Community Study of Outcome Monitoring for Emotional Disorders in Teens

NCT02567266 | Completed Results DMC

• 3 other identifiers: 20150187R01MH106536R01MH064089
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

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).

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Clinical Global Impression - Severity (CGI-S) Scores

  At 16 weeks, at 28 weeks.

• Children's Global Assessment Scale (CGAS) Scores

  At 16 weeks, at 28 weeks.

Study Arms (3)

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

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.

Unified Protocol for Adolescents (UP-A)

Youth Outcomes Questionnaire BEHAVIORAL

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 Plus (TAU+); Unified Protocol for Adolescents (UP-A)

Treatment as Usual BEHAVIORAL

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.

Treatment as Usual (TAU); Treatment as Usual Plus (TAU+)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

University of Connecticut Health Center

West Hartford, Connecticut, 06119, United States

Location

University of Miami

Coral Gables, Florida, 33124, United States

Location

Related Publications (1)

• 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.

  PMID: 40014505 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Dr. Amanda Jensen-Doss
• Organization: University of Miami

ajensendoss@miami.edu

+1 (305)284-8332

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 2, 2015
• Study Start: January 1, 2016
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 18, 2021
• Results First Posted: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)