Treating Co-Occurring PTSD and Substance Abuse in High-Risk Transition Age Youth
Phase: NA
Conditions: Substance Use Disorder, Posttraumatic Stress Disorder
Sponsor: UConn Health

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PROTOCOL: Treating Co-Occurring PTSD and Substance Abuse in High Risk Transition Age Youth 
Principal Investigator: Kristyn Zajac, Ph.D. 
SPECIFIC AIMS 
The overriding purpose of the proposed project is to develop and conduct a pilot evaluation of an 
integrated treatment for co-occurring substance use and posttraumatic stress disorder (PTSD) among 
an extremely high-risk clinical population – emerging adults. Over the past few years, data have emerged 
indicating that emerging adults (aged 18-25) have higher rates of initiation and increases in substance use than 
any other age group (SAMHSA, 2009). Further, although this population experiences a range of mental health 
problems, PTSD has been identified as a particularly problematic psychiatric disorder for these youth, as it is 
linked to the development and exacerbation of substance use disorders (SUDs). Indeed, in a large-scale 
longitudinal study, transition age youth with PTSD were five times more likely than those without PTSD to develop 
a new SUD, even after controlling for other SUD risk factors, such as gender, ethnicity, education, and 
socioeconomic status (Reed, Anthony, & Breslau, 2007). PTSD also predicts higher relapse rates and poorer 
outcomes among individuals in treatment for SUDs (Kessler et al., 2005; Tomlinson, Brown, & Abrantes, 2004). 
Thus, substance use problems are highly prevalent among emerging adults, and the transition from experimental 
use to the development of a SUD is exacerbated by co-occurring PTSD symptoms. Nevertheless, surprisingly 
little attention has been devoted to developing integrated SUD/PTSD treatment protocols for this age 
group. 
A majority of transition age youth with serious mental health concerns like PTSD will be arrested by age 25, 
and most will have multiple arrests, often with serious charges (Davis & Koroloff, 2007; Fisher, Silver, & Wolff, 
2006). Further, among adolescent and young adult offenders, up to 49% meet criteria for current PTSD, and up 
to 73% meet criteria for a current SUD (see Vermeiren, 2003) as compared to the rates of 3.4% for current PTSD 
and 6.6% for current drug abuse disorders found in community samples of young adults (Tanner et al., 2007). 
Given the elevated single-disorder rates, the overall rates of SUD/PTSD comorbidity are also substantially higher 
in this subgroup than in community samples. Therefore, development and validation of a SUD/PTSD 
treatment for this subgroup will target youth at the highest risk for this comorbidity and its negative 
sequelae.  
The integrated approach to treating SUDs and PTSD proposed in this application combines two evidence-
based interventions for PTSD (Prolonged Exposure Therapy; Foa, Hembree, & Rothbaum, 2007) and SUDs 
(Contingency Management; Higgins, Silverman, & Heil, 2008). Results from multiple studies support the 
efficacy of these treatments. Recent studies have demonstrated the advantages of integrated approaches that 
target SUDs and PTSD simultaneously for comorbid populations (e.g., Back, 2010; Back, Brady, Sonne, & 
Verduin, 2006). The current study provides the opportunity to develop and evaluate an integrated SUD/PTSD 
treatment approach for emerging adults, a group that arguably demonstrates the greatest need for such a 
treatment. Delivering an integrated SUD/PTSD treatment to this high-risk population may present multiple 
challenges as a result of competing clinical needs (i.e., severe behavioral and psychosocial problems) and 
frequent involvement with the criminal justice system. Thus, the specific aims of the study are:  
Aim 1: To develop and implement an integrated SUD/PTSD treatment that is developmentally appropriate and 
integrates evidence-based treatments for SUD/PTSD (Contingency Management, Prolonged Exposure).   
Aim 2: To evaluate feasibility, acceptability, and safety of the integrated treatment among emerging adults and 
clinicians using qualitative and quantitative methods. 
Aim 3: To conduct preliminary analyses exploring whether emerging adults who receive the intervention 
demonstrate improvement in key symptom domains. Specifically, 40 youth will be randomized to either the 
integrated treatment or standard care. Primary outcomes will include substance abuse and PTSD.  Secondary 
outcomes will include criminal justice involvement, adaptive functioning, and other mental health symptoms. 
 
 
 
 
 
 
 
The results of the study will have a significant impact on public health by informing treatments for co-
occurring SUD/PTSD among justice-involved transition age youth, a group at the highest risk for these 
problems. Demonstrating the efficacy of an integrated treatment approach will provide a valuable clinical tool 
for community-based therapists to employ in the context of existing evidence-based treatments. Further, should 
compelling indications of efficacy be found and safety and acceptability be established, these aims will position 
the research to advance to an appropriately powered randomized controlled trial. 

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A. SIGNIFICANCE 
Prevalence and consequences of substance use problems among emerging adults. Transition age 
youth (i.e., emerging adults, ages 18-25) represent the age group with the highest rates of initiation of 
substance use, increases in substance use, and progression of substance use into substance use 
disorders (Chassin, Flora, & King, 2004; Delucchi, Matzger, & Weisner, 2008; SAMHSA, 2009). Substance use 
plays a significant role in many serious problems during this developmental period, including suicide (SAMHSA, 
2010), automobile accidents (Hingson, Heeren, Winter, & Wechsler, 2005), and other lethal events. Emerging 
adults with SUDs also have increased rates of risky sexual behavior, increasing their chances of contracting HIV 
and other STDs (King, Nguyen, Kosterman, Bailey, & Hawkins, 2012). Further, SUDs significantly impede 
successful negotiation of important developmental tasks of this transitional age, leading to increased rates of 
unemployment and job instability and decreased college attendance (Bray et al., 2000; Mangione et al., 1999). 
Finally, emerging adults with SUDs represent a greatly underserved population, with a high likelihood of “slipping 
through the cracks” as they transition from child to adult substance use service providers (Davis, Green, & 
Hoffman, 2009). Thus, this group has a very high potential to present significant short- and long-term 
costs for individuals, families, and society. 
Comorbid SUDs and PTSD. Although emerging adults experience a range of mental health problems, PTSD 
has been identified as particularly problematic, predicting more severe and chronic substance use. In a 
longitudinal study of emerging adults, those with PTSD were 5 times as likely as those without PTSD to develop 
a new SUD, even when controlling for possible confounding factors (Reed, Anthony, & Breslau, 2007). Further, 
among those in SUD treatment, PTSD is a complicating factor, predicting high rates of relapse and low rates 
of treatment success (Kessler, Chiu, Demler, Merikangas, & Walters, 2005; Tomlinson, Brown, & Abrantes, 
2004). Despite these sobering statistics, PTSD treatment is rarely offered in conjunction with evidence-based 
treatments for SUDs, and little attention has focused on developing and validating integrated treatments for 
emerging adults.  
The group of emerging adults with the highest rates of SUD/PTSD comorbidity is those with justice 
system involvement. Almost half of adolescent and young adult offenders meet criteria for PTSD, and over 
70% meet criteria for a SUD (Vermeiren, 2003), representing rates that are dramatically higher than those found 
in community samples of emerging adults (3.4% for PTSD, 6.6% for SUDs). These rates are not surprising given 
that 90% of justice-involved youth are exposed to at least one traumatic event in their lifetime, including high 
rates of physical and sexual assault, witnessed violence, and traumatic loss (Ford, Hartman, Hawke, & 
Chapman, 2008). Left untreated, offenders who abuse substances tend to engage in more severe delinquency, 
continue offending well into adulthood (Dembo, Wareham, & Schmeidler, 2007), and experience poor 
educational and occupational outcomes (Belenko & Dembo, 2003). Moreover, societal costs of SUDs are 
substantial. Annual costs for drug-related crime victims are $1.8 billion, with associated law enforcement and 
incarceration costs totaling $39 billion (NIDA, 2004). Further, justice-involved youth are very unlikely to receive 
an evidence-based treatment for SUDs (Chassin, 2008; Garland et al., 2005), and no evidence-based 
approaches have been specifically tailored to treat SUD/PTSD in this group.  
Integrated Treatments for SUD/PTSD. Though SUDs and PTSD have been historically treated separately 
(often with the requirement of abstinence from substance use prior to treatment for PTSD), results of recent 
studies suggest the advantage of an integrated approach (see Back, 2010 for review). For example, a study 
of symptom change during treatment for co-morbid PTSD and alcohol dependence found that improvements in 
PTSD symptoms had a greater impact on improvements in symptoms of alcohol dependence than the reciprocal 
relationship (Back, Brady, Sonne, & Verduin, 2006), indicating the importance of targeting PTSD to improve 
substance use problems. Further, several promising integrated SUD/PTSD programs have been developed, and 
there is preliminary support for their effectiveness. Specifically, Concurrent Treatment of PTSD and SUDs with 
Prolonged Exposure (COPE; Killeen, Back, & Brady, 2011; Mills et al., 2012), which integrates an exposure-
based treatment for PTSD and a cognitive behavioral approach to SUDs, has demonstrated safety, feasibility, 
and preliminary efficacy in treating adults with comorbid SUD/PTSD. In addition, Seeking Safety (Najavits, 2009), 
another cognitive behavioral approach to SUD/PTSD, has established effectiveness with adult populations (e.g., 
Morrissey et al., 2005).  
Results of these studies highlight the importance of integrated approaches to comorbid SUD/PTSD and lay 
the groundwork for developing and validating treatments for high-risk emerging adults. Given the developmental 
features specific to this population (e.g., incomplete development of executive functions; Ernst, Pine, & Hardin, 
2006; Yurgelun-Todd, 2007), the multiple psychosocial risk factors faced by high risk youth populations, and the 

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need for a treatment that is congruent with justice system requirements, it is expected that an approach that 
relies heavily on behavioral principles, as opposed to the cognitive emphasis of existing adult treatments, will be 
more effective for this population. Thus, the current study aims to integrate and adapt evidence-based 
interventions for SUDs (Contingency Management) and PTSD (Prolonged Exposure) to meet the needs of 
emerging adults, adapted to be congruent with the demands of justice system involvement (i.e., frequent drug 
testing, use of contingencies, collaboration with parole officers), which is frequently seen in this group. An 
effective SUD/PTSD treatment that could be used in this context would provide clinicians with the tools to treat 
this complex population and establish the building blocks to adapt SUD/PTSD treatments for other high-risk 
youth. Given the high rates of SUD/PTSD in such populations and the deleterious effects of these 
problems on individuals and society, an evidence-based SUD/PTSD treatment for high-risk emerging 
adults has the potential for an enormous public health impact. 
B. INNOVATION 
 
Other models for targeting comorbid SUD/PTSD were developed for traditional outpatient adult samples and 
may be limited in their applicability to high-risk youth given the stringent demands of the justice system. The 
proposed project focuses on treating individuals with complex comorbidities who: (a) make up a large proportion 
of those seen in community-based care; (b) are at the highest risk for deleterious long-term outcomes; and (c) 
produce the most significant societal costs. Specifically, this research targets co-occurring SUD/PTSD among 
justice-involved emerging adults. The specific foci on justice involvement and emerging adults are innovative: 
• 
Justice-involved youth have very high rates of SUD/PTSD, yet there is a paucity of research on integrated 
treatments for this population. Though this study will not specifically recruit emerging adults from the criminal 
justice system, comprehensive assessments of past and current criminal justice involvement will allow for 
the examination of the impact of criminal justice involvement on treatment outcome.  
• 
In addition, despite compelling evidence that emerging adulthood is a distinct age group with unique 
developmental goals (Arnett, 2000), almost no research has focused on interventions adapted for their 
needs. Adolescent treatments require substantial parental involvement and are inappropriate for use with 
emerging adults who are often transitioning from their family of origin to more independent living situations. 
Adult treatments fail to consider multiple developmental transitions faced by this age group (e.g., from family 
to independence; from formal education systems to higher education/work force). 
Thus, designing integrated interventions adapted to meet the needs of this underserved, under-researched 
population is novel.  
 
Studies of adult outpatient populations have supported the hypothesis that integrated SUD/PTSD treatments are 
superior to sequential treatment that requires abstinence from substances prior to initiation of PTSD treatment 
(e.g., Back, Brady, Sonne, & Verduin, 2006). The proposed study will serve as the first step to extend the 
empirical evidence for this theoretical model to individuals in need of SUD/PTSD treatment while presenting with 
multiple problems (i.e., justice system involvement, significant psychosocial risk, additional comorbidities). 
C. APPROACH 
Preliminary Studies: This study builds on projects in which the candidate has had an active role. 
Study 1: Longitudinal Study of Risk and Resilience among Low-Income Adolescents: As part of this NIMH-funded 
study (PI: Kobak), Dr. Zajac examined trauma exposure and mental health among low-income parents and their 
adolescent children (Zajac & Kobak, 2009; Kobak, Zajac, & Levine, 2009; Kobak, Zajac, & Smith, 2009; Kobak, 
Rosenthal, Zajac, & Madsen, 2007). Involvement in this longitudinal project afforded Dr. Zajac important 
experience with recruitment and retention of high-risk youth populations, conduct of statistical analyses for 
longitudinal research, and design and oversight of detailed assessment protocols.  
Study 2: Prevalence and Correlates of Substance Use Problems among Youth: In this NICHD-funded study (PI: 
Kilpatrick) of a nationally representative sample of adolescents, Dr. Zajac collaborated on manuscripts focused 
on the prevalence and correlates of substance use, PTSD, and delinquency (Zajac, Ruggiero, Smith, Saunders, 
& Kilpatrick, 2011; Kofler, McCart, Zajac et al., 2011; McCart, Zajac et al., 2011; McCart, Zajac et al., 2012; 
Adams, McCart, Zajac et al., 2014). Results support the strong relationship between substance use and a range 
Focusing on a traditionally underserved, under-researched population that produces high costs 
Extending integrated treatments for SUD/PTSD to high-risk emerging adults with multiple problems 

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of negative outcomes, including PTSD and revictimization. Further, this study provided Dr. Zajac with solid 
training in epidemiological methods and assessment approaches for SUDs and mental health problems in youth 
samples.  
Study 3: Victimization, PTSD, and Substance Use among Teenage Mothers (intramurally funded; PI: Zajac): 
This developmental research examines the prevalence and correlates of victimization, PTSD, and substance 
use among teenage mothers through collection of detailed trauma history, substance abuse, mental health, and 
parenting assessments. Conduct of this study has added to Dr. Zajac’s experience in recruiting youth 
populations, ethical conduct of research, IRB procedures, and use of detailed substance use measures.  
Study 4: SUD and PTSD Outcomes in Multisystemic Therapy (MST) for Emerging Adults: Pilot studies of MST 
for Emerging Adults have focused on mental health, justice involvement, and vocational outcomes. However, 
examination of SUD and PTSD outcomes showed the need for additional treatment of these two problems. In a 
small pilot study of 11 youth, 4 (36%) met criteria for PTSD or subthreshold PTSD prior to MST treatment. 
Interestingly, at 12-month follow-up, 6 (55%) met criteria for full or subthreshold PTSD. In a larger ongoing trial, 
9 of 23 (39%) met criteria for PTSD at baseline. Though data collection is still in process, 3 of 9 (33%) and 3 of 
8 (37%) have continued to meet PTSD criteria at 1- and 4-months post-treatment, respectively. Similarly, in an 
ongoing study, 30 out of 38 (79%) youth had a substance use problem at intake, and 21 of 36 (58%) had 
continued substance use problems at discharge. These results indicate that, among justice-involved emerging 
adults receiving a treatment specifically adapted for this population, substance use and PTSD emerge as 
significant problems even after completion of treatment. Thus, there is a clear need for treatments that specifically 
target these co-occurring problems.  
 
Overview of Design: The proposed research will adapt and integrate evidence-based interventions for SUD 
(Contingency Management) and PTSD (Prolonged Exposure) to target co-occurring SUD/PTSD among 
emerging adults. The execution of the project will take place in two steps and will adhere to procedures outlined 
in Stage I of the Stage Model of Behavioral Therapies Research (Carroll & Nuro, 2002), which focuses on initial 
manual writing, development of a training program and therapist adherence measures, and pilot feasibility/safety 
testing. An overview of the design is presented in the table below. In Step 1, Contingency Management and 
Prolonged Exposure will be integrated and adapted for use with this population, and training manuals and 
adherence ratings will be developed. In Step 2, a pilot feasibility trial of the treatment will be conducted through 
an substance use treatment clinic. If evidence of feasibility is found, data will be used to support a grant 
application evaluating the integrated SUD/PTSD treatment in an appropriately powered RCT (i.e., Stage II RCT). 
Therefore, the project will result in three crucial products: 1) an adapted and integrated SUD/PTSD 
treatment for justice-involved emerging adults; 2) training materials and measures of therapist 
adherence specific to the treatment; and 3) preliminary data on feasibility, safety, and symptom 
reduction as a result of the intervention. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research Plan Timeline.  

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Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Treatment 
development 
(Step 1) 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Initial piloting and revision 
(Step 2) 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
Participant recruitment and randomization (Step 3) 
N = 40 
 
 
 
 
  
  
  
  
  
  
  
  
  
 
 
Assessments at baseline, post-treatment, and 3-month follow-
up  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
Data 
analysis, 
manuscript 
preparation, 
and 
grant submissions   
 
Procedure: Step 1, Treatment and Therapist Training Adaptation: Work on Step 1 will begin immediately 
upon receipt of the award and will include Dr. Zajac’s training on evidence-based treatments for youth SUDs as 
well as completion of several critical tasks described in detail below, including integrating the SUD and PTSD 
interventions, tailoring the integrated treatment to meet the needs of emerging adults and to be appropriate for 
delivery in the context of justice system involvement, and development of training materials and an adherence 
measure for the integrated treatment. This process will take an iterative approach and will follow the steps of 
new treatment development outlined for Stage 1a and 1b behavioral therapy research (Carroll & Nuro, 2002). 
Step 1a: Integration of SUD and PTSD treatments. Step 1a will involve integrating Contingency 
Management and Prolonged Exposure and specifying modifications for implementation with emerging adults. 
Prolonged Exposure was originally developed for adults, with multiple studies documenting its efficacy (see 
Powers, Halpern, Ferenschak, Gillihan, & Foa, 2010 for a review). More recently, an RCT provided initial support 
for the efficacy of a Prolonged Exposure protocol modified for adolescents (Gilboa-Schechtman, Foa et al., 
2010). Given that the developmental needs of emerging adults are likely to span adolescence and early 
adulthood, careful consideration will be given to which protocol is appropriate for this population, with expert 
input from the mentoring team. Similarly, versions of Contingency Management have been validated for both 
adolescents and adults. The adolescent version includes extensive caregiver involvement, whereas adult 
protocols focus on contingencies provided by the treatment program. In past studies of treatments for emerging 
adults (R34 MH081374; PI: Davis), the research team has noted low rates of caregiver involvement, despite 
substantial effort to engage social networks. Thus, the proposed project will utilize adult Contingency 
Management models. However, as Dr. Zajac will receive extensive training in a variety of treatments during the 
early stages of this project, she will be in an ideal position to consider alternatives to Contingency Management 
with the guidance of the mentoring team and substance abuse treatment experts. 
Prolonged Exposure is a 10-session exposure-based behavioral treatment for PTSD based on Emotional 
Processing theory (Foa & Kozak, 1986), which proposes that pathological fear structures underlie the 
development and maintenance of anxiety disorders. The goals are to promote processing of the trauma memory 
and reduce distress and avoidance evoked by trauma reminders through four components: 1) psychoeducation; 
2) breathing retraining; 3) in-vivo exposure (i.e., repeated prolonged exposure to anxiety-provoking people, 
places, or situations); and 4) imaginal exposure (i.e., repeated prolonged retelling of the trauma memory). 
Contingency Management procedures as specified by Petry and colleagues (2000; 2004) involve reinforcements 
for drug abstinence and withholding reinforcements when drug use occurs. An individualized menu is created 
using rewards that can compete with the client’s substance use (e.g., gift cards from stores and restaurants). 
The client receives frequent random drug tests, an escalating reinforcement schedule for continuous abstinence, 

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and rapid reset to maintain motivation. The principles underlying Prolonged Exposure and Contingency 
Management are theoretically and logistically compatible (i.e., using behavioral principles to promote symptom 
reduction), making these treatments ideal for integration. Further, behavioral approaches are likely to best meet 
the needs of high-risk emerging adults due to their unique developmental characteristics, multiple psychosocial 
risk factors, and justice system-related requirements. 
Step 1a will follow the stage model of treatment development specified by Carroll and Nuro (2002), which 
outlines seven sections integral to the development of a Stage I treatment manual. Dr. Zajac will take the lead 
on integrating the interventions with mentoring from Drs. Sheidow and Davis. Each mentor will review changes 
to the protocol and provide feedback. Dr. Zajac will integrate feedback, and the mentors will review the revised 
protocol. This process will continue until all mentors have agreed that the integrated protocol is: a) consistent 
with the Contingency Management and Prolonged Exposure models, b) developmentally appropriate, c) likely to 
meet the needs of the population, and d) meets the criteria specified by Carroll and Nuro (2002).  
Step 1b: Specification of modifications for implementation with emerging adults. Modifications will be 
made to best meet the needs of emerging adults who are often involved with the criminal justice system. The 
process for these modifications will be similar to Step 1a, with Dr. Zajac taking the lead and eliciting feedback 
from mentors. Mentors will be asked to review, provide feedback, and approve the integrated protocol at the end 
of this step, with particular focus on ensuring that the treatment approach is compatible with the demands of 
ongoing probation and court involvement (e.g., frequent drug testing, use of contingencies, establishing 
collaborative relationships with probation officers). Attention will also be paid to the logistics of the treatment 
(e.g., specifying treatment length, number of sessions per week) as well as other necessary modifications based 
on the justice involvement of the clients. 
Step 1c: Development of training materials. The Criterion-Based Development Model (CBDM; Carter, 
2005) will be followed in the development of the training materials. CBDM uses an iterative process that includes: 
(a) operationally defining the targeted intervention skills; (b) identifying criteria for each skill; (c) developing 
training materials; and (d) implementing phased evaluation and revision of materials. Dr. Zajac will complete 
items a-c, routinely eliciting feedback from the mentoring team as specific skills are identified, criteria are 
selected, and materials are developed for each component of the treatment.  
 
Procedure: Step 2, Feasibility Pilot Study with 40 Emerging Adults:  A feasibility pilot study will be 
conducted with 40 emerging adults recruited through substance abuse treatment clinics and from the community. 
Recruitment of emerging adults will begin halfway through the second year of the study with the last participant 
being recruited by the end of the fourth year to allow for a 6 month follow up of each participant.  
 
Subjects and settings: Subjects will be 40 patients seeking substance abuse treatment. In addition, up to 
10 pilot participants will be recruited to test study procedures. Pilot participants will not be randomized and all 
will receive the experimental treatment – see below for additional details. A subset of patients will be recruited 
from the Farrell Center (New Britain, CT) and at The Village for Families & Children (Hartford, CT). These 
participants will receive study treatment at their respective treatment centers. Additional participants will be 
recruited through flyers at other substance abuse treatment centers in the area and through ads. These 
participants will receive the study treatment at UConn Health in Farmington.  
To aid with study recruitment, participants who are randomized into the study will be given flyers to hand out 
to peers who are in their age group and who may use drugs or alcohol. Participation in the study will not be 
affected by whether or not a subject chooses to send referrals. The flyer will describe the study and include RA 
contact information. A unique code will be used to link returned flyers with the original participant. Subjects can 
earn $15 for each eligible recruit (up to 3 referrals) who attends an intake appointment regardless of whether the 
recruit consents to participate in the study. 
Participant inclusion/exclusion criteria. Participants must meet the following inclusion criteria: (a) 18-25 
years old; (b) meets diagnostic criteria for substance use disorder; (c) meets diagnostic criteria for full or 
subthreshold PTSD; (d) currently able to provide a urine drug screen that is negative for cocaine and non-
prescribed methadone or opiates in the past 60 days (since we are not able to test for methadone or determine 
whether a positive test for opiates is from a prescribed or non-prescribed source, we will rely on patient self-
reports to make final decisions about the methadone and opiate results); and (e) speaks English.  
Exclusion criteria are: (a) significant cognitive impairment or serious uncontrolled psychiatric problem (other 
than PTSD); (b) in recovery from pathological gambling or current pathological gambling diagnosis and desiring 

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to stop or reduce gambling (because of potential concerns of similarity of prize reinforcers and gambling even 
though no increases in gambling have been reported; Petry & Alessi, 2010; Petry et al., 2006); and (c) in a 
current domestic violence relationship (as Prolonged Exposure is contraindicated for individuals in this situation; 
Foa, Hembree, & Rothbaum, 2007). 
Informed consent will be obtained by a research assistant (RA) under supervision of the PI. Those who 
decide not to participate, or who are ineligible, will receive standard care at the clinic.  
 
Assessments. After informed consent, patients will undergo a 3-hour assessment to assess inclusion/ exclusion 
criteria and outcomes. All measures except those with an asterisk (at baseline [BL] only) will be collected at BL, 
~3-month post-baseline, and ~6-month post-baseline. Instruments were chosen based on psychometric 
properties, with briefer instruments chosen over lengthier ones when possible to minimize burden. Measures will 
be entered directly into UConn Health’s REDCap system. Measures will be administered by Dr. Zajac or by an 
RA after training from Dr. Zajac. The RA will audio record all assessments, which Dr. Zajac will review randomly 
for quality control. 
The DSM-5 criteria Checklist* (DSM) (APA, 2013) will be used to assess alcohol, cocaine, methamphetamine, 
opiate, benzodiazepine and marijuana use disorder. This instrument will be used to determine whether 
participants meet diagnostic criteria for a substance use disorder.  
The National Opinion Research Center Diagnostic Screen (NODS)* assesses DSM-IV pathological gambling 
with high sensitivity and specificity (Gerstein et al., 1999). This instrument will be used to determine whether a 
participant needs to be excluded based on a history of pathological gambling.  
The PTSD module of the Structured Clinical Interview for Diagnosis (Research Version) for DSM-V* (SCID-
V; First, Williams, Karg, & Spitzer, 2015) is a structured diagnostic interview that has been updated to reflect the 
DSM-V diagnostic criteria. The PTSD module will be used to determine if participants meet criteria for either 
PTSD or subthreshold PTSD. The SCID is considered the gold standard for diagnosis of mental health disorders.  
The Trauma Assessment for Adults (TAA; Gray, Elhai, Owen, & Monroe, 2009) will be used to screen for 
exposure to traumatic events, as the diagnosis of PTSD or subthreshold PTSD is contingent upon the experience 
of a qualifying traumatic event. In addition, the TAA assesses current involvement in violent relationships and 
will be used to assess the exclusion criteria “currently in a domestic violence relationship.” 
 The National Stressful Events Survey PTSD Short Scale (NSESP-SS: Miller et al., 2013), a validated self-
report measure of DSM-V PTSD symptoms, will be used to screen for PTSD. THE NSESP-SS is a 20-item 
measure including subscales for intrusion, avoidance, negative cognitive/mood alterations, and 
hyperarousal/reactivity. The reference period will be “since the crime event occurred” at the screening/BL 
assessment and “past month” for each subsequent assessment. It is likely that emerging adults with both clinical 
and sub-clinical levels of PTSD will benefit from this treatment; therefore, emerging adults will meet study criteria 
if they: (a) report an index trauma; (b) meet criteria for 2 of the 4 DSM-V PTSD symptom cluster and (d) have 
significant functional impairment (i.e., the recommendation for determining subthreshold PTSD using DSM-V 
criteria; McLaughlin et al., 2015). This instrument will be used at each of the assessments as well as once per 
week during the participant’s scheduled sessions. 
The Addiction Severity Index (ASI; McLellan et al., 1988) is a structured interview that assesses demographic 
information as well as areas affected by substance use disorders: alcohol use, drug use, medical status, legal 
status, psychiatric, employment, gambling, cigarette smoking, and social functioning. Adequate interrater and 
test-retest reliability, and concurrent and discriminant validity, have been established (McLellan et al., 1985; 
Zanis et al., 1994). An abbreviated version will be administered at follow-up. 
Timeline Follow-back (TLFB; Sobell et al., 1980) uses calendar prompts to elicit specific information about the 
frequency and intensity of substance use over time intervals with good test-retest reliability and validity (Sobell 
& Sobell, 1992). It will assess days and quantity of alcohol use and days of cocaine, opioid, benzodiapine, 
marijuana or other drug use 3 months before treatment, every session throughout treatment, and since the last 
interview at follow-up.  
The Psychiatric Diagnostic Screening Questionnaire (PDSQ; Zimmerman & Shereen, 2003) is a brief, 
psychometrically strong self-report scale that screens for the most common Axis I DSM-IV disorders encountered 
in outpatient settings. For the current study, modules for the following disorders will be used: 1) obsessive 
compulsive disorder; 2) panic disorder; 3) psychotic symptoms; 4) agoraphobia; 5) social phobia; 6) generalized 
anxiety disorder; 7) physical health problems; and 8) hypochondria. 

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The HIV Risk Behavior Scale (HRBS; Darke et al., 1991) assesses injection and sexual risk behaviors over 
time; it has adequate reliability and validity (Barry et al., 2008; Petry, 2001) and provides continuous summary 
scores. The HRBS will assess lifetime and past 3 months at baseline and the past 3 months at all other time 
points. 
The Quality of Life Inventory (QOL; Frisch, et al., 1992) assesses satisfaction in 17 life areas (work, health, 
recreation, goals, etc). It has test-retest coefficients of .80-.91 and correlates with other measures of well-being 
(Frisch, et al., 1992); scores change in response to CM (Petry et al., 2007b).  
The COPE Inventory (COPE; Carver, Scheier, & Weintraub, 1989) is a well validated measure of a broad 
range of coping responses that individuals use in response to stress. Five scales measure aspects of emotion-
focused coping (e.g., seeking of emotional social support, positive reinterpretation, acceptance, denial, turning 
to religion); and three scales that measure less adaptive coping strategies (e.g., focusing on and venting of 
emotions, behavioral disengagement, mental disengagement). 
The Center for Epidemiological Studies-Depressed Mood scale (CES-D; Radloff, 1977; Thomas et al., 2001) 
is a widely used, reliable and valid index for assessing depressive symptoms. This instrument will be used at 
each of the assessments as well as once per week during the participant’s scheduled sessions.  
The Self-Reported Offending Scale (SRO; Huizinga, 1991) was adapted from the Self-Reported Delinquency 
Scale (Elliott, Ageton, Huizinga, Knowles, & Canter, 1983) to be used for adult rather than juvenile offending 
(i.e., delinquency). The SRO will be used to assess the participant’s involvement in delinquent acts during the 
past 90 days. The SRO includes a general delinquency scale as well as subscales that pertain to person offenses 
(e.g., assault) and property offenses (e.g., vandalism).  
The Service Utilization Form (SU; Rosenheck et al., 1995) evaluates drug abuse, medical, and mental health 
treatments received at the clinic and elsewhere. It inquires about services in the past 12 months at baseline and 
since the last interview at other points. It also collects information about societal costs related to drug abuse 
(e.g., unemployment, homelessness, criminal justice involvement). It contains similar items as the Treatment 
Services Review (McLellan et al., 1992) but is more extensive. An abbreviated version will be administered at 
follow-up. 
Objective indicators of substance use will be assessed at each evaluation and during treatment. We will 
assess recent alcohol use (e.g., Alcosensor IV Alcometer, Intoximeters, St. Louis, MO) and cocaine, 
amphetamine, methamphetamine, opiate, benzodiazepine, and marijuana use (e.g., iCup, Brooklyn, NY) at BL, 
all follow-ups, and every treatment session.  
Treatment Feasibility. Individual qualitative interviews will be conducted with each participant to assess 
treatment feasibility, acceptability, and burden as well as acceptability and burden of the research protocol.  
 
Scale 
Data 
Baseline 
Weekly 
during 
sessions 
3 month 
follow-up 
6 month 
follow-up 
DSM-5 Criteria Checklist 
Substance use disorder 
X* 
 
 
 
Trauma Assessment for Adults 
Exposure to traumatic events 
X* 
 
X 
X 
Urine Toxicology, Breathalyzers 
Substance Use 
X* 
X 
X 
X 
National Stressful Events Survey PTSD Short Scale 
PTSD symptoms 
X 
X 
X 
X 
National Opinion Research Center Diagnostic Screen 
Pathological gambling 
X* 
 
 
 
Structured Clinical Interview for DSM-5 PTSD Module 
PTSD Diagnosis 
X* 
 
 
 
Timeline Follow-back 
Substance use 
X 
X 
X 
X 
Addiction Severity Index 
Substance 
use 
& 
related 
problems, demographics 
X 
 
X 
X 
Center for Epidemiological Studies-Depressed Mood scale  Depression symptoms 
X 
 
X 
X 
X 
Psychiatric Diagnostic Screening Questionnaire 
Co-occurring mental health 
problems 
X 
 
X 
X 
HIV Risk Behavior Scale 
HIV Risk Behaviors 
X 
 
X 
X 
Service Utilization Form 
Use of community services 
X 
 
X 
X 
Self-reported Offending (SRO) 
Criminal behavior  
X 
 
X 
X 
Quality of Life (QoL) 
Life satisfaction 
X 
 
X 
X 
COPE Inventory (COPE) 
Coping skills 
X 
 
X 
X 
Qualitative Interview with Participants 
Treatment acceptability 
 
 
X 
 
*indicates measures that will be used to assess inclusion/exclusion criteria 
 
 

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Follow-up assessments will be scheduled to take place immediately following treatment completion (i.e., 10-
12 weeks of PE/CM for the active group, 10 weeks of sample drop-off for the control group) and about 6 months 
post-baseline. In this study population, patients are often difficult to contact (e.g., homelessness, unstable 
housing) or become unavailable for follow-up assessments (e.g., in controlled environment). We have many 
procedures in place to address these issues (e.g., collection of contact information, reminder calls and cards, 
etc.). Given these difficulties, some flexibility in scheduling follow-up interviews is required to protect participants 
from unnecessarily limiting study procedures to a specific calendar day. If a participant misses the follow-up 
evaluation, research staff will attempt to contact and reschedule the evaluation, but we anticipate late and missed 
appointments. Given these circumstances, completion of follow-up assessments is likely to occur at about 3 
months and 6 months following study initiation. Study visits may be completed over the phone or mailed if 
needed. During the COVID-19 outbreak, participants who complete the follow-ups over the phone or through the 
mail will receive the full $100 follow-up payment. 
 
Retention Strategies: Dr. Zajac and her mentoring team have been very successful at recruiting and 
retaining participants from extremely challenging clinical populations. These strategies will be used to promote 
excellent recruitment and retention rates. First, to establish a collaborative relationship, assessments will be 
scheduled at participants’ convenience, contacts will be maximally personalized, participants will be reimbursed 
for completing assessments, and researchers will behave in a friendly and professional manner. Second, each 
time participants are assessed, they will be asked if they plan to move and for the names and contact information 
of three friends or relatives to facilitate tracking. When a participant cannot be located, the Research Assistant 
will immediately attempt to track them using this information. Third, contacts will be defined as confidential and 
independent of the treatment team so as to encourage disclosure. All reasons for failure to interview will be 
recorded to assess their impact on the proposed methods. 
Incarceration:  This is a minimal risk study that recruits non-prisoner patients from substance abuse 
treatment programs. However, a portion of the study patients are likely to be incarcerated during the study period 
due to illegal activities that are common in this population. If a patient is incarcerated during study participation, 
all study procedures are suspended except the evaluations. In the ICF, patients indicate whether or not they 
would like the evaluation questionnaires sent to them in prison. The mailing delivered to the incarcerated patient 
only contains the evaluation questionnaires and a cover letter indicating the questionnaires are follow-up to a 
study the patient participated in at UConn Health. A stamped and addressed return envelope is also provided 
with the questionnaires. If the patient completes and returns the questionnaires for Month 3 and 6, they will 
receive $25 in the form of a check. The patient will receive the check after their release from incarceration or 
they may designate a person to whom the check should be sent during their incarceration. The patient is notified 
in the ICF that their participation in this study while incarcerated will have no effect on their eligibility for parole. 
Compensation: To compensate for their time, participants will be given a $50 giftcard for the baseline 
interview and $100 in their choice of a check or giftcard for each subsequent interview. Participants in the control 
group will be compensated $5 (check or giftcards) for each urine sample they provide during the treatment phase 
(i.e., two samples per week for ten weeks). Participants who travel to UConn for their study visits will be provided 
with $15 (check or giftcards) to cover the cost of travel (bus passes, gas, parking, etc). Participants may also 
earn up to $45 for eligible referrals ($15 each, up to 3 referrals). 
Random Assignment occurs after the BL evaluation. A computerized urn randomization procedure (Stout et 
al., 1994) will balance patients on gender and submission of a positive sample for any illicit drug (i.e., cocaine, 
amphetamine, methamphetamine, opiate, benzodiazepine, or marijuana) at baseline, because positive samples 
at treatment initiation are related to poor outcomes (Preston et al., 1998; Silverman et al., 1998; Stitzer et al., 
2007). Prior to randomizing participants, up to 10 pilot participants will complete a pilot study consent form and 
study procedures described for Group B below, through month 3 follow-up, for the purpose of monitoring staff 
on study procedures prior to the randomized trial. 
Group A (Standard care [SC]; n=20) patients will receive SC at the substance use clinic where they are 
seeking treatment. This treatment approach typically consists of group therapy sessions, including daily planning, 
12-Step treatment, relapse prevention, coping and life skills training, and AIDS education. Groups are led by 
recovering individuals, nurses, and masters level counselors. Very few individual sessions are provided at these 
clinics, and then only in cases of emergencies (e.g., suicidality). These clinics rarely conduct breathalyzers or 
urine testing for illicit drug use. Any such testing will occur as it normally would, and study procedures will not 

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impact standard care in any way. If the participant is not already enrolled in SC at a substance use clinic, they 
will be provided with referrals to clinics convenient to their home.  
Study urine samples will be collected twice weekly. Patients will receive a $5 payment (check or gift cards) 
for each of 20 urine/breath sample submissions during weeks 1-10.  In addition, they will be asked to complete 
the NSSEP-SS and the CES-D to assess PTSD symptoms and depression weekly. If patients cease attending 
groups, they will still be encouraged to attend these brief meetings for sample monitoring. To maintain 
consistency with standard care in these clinics, results from toxicology screens will not be discussed with 
providers. 
Group B (SC + PE/CM Treatment; n=20) patients will receive the same SC groups as Group A. If they are 
currently enrolled in susbtance use treatment, they will continue with that treatment. If not, they will be provided 
with referrals for substance use treatment in the community. In addition, they will participate in an integrated 
Contingency Management (CM) and Prolonged Exposure (PE) treatment protocol described subsequently. 
Either the PI (Dr. Zajac) or Meredith Ginley, PhD, will serve as the study therapist for participants randomized to 
group B. For cases where Dr. Ginley serves as the therapist, Dr. Zajac will provide clinical supervision of study 
cases.  
As in Group A, participants will undergo testing twice weekly with a breathalyzer and urine drug screen. In 
addition, during the first meeting of the week, participants will engage in both CM and PE components of 
treatment (described below). During the second meeting of the week, participants will engage in CM and a brief 
check-in on the components of PE that the participant is working on for homework that week but no new PE-
related components will be introduced.  
 
Contingency Management Component.  Participants in Group B will participate in CM to target abstinence 
from substance use. In prize CM protocols, participants earn opportunities to draw cards from a prize bowl. The 
cards differ in prize value, ranging from $0 to $100 in value, and participants can earn increasing numbers of 
draws with consecutive performance. The variable reinforcement amount feature of prize CM distinguishes it 
from other reinforcement systems such as voucher CM. Participants will be allowed to draw from the prize bowl 
if their urine drug screen is negative for opiates, methadone, cocaine, amphetamines, methamphetamines, and 
marijuana (see additional information about marijuana use below) and their breath screen is negative for alcohol.  
The prize bowl contains 500 cards; 50% are winning and the remainder are non-winning (i.e., “Good 
Job”). The majority (209/500) of winning cards are small prizes (about $1 in value; e.g., small toiletries, food 
items); 40/500 cards are large prizes (up to $20 in value; e.g., small electronics, gift cards). One card (1/500) is 
a jumbo prize (up to $100 in value; e.g., MP3 players/iPod). The maximum number of draws is 132, with an 
expected average maximum earned per person of about $255 over 10 weeks. Slips are drawn consecutively 
(without replacement) within session and then replaced between sessions. This reinforcement approach has 
been used successfully in other treatment trials (Petry et al., 2004; 2005). Prize CM is equally effective as 
voucher CM (Petry et al., 2005) and it is more cost-effective than voucher CM (Olmstead & Petry, 2009).  
At week 1, participants will earn 1 draw for the first negative sample and the number of draws will increase 
by 1 draw for each consecutive negative sample up to a cap of 8 draws. Once the cap of 8 draws is achieved, 
participants will continue to receive 8 draws for each consecutive negative sample. No draws are earned for 
positive samples, unexcused absences (e.g., no shows), or refused samples, and these events will reset the 
schedule to 1 draw for the next negative sample and escalation will resume as described above. Excused 
absences (e.g., court appearance, doctor’s appointment) will be accommodated with valid proof and will not 
reset the reinforcement schedule.  
It is expected that, for some emerging adults, marijuana will be their drug of choice. Marijuana treatment 
requires a different CM schedule, as marijuana can continue to be detected on urine drug screens for up to 3-4 
weeks following last use among heavy marijuana users. In these cases, participants will earn 1 draw simply for 
attending sessions and providing a urine sample for the first 4 weeks of CM treatment. Once the participant is 
able to provide a negative screen, they will begin to earn escalating rewards starting at the same level as their 
peers who are in treatment for other illicit drugs. For example, if a participant is positive for marijuana until week 
3, s/he would receive one draw for each session attended leading up to the negative screen and then 5 draws 
for his/her negative urine drug screen in week 3. Once the participant tests negative for marijuana (or the 4 
weeks has elapsed), s/he is subject to the same rules for negative and positive screens as other participants. 

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This adaptation allows us to engage marijuana users in the CM treatment process during the time that they are 
waiting for their urine drug screens to reflect their abstinence.  
Prolonged Exposure Therapy. Participants in Group B will also engage in Prolonged Exposure (PE) 
therapy for the treatment of PTSD. PE is a well-established treatment for PTSD for a wide range of populations, 
including victims of sexual and/or physical assault, childhood trauma, accidents, and war veterans. A 2010 meta-
analysis reviewed 13 randomized controlled trials evaluating PE over 20 years and concluded that this treatment 
approach “is a highly effective treatment for PTSD, resulting in substantial treatment gains that are maintained 
over time” (Powers, Halpern, Ferenschak, Gillihan, & Foa, 2010). PE has also been evaluated with patients who 
have co-occurring PTSD and substance abuse disorders, resulting in evidence for its safety, feasibility, and 
efficacy with this patient population (Brady, Dansky, Back, Foa, & Carroll, 2001; Foa et al., 2013; Mills et al., 
2012).  
PE consists of 10 sessions and is based on Emotional Processing theory (Foa & Kozak, 1986), which 
proposes that pathological fear structures underlie the development and maintenance of anxiety disorders. The 
goals are to promote processing of the trauma memory and reduce distress and avoidance evoked by trauma 
reminders through four components: 1) psychoeducation; 2) breathing retraining; 3) in-vivo exposure (i.e., 
repeated prolonged exposure to anxiety-provoking people, places, or situations); and 4) imaginal exposure (i.e., 
repeated prolonged retelling of the trauma memory). Psychoeducation includes providing information to the 
participant about common reactions to trauma, how PTSD develops, and how exposure to trauma cues and 
reminders through PE can help reduce PTSD symptoms over time. As in other studies with substance using 
populations (e.g., Brady et al., 2001; Mills et al., 2012), psychoeducation will also be provided about the 
relationship between PTSD symptoms and substance abuse.  Breathing retraining involves teaching patients 
how to use their breathing to calm down their bodies and thoughts. Patients are educated on the relationship 
between calm breathing and subjective feelings of distress and coached in a method for slowing down breathing. 
Patients are encouraged to practice breathing retraining between sessions to promote mastery. In vivo 
exposure involves the gradual exposure to people, places, situations, and other triggers that the patient is 
currently avoiding due to trauma-related distress. The patient and the therapist work together to construct an in 
vivo exposure hierarchy and then choose targets for the patient to work on. In vivo exposures are conducted for 
at least 30-45 minutes at a time to promote new learning and block avoidance. As in other studies of PE with 
substance using populations, in vivo exposures will be approached gradually. Finally, imaginal exposure helps 
patients to overcome avoidance of thinking and talking about the trauma and involves the repeated retelling of 
the traumatic memory. The patient engages in imaginal exposure during the PE sessions with the therapist, and 
the therapist coaches the patient on how to process the memory emotionally rather than blocking it or pushing it 
away. Sessions are audiotaped with participant permission and patients are encouraged to listen to these tapes 
between sessions to promote habituation to the traumatic memories. As in past studies using PE for substance 
using patients, the therapist emphasizes the importance of not using drugs or alcohol prior to the PE sessions 
or during the between-session homework, as this is likely to decrease the effectiveness of the exposure 
exercises. The therapist will also ensure that patients are proficient in effective coping techniques, including 
breathing retraining, prior to conducting an in vivo or imaginal exposure exercises. 
Missed Sessions. When a participant misses a PE session, he or she will be encouraged to reschedule 
that session within the same week. To allow for the high likelihood of occasional missed sessions or scheduling 
conflicts that will result in a missed week of PE, participants will be given the opportunity to make up a missed 
session in the following week.  However, session length will be capped at 12 weeks, regardless of the number 
of sessions completed.   
Inclusion of Women and Minorities. Data from past studies with this clinical population (i.e., emerging 
adults seeking susbtance abuse treatment) suggests that 40% of the sample can be expected to be women. 
Thus, we anticipate that 16 of the 40 participants recruited will be women. Using the same data source, we 
estimate that 25% of the sample will identify as Hispanic, and 45% will identify as African American. Participants 
will be enrolled without regard to gender or minority status, and this study involves no gender or minority group 
exclusions. Because this is a feasibility study, our aim at this stage of development is to observe the capacity of 
our standardized recruitment protocol to engage females and minorities into the study. A higher rate of refusal 
for study participation in these groups will be examined. Similarly, apparent under-enrollment according to our 

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estimated enrollment rates will stimulate changes to protocols for subsequent applications.  
 
Data Quality Control: Instruments chosen are reliable and valid for assessing substance use, PTSD, and 
related outcomes. To maximize consistency of measurement, careful training will precede study initiation. Our 
staff is experienced in conducting similar trials, and the majority of these instruments are being used in ongoing 
studies. Training of new personnel consists of 2-4 days of intense training and >5 supervised ratings. Reliability 
is assessed at outset of data collection and then spot-checked about monthly via review of audiotapes. Interrater 
reliability on each instrument is >80% before study initiation and throughout its duration; if not, more training 
occurs. Kappas are used for diagnostic assessments, and Shrout and Fleiss intraclass correlations for 
continuous variables. 
Valid assessment requires that measures be obtained from different sources, including self-report and 
objective data, which will be compared. If discrepancies are noted, the most conservative index can be utilized 
with any index (self report or objective data) coding an individual as using substances for analysis purposes.  
Strict separation of clinical (therapy) and research components (structured evaluations) and the use of multiple 
sources of information including objective indicators of substance use will help to reduce bias. Importantly, for 
Group B, Dr. Zajac will be implementing the treatment but a trained RA will conduct the research assessments. 
As in prior trials, checksheets will be kept, in which all data to be collected are listed, draws earned and their 
outcomes are recorded, and patients are informed of draws possible at their next session (Petry, 2011; Petry, 
Alessi, Ledgerwood, & Sierra 2010).  
Data will be entered into electronic format (REDCap) and checked for out of range responses and missing 
data. Data cleaning procedures involve within and between file checks for inconsistencies, outliers, and missing 
data and nonresponse patterns.  
Steps are taken to minimize follow-up contact bias: obtaining names, phone numbers and addresses of >3 
locators and checking in regularly about changes. We generally achieve follow-up rates >90% at early follow-
ups (through month 6), and >80% at each longer-term follow-up, with <6% of patients lost to follow-up completely 
(Petry, Martin, Cooney, & Kranzler, 2000; Petry et al., 2004; Petry, Alessi, Tedford, Austin, & Terdif, 2005; Petry, 
Alessi, Hanson, & Sierra 2007). We expect similarly high follow-up completion rates in this study.  
 
Data Analysis Strategy: 
Aim 1: To develop and implement an integrated SUD/PTSD treatment for high risk emerging adults. 
There are no data analyses associated with this aim. 
Aim 2: To evaluate the feasibility, acceptability, and safety of the SUD/PTSD intervention for emerging 
adults. Feasibility measures relevant to recruitment and dropout proportions will be examined with 95% 
confidence intervals used to estimate the proportion of emerging adults who agree to participate out of the 
number deemed eligible and to compare those who complete versus do not complete the intervention. Feasibility 
will be evaluated by examining therapist adherence using ratings of taped sessions as well as emerging adults’ 
responses to qualitative interviews. Measures of safety will include repeat trauma exposure, suicidal ideation, 
and risky substance use behaviors. Patterns of safety indicators will be examined using frequency distributions 
and descriptive statistics. In addition, rates of these indicators will be compared across Group A and Group B to 
determine if there is any increased risk posed by the active treatment compared to treatment as usual. These 
data will be used to make any necessary protocol changes. 
Aim 3: To conduct a preliminary analysis of the efficacy of the integrated protocol in improving 
symptoms among emerging adults. Groups will be compared with respect to the primary outcome variables 
(substance use, PTSD symptoms) and secondary variables (delinquent behaviors, depression, adaptive 
functioning, HIV risk behaviors). An important issue preceding analyses is to identify baseline differences 
between groups despite random assignment.  Differences between groups that may be related to outcome will 
be used as covariates or fixed factors, as appropriate. We will conduct intent-to-treat analyses, with all 
randomized patients and apply random regression models, also known as hierarchical linear models (HLM), to 
determine if patients improve differentially between groups over time (Raudenbush & Bryk, 2002). HLM is 
specifically designed for repeated measures designs with missing data, allowing for intra-subject serial 
correlation and unequal variance and covariance structures over time by incorporating available trend data for 
each individual with information on the group from which the subject is drawn. Maximum likelihood estimation 
enables analyses to be performed for the full trial without having to drop subjects with incomplete data, and both 
continuous and dichotomous variables can be analyzed. If data cannot be normalized, group by time effects will 

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be assessed with HLM, coding patients as improved or not at each time point. The main analyses will focus on 
during treatment effects (baseline through follow-up) but long-term effects (baseline to 3-month post-treatment 
follow-up) will also be analyzed (see follow-up section). 
 
The primary outcomes are substance use is longest duration of abstinence from illicit drug use and 
symptoms of PTSD (NSESP-SS), continuous variables that can be transformed if needed.  The primary 
substance use outcome is longest duration of abstinence from substances (LDA), the main outcome variable in 
most CM trials and the variable most strongly associated with long-term abstinence (Higgins et al., 1994, 2000, 
2003; Petry et al., 2005). Linear regression will evaluate group differences in LDA, with condition as the 
independent variable (along with any important covariates). If data cannot be normalized, nonparametric tests 
will be used. While LDA is the primary substance use outcome measure, it is affected by retention as missing 
samples break a string of abstinence (unless preceded and followed by negative samples, and an excused ‘miss’ 
is obtained due to documented illness, court appearances, etc. usually comprising <5% of missed samples). 
Proportion of negative samples, in contrast, is unaffected by missing samples. Thus, we will also analyze 
proportion of samples negative for substances as a secondary outcome using similar analyses.  
 
Analyses will focus on the 10-week during treatment effects, but long-term effects will also be analyzed. 
These will involve logistic regressions to predict substance abstinence at the 3-month follow-up, with treatment 
group and any important baseline characteristics (e.g., baseline sample result) included as independent 
variables. HLM analyses for dichotomous measures will also be conducted to evaluate substance abstinence 
over time between treatments from baseline throughout the 3-month follow-up. Additional secondary drug use 
outcomes will investigate abstinence from all substances concurrently and from each of the other drugs 
independently. These analyses will parallel those outlined above.  
 
Effects of treatment on PTSD symptoms will be examined primarily using the weekly scores on the 
NSESP-SS. This is a continuous measure, with missing data likely. If no systematic differences in missing data 
are noted (the case in our prior studies), hierarchical linear models (HLM; Gibbons et al., 1993) using MIXREG 
(Hedeker, 1993) will analyze differences between groups over time. These analyses have advantages over 
repeated measures ANOVA as they estimate missing data via model parameter estimates and use real time, 
rather than scheduled time, of assessments. The model will include factors for group, time, and the interaction 
of group by time.  
 
Secondary outcomes include delinquent behaviors (SRD), HIV risk behaviors (HRSB), adaptive 
functioning (SAS-SR), and depression (CES-D). Using the same HLM modeling described above, we will 
examine the impact of group, time, and group x time on each of these secondary outcomes to determine if the 
PE/CM treatment produces better outcomes than usual services.  
 
Contingency Plan: If the intervention is not found to be feasible and/or produce symptom reduction, the 
candidate will work closely with mentors during Yr 5 to evaluate where positive outcomes are lacking and to 
refine the intervention using both quantitative and qualitative approaches. Assessment results will be evaluated 
to determine whether the intervention is equally effective across all areas targeted in treatment. If the intervention 
is found to be less effective in a specific area, modifications will be made to enhance the intervention in that area. 
Data will be examined to determine whether specific factors explain differential effects among participants. Input 
from participants will also be a critical source of information for improving the intervention. 
   
PROTECTION OF HUMAN SUBJECTS 
The 
proposed 
research 
does 
not 
meet 
the 
definition 
of 
a 
Phase 
III 
clinical 
trial 
(see 
http://www.drugabuse.gov/funding/clinical-research/guidelines-developing-data-safety-monitoring-plan), but a 
Detailed Data and Safety Monitoring Plan is provided following NIDA instructions. This plan includes continuous, 
close monitoring by the study investigators (including mentors) and prompt reporting procedures. All procedures 
and materials will be reviewed and approved by the Institutional Review Board at UConn Health prior to 
commencement of data collection To provide further protections to participants, a federal Certificate of 
Confidentiality will be sought. All procedures will follow guidelines as outlined in 45 CFR Part 46 Subpart D for 
research involving children, as well as those outlined in 45 CFR Part 46 Subpart C for research involving prisoner 
populations. 
  
1. RISKS TO THE SUBJECTS  
 
A. Human Subjects Involvement and Characteristics 

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Human subjects are being recruited for the proposed study to participate in a clinical trial evaluating an 
integrated treatment for substance use and PTSD (SUD/PTSD) for transition age youth. Specifically, 40 youth 
will be recruited to participate in this study.  
 
Inclusion criteria are: (a) 18-25 years old; (b) meets diagnostic criteria for a substance use disorder; (c) meets 
criteria for full or subthreshold PTSD; (d) currently able to provide a urine drug screen that is negative for cocaine 
and non-prescribed methadone or opiates in the past 60 days (since we are not able to test for methadone or 
determine whether a positive test for opiates is from a prescribed or non-prescribed source, we will rely on patient 
self-reports to make final decisions about the methadone and opiate results); and (e) speaks English. Exclusion 
criteria are: (a) significant cognitive impairment or serious uncontrolled psychiartic problems (other than PTSD); 
(b) in recovery from pathological gambling or current pathological gambling diagnosis and desiring to stop or 
reduce gambling (because of potential concerns of similarity of prize reinforcers and gambling even though no 
increases in gambling have been reported; and (c) in a current domestic violence relationship. Youth who meet 
eligibility requirements and consent to study participation will complete three assessment interviews over 6 
months (i.e., at baseline, 3-, and 6-months post-baseline). Youth will be randomized to either the integrated 
SUD/PTSD treatment (plus treatment as usual) or to treatment as usual alone.  
Targeted enrollment is based on estimates from past studies completed by the research mentors with 
transition age youth. There will be no restrictions with regard to gender, race, or ethnic background. Individuals 
will, however, be required to speak and understand English in order to participate in the study.  
 
B. Sources of Material 
  
Participant assessments will include self-report measures, interviews (semi-structured and qualitative), urine 
drug screens, and breathalyzer tests. Participants will be assessed at three time points (i.e., at baseline and 3-, 
and 6-months post-baseline). All assessments will be collected in person by the Research Assistant or PI. 
Assessments will be scheduled at a time and location convenient for the participant. At each occasion, 
participants will provide self-reports of substance use, symptoms of PTSD and depression, HIV risk behaviors, 
and adaptive functioning as well as a biological measurement of substance use. In addition, interviews will be 
used at the baseline measurement to assess demographics, other Axis I disorders, and PTSD diagnosis. Finally, 
youth in the PE-CM condition will participate in a qualitative interview at 3 and 6 months post-baseline focused 
on their perceptions of acceptability of the treatment and research protocols. All therapy sessions and research 
visits will be audiotaped to ensure therapist adherence to the treatment protocol and the Research Assistant’s 
adherence to the research protocol. To compensate for their time, participants will be paid $50 in giftcards for 
completing the initial assessments and $100 in checks or giftcards for completing each of the follow-up 
assessments. Participants in the treatment as usual condition will be paid $5 in checks or giftcards or small 
prizes per session for providing twice weekly urine and breathalyzer samples and completing brief self-report 
measures. Participants may also earn up to $45 for referrals who complete an intake ($15 each, up to 3 referrals). 
 
C. Potential Risks 
 
The risks that might be associated with this study include: 1) perceived coercion to participate; 2) potential 
embarrassment/distress due to sensitive assessment items; 3) potential distress if information obtained during 
the assessments were released to outside parties; and 4) potential distress due to participation in an exposure-
based treatment for PTSD. As described next, several procedures will be used to protect against these risks.  
 
2.  ADEQUACY OF PROTECTION AGAINST RISKS  
 
A. Recruitment and Informed Consent 
 
Participants will be recruited from substance abuse treatment clinics or from ads. Patients who meet general 
eligibility requirements (i.e., age, presenting problem) will be asked if they are interested in learning more about 
a research study. It will be made clear to the potential participant that their eligibility for services is not contingent 
on their participation in the research study. A research assistant will follow up with any interested youth to 
complete a study screening assessment to determine initial study eligibility. If the youth is eligible, the research 
assistant will explain the study in more detail and, if the youth is interested in participating, an appointment will 
be scheduled for the youth to complete the informed consent procedure. 

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To ensure that consent is fully informed, the nature of the treatment, potential benefits and risks, the voluntary 
nature of participation, and the data collection procedures will be explained to the potential participant. It will be 
communicated that all therapy sessions and data collection visits will be audiotaped as part of the study. If the 
individual agrees to participate, written informed consent will be obtained. Both the Research Assistant and the 
consent form will make it clear that the individual’s eligibility for services will not be affected by the decision to 
participate in the study.  
All consent forms and procedures will be approved and monitored by the IRB at UConn Health. All research 
staff will receive the requisite training in human subject protections.  
 
Incarceration:This is a minimal risk study that recruits non-prisoner patients from substance abuse treatment 
programs. However, a portion of the study patients are likely to be incarcerated during the study period due to 
illegal activities that are common in this population. If a patient is incarcerated during study participation, all study 
procedures are suspended except the evaluations. In the informed consent form, patients indicate whether or 
not they would like the evaluation questionnaires sent to them in prison. The mailing delivered to the incarcerated 
patient only contains the evaluation questionnaires and a cover letter indicating the questionnaires are follow-up 
to a study the patient participated in at UConn Health. A stamped and addressed return envelope is also provided 
with the questionnaires. If the patient completes and returns the questionnaires for Month 3 and 6, they will 
receive $25 in the form of a check. The patient will receive the check after their release from incarceration or 
they may designate a person to whom the check should be sent during their incarceration. The patient is notified 
in the informed consent form that their participation in this study while incarcerated will have no effect on their 
eligibility for parole. Approval for this aspect of the study will be obtained from OHRP before these procedures 
are implemented.  
 
B. Protection against Risk 
 
Coercion. Several strategies are embedded within the research protocol to reduce the risk of real or 
perceived coercion of potential participants. First, all research staff will complete an online Human Subjects 
Research Training course. This course discusses the importance of autonomy and informed consent in research.  
To protect against coercion, it will be emphasized to the Research Assistant that s/he should under no 
circumstance attempt to influence the youth’s participation, but rather provide information to potential participants 
and allow them to make their own decisions regarding participation. The Research Assistant will be trained to 
state clearly to potential participants that their access to services are in no way contingent upon their participation 
in the research study. Finally, the Research Assistant will make it clear to the participant that they may 
discontinue their participation in the research study at any time.  
Participant Discomfort Due to Assessment. There is a possibility that some participants might experience 
distress when asked questions pertaining to trauma and trauma-related mental health symptoms. Many people 
assume that asking such questions produces substantial distress, particularly in research settings. However, our 
prior clinical research experience, as well as the empirical literature, indicates that this risk is minimal. Most 
individuals with traumatic event histories do not report significant distress and actually report obtaining positive 
benefits from their participation in studies using assessment instruments similar to the ones proposed (Cercone 
et al., 2009; Griffin et al., 2003; Newman et al., 1999; Zajac et al., 2010).  
To minimize any possible embarrassment or distress associated with participation in the study: (a) the 
Research Assistant will be carefully chosen and trained by the Principal Investigator; (b) participants will be 
informed that they can discontinue participation at any time and that they do not have to answer any questions 
that they find objectionable; (c) study visits will be scheduled and conducted in ways that maintain participant 
privacy; and (d) the Research Assistant will be carefully supervised through weekly supervision meetings and 
auditing of audiotaped assessments by the Principal Investigator. 
Confidentiality. All information obtained from participants will be confidentially maintained. Because of the 
sensitivity of some of the data (e.g., self-reports of criminal behavior), a Federal Certificate of Confidentiality will 
be obtained to render participant data immune from subpoena. In addition, the Research Assistant will receive 
training from the Principal Investigator on the importance of confidentiality and will have regular supervision 
meetings with the Principal Investigator to ensure strict compliance with the Human Subjects Protection plan.  
Regarding data management and storage, interviews will be administered by either the Principal Investigator 
or a trained Research Assistant, who will enter data via laptop computers. Only participants’ study identification 
codes will be inputted in the interview via REDCap, a secure online data collection system. The codes that link 
the name of the participant and the study ID will be kept confidential by the Principal Investigator in a secured 
cabinet. The interview is programmed to check data at the time of entry to ensure that values are within the 

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specified range and that items are not inappropriately skipped. The data will be imported directly into a password-
protected SPSS data file. This file will only identify subjects by the study ID number. Audio files of the therapy 
sessions and the data collection visits will be used solely for research purposes. Files will be stored on encrypted 
hard drives or a secure server. Audio files will only be identified by numeric codes and will be destroyed at the 
end of the study. Only the therapists, Research Assistant, and investigators will hear the content of the audio 
recordings.  
The only exceptions to confidentiality include situations involving potential abuse/neglect or risk of harm to 
self or others. Study cases will be supervised by Dr. Zajac, a clinical psychologist who has substantial experience 
successfully handling crises, or by therapists with advanced degrees who will be directly supervised by Dr. Zajac. 
Specifically, when a therapist learns of potential abuse/neglect of a child, the Department of Children and 
Families (DCF) is notified, and a DCF worker takes steps to keep the potential victim safe. If a study staff member 
has concerns about potential suicidal or homicidal ideation, Dr. Zajac will be contacted immediately. Dr. Zajac 
will ensure study staff members are well trained in assessing distress and suicidality (intent, plan, etc). If a 
participant is deemed at risk for suicide and the will not contract for safety, or has made a suicidal gesture or 
attempt, the participant will be assessed by local emergency department for possible inpatient hospitalization Dr. 
Zajac also will ensure all participating individuals and their families are well educated on how to access 24-hour 
emergency care (through 9-1-1 or going to the local Emergency Department).  
Within the research context, the Research Assistant might hear indications of risk of harm to self or others 
or abuse/neglect through conversations with participants. If a Research Assistant is told that there is any risk of 
harm to the participant or others, s/he will immediately contact Dr. Zajac. Dr. Zajac will assess safety and provide 
instructions to the Research Assistant to address any risks. Dr. Zajac will conduct a comprehensive risk 
assessment with the participant. If there is any indication of a potential for harm, Dr. Zajac will take appropriate 
action (e.g., contacting the police or ensuring the participant is taken to the nearest emergency room). Routine 
monitoring of adverse events will also occur through weekly meetings between the Principal Investigator and the 
Research Assistant. 
All research personnel collecting and manipulating data will have completed a Human Subjects Research 
Training course and will meet weekly with Dr. Zajac to ensure strict compliance with the IRB protocol. Only study 
personnel (Principal Investigator and research staff) will have access to data.  
Distress Due To Participation in an Exposure-Based PTSD Treatment. Participants may experience 
temporary distress due to participation in Prolonged Exposure therapy for PTSD, which involves discussing a 
past traumatic event in detail. In past studies, Prolonged Exposure has been associated with participant reports 
of modest to moderate distress and, for some participants, temporary symptom exacerbation (e.g., Foa, Zoellner, 
Feeny, Hembree, & Alvarez-Conrad, 2002). However, these reports of distress and symptom exacerbation have 
been found to be transitory and not related to poor treatment outcomes (Foa et al., 2002). Further, decades of 
research have established the safety and efficacy of exposure-based treatments for PTSD (e.g. Foa et al., 1991, 
1999, 2005) even for high-risk samples, including adolescents (Gilboa-Schechtman et al., 2010), war veterans 
(e.g., Nacasch et al., 2011), and adults with co-morbid substance use problems (e.g., Killeen, Back, & Brady, 
2011; Mills et al., 2012), severe mental illness (Mueser et al., 2008), and borderline personality disorder (Feeney, 
Zoellner, & Foa, 2002). In addition, Dr. Zajac has received extensive training and has had over 5 years of 
experience conducting Prolonged Exposure therapy. She will provide intensive training and supervision to study 
therapists on all aspects of the treatment protocol, including how to teach participants techniques to cope 
effectively with trauma-related anxiety and how to assess and handle symptom exacerbation. 
Despite substantial evidence for the safety of Prolonged Exposure therapy, every effort will be made to 
minimize any potential negative effects of this approach. Adaptations made during the development of the 
integrated SUD/PTSD protocol will follow recommendations made by Back et al. (2001) based on their use of 
Prolonged Exposure therapy with substance using populations. Specifically, substantial attention will be given to 
(a) providing participants with extensive psychoeducation about the functional relationship between substance 
use and PTSD; (b) an incremental rather than implosive approach to exposure, such that the participants identify 
and follow an exposure hierarchy, beginning with less anxiety-provoking exposure tasks and working up to more 
difficult tasks; (c) intensive training on and frequent review of the use of adaptive coping strategies with 
participants; and (d) careful monitoring of substance use following exposure sessions. These techniques are 
described in more detail below:  
Assessment of Substance Use and Symptom Exacerbation 
• 
Each session (i.e., two times per week), the therapist checks-in with the patient about substance use, 
including substance use following sessions and/or following exposure exercises, in two ways: first, through urine 
drug screens and breathalyzers and second, through the patient’s self-report of use.  

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• 
Each week the therapist also checks in with the patient about symptoms of PTSD and depression using 
self-report measures during the weekly PE session. The therapist will also be doing a brief in-person check-in 
with the patient about PTSD symptoms during the second session of the week. This allows therapists to monitor 
symptom exacerbation.  
• 
Standard Prolonged Exposure therapy includes between session phone calls to check in on the 
completion of patient homework assignments. During these calls, the therapist checks in about the completion 
of exposure exercises, encourages patients to complete any planned homework assignments that have not yet 
been completed, and checks in on the patient’s response to the most recent session, including PTSD symptoms 
and substance use. In the current study, the patient will have an in-person meeting with the therapist between 
Prolonged Exposure sessions for the purposes of conducting the CM session (i.e., the second session of each 
week). This meeting will also include a check-in about homework assigned as part of Prolonged Exposure. Part 
of this conversation will also focus on PTSD symptoms and substance use. If the patient does not attend their 
second weekly session, the therapist will attempt to reach the patient by phone to conduct this check-in.  
Preventive Measures 
• 
Patients are educated about the connection between anxiety and substance use. They are also educated 
about the possibility that they may experience increased urges to use substances following an exposure session. 
The therapist and patient discuss strategies to cope with cravings in response to exposures. These may include 
the breathing retraining that is practiced in session 1 or coping techniques that the patient already uses (e.g., 
spending time with family members, exercise, etc). The patient is asked to make the therapist aware of any 
increased urges or symptoms in response to sessions or homework assignments.  
• 
The therapy will be conducted by the PI of the study or by a mental health professional with an advanced 
degree who will be closely supervised by the PI of the study. The PI is a licensed clinical psychologist with 
extensive experience delivering Prolonged Exposure therapy and in managing psychiatric crisis situations.  
Responses to Exacerbation of Substance Use and PTSD 
• 
Any instances of substance use following exposure exercises are discussed, with the therapist and client 
working together to determine whether there are feasible alternative coping strategies for the client to use in 
place of the substances. If the client is unable to come up with effective coping strategies that can be used in 
place of the substance use and substances are being consistently used following or during exposure exercises, 
the therapist will decrease the intensity of the exposure sessions and homework exercises, as is standard in 
Prolonged Exposure therapy for patients who are overwhelmed by a treatment component. Alternatively, the 
therapist may choose to postpone further exposure exercises and work with the client on improving coping skills 
before resuming them. 
• 
Some exacerbation in PTSD symptoms is expected in Prolonged Exposure treatment and does not 
indicate that Prolonged Exposure therapy should be discontinued. However, the Prolonged Exposure therapy 
protocol has built-in instructions for how to titrate the treatment to best match the patient’s presentation. In the 
case of patients who are considered “overengaged” in exposure exercises or become overly emotionally 
distressed during or following exposure exercises, steps are taken to scale back the intensity of the exposures. 
These steps include (in the case of in vivo exposures), choosing exercises that are rated lower on the patient’s 
In Vivo Hierarchy or (in the case of imaginal exposure), having the patient open his/her eyes during the exercise 
or write down the narrative instead of saying it aloud.  
Serious Adverse Reactions 
• 
Instances of exacerbation in PTSD symptoms or substance use, identified either during sessions or 
during phone calls, will trigger a more thorough assessment by the therapist. In these instances, the therapist 
will assess the patient’s safety, specifically asking about any suicidal ideation. Of note, Prolonged Exposure 
therapy has not been linked to increased risk of active suicidal ideation in the scientific literature. 
• 
Of note, patients who report serious uncontrolled mental health concerns are not eligible for this study. 
The Addiction Severity Index, which is used to assess this exclusion criterion, includes questions about serious 
suicidal thoughts and suicide attempts in the past 30 days. Patients answering affirmatively to these questions 
will be excluded from the study.  
• 
In the unlikely event that a participant experiences suicidal ideation and is unable to contract for safety, 
the therapist will take steps to ensure that the patient receives a higher level of psychiatric care. When 
appropriate, the therapist will ensure that the patient is assessed at the nearest emergency room for admittance 
to an inpatient psychiatry facility.  
 
Safety and Adverse Events. Risk of harm to self and others is directly assessed as part of treatment. The 
PI is a licensed clinical psychologist with substantial experience handling crisis situations, including suicidality 
and homicidality. Participants in the study who indicate any risk of harm will immediately be assessed and 

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referred for more intensive treatment if needed. Both expected and unanticipated adverse events will be 
continuously monitored by the Principal Investigator through weekly meetings.  
Within the research context, assessment tools administered at each time point evaluate depressive 
symptoms (including suicidal ideation/risk of harm). The Research Assistant may also observe indicators of risk 
of harm to self or others or child abuse/neglect aside from the assessment instruments (e.g., through 
conversation with participants). The Research Assistant will not make independent decisions about these issues 
except in an acute emergency. S/he will be required to discuss the issue with Dr. Zajac as indicated above before 
any action is taken, unless a delay in action would clearly place the participant or another person in immediate 
danger. In these cases, the Research Assistant will contact the police or provide warning to the intended victim. 
Routine monitoring of adverse events also will occur through weekly meetings with the research team. 
 
3.  POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS  
The risks to youth participating in this project are minimal. Potential benefits to participants who receive the 
integrated SUD/PTSD treatment are substantial, including decreased symptomatology and substance use and 
improved adaptive functioning, though these cannot be guaranteed. In addition, the successful validation of 
clinically effective and cost-effective treatment approaches for comorbid SUD/PTSD among transition age youth 
would be of significant benefit to society. 
 
4.  IMPORTANCE OF THE KNOWLEDGE TO BE GAINED 
Left untreated, comorbid SUDs and PTSD results in significant negative outcomes for justice system-involved 
transition age youth and extraordinary costs for individuals, communities, and society. Despite the significant 
consequences of these problems, research on integrated SUD/PTSD treatments for this population is limited. 
Therefore, the current application proposes to integrate and adapt two existing evidence-based treatments for 
SUDs and PTSD to meet the treatment needs of transition age youth and provide an initial test of feasibility, 
safety, and symptom reduction. This study represents the essential first step to the development of evidence-
based practice for treating comorbid SUD/PTSD among high-risk transition age youth. The minimal risks to 
participants are reasonable given the importance of the knowledge to be gained. 
 
5.  DATA AND SAFETY MONITORING PLAN 
The Principal Investigator will be responsible for monitoring the safety and efficacy of this trial, executing the 
NIDA-approved Data and Safety Monitoring (DSM) plan, and complying with the reporting requirements. The 
Principal Investigator will receive extensive consultation from her mentor, Dr. Petry, regarding these tasks. In 
particular, Dr. Petry has conducted a number of clinical research trials with populations with substance use 
disorders. The Principal Investigator will provide a summary of the DSM report to the study sponsors on an 
annual basis as part of the progress report. The DSM report will include the participants’ socio-demographic 
characteristics, expected versus actual recruitment rates, any quality assurance or regulatory issues that 
occurred during the past year, summary of adverse events, and any actions or changes with respect to the 
protocol. The DSM report will also include, when available, the results of any data analyses.  
 
A. Participant Safety 
 
Diligent safety monitoring will be conducted by the Principal Investigator throughout this study in compliance with 
the following required elements of the the IRB’s continuing review process: 
1. tracking of subject accrual (enrollment, drop-outs, demographics) 
2. timely and appropriate reporting of informed consent process deficiencies, protocol deviations, 
privacy breaches, conflicts of interest, and/or changes in personnel 
3. ongoing monitoring and appropriate reporting of adverse event activity 
4. interim assessment of risk/benefit relationship in reference to adverse event occurrences, preliminary 
observations, and emerging information 
5. timely and appropriate IRB submission of safety-related documents such as audit reports, sponsor 
progress reports, and other materials or communications that might impact the safe conduct of this 
study 
6. active cooperation with the IRB and other applicable entities in the event of a random or for-cause 
internal or external audit 
 
Participant Safety Relevant to Specific Application. Regarding the risk of harm to self or others, the nature 
of the population (transition age youth) and the inclusion criteria (symptoms of PTSD and substance use) entail 

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that specific adverse events, such as suicidal and homicidal ideation and attempts, are possible given the high-
risk nature of the population under study. Regardless, both expected adverse events and unexpected adverse 
events will be monitored and addressed continuously throughout the course of the project.  
Within the treatment context, risk of harm to self and others is directly assessed as part of the treatment. 
Participants in the study who indicate any risk of harm will immediately be assessed and referred to a higher 
level of care, if needed. Therapists and their supervisor, Dr. Zajac (who will be on-call 24 hours per day, 7 days 
per week for therapists) have extensive training in crisis management. Both expected and unanticipated adverse 
events will also be continuously monitored by the investigators through weekly meetings.  
Participant safety is assessed routinely as part of the research context through assessment tools given at 
each time point to evaluate depressive symptoms (including risk of harm). At other times, researchers may also 
observe indications of risk of harm to self or others or child abuse/neglect aside from the assessment instruments 
(e.g., through conversation with participants). In these situations, the Research Assistant will consult with Dr. 
Zajac before deciding on a course of action unless there is an acute emergency and a delay in action would 
place the participant or another person in immediate danger. In these cases, the Research Assistant will contact 
the police or provide warning to the intended victim. Routine monitoring of adverse events will occur during 
weekly meetings of the research team. 
For participants enrolled in the study, in any circumstances where the Research Assistant is concerned 
regarding suicidal or homicidal ideation or attempt, s/he will immediately contact the Principal Investigator, Dr. 
Zajac, who is a licensed clinical psychologist. Dr. Zajac will assess safety and provide instructions to the 
Research Assistant to address any risks. Dr. Zajac will conduct a comprehensive risk assessment with the 
participant. If there is any indication of a potential for harm, Dr. Zajac will take appropriate action (e.g., contacting 
the police or ensuring the youth is taken to the nearest emergency room). The Principal Investigator will ensure 
that the Research Assistant is well-trained in assessing distress and suicidality (ideation, intent, plan, etc). In 
circumstances where participants express suicidal ideation and are sincerely willing to contract for safety (i.e., 
will agree to keep her/himself safe), a plan will be made and carefully monitored. If a participant is deemed at-
risk for suicide and will not contract for safety or has made a suicidal gesture or attempt, the participant will be 
assessed by a local emergency department for possible inpatient hospitalization. Dr. Zajac will also ensure that 
participants who present with risk for suicidal or homicidal ideation are well educated on how to access 24-hour 
emergency care (through 9-1-1 or going to the local Emergency Department).  
 
B. Procedures for Monitoring Safety of Data 
Regarding data management and storage, interviews will be administered by the PI or a trained Research 
Assistant, who will enter data via a laptop computer using REDCap, a secure online data entry platform. Only 
participants’ study identification codes will be inputted in the interview. The codes that link the name of the 
participant and the study ID will be stored separately from the study data. The interview is programmed to check 
data at the time of entry to ensure that entered values are within the specified range and that items are not 
inappropriately skipped. In addition to these precautions, all personnel will have earned at least a bachelor’s 
degree and have experience in conducting research. All research personnel collecting and manipulating data 
will have completed a Human Subjects Research Training course and will meet weekly with the Principal 
Investigator to ensure strict compliance with the DSM plan. Only study personnel (Principal Investigator and 
research staff) will have access to data. No data will be released to other agencies unless participants consent 
to release. Audiotapes of therapy and data collection sessions will be used solely for research purposes. Audio 
files will be stored on an encrypted hard drive at the research office, digital recordings will only be identified by 
numeric codes, and recordings will be destroyed at the end of the study. Only the Research Assistant, therapists, 
and investigators will hear the content of the audio recordings.  
C. Adverse Events 
The Principal Investigator, with consultation from her mentoring team, will be responsible for monitoring trial 
data and participant safety.  
1. Reporting of SAEs. Participants who experience a significant psychiatric or medical problem requiring an 
overnight hospitalization at an acute care facility will be defined as having experienced an SAE, and these are 
our most common SAEs. Types of expected SAEs in this substance abusing population are as follows: (a) onset 
of clinically significant suicidal ideation, intent or action; (b) onset of clinically significant homicidal ideation, intent 
or action; (c) deterioration of mental status to an extent which renders the patient unable to care for self; or (d) 
deterioration of physical status renders need for inpatient medical treatment.  

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All SAEs (e.g., hospitalization, life threatening injury, death) are reported on an Adverse Events Monitoring 
Form and reviewed by the project manager and PI. The form collects detailed information about all adverse 
events, how they were handled, and their potential relationship to study participation with a sign-off by all 
appropriate supervisory personnel. Adverse events that are serious and unanticipated and probably, possibly, 
or definitely related or adverse events occurring with greater frequency than anticipated will be reported to the 
IRB per University policy within 48 hours of discovery. 
In the event that a participant either withdraws from the study or the investigator decides to discontinue a 
participant due to an SAE, the participant will be monitored by the investigator via ongoing status assessment 
until 1) a resolution is reached i.e., the problem requiring hospitalization has resolved or stabilized with no further 
changes expected 2) the SAE is determined to be clearly unrelated to the study intervention, or 3) the SAE 
results in death. Outcome of SAEs will be periodically reported to NIDA and the UConn Health IRB per policies. 
A summary of the SAEs that occurred during the previous year will be included in the annual progress report to 
NIDA. 
We anticipate that unexpected and possibly study-related SAEs will be rare, because participants will be 
receiving primarily a psychosocial intervention. Research staff who conduct breath and urine sample testing as 
well as the baseline and follow-up interviews will most typically detect SAEs. All research staff has completed 
required institutional training on research with Human Subjects. Research staff are trained in adverse event 
reporting and understand that the responsibility is to document and report adverse events reported by study 
participants. At monthly research staff meetings, past month and study cumulative SAEs are reviewed.  
2. Reporting of IRB actions to NIDA. The UConn Health IRB requires yearly reporting of all AEs (including 
those that are anticipated and unrelated), while any unanticipated and possibly related SAEs require reports 
within 48 hours. Any formal or non-routine IRB actions will be promptly reported to the NIDA Project Officer.  
3. Report of changes or amendments to the protocol. The PI will provide timely reporting to the NIDA 
Project Officer of any major changes in the protocol, or its overall status including: protocol amendments; 
suspension or termination of subject recruitment or the protocol itself; changes in the informed consent or IRB 
approval status; and other problems or issues that could have a significant impact on participants.  
4. DSM plan administration. The Principal Investigator will be responsible for monitoring the safety of this 
trial, executing the DSM plan, and complying with the reporting requirements. All DSM reports to NIDA will 
include a brief description of the trial, baseline sociodemographic characteristics, retention and disposition of 
study participants, Quality Assurance issues, regulatory issues, AEs and SAEs, and efficacy, as well as any 
actions or changes with respect to the protocol. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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