers and case managers will be used, with all recruitment processes conducted in settings where youth and families already receive supportive services.

Focus group setting

Focus groups will take place in private meeting rooms at community centres and youth-serving agencies that are familiar and accessible to participants. Locations will be selected based on feedback during the recruitment process to prioritise safety, ease of transportation and youth comfort. Food and transportation support (eg, ride share vouchers or transit cards) will be provided to reduce participation barriers.

Pilot implementation setting

The adapted intervention will be piloted in person at a youth community centre. The setting will be chosen through collaborative decision-making with youth and community stakeholders, ensuring alignment with the intervention’s goals of promoting healing, cultural identity and prosocial engagement.

ADAPT-ITT guidance

The phases of the ADAPT-ITT model map onto the three study-specific aims as indicated in figure 1 to inform the cultural adaptation of MET/CBT12 for black YILS.

Figure 1. Phases of the ADAPT-ITT model mapped onto the three study-specific aims to inform the cultural adaptation of Motivational Enhancement Therapy and Cognitive Behavioural Therapy (MET/CBT12) for black youth impacted by the legal system. ADAPT-ITT, Assess, Decision, Adaptation, Production, Topical Expert, Integration, Training, Testing; RCT, randomised controlled trial.

Phase 1: assessment

This phase of the study consists of conducting formative evaluations with black YILS, parents of black YILS and black community members to elicit their preferences for culturally relevant content to be included during the cultural adaptation process. Specifically, one focus group will be completed with local black YILS (N=15), one focus group will be completed with guardians of black YILS (N=10) and one focus group will be completed with black community members (N=10) that serve black YILS. Community members participating in this study will include adults with lived and professional expertise in the education system, the legal system, housing or the local neighbourhood, healthcare and/or financial literacy to reflect the voices of domains that are consistent with addressing social determinants of health, or the conditions that impact a person’s health outcomes, quality of life and functioning.⁴¹

Participants will be asked questions on strengths within the black community and their experiences with racism and discrimination, accessing substance use treatment in the community, resilience, coping and substance use knowledge. Participants will also be shown session content from the MET/CBT12 model to obtain feedback on session content and cultural aspects that could or should be added to the culturally adapted adolescent substance use treatment manual.

Although the PI identifies as a cisgender black woman, there is still a need to attend to the mistrust of research within the black community stemming from historical events like the Tuskegee Syphilis Study⁴² and the mistreatment of historical figures such as Henrietta Lacks.⁴³ Building a partnership with community members first will aid them in vetting the intentions of the PI and will provide the PI the opportunity to share the importance of prioritising black community member voices, along with the voices of black YILS and families throughout the duration of this study.

Phase 2: decision

According to the ADAPT-ITT framework, a decision about which intervention to adapt typically follows the assessment phase. At the time the study was conceptualised in 2022, MET/CBT12 was the adolescent substance use treatment approved for use with YILS by the then partnering state’s Department of Juvenile Justice, which resulted in the decision to culturally adapt MET/CBT12.

Phase 3: adaptation

The next phase of ADAPT-ITT begins the formal process of adaptation. Community members, parents of black YILS and black YILS will be recruited (in that order) to provide community member and parent participants the opportunity to vet the PI prior to referring black YILS for possible participation in CAST. Participants will participate in one recorded focus group for their respective participant group, each lasting up to 2 hours, and participants will be compensated US$100 for their time. Both adult and youth participants will be asked about experiences with anti-black racism and discrimination, ways participants have coped with anti-Black racism and discrimination, strength and resilience in the black community, knowledge about substance use in the black community, and thoughts on adolescent substance use treatment sessions. Specifically, all participants will be asked about format and delivery (eg, length of each session, what number of sessions would be feasible and if in-person vs online sessions are preferred), what session content should be added to address the unique needs of black YILS, and what delivery format, number of sessions or session content has and has not been useful in past experiences. Audio recordings will be transcribed by an outside HIPAA (Health Insurance Portability and Accountability Act)-approved transcription service, where names and identifying information will be redacted and transcriptions of each focus group will be reviewed by two independent coders. Coders will consist of the PI and one trained clinical research analyst. Coders will extract direct quotes and major themes from qualitative data collected during respective focus groups to inform adaptations to the original evidence-based intervention. The process of adaptation will be guided by an iterative qualitative data analysis approach. Recommendations for changes to the MET/CBT12 will be derived from thematic analysis of focus group discussions with black youth, caregivers and community stakeholders. Thematic findings will inform modifications to ensure cultural relevance and acceptability. To ensure systematic decision-making, a ranking process will be employed to prioritise changes based on feasibility, cultural significance and potential impact on treatment outcomes. High-priority adaptations will be incorporated into the manual, while lower-priority changes will be considered for future iterations. To ensure that adaptations reflect the lived experiences and priorities of black justice-involved youth, a Community Advisory Board (CAB) will be established to guide decision-making throughout the remainder of the cultural adaptation process. The CAB will be composed of youth with lived experience, caregivers, community advocates and behavioural health providers, all of whom will bring critical insight into the cultural, contextual and structural factors impacting treatment engagement. During the prioritisation phase, CAB members will review emergent themes from qualitative data and collaboratively decide on the relevance, urgency and cultural significance of potential adaptations. This participatory approach grounds adaptation decisions in community wisdom, ensuring the intervention is not only evidence-based, but also culturally responsive, acceptable and actionable.^{32 33}

The Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) will be used to inform the documentation of what, how and why adaptations occur. This type of documentation is important prior to finalising and delivering the anticipated culturally adapted substance use treatment to track changes and ensure replicability in the future if needed. Specifically, FRAME proposes the following considerations: (1) when and how in the implementation process the modification was made, (2) whether the modification was planned/proactive or unplanned/reactive, (3) who determined that the modification should be made, (4) what is modified, (5) at what level of delivery the modification is made, (6) type or nature of context or content-level modifications, (7) the extent to which the modification is fidelity-consistent and (8) the reasons for the modification, including (a) the intent or goal of the modification (eg, improve fit, adapt to a different culture, reduce costs, etc) and (b) contextual factors that influenced the decision.^{44 45}

Phase 4: production

Once adaptations are made, the first draft of the culturally adapted MET/CBT12 manual will be developed and shared through an iterative process with black YILS, parents and community members that provided input in previous focus groups. Specifically, the PI will host a community share back event with the respective community groups. In each share back event, the PI will reorient participants to the need for a culturally adapted adolescent substance use treatment and what the intervention aims to do. The PI will then present the new draft of the culturally adapted manual with attention to the content in the manual, differences between the original manual and the culturally adapted manual, delivery method, session length and design. Each share back event will last 2 hours and will be recorded to capture responses and feedback from attendees. After each share back event, audio recordings will be transcribed. The PI and clinical research analyst will update the manual based on any feedback received at the share back events in preparation for topical experts in the field to review the drafted manual.

Phase 5: topical experts

The first draft of the culturally adapted adolescent substance use treatment manual will be shared with an expert in community-engaged participatory research, an MET/CBT expert, and an expert on the cultural adaptation process during a recorded online session. All three experts will be asked to review the first draft of the culturally adapted adolescent substance use treatment manual and provide feedback individually to ensure accuracy in maintaining the evidence-based treatment’s core elements during the cultural adaptation process. Experts will also be asked to comment on the structure and anticipated delivery of the culturally adapted adolescent substance use treatment with black YILS. Once written feedback is received, the PI will meet with all three experts on a group Zoom meeting to discuss the feedback and resolve any differences in viewpoints prior to preparing the manual for use in an open trial. The core elements of MET/CBT12 include: (1) Motivational Enhancement, (2) Cognitive Behavioural Therapy, (3) communication and refusal skills, (4) skills to cope with cravings, (5) skills to manage emotions, (6) preparation for emergencies and safety planning and (7) goal setting.²⁷

Phase 6: integration

The PI and clinical research analyst will apply the feedback from participant groups and topical experts using the same principles for decision-making employed during the adaptation phase: feasibility, cultural significance and potential impact on treatment outcomes. This feedback will be integrated to inform the development of a second draft of the culturally adapted adolescent substance use treatment. The PI will rely on feedback from the CAB during the production phase to finalise the second draft of the culturally adapted MET/CBT12 intervention.

Phase 7: training

In preparation for an open trial of the newly culturally adapted manual, the PI will undertake several key tasks. The PI will develop handouts and resources to support treatment sessions and ensure that all relevant outcome measures are available electronically for use on smartphones and tablets. The PI and clinical research coordinator will conduct a comprehensive walkthrough of the open trial process, from participant recruitment, screening and consent to the completion of treatment sessions. This walkthrough will include testing the digital assessment format, verifying the functionality of oral drug screens and addressing any potential challenges to ensure a smooth and efficient open trial.^{31 34} The PI will also begin recruitment for the open trial of the culturally adapted MET/CBT12 protocol.

Phase 8: testing

In this phase, the PI will test the culturally adapted MET/CBT12 intervention with up to 30 black YILS. Partnering organisations in the Bay Area who participated in phase 1 focus groups will be asked to share information about the open trial in their respective organisations for recruitment purposes. Interested youth will contact the study clinical research coordinator who will conduct an eligibility screening, describe the study protocol in detail, describe the risks and benefits of participation, and obtain informed consent and assent (for youth under the age of 18). California state law permits minors aged 12 and older to independently consent to substance use and mental health treatment. We will request a waiver of parental consent for youth participants under 18. Given the sensitive nature of substance use and justice involvement, requiring parental consent may place youth at risk, deter participation or introduce coercion, especially for youth who are estranged from caregivers, in unstable home environments or experiencing fear of punishment. Consistent with ethical guidelines for research with vulnerable populations, a waiver of parental permission is justified to respect youths’ legal rights, maximise participation and reduce harm. Youth assent and informed consent will be obtained directly from participants in a developmentally appropriate manner, ensuring full understanding of the study’s purpose, procedures, risks and protections. Procedures to ensure privacy, safety and confidentiality will be strictly followed, including mandated reporting protocols as required by law.

Youth who assent to participate will have an individual in-person orientation session, will complete baseline measures and be provided with study resources and materials (eg, a binder containing handouts for each session). Youth orientation will also include instructions to complete the oral fluid drug screen that will be administered each week prior to the start of each group.

The culturally adapted intervention will be facilitated in a group format (10–12 youth per group) by the PI. To reduce barriers to participation, youth may choose to receive their group sessions either in-person or virtually. If youth prefer virtual participation and do not have a smartphone or tablet, a device will be provided to them. The clinical research coordinator will be present for group sessions to monitor the discourse, document any procedural or technical issues that need to be addressed prior to future sessions, respond to concerns posed by participants and monitor protocol fidelity. As mentioned in phase 7, materials like the fidelity forms will be developed along with handouts and other materials in preparation for the open trial. Youth will complete a set of measures and an oral drug screen prior to the start of each session.

Eligibility criteria

In the focus group phase, black YILS, parents and community members participate. In the open trial phase, only black YILS participate. Eligible parents of black YILS and community members must self-identify as black or African-American and either as a guardian of or an advocate for (ie, someone who supports change and reform in the justice community) for black YILS, respectively. Eligible black YILS are: (1) between the ages of 13 and 17, (2) self-identify as Black or African-American, (3) currently or previously affiliated with the juvenile legal system or on community probation within the last 3 years, (4) referred to or participated in substance use or mental health treatment within the last 3 years and (5) speak English as their first language. In the open trial phase, black YILS must meet the aforementioned criteria, except for the requirement for referral or participation in past substance use or mental health treatment. In the open trial, youth will also need to endorse the presence of mental health symptoms (eg, anxiety, depression or trauma-related distress) on a designated screener and agree to attend the full intervention session duration.

Exclusion criteria for this study are minimal. Guardians of black YILS and black community members will be excluded if they exhibit cognitive impairment that precludes their focus group participation. Black YILS are excluded from the focus groups if they are incarcerated or have a significant intellectual or developmental disability that precludes their focus group participation. Black YILS are excluded from the open trial if they meet the aforementioned exclusion criteria or if they are in immediate need of inpatient or intensive outpatient treatment. To be deemed cognitively able, the participant must not have significant or acutely unstable medical, psychiatric or substance use problems that would interfere with safety, compromise data integrity or preclude study participation.

Outcome measures

Outcomes will be collected in phase 8 (pilot), testing at baseline, weekly sessions, postintervention and 3-month follow-ups as shown in figure 2.

Figure 2. Outcomes to be collected in phase 8 (pilot) at baseline, weekly sessions, postintervention and 3-month follow-up. GAD-7, Generalised Anxiety Disorder-7; PHQ-9, Patient Health Questionnaire-9.

Mental health symptoms

MINI-KID will be used to comprehensively assess mental health symptoms.⁴⁶ The MINI-KID is a short, structured clinical diagnostic interview designed to assess the presence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition and International Classification of Diseases, 10th Revision psychiatric disorders in children and adolescents.⁴⁶

Symptoms Checklist-90 (SCL-90) is a self-report measure for persons aged at least 13 years. It consists of 90 items that represent nine factors and seven additional questions that are configured items, primarily concerning disturbances in appetite and sleep patterns, and are not scored collectively as a dimension.⁴⁷ SCL-90 will be used to evaluate the range and intensity of psychological distress, respectively.^{46 48}

Patient Health Questionnaire (PHQ-9) will be used to assess symptoms of depression. This questionnaire is a youth-report version of one of the most widely used adult depression screening measures, the PHQ-9.⁴⁹ The PHQ-9 consists of the same nine items as the adult version but with slight rephrasing to be more appropriate for adolescents.

Generalised Anxiety Disorder Scale (GAD-7) will be used to track changes in anxiety symptoms.⁵⁰ The GAD-7 is a seven-item instrument used to assess the severity of generalised anxiety disorder. Each item asks the person to rate the severity of their symptoms over the past 2 weeks.⁵¹

Adolescent Discrimination Distress Index will be used to track symptoms of distress associated with discrimination.³⁹ The Adolescent Distress Index is a 5-item measure capturing perceived racial and ethnic discriminatory experiences, to define any discrimination and discrimination distress.⁵²

Substance use

One of the two measures of substance use will be assessed at every time point.

Timeline Follow Back Interview (TLFB) is a reliable and valid measure of substance treatment outcomes (eg, quantity and frequency of use) for adolescents.⁴⁰ Using this measure, the PI will present a calendar to the participant and ask the youth to recall any alcohol or drug use behaviours in the past month.⁵³

Oral Fluid Drug Screens will be self-administered remotely by the subject and observed and read by the PI during each session. Oral fluid drug screens were chosen over urine drug screens because the therapist can observe and read oral fluid testing and it is non-invasive to adolescents.⁵⁴ Studies have also shown that saliva allows for detection of drugs excreted from the blood after recent use (ie, within 24–48 hours) that may not yet be detectable in urine.⁵⁵

Behavioural and emotional skill building

Various skills will be assessed at baseline, postintervention and during 1- and 3-month follow-up.

Difficulties in Emotion Regulation Scale will be used to assess emotion regulation. Adolescents will rate 15 items (eg, ‘when I am upset, I become out of control’) on a 5-point scale from 1 (almost never) to 5 (almost always).^{56 57}

Cognitive Emotion Regulation Questionnaire will be used to evaluate the thoughts that arise from experiencing negative events. Specifically, it measures cognitive strategies that people employ when experiencing negative or stressful events.⁵⁸

Brief COPE Questionnaire will be used to measure coping strategies. This measure will assess the use of seven coping strategies, including the use of substances to cope with stressful events.^{59 60}

Adolescent Racial and Ethnic Socialization Scale (ARESS) will be used to assess racial socialisation.⁶¹ The ARESS uses 14 items to assess three subscales of racial socialisation (1) racial barrier awareness, (2) coping with racism and discrimination and (3) the promotion of cross-racial relationships.⁶²

Multidimensional Inventory of Black Identity-Teen (MIBI-T) will be used to assess Racial Pride.⁶³ The MIBI-T is a measure of racial identity that is specifically designed for African American youth. It consists of 21 questions answered on a 5-point Likert scale that ranges from strongly disagree (1) to strongly agree (5).⁶⁴

Feasibility and acceptability

To measure feasibility and acceptability, participants will be given the Feasibility of Intervention Measure and Acceptability of Intervention Measure at the end of each weekly session.³⁴ At the postintervention assessment, participants will complete qualitative exit interview questions to solicit feedback on the culturally adapted intervention, delivery and any further refinements. Participants will be compensated at baseline, postintervention and at the 3-month follow-up for their time and participation (baseline=$20.00, postintervention=$30.00 and 3-month follow-up=$50.00). Participants will also receive an incentive for completing each weekly oral drug screen ($10 per screen).

Data analysis plan

The primary outcome of study feasibility will be determined by the study’s ability to successfully retain 80% of enrolled participants throughout the study treatment period while participants attend at least 75% (9 out of 12 sessions) of the culturally adapted MET/CBT12 sessions. In addition to retention, a low rate of missing primary efficacy outcome data (≤10% missing) will demonstrate the ability to integrate the intervention with standard care components. The PI’s adherence to the protocol will be monitored weekly by research staff with fidelity forms. Research staff will also keep track of the proportion of sessions attended by youth and weekly TLFB and drug screens completed. Any changes in substance use days and amounts of use per day, as well as discrimination distress and depression and anxiety symptoms, will be measured during study treatment and follow-up as secondary outcomes. The PI anticipates that treatment with the culturally adapted MET/CBT12 will decrease substance use and discrimination distress. Rates of change from baseline to the end of study treatment and follow-up will be estimated with generalised linear mixed effects regression models. Linear slope trends over time and associated SEs will be calculated for all data. Normality of model residuals will be assessed using Q–Q plots and data transformations will be performed as needed.

During the focus group phase, feedback will be analysed using Atlas.ti software by the PI and research coordinator. Latent and manifest qualitative content analysis will be used to identify and describe major themes and subthemes that emerge.⁶⁵ This is a dynamic type of analysis oriented toward recognising, coding and categorising patterns from text data. Manifest content analysis involves the visible, obvious components of what the transcript says; latent content analysis involves an interpretation of the underlying meaning of the text. Methods are used to explore participants’ unique perspectives via the identification of themes/patterns that naturally emerge from the data and the systematic classification of these themes. In qualitative analyses, independent coders will immerse themselves together with their analyses to confirm themes and resolve any divergent analyses through a reconciliation and refinement process. 35 participants were selected to ensure recurring themes reach saturation. Verification to examine rates of volunteered versus directed participant responses will be conducted to evaluate the reliability and validity of the conclusions and outcome.

Patient and public involvement

Study participants consist of black YILS (N=15), parents of black YILS (N=10) and community members who serve black youth (N=10) (total N=35 study participants). The voices of participants will be centred, and feedback will be directly taken and applied to the cultural adaptation of the CYT manual in preparation for the open trial. Input from the study’s CAB will also provide input in the design, planning and preparation of the pilot feasibility and acceptability trial. On completion of the open feasibility and acceptability trial, participant feedback will be requested to continue refining the culturally adapted CYT manual. A summary of study results will be disseminated to participants through papers, presentations and virtual ‘Share Back’ events. Share Back events are events exclusively for community members, participants with lived experience and those who may in some way directly benefit from this work to learn about the themes, results and possible ways to action and get involved. The study’s CAB will also be involved in the design, planning and reporting for each Share Back event.

Ethics and dissemination

This study was approved by the Institutional Review Board (IRB) at the University of California, San Francisco (IRB Protocol Number: 23-40126). All study procedures will be conducted in accordance with the ethical standards outlined by the institutional review board. Youth, parents and community members will receive verbal and written information explaining the purpose of the study. Minors can provide assent to participate in the study without approval from their parents. All participants will receive compensation for their participation in the study. The results from this study will be shared through peer-reviewed publications, academic conferences, community forums (Share Back events) and policy briefs to support broader implementation of culturally adapted adolescent substance use interventions that address discrimination-related stress and substance use among black YILS.

Discussion

Significant racial disparities in substance use treatment outcomes, engagement and retention have been well-documented among black YILS, highlighting the inadequacy of existing treatments that are predominantly validated with white US samples. Furthermore, no adolescent substance use treatment currently addresses the compounded effects of anti-black racism and discrimination, nor do they offer explicit tools for responding to substance use and discrimination distress in a healthy manner. CAST aims to fill this critical gap by reducing substance use, reducing discrimination distress and improving mental health outcomes through the enhancement of protective factors like the development of healthy culturally responsive coping skills among black YILS and racial and ethnic pride. By ensuring that black YILS can access these tools in a culturally relevant and appropriate way, the project has the potential to foster positive outcomes not only for black YILS but also for the broader black community and society at large.

Traditionally, many substance use interventions have employed a top-down approach to cultural adaptation, in which experts impose adaptations without meaningful input from the communities they intend to serve.⁶⁶ However, this approach often fails to capture the unique cultural, social and contextual nuances that affect treatment engagement and outcomes in marginalised populations. Top-down approaches can inadvertently perpetuate the very disparities they aim to address, as they may not fully account for the lived experiences, values and needs of the target population.^{66 67} In contrast, a bottom-up or grassroots approach, which involves co-designing interventions with direct input from the community, is more likely to produce culturally resonant and effective adaptations.^{68 69} Engaging black YILS and their communities in the adaptation process ensures that the intervention better reflects their lived experiences and addresses their specific needs. This approach fosters a sense of ownership and relevance, which can enhance engagement, retention and overall treatment effectiveness. The grassroots approach is particularly critical in addressing anti-black racism and discrimination, as it allows for the incorporation of culturally specific protective factors, such as ethnic pride, and the development of coping strategies that are directly informed by those who experience discrimination firsthand.^{68 69} In addition to focus groups informing the cultural adaptation of an evidence-based adolescent substance use treatment, qualitative data from the CAST project may also provide valuable insight into the contextual factors that have sustained ongoing substance use despite the presence of protective factors. This information could be instrumental for substance use prevention efforts and provide insights regarding the successful implementation and dissemination of a culturally adapted substance use treatment in a community-based setting.

Although this study is grounded in robust evidence-based frameworks (MET/CBT and ADAPT-ITT), there are limitations in this study to consider. (1) There are anticipated barriers around scalability and sustainability, as treatment programmes rarely deliver substance use treatment in clinical settings according to race. This programme would be well-suited within a community-based programme with culturally responsive programming. (2) This study will not conduct a cost-analysis to better understand how a culturally adapted programme could be successfully delivered in existing billing structures due to budget limitations. (3) This is an early-phase feasibility design with a small sample size, making it difficult to detect meaningful clinical change. (4) Finally, there is a heavy reliance on self-reported substance use and discrimination experiences in this study, which could lead to social desirability bias.

Considerations for future research will include a randomised controlled trial to examine overall efficacy and effectiveness of the culturally adapted treatment and if factors like race, gender and the age of the treatment facilitator affect treatment response, engagement and retention for black YILS receiving a culturally adapted adolescent substance use treatment intervention. Few adolescent substance use interventions have implemented a co-design model for cultural adaptation with and for the population it is intended to serve. An effective substance use intervention (such as MET/CBT12), designed with input from the community it intends to serve, could significantly reduce the short-term negative outcomes and long-term adverse effects of substance use-related problems on black YILS by addressing anti-black racism and its impact on drug use. The bottom-up or grassroots approach is designed to increase the likelihood that the intervention will be culturally relevant and effective in reducing substance use and improving mental health outcomes in black YILS.