February 29, 2008 |
April 2, 2009 |
July 2006 |
- Clinical Severity Rating (CSR) on the Anxiety Disorders Interview Schedule for DSM-IV, child and parent versions (ADIS-IV-C/P) [ Time Frame: Measured pre- and post-treatment, post-waitlist or 8 weeks into treatment and 3 and 6 months following treatment ] [ Designated as safety issue: No ]
- Treatment gains and overall patient functioning measured by: Clinical Global Impression Scale(CGI) [ Time Frame: Measured at all post-treatment, waitlist and other follow-up points ] [ Designated as safety issue: No ]
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Clinical Severity Rating (CSR) on the Anxiety Disorders Interview Schedule for DSM-IV, child and parent versions (ADIS-IV-C/P) [ Time Frame: Measured before and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: No ] |
Complete list of historical versions of study NCT00628888 on ClinicalTrials.gov Archive Site |
- Emotion Regulation indices [ Time Frame: Measured pre- and post-treatment, post waitlist or 8 weeks into treatment and 3 months and 6 months after treatment ] [ Designated as safety issue: No ]
- Changes in Anxiety and Depressive symptomology assessed by the CBCL and RCADS (parent and child version) [ Time Frame: Measured pre- and post-treatment, post waitlist or 8 weeks into treatment, 3 and 6 months following treatment ] [ Designated as safety issue: No ]
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- Positive and Negative Affect Scale (PANAS) [ Time Frame: Measured before and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
- Family Environment Scale (FES) [ Time Frame: Measured before and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
- Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS) [ Time Frame: Measured before and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
- Depression Symptom Inventory-Suicidality Subscale (DSI-SS) [ Time Frame: Measured before, during, and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: Yes ]
- Child Behavior Checklist (CBCL) [ Time Frame: Measured before and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
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Effectiveness of Emotion-Focused Cognitive Behavioral Therapy for Treating Adolescents With Emotional Disorders |
Treatment of Emotional Disorders in Adolescence |
This study will evaluate the effectiveness of an emotion-focused cognitive behavioral treatment program for adolescents with anxiety or unipolar depressive disorders. |
Anxiety and depression are among the most prevalent psychiatric disorders in youth. Adolescents with anxiety or depression experience persistent emotional distress that can cause problems with school, family, and friends. In addition, anxiety and depressive disorders commonly co-exist, causing further distress for those affected. If left untreated, the difficulties associated with these disorders can persist into adulthood. Fortunately, anxiety and depression are highly treatable using a combination of medications and forms of psychotherapy, but many youth in community settings are unlikely to receive these treatments. An emotion-focused, cognitive behavioral treatment, specifically designed to meet a broad range of treatment needs of adolescents, may provide one way of translating effective treatment components to community settings. This study will evaluate the effectiveness of a transdiagnostic, emotion-focused, cognitive behavioral treatment program, called the Unified Protocol for the Treatment of Emotional Disorders in Youth (UP-Y), for adolescents with anxiety or unipolar depressive disorders.
Participants in this study will be assigned to receive either immediate or delayed UP-Y program sessions. Study participation will last up to 12 months after beginning treatment. Upon initiation of treatment, parent and child participants will undergo initial assessments that will include questionnaires about anxiety, worry, depression and emotion regulation; and an interview pertaining to the adolescent's anxiety and depression. Both parent and adolescent participants will then attend up to 21 weekly treatment sessions, lasting 60 minutes each. During sessions, participants will learn skills regarding acceptance of intense emotional states, how to actively cope with emotions, and act in healthy ways during anxiety- and depression-provoking situations. Throughout the course of treatment, parent and adolescent participants will be asked to keep records about the adolescent's emotions and functioning. Participants will also be given at-home assignments to practice skills learned in treatment sessions. During and after treatment, participants will complete questionnaires about their thoughts on the treatment sessions. Participants will repeat the initial assessment either following the waitlist delayed treatment condition or 8 weeks into treatment, immediately after the last treatment session as well as at months 3 and 6 of follow-up. |
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Interventional |
Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Efficacy Study |
- Anxiety Disorders
- Depression
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Behavioral: Unified Treatment for Emotional Disorders in Youth (UP-Y) |
Experimental: Participants will receive the UP-Y, either immediately or after an 8 week wait list period. |
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Recruiting |
60 |
June 2011 |
June 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Principal diagnosis of major depressive disorder, social anxiety disorder, social phobia, panic disorder with or without agoraphobia, generalized anxiety disorder, obsessive compulsive disorder, agoraphobia, post-traumatic stress disorder, dysthymic disorder, anxiety disorder not-otherwise-specified, or depressive disorder not-otherwise-specified
- At least one parent (or caregiver with whom the adolescent is living) available to accompany the adolescent to all assessment sessions and attend parent sessions as prescribed
- For adolescents on medication, there must be a 1-month stabilization period (for benzodiazepines) or 3-month stabilization period (for selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, or tricyclics) before study entry
- Able to maintain current medication regimen (or remain off psychopharmacologic treatment if not currently taking such medications) throughout the study, unless changes are medically necessary
Exclusion Criteria:
- Co-occurring conditions, including positive diagnosis of schizophrenia, bipolar I or II disorder, pervasive developmental disorder, organic brain syndrome, mental retardation , or current suicidal/homicidal ideation
- A prior course of cognitive behavioral treatment
- Inability to speak, read, or understand English sufficiently well to complete study procedures
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Both |
12 Years to 17 Years |
No |
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United States |
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NCT00628888 |
Jill T. Ehrenreich, PhD, Assistant Professor of Psychology, University of Miami |
DDTR BK-TKPD |
National Institute of Mental Health (NIMH) |
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Principal Investigator: |
Jill T. Ehrenreich, PhD |
University of Miami |
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National Institute of Mental Health (NIMH) |
April 2009 |