Clinical trial NCT02567266: Community Study of Outcome Monitoring for Emotional Disorders in Teens
Official title: Community Study of Outcome Monitoring for Emotional Disorders in Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: University of Connecticut
name: National Institute of Mental Health (NIMH)
First posted: 2015-10-02
Enrollment: 196
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Global Impression - Improvement (CGI-I) Scores
timeFrame: At 16 weeks, at 28 weeks.
Secondary outcomes:
measure: Clinical Global Impression - Severity (CGI-S) Scores
timeFrame: At 16 weeks, at 28 weeks.
measure: Children's Global Assessment Scale (CGAS) Scores
timeFrame: At 16 weeks, at 28 weeks.
Other outcomes:
Locations:
city: West Hartford
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Connecticut
name: Golda Ginsburg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Amanda Jensen-Doss, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Jill Ehrenreich-May, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: