COMET: Community Study of Outcome Monitoring for Emotional Disorders in Teens

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT02567266
• Collaborator: University of Connecticut (Other), National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 196
• Locations: 2
• Arms: 3
• Duration (Months): 54.9
• Patients Per Site: 98
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Depression; Anxiety	Behavioral: Unified Protocol for Adolescents (UP-A); Behavioral: Youth Outcomes Questionnaire; Behavioral: Treatment as Usual	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 196 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: Jan 1, 2016
• Actual Primary Completion Date: Jul 30, 2020
• Actual Study Completion Date: Jul 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Clinical Global Impression - Improvement (CGI-I) Scores [At 16 weeks, at 28 weeks.]

   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.

Secondary Outcome Measures

1. Clinical Global Impression - Severity (CGI-S) Scores [At 16 weeks, at 28 weeks.]

   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.

2. Children's Global Assessment Scale (CGAS) Scores [At 16 weeks, at 28 weeks.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Connecticut Health Center	West Hartford	Connecticut	United States	06119
2	University of Miami	Coral Gables	Florida	United States	33124

Sponsors and Collaborators

• University of Miami
• University of Connecticut
• National Institute of Mental Health (NIMH)

Investigators

• 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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 13, 2021
• Informed Consent Form - Sep 16, 2019

More Information

Publications

None provided.

• Responsible Party: Amanda Jensen-Doss, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT02567266
• Other Study ID Numbers: 20150187; R01MH106536; R01MH064089
• First Posted: Oct 2, 2015
• Last Update Posted: Aug 18, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

Participant Flow

Arm/Group Title	Unified Protocol for Adolescents (UP-A)	Treatment as Usual Plus (TAU+)	Treatment as Usual (TAU)
Arm/Group Description	Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures. The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. 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.	Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual 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. 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.	Participants will receive Treatment as Usual provided at the study clinics. 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.
Period Title: Overall Study
STARTED	68	60	68
Midpoint (8 Weeks)	54	52	55
Post (16 Weeks)	49	43	53
Follow-up (28 Weeks)	45	45	52
COMPLETED	45	45	52
NOT COMPLETED	23	15	16

Baseline Characteristics

Arm/Group Title	Unified Protocol for Adolescents (UP-A)	Treatment as Usual Plus (TAU+)	Treatment as Usual (TAU)	Total
Arm/Group Description	Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures. The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. 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.	Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual 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. 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.	Participants will receive Treatment as Usual provided at the study clinics. 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.	Total of all reporting groups
Overall Participants	68	60	68	196
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.69 (1.56)	14.87 (1.76)	14.43 (1.72)	14.65 (1.68)
Sex/Gender, Customized (Count of Participants)
Male	20 29.4%	18 30%	27 39.7%	65 33.2%
Female	47 69.1%	40 66.7%	41 60.3%	128 65.3%
Transgender (Female to Male)	1 1.5%	1 1.7%	0 0%	2 1%
Other	0 0%	1 1.7%	0 0%	1 0.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	31 45.6%	21 35%	29 42.6%	81 41.3%
Not Hispanic or Latino	37 54.4%	39 65%	39 57.4%	115 58.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	1 1.5%	1 0.5%
Asian	0 0%	2 3.3%	1 1.5%	3 1.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	15 22.1%	17 28.3%	13 19.1%	45 23%
White	47 69.1%	32 53.3%	39 57.4%	118 60.2%
More than one race	2 2.9%	8 13.3%	9 13.2%	19 9.7%
Unknown or Not Reported	4 5.9%	1 1.7%	5 7.4%	10 5.1%

Outcome Measures

1. Primary Outcome

Title	Clinical Global Impression - Improvement (CGI-I) Scores
Description	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.
Time Frame	At 16 weeks, at 28 weeks.

Outcome Measure Data

Analysis Population Description

Not all participants were able to complete the CGI-I Questionnaire at Post Visit (16 Weeks) and at Follow Up Visit (28 weeks).

Arm/Group Title	Unified Protocol for Adolescents (UP-A)	Treatment as Usual Plus (TAU+)	Treatment as Usual (TAU)
Arm/Group Description	Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures. The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. 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.	Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual 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. 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.	Participants will receive Treatment as Usual provided at the study clinics. 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.
Measure Participants	46	41	49
Post (16 weeks)	2.85 (.965)	3.20 (1.167)	3.02 (.878)
Follow-up (28 weeks)	2.47 (.894)	2.45 (.904)	2.76 (1.128)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual Plus (TAU+)
	Comments	DV = CGI-I at Post-Treatment
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.338
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-.19
	Confidence Interval	(2-Sided) 95%; -.58 to .20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .20
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Treatment as Usual Plus (TAU+), Treatment as Usual (TAU)
	Comments	DV = CGI-I at Post Treatment
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.425
	Comments	Threshold: p <.05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 95%; -0.24 to 0.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .20
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual Plus (TAU+)
	Comments	DV = CGI-I at Post
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -0.77 to 0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .21
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual (TAU)
	Comments	DV = CGI-I at Follow-Up
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.126
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.72 to 0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.20
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Treatment as Usual Plus (TAU+), Treatment as Usual (TAU)
	Comments	DV = CGI-I at Follow-Up
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.28
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95%; -0.65 to 0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .21
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual Plus (TAU+)
	Comments	DV = CGI-I at Follow-Up
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.697
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95%; -0.51 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .21
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

2. Secondary Outcome

Title	Clinical Global Impression - Severity (CGI-S) Scores
Description	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.
Time Frame	At 16 weeks, at 28 weeks.

Outcome Measure Data

Analysis Population Description

Not all participants were able to complete the CGI-S Questionnaire at Post Visit (16 Weeks) and at Follow Up Visit (28 weeks).

Arm/Group Title	Unified Protocol for Adolescents (UP-A)	Treatment as Usual Plus (TAU+)	Treatment as Usual (TAU)
Arm/Group Description	Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures. The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. 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.	Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual 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. 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.	Participants will receive Treatment as Usual provided at the study clinics. 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.
Measure Participants	46	41	49
Post (16 weeks)	4.39 (1.341)	4.71 (1.230)	4.41 (1.153)
Follow-up (28 weeks)	3.98 (1.559)	4.00 (1.396)	4.02 (1.377)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual (TAU)
	Comments	DV = CGI-S at Follow-Up
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.779
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95%; -0.6 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .26
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Treatment as Usual Plus (TAU+), Treatment as Usual (TAU)
	Comments	DV = CGI-S at Follow-Up
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -0.42 to 0.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .27
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual Plus (TAU+)
	Comments	DV = CGI-S at Post
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.629
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.51 to 0.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .21
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual (TAU)
	Comments	DV = CGI-S at Post
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.938
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -0.41 to 0.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .20
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Treatment as Usual Plus (TAU+), Treatment as Usual (TAU)
	Comments	DV = CGI-S at Post
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; -0.32 to 0.49
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .21
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual Plus (TAU+)
	Comments	DV = CGI-S at Follow-Up
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.479
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -0.75 to 0.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .28
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

3. Secondary Outcome

Title	Children's Global Assessment Scale (CGAS) Scores
Description	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.
Time Frame	At 16 weeks, at 28 weeks.

Outcome Measure Data

Analysis Population Description

Not all participants were able to complete the CGAS Questionnaire at Post Visit (16 Weeks) and at Follow Up Visit (28 weeks).

Arm/Group Title	Unified Protocol for Adolescents (UP-A)	Treatment as Usual Plus (TAU+)	Treatment as Usual (TAU)
Arm/Group Description	Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures. The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. 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.	Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual 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. 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.	Participants will receive Treatment as Usual provided at the study clinics. 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.
Measure Participants	46	41	49
Post (16 weeks)	53.22 (9.575)	52.05 (9.047)	52.29 (8.571)
Follow-up (28 weeks)	56.51 (12.230)	56.76 (12.056)	56.00 (11.281)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual (TAU)
	Comments	DV = CGAS at Post
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.852
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -2.85 to 3.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.58
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Treatment as Usual Plus (TAU+), Treatment as Usual (TAU)
	Comments	DV = CGAS at Post
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.917
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -3.41 to 3.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.62
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual Plus (TAU+)
	Comments	DV = CGAS at Post
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.778
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 95%; -2.81 to 3.74
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.66
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual (TAU)
	Comments	DV = CGAS at Follow-Up
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; -3.3 to 5.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.12
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Treatment as Usual Plus (TAU+), Treatment as Usual (TAU)
	Comments	DV = CGAS at Follow-Up
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.935
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -4.55 to 4.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.19
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Unified Protocol for Adolescents (UP-A), Treatment as Usual Plus (TAU+)
	Comments	DV = CGAS at Follow-Up
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.615
	Comments	Threshold: p < .05
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; -3.29 to 5.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.21
	Estimation Comments	A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.

Adverse Events

Time Frame	28 weeks.
Arm/Group Title	Unified Protocol for Adolescents (UP-A)		Treatment as Usual Plus (TAU+)		Treatment as Usual (TAU)
Arm/Group Description	Participants will be treated with the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A). Their clinicians will also receive feedback using the Youth Outcomes Questionnaire feedback system, consisting of youth and caregiver progress measures. The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. 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.		Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual 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. 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.		Participants will receive Treatment as Usual provided at the study clinics. 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.
All Cause Mortality
	Unified Protocol for Adolescents (UP-A)		Treatment as Usual Plus (TAU+)		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/60 (0%)		0/68 (0%)
Serious Adverse Events
	Unified Protocol for Adolescents (UP-A)		Treatment as Usual Plus (TAU+)		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/68 (7.4%)		2/60 (3.3%)		1/68 (1.5%)
Psychiatric disorders
Hospitalization due to Suicidality	3/68 (4.4%)		1/60 (1.7%)		1/68 (1.5%)
Suicidal behavior	2/68 (2.9%)		1/60 (1.7%)		0/68 (0%)
Other (Not Including Serious) Adverse Events
	Unified Protocol for Adolescents (UP-A)		Treatment as Usual Plus (TAU+)		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/60 (0%)		0/68 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.