Community Study of Outcome Monitoring for Emotional Disorders in Teens

Emotional disorders, encompassing a range of anxiety and depressive disorders, are the most
prevalent and comorbid psychiatric disorders in adolescence. They are chronic, impairing,
costly, and share overarching commonalities. Unfortunately, evidence-based therapies (EBTs)
exist for only single disorders or domains (e.g., depression), are rarely adopted by
community mental health center (CMHC) clinicians, and effect sizes are modest (40-50% of
youth are treatment non-responders). Thus, methods for improving outcomes for these youth,
particularly in CMHCs are needed. This study tests the effectiveness of two novel
interventions to address this need. The first intervention is a transdiagnostic treatment
(the Unified Protocol for the Treatment of Emotional Disorders in Adolescents, UP-A), a
promising new approach that uses a small number of common strategies to treat a broad range
of emotional disorders. Transdiagnostic models align with NIH's initiative to advance the
understanding and treatment of psychopathology using the Research Domain Criteria (RDoC).
Importantly, this treatment approach is expected to improve client outcomes and have quicker
uptake by CMHC clinicians because:

1. comorbidity is the rule, rather than the exception making this intervention more
relevant for the patients seen in CMHCs, and

2. protocols cutting across diagnostic boundaries reduce training burden.

The second intervention is a standardized monitoring and feedback system (MFS; Youth Outcomes
Questionnaires, YOQ). This intervention can be built into the existing electronic medical
records infrastructure of CMHCs and thus has appeal for its acceptability, ease of transport
into clinical practice, and sustainability. Emerging data suggests that MFS alone improves
outcomes relative to TAU but has not been adequately tested in youth. As an added value, this
study also addresses a common threat to the internal validity of previous RCTs evaluating an
EBT by isolating the confounding effects of increased measurement and feedback to clinicians.
Finally, addressing a central aim of this RFA and making a unique and critical contribution
to the treatment literature, this study will examine theoretically-linked mechanisms (both
patient and provider level) of treatment outcomes of both the UP-A and the YOQ. This
collaborative R01 proposal (in response to RFA-MH-15-325) was prepared by Drs. Ehrenreich-May
and Jensen-Doss at the University of Miami (Miami) and Dr. Ginsburg at The University of
Connecticut School of Medicine (UConn; applications are identical). To test study aims, 222
adolescents (ages 12-17) with anxiety and/or depressive disorders will be recruited in CMHCs
in Miami and Hartford (111 adolescents and 9 clinicians at each site).

Both adolescents and clinicians will be randomized to one of three conditions:

1. TAU alone;

2. TAU plus YOQ, and

3. UP-A plus YOQ.

Research assessments will occur at baseline, 8 weeks and 16 weeks after treatment initiation
and a 3-month follow-up. If effective, these interventions have the potential to change
clinical practice in CMHCs by equipping clinicians with more effective interventions that can
be applied to a broad range of patients.

Inclusion Criteria:

1. Male or female adolescents between the ages of 12-18 years at the time of enrollment
with 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.

2. The adolescent is determined by the community mental health center to be eligible for
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.

Exclusion Criteria:

1. Adolescents will be excluded if they are receiving concurrent psychotherapy, family
therapy or similar psychosocial interventions.

2. Consistent with the prior RCT of the UP-A, the use of psychopharmacologic treatments
for anxiety or depression is allowable; but the adolescent must be on a stable dosage
for 2 months for SSRI or 1 month for benzodiazepine prior to consenting to the study.
The type, dosage and frequency of medication will be monitored at all major study
assessment points, but subsequent changes will not incur exclusion from the
investigation. Adolescents on stable doses of a stimulant for ADHD for at least one
month or on a SNRI (e.g., Strattera) for ADHD for at least two months can also be
included.

3. Adolescents who are currently suicidal or who have engaged in suicidal behaviors
within the past 6 months will be excluded and referred for appropriate clinical
intervention.

4. Adolescents with a current substance abuse disorder as determined using the
ADIS-5-C/P, will be excluded.

5. 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.

6. 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.

7. Given additional complexities obtaining informed consent, adolescents who are
currently placed in the foster care system will be excluded.