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

This study is being done to compare three types of talk therapies for youth who struggle with emotional and behavioral problems (e.g., anxiety, sadness, worries) in Community Mental Health Clinics in Connecticut (CT) and Florida (FL).

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Unified Protocol for Adolescents (UP-A); Behavioral: Youth Outcomes Questionnaire; Behavioral: Treatment as Usual

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Hartford, Connecticut, United States, 06119
      • University of Connecticut Health Center
  • Florida
    • Coral Gables, Florida, United States, 33124
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression - Improvement (CGI-I) Scores	This is a independent evaluator rated measure of improvement in symptoms and functioning. The CGI-I has a total range from 1-7 with the lower scores indicating more improvement in functioning.	At 16 weeks, at 28 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression - Severity (CGI-S) Scores	This is a independent evaluator rated measure of severity of symptoms. The CGI-S has a total range from 1-7 with the higher scores indicating higher symptom severity.	At 16 weeks, at 28 weeks.
Children's Global Assessment Scale (CGAS) Scores	This is a independent evaluator rated measure of global functional impairment.The GCAS has a total range from 1-100 with the higher scores indicating better functioning.	At 16 weeks, at 28 weeks.

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Mental Health (NIMH); University of Connecticut
• Investigators: Principal Investigator: Amanda Jensen-Doss, Ph.D., University of Miami; Principal Investigator: Jill Ehrenreich-May, Ph.D., University of Miami; Principal Investigator: Golda Ginsburg, Ph.D., University of Connecticut

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 20150187; R01MH106536 (U.S. NIH Grant/Contract); R01MH064089 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No