Community Study of Outcome Monitoring for Emotional Disorders in Teens

Not Applicable

Completed

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

• Registration Number: NCT02567266
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Study Start: 2016-01
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30
• Results First Submitted: 2021-07-20
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-16
• Last Update Submitted: 2021-08-16
• Results First Posted: 2021-08-18
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unified Protocol for Adolescents (UP-A)	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.
Treatment as Usual Plus (TAU+)	Youth Outcomes Questionnaire	Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual
Treatment as Usual (TAU)	Treatment as Usual	Participants will receive Treatment as Usual provided at the study clinics.
Unified Protocol for Adolescents (UP-A)	Youth Outcomes Questionnaire	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.
Treatment as Usual Plus (TAU+)	Treatment as Usual	Participants will be treated by clinicians who receive feedback using the Youth Outcomes Questionnaire, but who otherwise use Treatment as Usual

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

University of Miami; 🇺🇸 Coral Gables, Florida, United States

University of Connecticut Health Center; 🇺🇸 West Hartford, Connecticut, United States