Community Study of Outcome Monitoring for Emotional Disorders in Teens
Phase: NA
Conditions: Depression, Anxiety
Sponsor: University of Miami

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Revised: July 13, 2021
Official Title:  Community study of Outcome Monitoring for Emotional disorders in Teens 
(COMET)
Principal Investigator Name: Amanda Jensen-Doss
Version Number: 37
Version Date: 07/13/21
NCT Number: NCT02567266
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Revised: July 13, 2021
1)
Protocol Title
Community study of Outcome Monitoring for Emotional disorders in Teens (COMET)
2)
IRB Review History*
This project will be concurrently reviewed by the University of Connecticut Institutional 
Review Board (IRB), 860-486-8802.
3)
Objectives*
Emotional disorders, encompassing a range of anxiety and depressive disorders, are the most 
prevalent and comorbid psychiatric disorders in adolescence (Costello, Mustillo, Erkanli, Keeler, 
& Angold, 2003). Evidence-based therapies (EBTs) exist for single disorders (e.g., depression) 
or small clusters of disorders (e.g., anxiety disorders) but such EBTs are rarely integrated in 
community mental health clinic (CMHC) settings (Weiss, Catron, & Harris, 2000) and effect 
sizes are modest (40-50% of youth are treatment non-responders; (Walkup et al., 2008). Thus, 
methods for improving outcomes for these youth, particularly in CMHCs, are needed. 
Transdiagnostic treatment, such as the Unified Protocols for the Treatment of Emotional 
Disorders in adults (Barlow et al., 2010), adolescents (UP-A; (J. Ehrenreich et al., 2008) and 
children (Ehrenreich-May & Bilek, 2012), is a promising new approach that uses a small number 
of common strategies to treat these conditions. 
Another novel approach to improving clinical outcomes for youth with emotional disorders in 
CMHCs is the incorporation of a standardized measurement and feedback system (MFS). 
Emerging data suggests that MFS alone improves outcomes relative to treatment as usual (TAU) 
(Bickman, Kelley, Breda, De Andrade, & Riemer, 2011) but this has not been adequately tested 
in youth. Thus, our first aim is to examine the effectiveness of UP-A and a MFS (Youth 
Outcomes Questionnaires [YOQ; (Burlingame et al., 2005)  relative to TAU, when delivered in 
CMHCs. 
A serious shortcoming of RCTs comparing EBTs to TAU is the confounding effects of increased 
measurement and feedback to clinicians as RCTs of EBTs often “build in” monitoring that is not 
part of standard care. This raises the possibility that increased monitoring, rather than the unique 
treatment components of the EBT, may be responsible for better outcomes over TAU. Thus, the 
second aim of this proposal is to isolate these effects from UP-A. Finally, this study will examine 
theoretically-linked mechanisms (both patient and provider level) of treatment outcomes of both 
the UP-A and the YOQ.
This project is an NIMH-funded collaborative R01 two-site trial (University of Miami (UM) 
grant PIs Jill Ehrenreich-May and Amanda Jensen-Doss; University of Connecticut PI Golda 
Ginsburg - for IRB purposes, the UM PI will be Amanda Jensen-Doss). To address the three 
study aims, adolescents with anxiety and/or depressive disorders will be recruited from CMHCs 
in Miami and in CT (under the supervision of Dr. Golda Ginsburg at the University of 
Connecticut). Both adolescents and clinicians will be randomized to one of three conditions: (1) 
TAU alone; (2) TAU plus YOQ (TAU+); and (3) UP-A plus YOQ (UP-A). Research 
assessments by Independent Evaluators (IEs), children, parents, and clinicians will occur at 
baseline, 8 weeks and 16 weeks after treatment initiation and a 3-month follow-up. 
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The primary aims of this study are as follows:

Aim 1: To examine the effectiveness of UP-A and YOQ compared to TAU. Aim 1 will test 
whether adolescents treated with UP-A and YOQ (plus TAU referred to as TAU+) 
demonstrate better response than those receiving TAU alone.
o
Hypothesis 1: A higher percent of adolescents treated with UP-A and TAU+, 
compared to TAU, will be treatment responders at 16 weeks after treatment initiation 
and at follow-up.

Aim 2: To isolate the effects of evidenced-based measurement and feedback. Aim 2 will 
examine the relative effectiveness of the UP-A condition to the TAU+ condition. 
o
Hypothesis 2: A higher percent of UP-A participants will be treatment responders 
than TAU+ participants at the 16 week and follow up assessments.

Aim 3: To examine mechanisms theoretically associated with UP-A and YOQ.
o
Hypothesis 3a: Differences in outcomes between the UP-A and the other two 
conditions will be mediated by changes in: Distress Tolerance (Using the Behavioral 
Indicator of Resiliency to Distress; BIRD and Distress Tolerance Scale; DTS) and 
Behavioral Avoidance (using the Avoidance Hierarchy). 
o
Hypothesis 3b: Among participants in the TAU+ and UP-A conditions, treatment 
outcomes will be better for participants whose therapists: 1) rate the YOQ results as 
more credible, 2) view the YOQ reports more frequently, and 3) discuss the reports 
with them in session more frequently. Among participants who are flagged as “at risk 
for treatment failure” by the YOQ, outcomes will be better for those whose therapists 
report changing treatment strategies in response to the YOQ feedback. 
o
Hypothesis 3c: Differences in outcomes between TAU and the two treatments using 
the YOQ (UP-A and TAU+) will be mediated by differences in 1) therapy alliance 
and 2) therapy engagement. 
4)
Background*
Over the last several decades, researchers have developed dozens of disorder-specific evidence-
based psychosocial treatments (EBTs) (Chorpita et al., 2011). However, even in the most highly 
controlled research studies, a substantial percentage of youths with emotional disorders are 
treatment non-responders (e.g., approximately 40% for anxiety disorders [Walkup et al., 2008], 
and 52% for depressive disorders [March, Silva, & Vitiello, 2006]). Moreover, the effectiveness 
of these interventions in community settings has been disappointing. A recent meta-analysis of 
52 effectiveness trials of youth psychotherapy concluded that, although EBTs typically 
outperform TAU, the average effect was small (d =.29) (John R. Weisz et al., 2013). In addition, 
the adoption of EBTs into community practice settings has been slow (McHugh & Barlow, 
2012), 2012), suggesting that these treatments still may not be appealing and/or feasible for 
clinicians and highlighting the need for improved interventions. 
A recent innovation in EBTs that may prove more feasible for use in community settings is 
transdiagnostic treatment. Transdiagnostic approaches draw from theoretical models that explain 
distinct conditions via common mechanisms and use flexible treatment strategies to address 
diverse problems simultaneously. Furthermore, this treatment approach may have quicker uptake 
by CMHC clinicians because: (1) comorbidity is the rule, rather than the exception for patients in 
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CMHCs (Jensen & Weisz, 2002), (2) protocols cutting across diagnostic boundaries reduce 
training burden, and (3) flexible protocols may be more appealing to clinicians (Borntrager, 
Chorpita, Higa-McMillan, & Weisz, 2009) and more effective than single disorder EBTs (John R 
Weisz et al., 2012).The primary transdiagnostic intervention examined among youth populations 
is the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A), 
developed by one of the PIs, Dr. Ehrenreich-May (J. Ehrenreich et al., 2008). Since UP-A has 
been found to be efficacious for complex and comorbid anxiety and depression in a research 
setting (Allen, Tsao, Seidman, Ehrenreich-May, & Zeltzer, 2012; Bilek & Ehrenreich-May, 
2012; Ehrenreich-May & Bilek, 2012; Ehrenreich-May, Queen, Rodriguez, Rosenfield, & 
Barlow, 2012, November; J. T. Ehrenreich, Goldstein, Wright, & Barlow, 2009; Trosper, 
Buzzella, Bennett, & Ehrenreich, 2009), a logical next step, and the first aim of this study, is to 
examine its effectiveness in community settings.
While evaluating the effectiveness of the UP-A in community settings is a sensible next step for 
the testing and dissemination of this approach, interpretation of a two-condition (UP-A vs. TAU) 
RCT is confounded by changes in variables other than treatment strategies. Although the 
assumed independent variable is the novel treatment, EBTs often differ from TAU in other ways. 
Clinicians in EBT conditions receive regular feedback through standardized assessment and 
supervision about how they and their clients are doing in treatment. If EBTs outperform TAU, it 
can therefore be difficult to determine the degree to which these differences are due to the 
treatment techniques themselves, or to the “confounding effects” of increased outcome 
monitoring and feedback to clinicians. One strategy to control for these effects is the use of a 
standardized measurement and feedback systems (MFSs).
MFSs consist of assessment tools, often part of an online system, to regularly track the processes 
(e.g., therapy alliance) and outcomes (e.g., symptom improvement) of therapy and provide 
reports summarizing the results of these assessments, often with “alarm indicators” that alert 
clinicians to treatment nonresponse or ruptures in alliance. These systems were designed to be 
used in community practice settings, and extensive research with adults suggests that using an 
MFS, without any additional efforts to change clinician treatment practices, can double the 
success rates of therapy and result in longer-lasting treatment effects (Hawkins, Lambert, 
Vermeersch, Slade, & Tuttle, 2004; Lambert et al., 2003; Shimokawa, Lambert, & Smart, 2010). 
Preliminary evidence suggests that measurement and feedback is also associated with improved 
youth treatment outcomes (Bickman et al., 2011; Stein, Kogan, Hutchison, Magee, & Sorbero, 
2010). However, only one clinical trial has been conducted with youth, and limited examination 
has been made of its mechanisms of action (Carlier et al., 2012). Using the youth version of the 
most well-studied adult MFS, the Youth Outcomes Questionnaire (YOQ; (Burlingame et al., 
2005), this study seeks to expand the research base on measurement and feedback, including 
tests of mechanisms of action, and to dismantle the “confounding effects” of increased 
measurement and feedback from the active mechanisms of a novel EBT for emotional disorders 
for youth.
5)
Inclusion and Exclusion Criteria*
Both youth and community clinicians will be considered participants in this trial. Two sets of 
inclusion and exclusion criteria have been developed for both groups, as follows:
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Youth Inclusion Criteria:
(1) Male or female adolescents between the ages of 12-18 years at the time of enrollment with:
(i) Clinically significant symptoms of anxiety or depression at baseline. Evidence of 
clinically significant symptoms will be defined as a Clinical Severity Rating (CSR) 
greater than or equal to 4 on any DSM-5 defined anxiety disorder (e.g., generalized 
anxiety disorder, social phobia, selective mutism, separation anxiety disorder) or 
depressive disorder (e.g., major depressive disorder, persistent depressive disorder), 
or an adjustment disorder with depressed mood, anxiety, or mixed anxiety and 
depressed mood. 
This will be determined via baseline administration of the anticipated research 
version of the Anxiety Disorders Interview Schedule for the DSM-5, Child Version, 
Child and Parent Report Forms (ADIS-5-C/P), administered by an independent 
evaluator on study staff. 
(2) The adolescent is determined by the CMHC to be eligible for once weekly outpatient 
psychosocial services at the clinic and determined by the study IE to be appropriate for 
outpatient psychosocial intervention (e.g., no major cognitive impairment or active 
suicidality) based on clinical interview.
(3) The adolescent lives (for at least 50% time) with legal guardian and this guardian is willing 
to attend treatment sessions and participate in study assessments (every effort will be made to 
encourage the same caregiver to participate in all assessments).
(4) Adolescent and parent/guardian are able to complete all study procedures in English or 
Spanish.
Youth Exclusion Criteria:
(1) Adolescents will be excluded if they are receiving concurrent psychotherapy, family therapy 
or similar psychosocial interventions. 
(2) Adolescents who are currently suicidal or who have engaged in suicidal behaviors within the 
past 6 months will be excluded (or discussed on a case by case basis). Specifically, the 
evaluator will meet with the IE supervisor and discuss the youth and parent responses 
obtained during the clinical evaluation and determine whether the youth is currently at risk of 
imminent suicidality and in need of an alternative treatment. The short version of the 
Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to screen for suicidality at 
baseline. The C-SSRS allows the IE to gather information on suicidal behavior, suicide 
attempts, and presence and intensity of suicidal ideation. The information will be used to 
identify adolescents possessive or active suicidal ideation, intent or plan. 
(3) Adolescents with a substance abuse problem within the last 6 months, as assessed by the 
CRAFFT and ADIS-5-C/P, will be excluded. 
(4) Consistent with prior trials of the UP-A, youth with primary conditions not specified for 
exclusion (e.g., eating disorders, schizophrenia) will be screened. As long as study staff 
concur that an emotional disorder treatment focus is appropriate, these youth will be 
included.
(5) Adolescents with a reported history of intellectual disability or for whom there is substantial 
evidence (e.g., multiple learning disorders, extensive school-based accommodations for 
learning) that the cognitive level of the UP-A would make it inappropriate as an individual 
therapy modality, as determined via Family Background Questionnaire and/or based on PI 
judgement, will be excluded.
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(6) Given additional complexities obtaining informed consent, adolescents who are currently 
placed in the foster care system will be excluded. 
(7) If an agency is not able to provide at least three Spanish speaking therapists for the study, 
Spanish speaking adolescents and caregivers will be excluded at that agency because they 
could not be randomized to condition. 
Clinician Inclusion Criteria:
(1) Clinicians will be at least part-time employees or completing an approved internship of at 
least one year in duration at the study clinics.
(2) Clinicians may conduct sessions in English or Spanish, but must be able to speak, read and 
understand English well enough to participate in English-language training and consultation 
meetings.
6)
Number of Subjects*
The study aims to enroll approximately 222 adolescents aged 12-18 years (111 per site, at Miami 
and UConn) who meet study criteria. We anticipate that up to 300 participants (150 per site) will 
need to be recruited and screened to reach this goal.
At least eighteen clinician employees of the participating clinics (at least 9 at the Miami site and 
at least 9 at the UConn site) will be enrolled initially. Although every effort will be made to 
retain clinicians recruited to the investigation, it is anticipated that new clinicians will be trained 
annually to replace any clinician who leaves the organization or terminates study participation. 
Up to 80 (40 at each site) clinicians will participate in the project.  
7)
Study-Wide Recruitment Methods*
Though the study will be conducted at multiple sites, recruitment will take place locally at each 
of the participating clinics. Miami will be recruiting participants and clinicians from CMHCs in 
FL: PsychSolutions Inc., Chrysalis Health, Inc., Jewish Community Services, Goodman 
Psychological Services Center, Stop Parenting Alone, Live Well Therapy Group, and Behavioral 
Aid Solutions. We may also recruit through social media (e.g., Twitter, Facebook, Instagram), by 
posting advertisements through existing accounts for the CMHCs, CHMC staff, the University of 
Miami Psychology Department, and/or PI accounts. Specific social media accounts will not be 
established for the project, but rather we will use others’ accounts to distribute materials about 
the study. At UConn, participants will be recruited through several CMHCs in CT and MA. 
Adolescent/Caregiver Recruitment: Adolescents and their caregivers will be recruited from 
study clinics at the time of treatment initiation through intake staff. At both sites, agencies are 
given the option to insert four questions regarding the presence of anxiety or depressive 
symptoms that were adapted from the Patient Health Questionnaire (PHQ-4) into their own 
screening system in order to identify potential study candidates. If the person completing the 
phone screen answers “Yes” to any of the questions, the phone screener will next ask whether 
the family is willing to be contacted by study staff to learn more about the opportunity. Agencies 
may also opt to use their own method of identifying potential study candidates. 
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In addition, we will post study flyers in waiting rooms in participating CMHCs and distribute 
flyers about the study to local referral sources to let them know that the study is taking place in 
these clinics. These flyers can be used by individuals who refer adolescents for treatment if they 
want to send families to clinics taking part in COMET. We will also post the recruitment 
materials on social media. Families who contact COMET prior to contacting these clinics will be 
screened for the study and referred to one of the study clinics. 
Families who appear to meet inclusion/exclusion criteria and express interest in participating will 
be contacted by study staff and provided additional information about the study. If they are 
interested in the study, they will be asked additional questions by phone to determine study 
eligibility. The information script and screening questions are in the document titled COMET 
Project Phone Screen. If their responses to the phone screen suggest they may be eligible for the 
study, they will be scheduled for an in-person research assessment, ideally coincident with their 
CMHC intake. To reduce the burden and risk of participation, all efforts will be made to ensure 
that treatment initiation is not delayed as a result of study screening procedures. We aim to have 
participants complete their study screening assessment as close as possible to their initial clinical 
intake at the CMHC. Families will be informed that they have the option to re-enter the clinic’s 
“as usual” services should they change their mind about participating, feel that the research 
project is interfering with their access to services, or do not meet study inclusion criteria. 
Clinician Recruitment: Eligible clinicians will be volunteers from the participating 
CMHCs. Clinic directors, in consultation with their staff members, and/or study staff will 
contact clinicians to recruit them for the study. A flyer has been developed to assist with 
recruitment. They will be informed that their participation is voluntary and will not affect 
their relationship with the clinics, and about the possibility that they may not be assigned 
to receive training in the experimental procedures.  They will also be informed that if 
they are not assigned to one of the experimental conditions, they will have the 
opportunity to receive the training once the study is over. Therapists who agree to 
participate in the study will participate in a written consent process, conducted by 
designated study staff, explaining their role in the study and risks associated with their 
participation. Therapists who consented to the study and received UP-A training will also 
be contacted via email and/or phone to participate in a qualitative interview and complete 
questionnaires (the UP-C/A Therapist Beliefs Questionnaire, the Adaptations to 
Evidence-Based Practices Scale, and the Abbreviated Multidimensional Acculturation 
Scale) about their experience delivering the study’s treatment programs.
8)
Study Timelines*
Subject participation: Given the flexibility of the UP-A and TAU interventions, the exact 
duration of subject participation is estimated to be approximately 25 weeks, plus an additional 3 
month follow-up. The UP-A is delivered in 8 to 21 weekly sessions, and no treatment duration is 
specified for the TAU conditions. 25 weeks is estimated to account for any additional time 
required for screening and intake (though, as noted above, all efforts will be made to ensure that 
treatment initiation is not delayed as a result of study participation). However, this interval may 
vary slightly due to holidays, typical clinic closures or other naturally occurring delays.
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Assessments will take place at the CMHC, university setting, Center for Autism and Related 
Disorders office, and/or in another private setting within the community at baseline, 
approximately 8 weeks after treatment initiation (estimated to be mid-treatment), and 
approximately 16 weeks after treatment initiation ([post treatment] estimated to correspond with 
the length of UP-A treatment, based on average number of sessions from a recent RCT of the 
UP-A). Finally, a 3 month follow-up assessment will take place 7 months after treatment 
initiation (16 weeks + 3 months). All efforts will be made to have these assessments take place 
within a window of +/- 2 weeks when they are scheduled to occur.
Clinician participation: Though efforts will be made to retain the same clinicians throughout 
the study, we anticipate that there will be personnel turnover at the clinic sites. However, the 
maximum duration of clinician participation will be approximately four years, as this is the 
estimated timeline for study completion. UP-A clinicians who stopped participating in the larger 
study will still be invited to take part in the qualitative interview portion of the study.
Recruitment Timeline: We anticipate that recruitment of all subjects across both sites will take 
approximately 3.5 years. 
Investigator Timeline: We estimate that the primary analyses will be completed at the end of 
the fourth year of the study once all study assessments have been completed.
Table 1: Study 
Timeline
Year 1
Months:
Year 2
Months:
Year 3
Months:
Year 4
Months:
1-3
4-6
7-9 10-12 1-3
4-6
7-9 10-12 1-3
4-6
7-9 10-12 1-3
4-6
7-9
10-12
Participant Recruitment and Assessment
Enrolling clinicians 
X
Ongoing as needed
Enrolling new 
adolescent/caregiver 
participants
X
X
X
X
X
X
X
X
X
X
X
X
X
Study assessments
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Data Management Activities
Final Database 
Ready
M-11
Final Session 
Recording Collected
M-7
IE Coding of Tapes 
for Fidelity & 
Differentiation
Ongoing for consultation purposes
X
X
Data Analysis
X
Preparation of 
manuscripts
X
9)
Study Endpoints*
The primary study outcome will be treatment response. Response will be defined as a Clinical 
Global Impression-Improvement (CGI-I) of 1 or 2 at 16 weeks after treatment initiation and at 
the 3 month follow-up. Secondary outcomes will include scores on the Children's Global 
Assessment Scale (CGAS), Screen for Child Anxiety Related Emotional Disorders-Youth and 
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Parent Reports (SCARED/-P), and the Mood and Feelings Questionnaire-Self & Parent Reports 
(MFQ), as well as diagnostic status on Anxiety Disorders Interview Schedule for the DSM-5, 
Child Version, Child and Parent Report Forms (ADIS-5-C/P).
The following measures will be taken to monitor data relating to safety:
Throughout the study, trained study staff will monitor participants’ risk of harm. It is possible 
that participants’ clinical data might indicate, for example, that a parent or adolescent is at risk 
(e.g., adolescent or parent reports suicidal ideation, or an adolescent’s physical safety or well-
being is in question). In order to address such situations, all study therapists and staff will be 
thoroughly trained in the ethics of conducting research with human participants, and will be 
thoroughly educated about the project’s data safety and monitoring procedures. All such 
incidents will be reported immediately to the principal investigators, and, if necessary, to the 
local IRB according to their policies. 
In addition, we will use the short version of the Columbia-Suicide Severity Rating Scale (C-
SSRS) at baseline, 16 weeks, and 3 month follow-up and following any evidence of suicidal 
ideation or significant adolescent deterioration. The C-SSRS allows the IE to gather information 
on suicidal behavior, suicide attempts, and presence and intensity of suicidal ideation. The 
information will be used to identify adolescents possessive of active suicidal ideation, intent or 
plan that may need to be excluded due to needs for more acute care.
If clinical or questionnaire data indicate that a child is showing a notable decline in functioning 
during the course of the study, this will be discussed with the child’s caregiver and the child will 
be referred for additional and/or alternative treatment if appropriate.
10) Procedures Involved*
Study Conditions:
This study will involve 3 arms, with participating adolescents and clinicians randomized within 
sites to each arm. Each of the treatment arms is described below:
The Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A): 
The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a 
primary emotional disorder. It is a developmental adaptation of the Unified Protocol, a 
transdiagnostic treatment for adults with emotional disorders. Clinicians present all skills in the 
context of the emotions most salient to presenting concerns and adolescent/caregiver 
conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 
8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which 
various sections are presented to clients and caregivers, as well as the emotions targeted during 
the course of the intervention. 
A parent or primary guardian is asked to attend all sessions of the UP-A, although the degree of 
involvement varies based on clinical need. At a maximum, clinicians may elect to use optional 
parenting materials throughout treatment and for up to three parent-alone sessions. These 
sessions use the guiding acronym ICE (Independence, Consistency and Empathy) to reinforce 
youth session materials and problem-solve concerns common in the parenting of youth with 
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emotional disorders (e.g., overprotection, conflict, etc.). Clinicians assigned to the UP-A 
Condition will also use the YOQ, as described below.
Treatment as Usual + Youth Outcomes Questionnaire (TAU+): Clinicians in the TAU+ 
condition will use their “as usual” therapy practices, but will be asked to use the YOQ during 
every session. The YOQ consists of parent- and youth-report measures of symptoms and alliance 
administered weekly on a tablet computer. The YOQ online system then generates reports to 
provide clinicians with systematic feedback about client progress, flagging “critical items” that 
have been endorsed  (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and 
providing empirically-derived  “alerts” when clients are failing to progress or showing 
deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share 
it with families as appropriate, and use it to enhance use of supervision. The TAU+ and UP-A 
clinicians will use identical versions of the YOQ. 
Treatment as Usual (TAU): Clinicians assigned to the TAU condition will be instructed to use 
whatever treatment methods and outcome monitoring strategies they typically use with 
adolescents with internalizing disorders. Neither the Miami nor UConn clinics currently use any 
measurement and feedback strategies.
Clinician Training and Consultation:
UP-A: Training for the UP-A will consist of approximately 12 hours (e.g., one to two day 
workshop, role-plays, and knowledge checks to ensure comprehension of materials) followed by 
ongoing weekly one hour consultation. Dr. Ehrenreich-May will lead trainings at both sites, hold 
weekly cross-site calls and oversee assessment of adherence to ensure fidelity to the treatment 
model over time. The UP-A consultation for each clinician’s first case will be provided directly 
by Dr. Ehrenreich-May, who will be shadowed by the study site-specific UP-A consultant; if a 
clinician does not demonstrate competence in this case, or the study site-specific UP-A 
consultant would like additional training, Dr. Ehrenreich-May will continue to provide 
consultation for subsequent cases until the clinician is deemed competent and the site-specific 
UP-A consultant is prepared to provide consultation independently. Thereafter, site-specific 
study consultant will be responsible for providing consultation in the UP-A; clinicians’ regular 
clinic supervisors will supervise crises whenever appropriate. Dr. Ehrenreich-May will hold 
voluntary weekly consultation calls for clinicians and study UP-A consultant, and a listserv will 
be created to allow clinicians to post de-identified general questions about the UP-A and to read 
responses to their and others’ questions. Finally, all therapy sessions will be video or audiotaped 
and 20% of UP-A tapes will be reviewed as they become available by Dr. Ehrenreich-May and 
the Miami project coordinator to assure high quality UP-A treatment delivery. Clinicians 
evidencing challenges with UP-A delivery will be provided with corrective feedback and 
assistance in re-establishing acceptable levels of competence before proceeding with additional 
UP-A cases. UP-A clinicians will also complete adherence and competency forms for each 
completed session and these forms will be reviewed in consultation meetings. 
Any clinicians who have received UP-A training will be contacted to participate in a voluntary 
qualitative interview and complete  questionnaires (the UP-C/A Therapist Beliefs Questionnaire, 
the Adaptations to Evidence-Based Practices Scale, and the Abbreviated Multidimensional 
Acculturation Scale) about their UP-A experiences and perspectives. They will be verbally re-
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consented, and receive separate compensation for their participation in the qualitative interview 
and questionnaires (outlined in detail below).
YOQ (UP-A and TAU+): Approximately 4 hours of training in the YOQ will be provided to 
clinicians by trainers from OQ Measures, the company that created the YOQ. Ongoing 
implementation support for YOQ will involve weekly 30 minute YOQ consultation calls. This 
consultation will be provided by Dr. Susan Douglas Kelley, an expert in the implementation of 
MFSs in CMHCs, and Dr. Jensen-Doss. The YOQ data system allows the TAU+ consultants to 
monitor whether clinicians are completing forms with clients and reviewing reports. If clinicians 
are not engaging in these activities, TAU+ consultants will use the consultation calls to discuss 
strategies for increasing adherence. 
TAU (TAU+ and TAU): In order to replicate usual practice in the CMHC, the TAU+ clinicians 
and TAU clinicians will receive the standard dose of clinic supervision at their site.  
Randomization: 
Eligible adolescents will be randomly assigned within each CMHC to the TAU, TAU+ or UP-A 
conditions. Eligible and participating clinicians will be randomly assigned to one of the three 
treatment arms and replaced as needed. Replacement clinicians will not always be fully 
randomized, as there may sometimes be only one or two conditions needing to be filled. 
We estimate that each clinician will maintain a caseload of approximately four participants per 
condition annually. With a total of ranging from 3-9 clinicians per condition per site, we 
anticipate routine availability of new youth participant slots within two weeks of initial baseline 
assessment across conditions. If wait times become substantially uneven across conditions (e.g., 
adolescent participants waiting longer for a study clinician to become available in the TAU or 
TAU+ condition versus UP-A), additional clinicians (or clinics) may be added as needed to such 
conditions to ensure rapid randomization of participants. Clinician and adolescent participants 
who are randomized will either receive TAU, TAU+ or UP-A in a 1:1:1 ratio. We will use block 
randomization of adolescents within CMHC, blocked by presence of an adolescent depressive 
disorder (as assessed by the ADIS-5-C/P) and use of psychiatric medications (specifically, a 
SSRI, SNRI or benzodiazepine) at the time of study enrollment. If adolescents are randomized to 
a condition for which a clinician is not currently available (e.g., the clinician in that condition has 
a full caseload, the clinician in that condition does not have an appointment available at a time 
that works for the family, the clinician in that condition has left the study and has not yet been 
replaced), we will move down the randomization list until the adolescent can be assigned to a 
clinician. In the case of siblings, both youth will be randomized to the same condition and we 
will cross two rounds of that condition off the randomization list. A maximum of two 
adolescents from the same family may be admitted to the study. 
Study Procedures:
Table 2 details the study Assessment Schedule and descriptions of measures are provided below. 
Once informed consent and assent has been obtained from caregivers and participants 
respectively, an initial study assessment to determine eligibility will take place as close as 
possible to the standard intake at the participating CMHC, prior to treatment initiation. Consent 
process will occur face to face at the CMHC, University, or at a private place within the 
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Revised: July 13, 2021
community. This assessment will include completion of some or all of the 
questionnaires/procedures listed in the “Pre Treatment” column in Table 2 and described in 
additional detail below. Randomization will take place following this first assessment once 
subjects have been deemed eligible for participation. If a participant is unable to begin treatment 
within 4 weeks of their initial baseline assessment, an abbreviated baseline re-assessment may be 
conducted prior to the start of treatment. This re-assessment will include review of the symptoms 
previously endorsed on the ADIS-5-C/P, SCARED, MFQ, YOQ, SDQ, DTS, and Avoidance 
Hierarchy (see Measures, below). 
If any study assessment is to occur at the University of Miami, parents/guardians will be emailed 
a “paybyphone” link to register their car for parking through the University’s Parking and 
Transportation department. They may be asked to supply their license plate number so that study 
staff may register their car for them in the case of user or system error. License plate numbers 
will be discarded following termination of study participation, and will not be used for research 
purposes. 
At every therapy session, some or all of the assessments/questionnaires listed in the “Every 
Session” column in Table 2 will be completed. Additional assessments will take place 
approximately 8 (mid-treatment) and 16 weeks (post-treatment) after treatment initiation, as well 
as 3 months after the post-treatment assessment. All efforts will be made to have these 
assessments take place within a specified time window in relation to the 8, 16, or 28 week time-
point date. The windows allow for data collection up to two weeks before the time-point date and 
up to 2 weeks, 4 weeks, or 8 weeks after the time-point date for the mid-treatment, post-
treatment, and follow-up evaluations respectively, although data may still be collected should 
participants miss this window. During these visits, some or all of the measures detailed in the 
respective assessment point columns in Table 2 will be administered. With the exception of the 
computer-based tasks (e.g., the BIRD task), all adolescent- and parent-report measures will be 
available in English and in Spanish. The Spanish translations of these measures will be submitted 
in an amendment prior to initiating data collection. 
UP-A qualitative interview and questionnaires. Clinicians who have received UP-A training 
will be contacted to participate in a voluntary qualitative interview and complete questionnaires 
(the UP-C/A Therapist Beliefs Questionnaire, the Adaptations to Evidence-Based Practices 
Scale, and the Abbreviated Multidimensional Acculturation Scale) about their UP-A experiences 
and perspectives. These semi-structured qualitative interview will be conducted over the phone 
(or in person if preferred) and will last approximately 30-60 minutes. A trained research assistant 
will lead the interview, and once the participant has consented, will take notes and audio record 
the interview. The questionnaires will be completed online through a link sent to the clinician’s 
email (or will be completed via paper if preferred) and will take approximately 10-15 minutes to 
complete. Given the low-risk nature of this qualitative study, participants will be re-consented 
over the phone prior to completing the interview and questionnaires (see consent attachment). 
UP-A qualitative interview and questionnaires participants will be compensated with a $30.00 
gift card for their participation.
Cultural adaptations survey and qualitative interview. Participating clinicians across conditions 
will be contacted to participate in a brief, voluntary survey and qualitative interview about their 
experiences working with racial minority youth within the study and any adaptations made to the 
interventions they provided to these youth. Prior to the qualitative interview, clinicians will be 
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contacted by phone or email by research staff to assess interest and obtain consent. Those 
clinicians who consent to the interview will receive a link to the Cultural Adaptations 
Background Survey to provide information about their caseload, therapeutic approach, and work 
with diverse clients. This survey will take approximately 10 minutes to complete. After survey 
completion, clinicians will complete a semi-structured interview with trained research staff. 
These follow-up interviews will be conducted over the phone or via Zoom and will take 
approximately 30 minutes. Participating clinicians will be compensated $30.00 after completion 
of the interview. 
Table 2: Assessment Schedule
Measure
Reporter
Every 
Session
Pre 
Treatment
8 
Weeks
16 
Weeks
3 month 
follow-up
C-SSRS 
IE
X
X
X
Family Background 
P
X
Youth Demographics
C
X
Family Contact
P
X
Service Utilization
P
X
X
X
IE Blindness Check
IE
X
X
ADIS-5 C/P 
C, P, IE
X
X
X
CGI-S
IE
X
X
X
CGI-I
IE
X
X
CGAS 
IE
X
X
X
SCARED 
C, P
X
X
X
X
MFQ
C, P
X
X
X
X
YOQ  
C, P
X
(UP-A, 
TAU+ 
Only)
X
X
X
X
SDQ
C,P
X
X
X
X
Avoidance Hierarchy C, P, IE
X
X (C, P 
only) 
X 
X 
PHQ9
P
X
X
X
X
GAD7
P
X
X
X
X
CCNES
P
X
X
X
X
DTS
C, P
X
X
X
X
S-EMBU
C, P
X
X
X
X
BIRD
C
X
X
X
X
CEMS
P
X
X
X
X
CEASE-A
C
X
X
X
X
EASI-A
C
X
X
X
X
PANAS-C
C
X
X
X
X
WAI
C, T
X
X
BTPS
P
X
CSQ
C, P
X
X
X
HURTE-II
C,P
X3
X3
X3
X3
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Session Report Form T
X
EBPAS
T
X1
X2
ASA-MF
T
X1
X2
MFA
T
X1
X2
TCU-ORC
T
X1
UP-A Knowledge 
Check
T*
X2
Therapist 
Background
T
X1
C = Child, P = Parent/Caregiver, IE = Independent Evaluator, T = Therapist
1. Administered to the clinician before they start treating their first study case.
2. Administered to the clinician after they complete their first study case. 
3. May be administered to participants to screen for Hurricane Irma related stressful life 
events at the first contact the study has with the participants after the storm. 
*Administered to clinicians randomized to the UP-A condition only
Description of Measures and Data Collected:
Screening/Baseline Measures:

Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a semi-structured 
interview designed to screen for presence and severity of suicidal ideation and suicidal 
behavior.  There are parent and child report versions, as well as versions designed to assess 
suicidality at baseline (which assesses the last 6 months for study inclusion) and for later 
assessment points (which assesses ideation and behaviors since the last assessment).

CRAFFT Screening Test: The CRAFFT is a 9 item screening questionnaire, with yes and 
no questions related to substance use.  The questionnaire is used as an interview administered 
by the independent evaluator.

Family Background and Medical History Form: The project created a form to gather 
background information, such as demographic and educational information, as well as 
medical history data. 

Youth Demographics Form: The project created a form to gather race/ethnicity, gender, 
and sexual orientation information directly from adolescents, as parents may report these 
items differently than adolescents. 

Family Contact & Locator Form: This form will be used to gather contact information and 
other identifying information, as well as additional people who could locate the family if the 
project loses track of them.  

Service Utilization Assessment: This form will be used to gather information about outside 
use of psychiatric services. Two versions of the form will be administered- one for the 
baseline assessment and one to gather updated information at subsequent assessments. 

IE Blindness Check: At the post and follow-up assessments, the independent evaluator will 
complete a form to assess whether he or she has remained blind to the participant’s treatment 
condition. 

Barriers to Treatment Participation Scale – Expectancies (BTPS).  The BTPS is a 
questionnaire rated by parents.  Parents will indicate how much they agree with statements 
about their expectancies of barriers to treatment participation, using a 5-point scale from 1 
(totally disagree) to 5 (totally agree).  Only 38 items will be used in this study (questions 
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about relationship with therapist will not be used in this study).  It yields a total score and 3 
subscales.  The subscales and total score have excellent internal consistency (.85 to .95).

Hurricane Related Traumatic Experiences- Version 2 (HURTE-II_. The HURTE-II is a 
questionnaire rated by parents and/or youth. In order to more fully assess participant 
experiences after Hurricane Irma, caregivers or youth may complete some or all of this 
questionnaire during their first contact with the study after the storm. 
Independent Evaluator-Rated Measures of Primary Outcomes:

Anxiety Disorders Interview Schedule for the DSM-5, Child Version, Child and Parent 
Report Forms (ADIS-5- C/P), English and Spanish Versions: The ADIS-5-C/P is 
comprised of semi-structured interviews conducted with both parent and child that permit the 
diagnosis of all DSM-5 anxiety disorders, mood disorders, and externalizing disorders of 
childhood and adolescence, and also provide screening questions for selected other disorders 
(e.g., psychotic disorders, eating disorders, somatization disorders, and parent-report of 
mental retardation and learning disorders). Inquiries about current suicidal ideation or related 
plans are made to both adolescent and parent as part of this interview. Parents and 
adolescents are asked to provide ratings, ranging from 0 to 8, of the severity and degree of 
interference for each disorder. Clinician ratings are also recorded for disorders that border on 
or are clearly clinical in significance. 

Clinical Global Impression-Severity (CGI-S): The CGI-S is a 7-point clinician rating of 
severity of psychopathology. Severity ratings range from 0 (no illness) to 6 (extremely 
severe).

Clinical Global Impression-Improvement (CGI-I): The CGI-I is a 7-point rating of 
treatment response anchored by 1 (“very much improved) and 7 (“very much worse”).

Children's Global Assessment Scale (CGAS): The CGAS is a widely used 100-point rating 
scale used to measure global functional impairment.
Adolescent- and Parent-Rated Measures of Anxiety, Depression, and General 
Psychopathology:

Screen for Child Anxiety Related Emotional Disorders-Youth and Parent Reports 
(SCARED/-P): The SCARED and SCARED-P are 41-item self- and parent-reports of 
anxiety severity across five domains: panic disorder, generalized anxiety disorder, separation 
anxiety disorder, social phobia, and school anxiety.  

Mood and Feelings Questionnaire-Self and Parent Reports (MFQ): The MFQ Self 
Report is a 33 item and the Parent Report is a 34 item youth mood and feelings scale that 
yields a total score.

Strengths and Difficulties Questionnaire- Self and Parent Reports SDQ): The SDQ is a 
25 item measure of youth psychopathology that yields a total score and five subscale scores: 
emotion problems, conduct problems, hyperactivity, peer problems, and prosocial. Separate 
versions are administered to youth and caregivers. 
Measures of Parent Psychopathology and Emotion Regulation:
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
Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is a 9-item parent report measure of 
parent depression symptoms rated on a 4-poin Likert-type scale (0=Not at all, 1=Several 
days, 2=More than half the days, 4=Nearly every day).  It yields a total score and rating of 
impairment.

Generalized Anxiety Disorder-7 (GAD-7): The GAD-7 is a 7-item parent report measure of 
parent anxiety symptoms rated on a 4-point Likert-type scale (0=Not at all, 1=Several days, 
2=More than half the days, 4=Nearly every day).  It yields a total score and rating of 
impairment.

Coping with Children’s Negative Emotions Scales (CCNES): This measure was adapted 
for adolescents from the Coping with Children’s Negative Emotions Scale and consists of 
nine scenarios in which youth experience negative emotion. Parents are asked to identify how 
they respond to each scenario (e.g. “When my teenager gets down because he/she has had a 
bad day, I usually:”). Each scenario then has six responses which parents rate on a 7 point 
Likert-scale regarding their likelihood of responding that way (1 = very likely, 7 = very 
likely). This measure has six subscales which include emotion focused, problem-focused, 
minimization, punitive, expressive encouragement, and distress responses.

Distress Tolerance Scale (DTS): The DTS is a 16-item self-report measure of difficulties 
managing distress and related emotions on a 5-point Likert-type scale. Four types of items 
assess the reporter’s perceived ability to tolerate distress, subjective appraisal of distress, the 
attention consumed by the process, and the efforts made to alleviate the distress. High scores 
on the scale indicate high distress tolerance. Scores for a single factor demonstrate excellent 
internal consistency (.89). 

Egna Minnen Betraffande Uppfostran – Short Form (S-EMBU): The S-EMBU (Swedish 
for “My memories of upbringing”) consists of 23 items designed to assess perceptions of 
parental rearing behaviors. The Short Form questionnaires (parent and child report) consist of 
three subscales: rejection (7 items), emotional warmth (6 items), overprotection/control (9 
items), and 1 unscaled item. Items are answered on a 4-point Likert scale (1=No, 2=Yes, but 
seldom, 3= Yes, often, 4= Yes, most of the time).
Measures of Potential Mediators of UP-A:

Children’s Emotion Management Scales (CEMS): The CEMS-parent is a version of the 
Children’s Emotion Management Scales: Anger and Sadness that has been adapted for use 
with parents. It also includes a worry management scale that was developed to accompany 
the anger and sadness scales. Items are rated on a 3-point Likert-type scale (hardly ever, 
sometimes, and often). Only the 9 items from the Dysregulated expression subscale will be 
used in this study.

Checklist of Avoidance Strategy Engagement for Adolescents (CEASE-A): The CEASE-
A is a 29-item checklist assessing frequency of engagement in avoidance and safety 
behaviors in adolescents. Respondents are asked to indicate the frequency with which they 
use certain behaviors to manage or avoid feelings of anxiety, anger, fear, or sadness on a 5-
point Likert-type scale (0 = Never do to deal with feelings; 1 = Rarely do to deal with 
feelings; 2 = Sometimes do to deal with feelings; 3 = Usually do to deal with feelings; 4 = 
Always do to deal with feelings). The CEASE-A has five subscales: Use of Distraction, Use 
of Individuals as Safety Signals, Use of Safety Behaviors, Avoidance of Situations that 
Promote Strong Sensations, and Avoidance of Emotional Situations. 
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Revised: July 13, 2021

Emotional Avoidance Strategy Inventory for Adolescents (EASI-A): The EASI-A is a 17-
item measure assessing the use of emotionally avoidant strategies in adolescents. 
Respondents are instructed to use a 5-point Likert-type scale to indicate the degree to which 
each statement is true of them (0 = Not at all true of me; 1 = A little true of me; 2 = 
Somewhat true of me; 3 = Very true of me; 4 = Extremely true of me). The EASI-A has 3 
subscales: Avoidance of Thoughts and Feelings, Avoidance of Emotion Expression, and 
Active Avoidance Coping. 

Positive and Negative Affect Scale for Children (PANAS-C): The PANAS-C is a 27 item 
self-report scale that measures positive and negative affect in children and adolescents. Items 
are scored on a 5 point Likert scale ranging from 1 (very slightly or not at all) to 5 
(extremely). Participants are told to respond to items regarding how often they have felt a 
certain way over the past two weeks.

Behavioral Indicator of Resiliency to Distress (BIRD): The BIRD measures distress 
tolerance by having subjects engage in a computer task that increases in difficulty as the task 
progresses. The BIRD, which is based on the well-validated version for adults, the PASAT, 
measures distress tolerance by determining how long a participant persists on a task that 
becomes increasingly more difficult over the duration of the task. Specifically, participants 
are asked to use the computer’s mouse to click on the green dot that appears above a number 
(with numbers ranging from 1-10) before the green dot disappears. If the number is clicked 
on before the dot disappears, then a bird on the screen sitting in a cage is let out of the cage 
and the computer makes a chirping sound.  If, alternatively, the green dot disappears before 
the adolescent clicks on the number, then an “Uh oh” noise is made. A participant receives 
one point for every number that is clicked prior to the green dot disappearing. There are three 
levels of difficulty. The first level of the BIRD lasts 3 minutes. This level begins with a 5-
second latency in between dot presentations and titrates this latency based upon performance. 
The second level is more difficult, beginning with the average latency from the previous 
level for four minutes and then reducing the latency in half for the final minute making the 
task extremely difficult (i.e., challenge latency). The final level lasts up to 5 minutes and 
utilizes the extremely difficult challenge latency while the adolescent has an escape option 
throughout this final stage. Specifically, the adolescent is informed prior to beginning the 
task that once the final level has begun, the task can be quit clicking the quit game button on 
the computer screen. Throughout the task, a point meter remains visible on the upper right 
hand screen that demonstrates how many points the youth has earned. In order to motivate 
the adolescents to persist in the task, prior to completing the task they will be informed that 
they may receive up to $4 for their performance on the task. Adolescent participants will 
receive $1 after completing the first level and $1 after completing the second level. They will 
receive up to $2 after the third level depending on how long they persist in the task (i.e. $1 if 
they persist for less than half the time allotted for the third level and $2 if they persist for half 
of the time or greater). This method of using incentives to motivate participants to continue 
in the BIRD task has been used in other studies.  Studies using the PASAT (the adult version 
from which this task was adapted) indicate that most subjects do terminate the task before the 
time limit when the task becomes most difficult, and that considerable variability exists on 
this measure of task persistence. As this is a computer-based task, we are not uploading a 
document related to this measure, but it can be viewed at 
http://www.millisecond.com/download/library/BirdTask/. 
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Revised: July 13, 2021

Avoidance Hierarchy: IE, along with the adolescent participants and their parents will 
construct a 5-item Avoidance Hierarchy of situations and stimuli most frequently avoided, 
escaped or withdrawn from by the adolescent using a 0-10 scale for each item. IEs, 
adolescents, and parents will also rate this hierarchy at all subsequent time points. A total 
avoidance score will be derived by summing avoidance ratings for each of the five items 
across all three informants.

Distress Tolerance Scale (DTS): Difficulties managing stress and related emotions will be 
measured using the DTS. Adolescents will also fill out the same measure their parents are 
completing about their distress tolerance (see above). 

Client Satisfaction Questionnaire (CSQ): The CSQ is a 8 item questionnaire completed by 
the adolescent and the parent.  Adolescents and parents will indicate how satisfied they are 
with the services received.  A total score for the scale will be used, and has demonstrated 
excellent internal consistency (.89).
The YOQ and Measures of Potential YOQ Mechanisms:

Youth Outcome Questionnaire-30 Therapeutic Alliance, parent and self-report versions 
(YOQ 30 TA and YOQ 30 SR TA): These scales consist of 30 symptom items and 4 
(parent version) or 5 (youth version) alliance items. The symptom items yield a total score 
and an alliance score.  At research assessments, the YOQ will be administered in REDCap; 
for the UP-A and TAU+ participants, these measures will be administered every session 
through the YOQ website or app. The alliance items will not be administered at the baseline 
assessment because participants will not have met their therapists yet. 

Therapist Behaviors measured via the Session Report Form (UP-A and TAU + only): 

Viewing YOQ Reports: Therapist viewing of the YOQ reports will be tracked through 
the YOQ website. 

Use of YOQ Feedback: Therapists discussing feedback with clients will be coded from 
session recordings (see Assessment of Treatment Differentiation and Fidelity). 
o
Self-report YOQ Use: The Session Report Forms (see Session Report Forms under 
Assessment of Treatment Differentiation and Fidelity below) for the UP-A and TAU+ 
will include items assessing therapists 1) indicating whether they viewed the YOQ report, 
2) rating their perception of the credibility of the report on a 7-point Likert-type scale 
from “Not an Accurate Reflection of My Client’s Progress”  (1) to “Extremely Accurate 
Reflection of My Client’s Progress” (7), 3) indicating whether they discussed the YOQ 
feedback with their client, and 4) indicating what, if any, changes to the treatment plan 
they made in response to the feedback .

Working Alliance Inventory (WAI): The short version of the Working Alliance Inventory, 
completed by the client and therapist, includes 12 items rated on a 7-point Likert-type scale 
from never (1) to always (7), with items reflecting three core components of alliance: 
agreement on tasks, agreement on goals, and bond.

Engagement in treatment: Two indicators of treatment engagement will be tracked— 1) 
Missed sessions will be counted and 2) premature treatment terminations will be 
documented. Engagement will be tracked throughout the study, although data of interest will 
be engagement data collected during tracked for the first 16 weeks of treatment only, given 
potential variability in treatment length across conditions.
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Revised: July 13, 2021
Measures to be Completed by Clinicians Only:

Therapist Background Questionnaire and Locator Form: These forms will be used to 
gather demographic and professional information about clinicians, as well as contact 
information to help locate the participant for future assessments. 

Evidence-Based Practice Attitude Scale (EBPAS): This 15-item rating scale measures 
provider attitudes toward evidence-based practice and includes four subscales: Requirements, 
Appeal, Openness, and Divergence. 

Attitudes Toward Standardized Assessment Scales-Monitoring and Feedback (ASA-
MF): This 18-item rating scale measures provider attitudes toward using standardized 
progress measures for treatment planning and includes three subscales: Clinical Utility, 
Benefit for Treatment Planning, and Practicality. 

Monitoring and Feedback Attitudes Scale (MFA): This 17-item rating scale assesses 
provider attitudes toward routine progress monitoring and providing feedback to clients 
about treatment progress. It has three subscales: Benefit, Harm, and Trust. 

TCU Organizational Climate Form (TCU-ORC): The TCU-ORC is a measure of 
organizational climate that consists of multiple subscales that can be used based on project 
needs. 

UP-A Knowledge Check: This measure consists of 25 multiple-choice questions covering 
concepts from Core Modules 1-8 as well as Module-P of the Unified Protocol for the 
Treatment of Emotional Disorders in Adolescents. 

UP-C/A Therapist Beliefs Questionnaire: This is a 22-item measure created for the current 
study that assesses clinicians’ beliefs about the UP-A.

Adaptations to Evidence-Based Practices Scale: Six-item measure about treatment 
adaptations.

Abbreviated Multidimensional Acculturation Scale: A measure with 42 very brief items 
that assesses acculturation and cultural identity. 

Cultural Adaptations Background Survey:  A 6-item measure about clinician’s caseload, 
diversity of clients, and intervention selection and use with clients.
Measures derived from Clinic’s Medical Records:

The following data will be derived from the clinic’s medical record for each study 
participant: 
o
Use of medication
o
Treatment  attendance
o
Session notes
o
Supplemental mental health service use
o
Funding Source for Services
o
Intake and Discharge Diagnoses
o
Reasons for Treatment Termination
Assessment of Treatment Differentiation and Fidelity:
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
All clinicians will be asked to complete a Session Report Form after each session. The items 
included in these forms will vary by condition, but will include reports of who attended the 
session, how long the session lasted, and items about session content. Clinicians may be 
asked to include a copy of their session progress note with the form if the project is not able 
to access session progress notes during the review of clinic medical records.

All treatment sessions in all conditions will be video or audiotaped; these recordings will be 
used to monitor ongoing fidelity for UP-A, to quantify treatment adherence in the UP-A and 
TAU+ conditions, to assure differentiation of treatments, and to document characteristics of 
TAU.

The UP-A Adherence and Competence Checklist: This measure of UP-A adherence and 
competency was developed for the prior RCT of this intervention. Dr. Ehrenreich-May and 
the Miami project coordinator will apply this system to 20% of UP-A session recordings on 
an ongoing basis to monitor fidelity. In addition, at the end of the project, an IE will code 
20% of UP-A tapes to generate data regarding overall levels of fidelity in the trial. 

The Treatment Adherence, Content, and Competence Checklist: This will be completed 
by an IE while reviewing 20% of audiotapes of treatment sessions from all three treatment 
conditions to assure treatment differentiation and to characterize TAU. The subscales 
include: (1) treatment content; (2) session components; and (3) nonspecific factors. In 
addition, for the UP-A and TAU+ groups, an item will be added to the measure to document 
whether clinicians are discussing feedback reports from the YOQ with their clients; data 
regarding other aspects of YOQ fidelity (i.e., administering measures, reviewing reports) will 
be gathered directly through the YOQ system. To ensure that data are available for all 
participants, recordings will be randomly sampled within participants.
Training for Independent Evaluators:
IEs will be blind raters who have at least a bachelor’s degree in psychology or a related field (i.e. 
postdoctoral fellows, master’s level clinicians).  IE training will be coordinated by Dr. Golda 
Ginsburg and will include a review of measures and co-rating videotaped gold standard cases. 
New IEs will independently rate 4 ADIS-IV-C/P and CGI criterion tapes (experienced IEs will 
rate 3). On the ADIS-IV or 5-C/P and CGIs, the criterion will be presence/absence of diagnosis 
and within one point on the clinical severity rating (CSR; rated as part of the ADIS) and CGI 
against the gold standard. These rating tapes may be drawn from other protocols (e.g. Protocol 
#20130139). These recordings and related assessment data will be transferred via secure online 
sharing platforms (e.g., OneDrive, Box.com, UM’s SecureSend system) and visible only to 
authorized personnel. It is anticipated that Dr. Ginsburg will hold twice-monthly cross site 
conference calls. Furthermore, IEs will be provided with ongoing supervision at each site by the 
study PIs. To address cross-site consistency, all assessments will be video recorded and 20% of 
interviews per year will be blindly reviewed by the project coordinator or senior project staff 
under Dr. Ginsburg’s supervision to assess inter-rater reliability and rater drift on the ADIS-5-
C/P and CGI-S/I. In the event that an IE rating falls below the criterion, efforts will be made to 
re-establish the reliability criterion (e.g., having the IE redo training)
11) Data and Specimen Banking*
N/A, no specimens will be collected as a part of this research study
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12) Data Management*
Data management at all sites will be supervised by the data management team, consisting of the 
three grant PIs and Dr. David Rosenfield, the biostatistician. Data management issues will be 
discussed in regular conference calls. Whenever possible, measures will be administered by 
computer or tablet computer, obviating the need for double entry and minimizing the likelihood 
of missing data. Research assessment data will be collected via the University of Miami’s 
REDCap or Qualtrics systems. Site-specific data access groups will be created so that only 
personnel at each site can access that site’s data. PI Jensen-Doss, the research coordinator, and 
the post-doctoral fellow at the University of Miami will have access to both data access groups to 
facilitate data monitoring and cleaning. The only identifying information entered into REDCap 
or Qualtrics will be the e-mail addresses for clinician participants to allow surveys to be e-mailed 
to them. When datasets are extracted from REDCap or Qualtrics, this information will be 
removed and fully de-identified files will be stored on the University of Miami Psychology 
department server. These de-identified files will also be securely transferred to the UConn site 
and to Dr. Rosenfield (the project statistician). Dr. Rosenfeld will not have access to any 
identifying information or links which could potentially identify participants. Consent forms for 
both sites specify that data will be shared across both sites. 
When clinics send screening data to the project, they will e-mail this information, consistent with 
their agency standards for transfer of clinical information, or utilize an online screening form via 
REDCap or Qualtrics. In cases where project staff need to e-mail information back to the clinics, 
all files will be password protected and sent via the Psychology Department’s e-mail server. 
When clinicians initially transfer session recordings to the project, they will be uploaded onto 
Box.com or sent via SecureSend by the clinician and then downloaded by project staff and 
removed from these online platforms.  Interviews and session recordings will also be stored on 
each site’s secure servers or on OneDrive. Cross-site review of recordings will be necessary to 
facilitate cross-site supervision of clinicians and IEs, and to allow for fidelity coding of tapes. 
The informed consent forms will inform participants that research staff from both sites will have 
access to their data. When cross-site review of tapes is necessary, recordings will be transferred 
between sites via SecureSend. 
YOQ data will be collected each session through the YOQ web-based application, whose server 
is managed by Rackspace®, a managed hosting firm whose security standards meet the industry’
s highest standards, including HIPAA compliance, and have earned it SAS 70 Type II 
Certificaton, indicating third party verification of its security procedures.  All data are stored on a 
remote firewalled web server. Users must have a password to access the application, and access 
within the application is controlled by a permission structure (e.g., clients do not have access to 
data or to view any other users, clinicians only have access to their own clients' data, etc.). The 
research project staff will be able to directly download data from these servers.
All paper records and clinical data will be stored securely in locked offices and/or filing cabinets 
accessible only to members of the study team. Electronic data files and digital recordings will be 
stored on secure servers at UM and UConn, accessible only by project staff. Data and recordings 
will be labeled with ID numbers and initials in the place of names, and information linking 
participant identifying information with IDs and initials will be stored securely in a password-
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protected log, accessible only to study personnel. Study consent forms will indicate that data will 
be shared across the two sites and that project staff at both sites will have access to the data.  
When these data are transferred, all data files will be password protected and saved on secured 
servers in dedicated files accessible to project staff only.
All project staff will be educated about the importance of confidentiality, and trained on 
procedures used to protect this within the study. Information about participants will be kept 
strictly confidential (to the extent permitted by law) and information about participants will not 
be released without a signed release form by the child’s caretaker. 
Data Analysis Plan:
We plan to use GLMM (multilevel modeling, MLM, with a logistic linking function) to 
examine treatment effects on the dichotomous primary outcome (“response”, defined as CGI-I of 
1 or 2). Additional clinician-rated (e.g., CGI-S, CSR) and questionnaire-based (e.g., SCARED, 
MFQ) outcomes are all continuous measures and will be analyzed using traditional MLM.  
13) Provisions to Monitor the Data to Ensure the Safety of Subjects*
The Principal Investigators, in accordance with the policies outlined by the University of Miami 
and UConn Institutional Review Boards (IRBs), are responsible for ensuring the safety of 
participants and the integrity of research procedures. Throughout the study, the PIs will work 
with all staff, Co-I’s, and grant consultants, to ensure compliance with the study’s procedures 
and data and safety monitoring plan. Finally, a Data Safety Monitoring and Board has been 
appointed to monitor progress of the study and at least annually (more frequently if needed). The 
Board members are Cindy Rowe and Annette La Greca from the University of Miami and 
Margaret Briggs-Gowan from UConn. 
Procedures to monitor participant Safety: Throughout the study, the PIs and all study staff 
will monitor participants’ risk of harm, as described above under 9) Study End points. Any 
evidence of risk of self-harm will be reported immediately to the principal investigators. When 
possible, at times when patients are seen for the study, a trained mental health professional will 
be present and available at the clinics to take appropriate measures; at all other times the 
principal investigators or post-doctoral fellow will help the assessors generate a safety plan. In 
the case that abuse or neglect is discovered, appropriate measures will be taken, in accordance 
with the laws of Florida or Connecticut. Prior to making this report, every effort will be made to 
inform the family first and discuss the situation with them.  However, if the family cannot be 
reached, the report will still be made promptly, as required by Florida or Connecticut statutes. 
All families will be informed of the limits of confidentiality during the consent process.  
If clinical or questionnaire data indicate that a child is showing a notable decline in functioning 
during the course of the study, this will be discussed with the child’s clinician and caregiver and 
the child will be referred for additional and/or alternative treatment if appropriate. 
Procedures to report any Adverse Event or Unanticipated Problem during the 
study: Throughout the study, the PIs will be responsible for reviewing and reporting 
adverse events occurring during the study to their local IRB. If any type of adverse event 
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occurs, the PIs will report that event to the Miami and/or UConn IRB according to the 
local IRB policies. If an unanticipated problem occurs to compromise the data or 
confidentiality of the data storage plan (e.g., a break-in to the laboratory space), the PI 
will notify the IRBs as well as any participant potentially affected by the event.
14) Withdrawal of Subjects*
Participants and their parents/guardians may be withdrawn from the study without their consent 
if they are withdrawn from clinical care in the CMHC. Should the client be terminated or 
transferred in accordance with the local clinic policy, he/she will be withdrawn from the study. 
In addition, participants may be withdrawn for the following reasons:

Parent/guardian no longer available to participate with the adolescent.

Failure to adhere to clinic guidelines and/or clinician guidelines.

The participant is no longer able to attend clinic visits or complete research assessments.

There may be other reasons that are unforeseen at this time.

The clinician and/or evaluator determine, during interim treatment assessments, that an 
emotional disorder treatment focus is no longer appropriate/sufficient. If this determination is 
made by the evaluator, the clinician must also agree that emotional disorder focused 
treatment is no longer appropriate/sufficient and alternative or additional care is necessary.

During the course of treatment, the adolescent begins an outside psychosocial intervention 
similar to that given in the study, or one that the investigators feel may be confounding.
Those participants who voluntarily withdraw from treatment may be asked to complete 8 week, 
16 week, and 3 month follow-up assessments for data collection purposes, if appropriate. 
Clinicians may be excluded from the study for any of the following reasons:

They leave the clinic and are no longer seeing clients at the CMHC.

They are unable to attend and/or participate in training and consultation meetings.

They are determined inappropriate for the research study (i.e. failure to adhere to treatment, 
failure to adhere to study procedures).
In the event that a clinician is withdrawn or voluntarily withdraws from the study, clients who 
are still in treatment will be offered to transfer to another study clinician if appropriate. All 
clinicians will be asked to consider the best interests of the adolescents when withdrawing from 
the study, and encouraged to complete treatment with study clients before withdrawing.
15) Risks to Subjects*
There are no physical risks associated with participation in the study. There are minor 
psychological risks to child and caregiver participants. During assessment procedures, there may 
be some risk of discomfort, irritability, or anxiety resulting from discussion of personal or 
emotion-provoking subjects. However, this risk is not greater than that which occurs in the usual 
clinical evaluation process. Participants and their parents/guardians may experience mild 
inconvenience from having to complete additional research assessments which may take 
additional time. 
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Some UP-A treatment procedures involving exposure or activation activities may provoke minor 
distress or discomfort. However, these risks are known and therapists will be well trained to 
present such tasks in a developmentally sensitive manner that is appropriate for each participant. 
Appropriate provision of UP-A exposure activities will also be a routine subject during study 
therapist consultation with Dr. Ehrenreich-May. As is the case with any form of treatment, there 
is no guarantee that the treatment strategies offered in this study will be effective with all 
participants. Any participant who shows a notable decline in functioning during the course of the 
study will be referred for additional and/or alternative treatment immediately as per usual clinic 
procedures.
Risks to parent and adolescent participants are minimized by the use of standard clinical care 
procedures and assessments. The BIRD task might cause adolescents mild to moderate levels of 
frustration, but care will be taken to ascertain an objective rating of such (Subjective United of 
Distress; SUDS) before and after the task. If the adolescent shows or expresses any distress, 
clinically appropriate interventions will be used to help reduce distress.  All IEs will be trained to 
assist youth throughout the evaluation process in this manner. 
The risks to therapist participants are minimal, and do not exceed those routinely encountered in 
their work life. They may experience slight discomfort participating in project consultation or 
from seeing client progress reports through the YOQ, although these therapists could experience 
this same discomfort in the routine supervision they receive. 
16) Potential Benefits to Subjects*
Child participants will potentially experience alleviation of distress associated with an emotional 
disorder. In all conditions (TAU, TAU+, and UP-A), adolescents have the prospect of direct 
benefit, given that all study arms contain active treatments (i.e. no sham treatment or waitlist 
condition is being used). In both the UP-A and TAU+ conditions, subjects may benefit from the 
monitoring and feedback system, as well as the additional consultation provided to therapists in 
these conditions. The additional monitoring and assessment in the UP-A and TAU+ conditions 
may lead to enhanced treatment, alerts regarding issues of immediate concern (i.e. suicidality), 
and alerts regarding poor progress or deterioration during treatment. For adolescents in the TAU 
condition, the addition of 8 week, 16 week, and 3 month assessments may also provide 
additional monitoring during and after treatment beyond the standard monitoring in clinical care.
Therapist participants will potentially have access to training and/or consultation in a new 
intervention and measurement/feedback systems. 
17) Vulnerable Populations*
This research involves adolescents 18 and under. A number of safeguards have been put in place 
and careful consideration has gone in to the decision to conduct this research with this particular 
population.
The PIs have extensive experience conducting research and clinical work with this population. 
All study staff involved will be trained in conducting research with vulnerable populations, 
including minors. All study therapists will have experience treating mental health concerns in 
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youth.  In addition, all caregivers will be asked to give written informed consent, and all youth 
will be asked to give written assent. 
As discussed above under benefits, all adolescent participants have the potential for benefit in 
this study. As such, the investigators believe that the research presents the possibility of direct 
benefit to the adolescents beyond standard clinical care or no treatment, and possible risks and 
discomforts resulting from the research are minimized and/or outweighed by the benefit.
18) Multi-Site Research*
The following factors will ensure successful collaboration and completion of this multi-site 
study:
Each site is very experienced in the conduct of clinical trials across multiple psychiatric 
disorders: including efficacy tests of EBTs for emotional disorders in youth (Ginsburg, 
Ehrenreich-May), effectiveness tests of youth EBTs (Ginsburg, Jensen-Doss) and multi-site 
investigations of such (Ginsburg, Ehrenreich-May). As well, the investigators have a wealth of 
experience in emotional disorder assessment (Ginsburg, Jensen-Doss, Ehrenreich-May), 
measurement/feedback systems (Douglas, Jensen-Doss), and examination of hypothesized 
mediators of intervention effects in the UP-A (Ehrenreich-May) and MFS (Douglas, Jensen-
Doss). 
To ensure scientific integration of research procedures, the study Steering Committee (comprised 
of Drs. Ehrenreich-May, Jensen-Doss and Ginsburg) will oversee all managerial and 
administrative matters. The Steering Committee will be responsible for all decisions concerning 
the overall research study, including plans for data analysis and publications, and Steering 
Committee weekly conference calls will monitor the overall course of the study including 
recruitment, retention, participant eligibility decisions, randomization protocols, budget, data 
collection, training, assessment issues, treatment issues, data analysis, and quality assurance 
issues including missing data and data integrity. In addition, human subjects issues will be 
discussed, especially as they apply to adverse events and minority group participation. 
Extensive quality assurance procedures will be ongoing to ensure cross-site comparability in 
administering the UP-A and MFS, and in conducting assessments. Conference calls on various 
study components will occur regularly. While data at each site will be collected and entered into 
the encrypted electronic data system, the Miami site will provide data management, under the 
oversight of Drs. Jensen-Doss and Rosenfield. In consultation with the study statistician, Dr. 
Rosenfield, the PIs will be responsible for all aspects of statistical design and analysis for the 
study. 
Though this project will be a multi-site collaboration (between University of Miami and UConn), 
each participating institution will submit to their local IRB. For this reason, protocol formatting 
and consent documents may vary slightly based on institutional templates and materials.
Regulatory changes and procedural changes will be managed by the PIs at the University of 
Miami and communicated with Dr. Ginsburg at the University of Connecticut. Compliance with 
local regulatory policy will be the responsibility of the PIs at each site. To ensure that sites are 
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using the most up-to-date protocol documents and study materials, the PI’s will have at least 
weekly meetings to discuss progress and any issues that may arise during the research. In 
addition, joint meetings will take place regularly with the project coordinator(s) as well as the 
IEs. The project coordinator(s) will be responsible for implementing procedural changes at the 
CMHCs. The PIs and the project coordinator(s) will communicate regularly with the IEs as well, 
to ensure fidelity to the project procedures and provide updates, should these procedures change.
 
Upon completion of the study, a final meeting will take place that the University of Miami. 
During this meeting, data analyses and manuscript preparation. All UM Study staff, Dr. 
Ginsburg from UConn, and Dr. David Rosenfield, the study’s statistical consultant, will attend 
this meeting (their travel has been accounted for in the grant budget).
19) Community-Based Participatory Research*
N/A
20) Sharing of Results with Subjects*
The data collected from this study is primarily for research purposes. All assessments (including 
the ADIS-5 C/P) are research assessments used for the purposes of assessing study eligibility and 
outcomes. No information will be shared with legal guardians or participants over the age of 18 
without a direct request. No information will be shared with others without a written release 
signed by the legal guardian or a participant over the age of 18. The consent form will inform 
participants that the study may share some of their assessment results with their clinician to help 
with treatment planning or to manage crises. 
Information shared with parents/guardians and/or participants will be consistent with standard 
clinical practice at each of the sites (for example, therapists may wish to meet with guardians 
during the session to discuss the adolescent’s progress and functioning). Any assessments or 
results derived for research purposes will be shared on an as-needed basis. For example, if 
ADIS-5 assessment results suggest possible suicidality that is not otherwise captured by the 
treating clinician, this information will be shared with the appropriate individuals consistent with 
local laws and IRB regulatory policy. 
21) Setting
For the Miami site, the study will draw from the pool of clinicians and adolescent clients at three 
community mental health centers, PsychSolutions, Inc., Jewish Community Services, Chrysalis 
Health, Inc., Goodman Psychological Services Center, Stop Parenting Alone, Live Well Therapy 
Group, and Behavioral Aid Solutions. All centers provide mental health services in their office 
locations, as well as in hundreds of schools and homes in the community. All agencies have 
agreed to allow participant recruitment and research assessments take place at their clinics, and 
all clinical services will be delivered wherever the agencies typically deliver services. 
Participants who prefer to do so may complete their research assessments in research space at the 
University of Miami instead. In circumstances were participants are unable or unwilling to come 
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in for a research assessment, they may complete measures via RedCap or Qualtrics online, by 
phone, or via Zoom, as long as they have already signed a study consent form. A phone script to 
explain these options to families has been uploaded as a study document. 
Resources Available
Project staff will include: 
PIs (Jensen-Doss, Ehrenreich-May): Both PIs have extensive experience conducting 
research with children, with clinical populations, and in clinical settings. 
Postdoctoral Fellow/Project Coordinator: This individual will hold a doctoral degree in 
clinical psychology, or a related field, and have a background in conducting psychosocial 
interventions and research with children or adolescents.  This individual will be 
supervised closely by the PIs.
Independent Evaluators: These individuals will be graduate students in clinical 
psychology, or a related field, or hold at least a master’s degree in a mental health field.  
These individuals will be supervised closely by the PIs, the postdoctoral fellow, and Dr. 
Ginsburg at UConn. 
Research Assistant: This individual will hold a bachelor’s degree.  This individual will be 
supervised closely by the PIs and the postdoctoral fellow.  
Throughout the study, Drs. Ehrenreich-May and Jensen Doss will devote approximately 20% of 
their time and effort. Together, they will be responsible for selection, hiring, management, and 
training of study staff. All study staff will be required to complete CITI training on the 
responsible conduct of research. Furthermore, any UM staff participating in the study will 
complete a training to adequately prepare them for their role in the study (e.g. IEs will undergo 
training in assessments; all staff will undergo training in study administrative procedures and 
policy). In addition, any staff member obtaining informed consent and assent from participants 
and their parents/guardians and participating therapists will be required to complete informed 
consent training to ensure adequate preparation for this responsibility
Drs. Ehrenreich-May and Jensen Doss both have dedicated faculty offices, laboratory 
space, offices for postdoctoral associates and additional graduate student office space, all 
on the same floor at UM. This space is large enough to house all UM site staff working 
on this grant. All of this space is wired for internet and phone access. The UM 
Department of Psychology has an in-house team of three, full-time consultants for 
hardware and software needs and an additional IT support technician. The project also 
has access to private rooms in the department where research assessments can be 
conducted, should participants prefer to come to UM for those assessments. Details 
regarding resources facilities at participating clinics are describe in Section 21 (Setting).
22) Prior Approvals
Neither CMHC has its own IRB, so no prior approvals will be submitted. 
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23) Recruitment Methods
Recruitment methods are described in detail in Section 7 (Study Wide Recruitment Methods).
 
Adolescent participants/their caregivers will be paid up to $220 for participation in this study 
($40 for the baseline evaluation, $20 for the 8 week evaluation, $80 for the 16 week assessment 
and $80 for the 3-month follow up). This payment will be delivered in the form of gift cards, 
split evenly between the adolescent and the caregiver, and will be given to participants after 
successfully completing each assessment point. If participants only complete part of an 
assessment, payment will be prorated according to the amount of the assessment that was 
completed and they will receive the remainder of the payment for that assessment if they 
complete the assessment at another time. As detailed above in the description of the BIRD task, 
adolescents may also earn up to $4 in cash for their participation in the BIRD task. 
If their clinics do not pay them for these activities, participating clinicians will be compensated 
for the time spent on extra training and consultation associated with the study at a rate of $30 per 
hour. The exception to this is trainee therapists, such as interns or practicum students, who are 
typically not allowed to be paid for taking part in training activities; these trainees will complete 
a trainee-specific consent form that explains this. While the respective clinics will continue to 
pay their regular salary for treatment sessions, study funds will provide a research incentive of 
$60 per case for time spent completing session-by-session study paperwork and collecting and 
submitting session recordings. Trainee clinicians will receive this research incentive. 
In the cases where participants are asked to complete an abbreviated baseline re-assessment prior 
to the start of treatment, they will be paid $20 for their time to complete this re-assessment. 
24) Local Number of Subjects
An estimated 150 youth participants will be enrolled locally at each site, with the aim of having 
222 (111 at each site) adolescents complete the treatment. Up to 40 clinician participants will be 
enrolled locally at each site. 
25) Confidentiality
Confidentiality of study participants will be protected by keeping all records and clinical data in 
secure, locked file cabinets and/or offices accessible only to study staff. At UConn, these offices 
will be located in the Department of Psychiatry. Study materials (including assessments, 
questionnaires, and recordings) will be labeled with initials and code numbers in place of patient 
names. Further, no information will be given to anyone (to the extent permitted by law) about 
participants without a signed release by the child’s guardians. Electronic data at UConn will be 
stored on the Psychiatry Department’s secure server, only accessible to study staff. Any files 
containing identifiable information will be password protected. Participants’ identities will not be 
revealed in the presentation or publication of any result from this project. When de-identified 
data are transferred between UM and UConn, all data files will be password protected and saved 
on secured servers in dedicated files accessible to project staff only. All project staff will be 
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educated about the importance of strictly protecting participants’ rights to confidentiality. All 
appropriate measures will be taken to further protect the confidentiality and safety of the patient 
and family.
26) Provisions to Protect the Privacy Interests of Subjects
Participants and their guardians will be informed about the confidential nature of study 
participation and treatment. All efforts will be made to ensure that the adolescent consistently 
meets with the same therapist throughout participation. Families will be informed that a signed 
release will be required to disclose information to others. Furthermore, the limits of 
confidentiality will be discussed—specifically as it relates to mandated reporting of abuse or 
neglect in vulnerable populations and in regard to suicidal/homicidal ideation. Parents and 
adolescents will be reminded during assessments that information is confidential, and that they 
may choose to skip items or discontinue should they feel uncomfortable. 
Participants will be informed that information will be obtained from their clinic/medical record. 
The consent and assent forms will explain what information is to be gathered from medical 
records, and who will access this information. 
Data from clinic/medical records will be collected through the study’s 3 month follow-up period. 
Should a participant turn 18 prior to completing the follow up assessment, they will sign a study 
consent form before information in the clinic/medical record created after the participant was 18 
may be extracted. 
Any other outside communication for clinical purposes will be done according to the clinic’s 
policy. 
27) Compensation for Research-Related Injury
N/A
28) Economic Burden to Subjects
Participants will not be responsible for any additional costs for participating in the research. 
29) Consent Process
Clinician Participants:
Informed consent for clinician participants will take place in a private room at the clinic or 
facility where study trainings are conducted. Written informed consent will be obtained from all 
clinicians from a project staff member. Clinicians will be informed that they may take as much 
time as they wish to make a decision regarding participation, and their refusal to participate will 
not result in any penalties whatsoever. They will be offered ample opportunity to ask questions 
and seek clarification. Upon signing consent, a second copy of the consent form will be given to 
the clinician. 
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As indicated in previous sections, the UP-A qualitative interview and questionnaires will involve 
a separate consent process. Given the low-risk nature of these qualitative procedures, 
participating clinicians will be re-consented via phone. The verbal consent script is included with 
this amendment application.
The cultural adaptations qualitative interview and background survey will involve a separate 
consent process. Given the low-risk nature of these qualitative procedures, participating 
clinicians will be recruited first by email and phone and re-consented verbally before 
participating in interview procedures. The recruitment script and consent are included in the 
amendment documentation.
Adolescent Participants: 
Informed consent for adolescent participants will take place in a private room in the clinics or at 
the University of Miami. Any adolescent participants in this study that are under the age of 18 at 
the time of enrollment must have a legally authorized representative able to provide consent for 
their participation in research. This guardian must be above 18 years of age at the time of 
consent. Only legal guardians will be allowed to provide consent for adolescent participants. In 
cases where parents are divorced, efforts will be made to obtain both parents’ consent if possible. 
Adolescents who are wards of the state or are unable to be accompanied by a legal guardian will 
not be enrolled in the study.
Written informed consent will be obtained from the parents/guardians of participating children. 
A member of the study team (i.e. project coordinator or independent evaluator) will obtain 
consent prior to the performance of any procedures. Guardians will be informed that they may 
ask any questions they wish to, and take as much time as necessary to consider participation. 
Written assent will be obtained from all participating adolescents as well, prior to any study 
procedures. Adolescent participants who are 18 years old will provide their own consent, which 
includes a release for their parents to take part in the study activities. Assent will take place 
similarly to the consent, with ample time to consider participation as well as the opportunity to 
ask questions of the study team member obtaining consent. Guardians and/or adolescents may be 
given a blank copy of the consent/assent form to review prior to making a decision. A second 
copy of the consent/assent form will be given to the guardian/adolescent once they have signed. 
Adolescents who turn 18 during study participation will be re-consented using an adult consent 
form. 
If a second caregiver serves as the informant at any of the research assessments, informed 
consent will also be obtained from them prior to their participation. This consent form (COMET 
Consent Over 18 Second Adult Informant) only covers that individual’s participation, as another 
legal guardian will have already provided consent for the adolescent. 
Consent Language:
Adolescent participants and their caregivers may speak Spanish or English. Their consent and 
assent forms are available in both Spanish and English, and participants may choose which 
version they feel most comfortable with. The Spanish translation of all consent and assent forms 
was written by a fluent Spanish speaker, and reviewed carefully. They were back-translated to 
ensure that all wording is consistent in both languages. 
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If a participant chooses to use a Spanish consent form, the study staff member obtaining consent 
will obtain consent in their native language. Currently, there are a number of study team 
members that have been identified as fluent Spanish speakers, and we anticipate the addition of 
others in the future. In addition, Dr. Jensen-Doss speaks Spanish, and will be able to supervise 
the consent process and any other study procedures that are done in Spanish. 
30) Process to Document Consent in Writing
The study will obtain written documentation of consent for all parts of the study except the 
qualitative interview and questionnaires with therapists. Given the low-risk nature of the 
qualitative portion of the study, participants will be consented verbally over the phone. See 
Section 29 (“Consent Process”) details.
31) Drugs or Devices
N/A, this study does not involved drugs or devices.
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Christina L, May, Jill T Ehrenreich, & Allen, Laura B. (2010). Unified Protocol for 
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(2005). The administration and scoring manual of the Youth Outcome Questionnaire. Salt 
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