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Community Study of Outcome Monitoring for Emotional Disorders in Teens (COMET)

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ClinicalTrials.gov Identifier: NCT02567266
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : May 3, 2019
Sponsor:
Collaborators:
University of Connecticut
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Amanda Jensen-Doss, University of Miami

Brief Summary:
Emotional disorders, including an array of anxiety and depressive syndromes, are the most common psychiatric disorders among adolescents, are highly comorbid, and severely impair the lives of youth and their families. Extant evidence-based therapies target only single disorders or symptom domains, are often not adopted by community mental health center (CMHC) clinicians, and have only modest effect sizes. To improve the clinical outcomes of these youth, the proposed study tests the effectiveness of two novel interventions (a transdiagnostic intervention, the Unified Protocol for the Treatment of Emotional Disorders in Adolescents, and a measurement and feedback system, the Youth Outcomes Questionnaires) relative to usual care in CMHCs.

Condition or disease Intervention/treatment Phase
Depression Anxiety Behavioral: Unified Protocol for Adolescents (UP-A) Behavioral: Youth Outcomes Questionnaire Behavioral: Treatment as Usual Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Community Study of Outcome Monitoring for Emotional Disorders in Teens
Study Start Date : January 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Unified Protocol for Adolescents (UP-A)
Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence. Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system.
Behavioral: Unified Protocol for Adolescents (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.

Behavioral: Youth Outcomes Questionnaire
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.

Experimental: Treatment as Usual Plus (TAU+)
Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual
Behavioral: Youth Outcomes Questionnaire
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.

Behavioral: Treatment as Usual
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.

Active Comparator: Treatment as Usual (TAU)
Participants will receive Treatment as Usual provided at the study clinics.
Behavioral: Treatment as Usual
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.




Primary Outcome Measures :
  1. Change over time in Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 16 weeks, 3 month follow up ]
    This is a independent evaluator rated measure of improvement in symptoms and functioning


Secondary Outcome Measures :
  1. Change over time in Clinical Global Impression-Severity (CGI-S) [ Time Frame: 16 weeks, 3 month follow up ]
    This is a independent evaluator rated measure of severity of symptoms

  2. Change over time in Children's Global Assessment Scale (CGAS) [ Time Frame: 16 weeks, 3 month follow up ]
    This is a independent evaluator rated measure of global functional impairment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567266


Contacts
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Contact: Amanda Jensen-Doss, Ph.D. 305-284-8332 ajensendoss@miami.edu
Contact: Jill Ehrenreich-May, Ph.D (305) 284-6476 j.ehrenreich@miami.edu

Locations
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United States, Connecticut
University of Connecticut Health Center Recruiting
West Hartford, Connecticut, United States, 06119
Contact: Golda Ginsburg, Ph.D.    860-523-3788    Gginsburg@uchc.edu   
United States, Florida
University of Miami Not yet recruiting
Coral Gables, Florida, United States, 33124
Contact: Amanda Jensen-Doss, Ph.D.    305-284-8332    ajensendoss@miami.edu   
Contact: Jill Ehrenreich-May, Ph.D.    305-284-6476    j.ehrenreich@miami.edu   
Sponsors and Collaborators
University of Miami
University of Connecticut
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Golda Ginsburg, Ph.D. University of Connecticut
Principal Investigator: Amanda Jensen-Doss, Ph.D. University of Miami
Principal Investigator: Jill Ehrenreich-May, Ph.D. University of Miami

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Responsible Party: Amanda Jensen-Doss, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02567266     History of Changes
Other Study ID Numbers: 20150187
R01MH106536 ( U.S. NIH Grant/Contract )
R01MH064089 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms