Project CARE (Community Treatment Adherence at Re-Entry): An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Pilot RCT
Phase: NA
Conditions: Bipolar Disorder
Sponsor: Brown University

 
Project CARE: An Integrated Treatment Adherence Program for Bipolar 
Disorder at the Time of Prison Release - Pilot RCT 
 
NCT04269772 
 
Study Protocol Version 9, 10/20/2020 
 
 
 Please note: This study protocol includes details on this clinical trial registration 
and the open trial, developmental phase, which is a separate clinical trial 
registration (NCT03825640). 
 

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entry. Development of CARE will be informed by our experiences successfully piloting a similar 
intervention (the Integrated Treatment Adherence Program; ITAP1) for individuals with BD and 
comorbid substance dependence across another vulnerable transition, from inpatient to outpatient care 
in the community.2 As an adaptation of ITAP for community re-entry, CARE will be designed to be 
delivered by a range of clinicians, providing advantages for scalability in the resource-poor criminal 
justice system. Its proposed mechanisms of action (i.e., increasing values-action consistency, 
enhancing social supports, and linkage to community treatment services, all to promote treatment 
engagement, thereby improving clinical outcomes) are further well-matched to the practical and clinical 
needs of re-entering individuals. 
The secondary aim of this research will be to compare outcomes, within 95% confidence intervals, 
between CARE as an adjunct to treatment as usual (TAU) vs a TAU control condition. In keeping with 
ethical obligations, we will enhance TAU by providing post-release monitoring and emergency referral, 
as needed. We will explore future dissemination potential by using community mental health counselors 
for treatment delivery. 
The development aims of this project are to: 
1) Develop a comprehensive treatment manual, interventionist training program, and fidelity scales 
for CARE, comprised of 3-4 individual sessions prior to release, and 1 family meeting (when 
applicable), followed by a series of 11 brief telephone outreach contacts up to 6 months post-
release. 
2) Improve the clarity, content, acceptability, and feasibility of CARE through a small open trial 
(n=12) of prisoners with BD treated through 6 months post-release, followed by stakeholder 
interviews (participants, prison staff, community mental health partners) as part of the refinement 
process. 
The pilot study aims of this project are to: 
3) Conduct a randomized pilot trial in 40 prisoners with BD, comparing CARE to TAU to 
demonstrate the feasibility and acceptability of the proposed recruitment methods, research 
design, intervention, and counselor training program, with assessment at baseline, pre-release, 
and 1 and 6 months post-release. For those recruited post-release, assessments will be at 
baseline, 1 month and 6 months.  
4) Examine 95% confidence intervals around differences between CARE and TAU for the following 
outcomes: reduced mood symptoms (primary); suicidal ideation and behaviors, substance use, 
rates of re-arrest, and more stable employment and housing (secondary);  
5) Examine 95% confidence intervals around differences between CARE and TAU to evaluate 
differential engagement of purported mechanisms of action: increased values-action 
consistency, practical and emotional social support, and increased treatment engagement (i.e., 
utilization and adherence).  
 
3b. Methodology: 
 
3.b.1. Description of study participants.  
Participants will be sentenced prisoners who are incarcerated in the women’s and men’s minimum 
and medium security prison facilities at the 
. In 
the development (open trial) phase, we will consent up to 36 prisoners in order to achieve our 
enrollment goal of 12 prisoners who meet study inclusion criteria for participation. In the pilot trial 
phase, we will consent up to 160 prisoners in order to achieve our enrollment goal of 40 prisoners who 
meet study inclusion criteria for randomization to conditions. Additional inclusion criteria across both 
phases include: 1) DSM-5 diagnosis of bipolar I, bipolar II, bipolar disorder not elsewhere classified, or 
schizoaffective disorder, bipolar type, as determined by the Structured Clinical Interview for DSM-5 
Disorders (SCID-5); 2) 18 years or older; 3) Anticipated prison release within 4-10 weeks or recent 
prison release; 4) Expected release to or current living in locations anywhere within 
 
; and 5) Willingness to sign an informed consent 

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document that describes study procedures. Exclusion criteria include: 1) Presence of current 
psychiatric symptoms severe enough to warrant separation from the general prison population; 2) 
Cognitive impairment sufficient to prevent successful completion of the baseline interview; and 3) 
Inability to understand sufficiently well to understand the consent form or assessment instruments when 
they are read aloud. Virtually all prisoners at the 
 speak English. Because a few prisoners may 
have reading difficulties, consent forms will always be read aloud and RAs will offer to read self-report 
measures aloud. As CARE is designed to be purely adjunctive and because release dispositions can 
change dramatically in the days leading up to release, participants will not be included/excluded based 
on post-release treatment plans (or lack thereof).  
Those assigned to receive the CARE intervention (n= 12 in the open trial; n = 20 in the pilot 
randomized trial) will be invited to have a family member or significant other (heretofore referred to as 
SO) participate in the intervention with them. We highlight that this is not a requirement for participation 
of the prisoner participant, but will be optional. Hence, we will enroll up to 32 SOs into this study. In 
order to be eligible for participation, SOs must be over 18, speak and read English, have frequent (at 
least every other week) contact with the prisoner participant, be on the prisoner participant’s visitor list 
at the 
 (for those prisoners recruited while still incarcerated), and consent to participate in 
treatment. 
Finally, as part of the treatment development process, we will conduct brief (~30 min) stakeholder 
interviews with relevant parties (e.g., 
 staff and administrators, community mental health 
partners). We anticipate conducting up to 6 interviews with relevant stakeholders (2 each with 
 
staff, administrators, and partnered community mental health center administrators), half of which will 
occur upon completion of the open trial and half of which will occur upon completion of the pilot 
randomized trial. In order to be eligible to participate in this interview, individuals must be: 18 years or 
older, currently employed in one of the stakeholder settings described above, able to speak English 
sufficiently well to participate in the interview, and to consent to participate in the interview. 
Special classes. Because the purpose of this study is to develop and evaluate the feasibility and 
acceptability of CARE in prisoners during the vulnerable period of community re-entry, it is necessary to 
sample a prison population. Prisoners are an understudied population with complex treatment needs; 
hence the urgency for more research attending to the mental health concerns of this population. 
Incarcerated children 18-21 will be eligible. Recruitment procedures are described in more detail in the 
“Protection of Human Subjects” section. 
 
3.b.2. Description of interventions.  
Overview. In the open trial phase of the study, participants who provide informed consent and are 
determined to be eligible for participation will be assigned to receive the CARE intervention as an 
adjunct to enhanced treatment as usual (E-TAU). In the pilot trial phase of the study, participants will be 
randomized to the CARE intervention as an adjunct to E-TAU or to E-TAU alone. 
Enhanced treatment as usual (E-TAU). To meet our ethical obligations for human subjects 
protections, we note that TAU will be enhanced with routine monitoring (i.e., through scheduled 
research assessments) and emergency referral, as clinically indicated. We will also provide all study 
participants a resource packet containing information about treatment and other supportive resources 
available in prison and in the community. In those respects, the control condition will be “enhanced 
TAU” because it provides a level of clinical monitoring and referral that is not typically available to re-
entering prisoners as part of routine care, but will be available to all study subjects as part of their 
participation in human subjects research. Given the adjunctive nature of CARE, other treatments (e.g., 
medication management, counseling, case management, discharge planning, etc.) will be unrestricted, 
and in fact, encouraged. We acknowledge that TAU will be highly variable both in prison and after re-
entry, ranging from any to no treatment for BD. We will carefully monitor and assess treatment 
utilization (e.g., initiation, maintenance, changes, discontinuation, adherence) and clinical severity for 
participants in both conditions at each study assessment time point. For treatments that participants 
report receiving, we will obtain signed release of information (ROI) forms for prison and community 

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treatment providers, so that we may communicate with them in cases of clinical need. Please see 
“Protection of Human Subjects” section for details re: our emergency referral procedures, as needed.   
Community treatment Adherence at Re-Entry (CARE) intervention. CARE will begin within the 2 
months preceding prison release, and will continue for 6 months following community re-entry. Or, for 
those enrolled post-release, CARE will begin right after enrollment and continue for 6 months. CARE 
will be comprised of: a) 3 individual sessions with the CARE counselor prior to prison release or right 
after prison release; b) either a fourth individual session or 1 family/significant other (SO) session either 
prior to prison release or as soon as possible after release into the community (when applicable); and 
c) a series of 11 brief (15-20 min) follow-up telephone contacts with prisoners and their SO. If a 
participant is released earlier than expected before finishing the in-prison sessions or if the participant 
is recruited after release from prison, we will complete the sessions by telephone, by zoom, or in 
person at our offices (or in any residential facility where the participant is located, with facility approval).  
The CARE intervention will incorporate motivational strategies from existing interventions3–5 in  
order to clarify values and goals to enhance motivation for behavior change. These strategies will be 
primarily derived from Acceptance and Commitment Therapy (ACT; note that this is different from 
Assertive Community Treatment), a “third wave” cognitive-behavioral approach that has demonstrated 
efficacy in a wide range of disorders, including mood disorders,6 psychosis,7,8 and SUDs.9 ACT 
proposes that a discussion and clarification of the patient’s personal values can facilitate motivation, 
hopefulness about the future, and behavior change. Values are defined as broad, personally defined 
verbal constructs that provide the context for more specific behaviorally consistent goals. Values 
provide a personal rationale that can help motivate individuals to remain committed to desired actions, 
even if they are associated with other undesirable consequences. In contrast, goals represent more 
narrowly defined desired consequences that can be impeded by various internal and external factors. 
Procedures have been developed to clarify values and goals in order to assess and decrease 
discrepancies (thereby promoting consistency) between patient values and daily actions. Such values 
strategies will inform the initial,  sessions 
with the patient and SO, and culminate in 
an individualized “Re-entry Plan” 
document that clarifies important goals for 
re-entry that are in line with core values, 
potential obstacles to achieving these 
goals (e.g., non-adherence, substance 
misuse), early warning signs for 
mood/substance relapse or increased 
suicide risk, appropriate corrective actions, 
and a safety plan, particularly given the 
high risk for suicide in this population.10 
CARE will also integrate strategies 
from existing family models of intervention 
for BD (e.g., Family Focused Therapy,11 
the McMaster Model of Family 
Functioning12,13) that are designed to 
improve family communication, social 
support, and problem-solving around BD 
illness management. The family/SO 
meeting will provide an opportunity to 
solicit feedback from and review the 
patient’s “Re-entry Plan” with the family 
member, in order to enlist them in 
supporting the patient’s specified values-
consistent actions and goals as they 

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participate if no family member or close friend is willing/able. If a participant has no SO available, we 
will omit this portion of the intervention. However, we will allow for the participation of an SO later in 
treatment, should one become available. Although we expect the family component of the intervention 
to be feasible, given our previous experience with prisoner re-entry,19–21 assessing its 
feasibility/acceptability in the context of CARE will be part of the proposed study. In our previous 
studies with prisoners, 10-15% of participants have been unable to identify an SO.  
Patient-SO conflict: In situations of mild-moderate relationship impairment, we will carry out CARE 
as outlined and identify relationship issues as one additional risk factor to be addressed. We will then 
engage the patient and the SO in problem-solving to determine what to do about their relationship 
issues (e.g., referral to marital/family treatment). In a minority of cases, there may be such severe 
impairment and/or abuse that facilitating increased involvement is not clinically appropriate. As in our 
previous studies of re-entering prisoners, we will work with the participant to identify another SO for 
participation and we will privately provide information about partner violence resources to participants 
as needed (see Human Subjects). 
Illness severity: If the patient’s symptoms (e.g., mania, psychosis, substance use) are so severe 
that he/she is unable to participate in the contacts, we will continue to work with the SO and with other 
providers (with a release of information) to help obtain adequate treatment for the patient. (see Human 
Subjects Protections) 
 
3.b.5. Recruitment and Informed Consent. 
Prisoner participants: Prison recruitment will follow procedures successfully used to recruit 
prisoners into our completed and ongoing trials at the study site over the past decade. Participants will 
either be recruited pre-release from women’s and men’s minimum and medium security prison facilities 
of the 
 or post-release in the community.  
In-Person Recruitment at 
 will occur in one of three ways. First, with permission from prison 
treatment staff and security personnel, research staff will attend housing unit community meetings to 
briefly explain the study.  Research staff will hand out “interest slips” of paper, on which participants can 
confidentially indicate interest or lack of interest in learning more about the study. We request that all 
prisoners complete the “interest slip,” regardless of interest in participation, to ensure privacy of 
responses. Second, we will identify potentially eligible participants based on their time in prison and 
release dates from prison records and approach them privately. Third, with the assistance of 
 
 Director of Psychiatric Services at the 
 we will provide an in-service to 
prison psychiatrists and mental health counselors, and will distribute study brochures and flyers for 
them to place around treatment areas. Brochures will contain study details and guidance regarding how 
a participant can submit a confidential “interest slip” to request a meeting with an RA, if interested in 
learning more about the study.  
Post-Release Recruitment will occur due to the COVID-19 pandemic and the inability to recruit 
participants in-person at 
 The following recruitment strategy is in place to continue study 
recruitment without in-person activities at 
 We will solicit referrals directly from 
 
behavioral health workers (discharge planners, counselors, etc.), from probation and parole, and 
service organizations that that work directly with recently released inmates. Referral sites will be given 
our study materials (i.e. consent-to-contact form, etc.). They will present the forms to potential 
participants. Interested inmates will complete the consent-to-contact form, and referral sites will fax 
completed forms to our offices. As referral sites will be involved in our recruitment procedures, we will 
make every effort to minimize potential risks of coercion.  There is a note in the consent-to-contact form 
explaining to potential participants that their decision whether or not to complete the form will not impact 
their  privileges, relationship, or treatment with 
 probation and parole, and/or their service 
organization. Additionally, study RAs will be very clear to participants, as soon as possible after they 
make contact, that the study is voluntary and their relationship with 
 probation, parole, and/or 
their service organization will not be impacted if they decide not to participate. If they are interested, 
study RAs will screen them for study eligibility over the phone or by HIPAA complaint zoom.  Due to the 

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COVID-19 pandemic, a waiver of documentation of consent will be utilized for post-release recruitment.  
We will consent participants over the telephone or via HIPAA complaint zoom.  As part of the informed 
consent process, participants will always be informed that: (1) a decision to not participate in the 
research will have no impact on their status, access to treatment, or length of stay at the prison; (2) the 
study has a Certificate of Confidentiality; and (3) the study information will be kept confidential from 
prison staff, officers of the court, parole officers, or others in the criminal justice system. Study staff will 
also carefully review the limits to confidentiality, including the prison’s mandatory reporting procedures 
(see page 16). Informed consent procedures have been developed to comply with the Code of Federal 
Regulations 45 CFR 46.116, General Requirements for Informed Consent and 46.117 Documentation 
of Informed Consent. Freedom to refuse to participate or to discontinue participation at any time without 
penalty will be emphasized. Participants will be asked to provide written permission for us to try to 
locate them through significant others, their appointed parole/probation officer, and/or post-release 
treatment program, but will not be excluded if they are unwilling to do so.  Participants will be able to 
refuse or revoke locator consent. Because of the NIMH data sharing requirements, which we are bound 
to, we will need to obtain the participant’s city or municipality of birth at the time of consent as well as 
the participant’s full name a birth. This will be used to link the participant’s data with any existing data 
they may already have in the National Database for Clinical Research Related to Mental Illness, using a 
global unique identifier (GUID) to protect the participant’s privacy. Once a participant has agreed to 
participate in the research and signed the informed consent, s/he will undergo the baseline assessment 
phase. The participant will provide the RA with verbal consent over the phone or over HIPAA complaint 
zoom and the RA will document this consent on a blank consent form.  These forms will be stored in a 
lockbox in the RAs homes and will be transported to the office in the lockbox. Once in the office, these 
consents will be filed with the other study consent forms in a locked file cabinet in our offices.  We will 
also mail a copy of the consent form to the participant. Once a participant has agreed to participate in 
the research and provided informed consent, s/he will undergo the baseline assessment phase. 
For in-person recruitment, participants who indicate potential interest in the study are approached 
privately in a confidential setting.  Research staff will carefully explain all aspects of the study to a 
potential participant, including its voluntary nature, risks and benefits, the schedule of visits, and the 
expected duration of participation, and will elicit and answer any questions the participant may have. If 
still interested, we will request participant verbal permission to conduct a brief screen to determine if 
they meet initial eligibility for participation in the study (i.e., current age, remaining duration of prison 
sentence, expected location following prison release). If they meet initial eligibility criteria, we will ask 
them if they would like to continue with the informed consent process. We will ask participants if they 
would like us to read the consent forms aloud. As part of the informed consent process, participants will 
always be informed that: (1) a decision to not participate in the research will have no impact on their 
status, access to treatment, or length of stay at the prison; (2) the study has a Certificate of 
Confidentiality; and (3) the study information will be kept confidential from prison staff, officers of the 
court, parole officers, or others in the criminal justice system. Study staff will also carefully review the 
limits to confidentiality, including the prison’s mandatory reporting procedures (see page 16).  
Participants who give their consent will sign a copy of the document and will be given a signed copy 
of the informed consent document.  Informed consent procedures have been developed to comply with 
the Code of Federal Regulations 45 CFR 46.116, General Requirements for Informed Consent and 
46.117 Documentation of Informed Consent. Freedom to refuse to participate or to discontinue 
participation at any time without penalty will be emphasized. Participants will be asked to provide 
written permission for us to try to locate them through significant others, their appointed 
parole/probation officer, and/or post-release treatment program, but will not be excluded if they are 
unwilling to do so.  Participants will be able to refuse or revoke locator consent. Because of the NIMH 
data sharing requirements, which we are bound to, we will need to obtain the participant’s city or 
municipality of birth at the time of consent as well as the participant’s full name a birth. This will be used 
to link the participant’s data with any existing data they may already have in the National Database for 
Clinical Research Related to Mental Illness, using a global unique identifier (GUID) to protect the 

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Following prison release, the counselor will initiate the phone follow-up calls, delivered across the first 6 
months post-release. The schedule for phone follow-up will be: weekly for the first month, biweekly for 
the next 2 months, and then monthly for the final 3 months. Calls will be made separately to the 
prisoner participant and to the identified SO (if applicable).  
In addition to the baseline assessment in prison, outcome assessments will occur on the following 
schedule: a) following the in-prison sessions, prior to prison release (~1-2 weeks prior to prison 
release); b) 1 month after prison release; and c) 6 months after prison release, immediately post-
treatment. To enhance feasibility and therefore retention, we will aim to complete all post-release 
follow-up assessments by telephone, using procedures we have in place for other studies (see “Human 
Subjects Protections”). However, there may be some circumstances that might make it difficult for a 
participant to complete the follow-up assessment by telephone (e.g., rearrest and reincarceration, 
participation in a residential treatment program). In such cases, we will complete the follow-up 
assessment in person. 
In the Pilot Randomized Trial Phase, if a participant is determined to be eligible following the 
baseline assessment, s/he will be randomized to either E-TAU plus CARE or to E-TAU alone. 
Randomization will be determined in a 1:1 ratio, with 2 stratification variables, the maximum number 
advisable in a sample of this size: sex (male vs. female) and polarity of most recent mood episode 
(depression vs. (hypo)mania) using a randomization table. 
Participants randomized to receive CARE will receive 4 counseling sessions. The first 3 sessions 
will be individual sessions that take place in prison in the time between the baseline assessment and 
the anticipated date of release from prison; or they will take place after release for those enrolled post-
release. A fourth session will either be an individual counseling session or a family/SO session (as 
applicable). This session will take place either in prison prior to release or as soon as possible after 
release either by telephone, by zoom, or in person (e.g., at our offices or in any residential facility where 
the participant is located, with facility approval). Ideally, the first two sessions will be delivered within 1 
week, the third session will be delivered within the following week, and the fourth session will be 
delivered within the week after that as either an individual session or a family/SO session. However, we 
acknowledge that time to release will be variable, and the session schedule may be compressed or 
spread out depending upon length of time available to complete the sessions between the baseline 
assessment and the prison release date. Following prison release (in prison enrollment) or completion 
of the initial sessions (post-release enrollment), the counselor will initiate the phone follow-up calls, 
delivered across the first 6 months post-release (in prison enrollment) or 6 months post-baseline (post-
release enrollment). The schedule for phone follow-up will be: weekly for the first month, biweekly for 
the next 2 months, and then monthly for the final 3 months. Calls will be made separately to the 
prisoner participant and to the identified SO (if applicable).  
Assessments will occur on the following schedule: For participants recruited in person at 
 
prior to release: a) baseline assessment; b) following the in-prison sessions, prior to prison release (~1-
2 weeks prior to prison release); c) 1 month after prison release; and d) 6 months after prison release, 
immediately post-treatment. For participants recruited post-release: a) baseline assessment; b) 1 
month after baseline; and c) 6 months after baseline, immediately post-treatment. The post-release 
enrollment baseline would include any additional questionnaires/items from the pre-release assessment 
that were not already included in the baseline assessment. To enhance feasibility and retention, we will 
aim to complete all post-release follow-up assessments by telephone or zoom, using procedures we 
have in place for other studies (see “Human Subjects Protections”). However, there may be some 
circumstances that might make it difficult for a participant to complete the follow-up assessment by 
telephone or zoom (e.g., limited phone minutes, participant rearrest and reincarceration, current 
enrollment in a residential treatment program). In such cases, we will complete the follow-up 
assessment in person in our offices at 
 or in the facilities where the participant may be 
located (e.g., jail or prison, residential treatment facility). Additionally, if a participant is released earlier 
than expected before finishing the in-prison assessment, we will complete the assessment by 

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by time to calculate effect sizes and 95% CIs for change in VLQ, NIH Toolbox Instrumental Support, 
MSPSS, THI, and BARS scores across study time points. Across the four assessment time points, we 
will also evaluate associations between change in these intermediary constructs and primary/ 
secondary outcome measures, using multilevel models. 
3.b.10. Material inducements. 
We will compensate participants $40 for each of the three follow-up assessments for pre-release 
enrolled participants (immediate pre-release, 1 month post-release, 6 months post-release) in the form 
of a money order or a gift card (if they do not have state or federal identification to cash the money 
order). For post-release enrolled participants, they will be compensated $40 for each of their completed 
assessments (baseline, 1 month follow-up, and 6 month follow-up). In total, participants may receive up 
to $120 if they complete all study assessments. Compensation for the pre-release assessment will be 
mailed to an address of the participant’s choosing after it is confirmed that the participant has been 
released from prison. If a follow-up is completed in jail or prison, we will provide the participant the 
following options: a) us mailing the compensation once they are released, or b) mailing it to a family 
member or significant other of their choosing, or c) depositing it into their commissary account at the 
  
3.b.11. Training of research personnel. 
 
All research personnel will have formal training in research with human subjects (e.g., CITI 
training, GCP training).  
 will provide training to and supervise research assistants. RAs 
will have a bachelor’s or master’s degree, and will receive training in the informed consent process and 
their ethical responsibilities when conducting research, with a particular focus on the ethics involved 
with research in perinatal populations. All interviewers will receive specific training in the assessment 
instruments to be administered and in all study-related safety protocols. With assistance from study 
 will supervise the study therapists. 
 
3c. Protection of Human Subjects 
Please see section 3.b.1 for a detailed description of study participants. Special classes. Because 
the purpose of the application is to develop and evaluate the feasibility and acceptability of CARE in 
prisoners during the vulnerable period of community re-entry, it is necessary to sample a prison 
population. Prisoners are an understudied population with complex treatment needs; hence the urgency 
for more research attending to the mental health concerns of this population. Because the target 
population for this study is constituted by sentenced prisoners with BD, the Prisoner Checklist for 
research has been included as an appendix to this application. It is anticipated that, once approved, the 
 IRB will apply to OHRP for project certification. Incarcerated children 18-21 will be eligible.  
 
 3.c.1. Inclusion of Women and Minorities 
Because the purpose of this application is to develop and pilot an intervention for prisoners with 
bipolar disorder (BD) around the period of community re-entry, the study population will consist of 
sentenced male and female inmates who meet criteria for BD. The study sample will also include 
participating family members/significant others (SOs). Equal numbers of male and female prisoners and 
SOs will be recruited. 
Extant data from prisoners at participating facilities in 
 have been used to estimate the 
racial and ethnic distribution of the 104 participants (52 prisoners; 52 SOs) in the open and randomized 
trials. For females, the overall racial distribution will be approximately 66% White, 17% African 
American, 2% Asian, 4% American Indian or Alaska Native, and 11% other. The overall ethnic 
distribution for women will be approximately 17% Hispanic or Latina and 83% Non-Hispanic or Latina. 
For males, the overall racial distribution will be 48% White, 28% African American, 2% Asian, 4% 
American Indian or Alaska Native, and 18% other. The overall ethnic distribution for men will be 
approximately 24% Hispanic or Latino and 76% Non-Hispanic or Latino. 
If the minority distribution of our participants falls below the targeted minority distribution (i.e., if 

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halfway through the study, the proportions of African Americans or Hispanics recruited are less than 
two thirds of the proportion of that minority distribution for the 
), then we will conduct additional 
outreach to the group that fell below their targeted enrollment numbers. We will also attempt to obtain 
feedback on why individuals for that group may refuse to participate in the study. Based on the 
feedback, we will take corrective action. All subjects will be asked to identify their race and ethnicity 
separately, by self-report, at the time of study entry, when demographic information is collected. We 
plan to conduct analysis to determine whether minority status is associated with any of the treatment 
utilization or clinical outcome data collected as part of this investigation.  
 
 
3.c.2. Inclusion of Children 
Individuals aged 18-21 who meet our inclusion criteria will be included in this study. Individuals 
younger than 18 will not be included. This study includes children 18-21, but does not include anyone 
under 18 years of age (the age of emancipation in 
) because adolescent developmental 
issues would confound outcomes of interest to the study. Additional instruments and study methods 
would also be required to assess the unique mental health needs of a younger population. Thus, the 
current research is not applicable to children under the age of 18. 
Because children ages 18-21 are of legal age, they will be treated as adults and will be able to 
consent and agree to participate in the study themselves. Our consent procedures are conducted face-
to-face, with trained interviewers guiding eligible subjects step-by-step; materials are written at a Grade 
7 level and the interviewers ensure that each element is understood. In addition, consent forms will be 
read aloud. 
 
3.c.3. Potential Risks 
There are three major sources of low to moderate risk associated with participation in the proposed 
study. 
1. Potential coercion. It is possible that individuals may feel coerced into participating. This is a  
    particularly important risk to minimize with incarcerated individuals. 
2. Increased distress due to assessment or intervention procedures. It is possible that some  
participants will experience increased intrapersonal or interpersonal psychological distress as a 
result of participating in assessment or intervention. In the vast majority of cases, we believe that 
any increased distress experiences will be mild and transitory in nature. 
3. Confidentiality and loss of privacy. The greatest potential risks to those participating in the  
research are legal or social, caused by the inadvertent loss of confidential information obtained 
during the data collection process. That is, a participant’s identity may be inadvertently exposed 
or questionnaire material may be released or disclosed to unauthorized persons. In the case of 
such a breach, serious personal and social consequences could conceivably occur. However, 
such risks can be minimized by instituting the proper procedures to protect confidentiality and by 
having resources in place to provide counseling and referrals. We have extensive experience 
taking appropriate measures to safeguard confidential information in research with criminal 
justice populations. These measures are described below. 
 
3.c.4. Protection Against Risks 
All aspects of the study will be conducted in accordance with HIPAA regulations. Data and safety 
monitoring will take place to assure the safety of subjects (see below). All participants will be reminded 
that their participation is voluntary and that they can withdraw at any time without penalty. Additionally, 
the risks described above will be minimized by the following procedures: 
1. We will minimize the risk of potential coercion by following standard procedures for obtaining 
informed consent (please see section 3.b.5). We will begin this process during the intake where we will 
clarify the nature of the study and possible alternatives upfront. Prior to enrolling participants in the 
research, we will fully explain the study procedures, risks, benefits, and alternatives to participants, 

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emphasizing that participation has no impact on the other services they receive at the prison, the terms 
or length of their confinement, or any other community services that they receive post-release.  Also, 
participants who do not consent or who withdraw will receive appropriate referrals (e.g., for mental 
health treatment), if needed. All participants will be reminded that there is no penalty for participants 
who choose to not participate or to withdraw from the study. All reimbursements for participating will be 
commensurate with participants’ time required for participating in the research. 
2. We will minimize the risk of distress. Incarcerated individuals with BD who serve as participants 
in this research face the risk of increased distress during assessment procedures or study intervention. 
All participants will be informed that they do not have to answer questions that they find too distressing 
and will be reminded that they can discontinue participation at any time. Moreover, clinical backup will 
be provided during all assessments and intervention sessions by a licensed clinician to help facilitate 
the stabilization and referral process for participants who decompensate during study procedures. The 
need for additional services will also be monitored during each clinical (assessment or intervention) 
contact. Participants will be formally assessed while they are in prison (intake, pre-release) and after 
release (1 and 6 months post-release). Incarcerated participants who report significant homicidal 
ideation or suicide risk, or who manifest significant manic or psychotic symptomatology, will be referred 
to appropriate clinical prison staff for evaluation, per 
 policy. For assessments in the community, 
a licensed clinician (the PI or her covering clinician) will be available at all times by cell-phone. 
Research staff will contact the licensed clinician if there are any safety concerns.  
3. We will minimize potential risks due to loss of confidentiality of research data by having all 
information collected and handled by research staff, including study interventionists, trained to deal 
appropriately with sensitive clinical issues.  All participants will be informed about the limits of 
confidentiality concerning suicidal intent, homicidal intent, suspected child abuse, suspected elder 
abuse, and prison-required mandatory reporting issues (i.e., sexual contact within the prison, weapons 
in the prison, prison escape plans). All information will be treated as confidential material and will be 
available only to research staff. All information will be kept in locked file cabinets at 
. 
Computer data files will be kept on 
 secure research servers, will be available only to 
authorized personnel, and no names or obvious identifying information will be stored in data files. No 
participant will be identified in any report of the project. Written consent will be obtained to contact other 
persons for the purpose of locating the participant for follow-up and participants can refuse or revoke 
such requests. Participants will update their contact information and contact person for the post-release 
period at each assessment point to ensure that this information remains appropriate. To further protect 
participants, a Federal Certificate of Confidentiality will be granted by the NIH at the time of the 
Notice of Grant Award. Potential subjects will be informed that a Certificate of Confidentiality has been 
obtained for this project and that this certificate will protect the investigators from being forced to 
release any research data in which participants can be identified, even under court order or subpoena, 
although this protection is not absolute. Potential participants will be informed of the situations in which 
they may not be protected under the Certificate of Confidentiality. No information about participants will 
be released without their permission or where required by law.  
Audio recording is necessary to rate reliability of the interview assessments and also study 
interventionists’ fidelity to the treatment. As in our past 10 years of prison research, audio recording is 
accomplished through the use of credit-card size digital audio recorders, which have password-
protection and encryption capabilities thereby protecting their contents during transport between the 
 and our research offices. These digital recordings are regularly transferred to 
 secure 
computer server (designed to hold and protect digital audio and video recordings for clinical trials) via 
USB connection and secure file transfer to 
 secure audio server, and the recorders are wiped. 
This is the same procedure that has been used in our completed and ongoing intervention studies with 
prisoners and jail detainees at the recruitment site. Participants will be asked to give informed written 
consent to audio recording at the time of intervention study entry. To assure the confidentiality and 
protection of participants with respect to audio taping, the following steps will be taken: a) each 
recording will be labeled with the participant’s study identification number, the intervention 

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3.c.7. Data Safety and Monitoring Board 
An external local DSMB will be assembled to evaluate the data and safety to participants enrolled in 
the study. We will recruit 3 
-affiliated board members who have experience in clinical trials 
and/or BD treatment research and/or research with criminal justice samples as well as the ethical 
issues involved with a randomized control study. The external DSMB will convene twice in Year 1, and 
then at the end of each year in Years 2-3 for a meeting. Initially, the Board will convene with the PI and 
study Co-Is to review the study protocol and review the guidelines for data and safety monitoring. At 
this meeting and at each subsequent meeting, the DSMB will evaluate recruitment, the progress of the 
trial, subject retention, data quality and confidentiality. In addition, they will review participants' clinical 
status, rates of adverse events and whether or not there have been any changes in risk to participants. 
 
3.c.8. Benefits of the Proposed Research to the Subjects and Others 
The potential risks associated with participation in this study appear to be mild to moderate. 
Although there is a risk for distress, the procedures proposed for monitoring distress should ensure that 
participants who require a higher level of care receive it. The study provides additional screening, 
assessment, and referral to emergency services, as needed, for all study participants, and in no way 
restricts or limits the treatment individuals would have received had they not participated in the study.  
Moreover, participants are helping other incarcerated individuals with BD by providing information that 
will improve treatments for this population. Thus, the potential benefits outweigh the potential risks of 
the study. 
 
3.c.9. Importance of Knowledge to Be Gained 
To our knowledge, this proposed study represents the first attempt to develop and pilot a targeted 
intervention for BD treatment engagement – with the aim of improving mood symptom and functioning 
outcomes – surrounding the period of community re-entry. This pilot study will lay the groundwork for a 
larger, stage II clinical trial (R01) to evaluate the effectiveness of CARE for increasing treatment 
engagement, and thus improving clinical outcomes, among this seriously ill, high risk, understudied 
population during the vulnerable transition from prison to the community. The risks involved in the study 
are minimal compared to the need for treatments for this population. 
 
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