Community Study of Outcome Monitoring for Emotional Disor... | NCT02567266

NCT02567266

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
R01MH106536	U.S. NIH Grant/Contract		View source
R01MH064089	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
University of Connecticut	OTHER
National Institute of Mental Health (NIMH)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unified Protocol for Adolescents (UP-A)	Experimental	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) Behavioral: Youth Outcomes Questionnaire
Treatment as Usual Plus (TAU+)	Experimental	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 Behavioral: Treatment as Usual
Treatment as Usual (TAU)	Active Comparator	Participants will receive Treatment as Usual provided at the study clinics.	Behavioral: Treatment as Usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Unified Protocol for Adolescents (UP-A)	Behavioral	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
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.
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).
Adolescent and parent/guardian are able to complete all study procedures in English or Spanish.

Exclusion Criteria:

Adolescents will be excluded if they are receiving concurrent psychotherapy, family therapy or similar psychosocial interventions.
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.
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.
Adolescents with a current substance abuse disorder as determined using the ADIS-5-C/P, will be excluded.
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.
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.
Given additional complexities obtaining informed consent, adolescents who are currently placed in the foster care system will be excluded.

Name	Affiliation	Role
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	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Connecticut Health Center		West Hartford	Connecticut	06119	United States
University of Miami

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40014505	Derived	Ehrenreich-May J, Jensen-Doss A, Milgram L, Rosenfield D, Shaw AM, LoCurto J, Nanda Robinson M, Caron EB, Lee P, Ginsburg GS. A randomized controlled effectiveness trial of transdiagnostic treatment and measurement-based care for adolescents with emotional disorders in community clinics. J Consult Clin Psychol. 2025 Mar;93(3):144-160. doi: 10.1037/ccp0000947.
39397117	Derived	Casline E, Woodard GS, Lane E, Pollowitz S, Douglas S, Ehrenreich-May J, Ginsburg GS, Jensen-Doss A. Consultation Content and Techniques for measurement-Based Care Implementation in Youth Community Mental Health Settings. Adm Policy Ment Health. 2025 Mar;52(2):401-414. doi: 10.1007/s10488-024-01417-8. Epub 2024 Oct 13.

Arm/Group Information

ID	Title	Description
FG000	Unified Protocol for Adolescents (UP-A)	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.
FG001	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 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.
FG002	Treatment as Usual (TAU)	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Unified Protocol for Adolescents (UP-A)	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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

Posted

Mean

Standard Deviation

score on a scale

At 16 weeks, at 28 weeks.

ID	Title	Description
OG000	Unified Protocol for Adolescents (UP-A)	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Unified Protocol for Adolescents (UP-A)	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 13, 2021	Jul 17, 2021	Prot_SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	Sep 16, 2019	Nov 10, 2020	ICF_000.pdf

ID	Term
D003863	Depression
D001008	Anxiety Disorders

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders