Unified Protocol for Adolescents (UP-A) Change Processes

NCT03102008 | Completed

• 1 other identifier: 20161193
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this protocol is to employ single case analytic strategies, including a multiple baseline design and novel modeling techniques to identify changes in cross-cutting features of emotional disorders as well as emotional disorder symptoms during the implementation of The Unified Protocol for the Treatment of Emotional Disorders in Adolescents (UP-A). The first aim is to investigate relationships between the use of UP-A treatment components and changes in measures of cross-cutting features of emotional disorders. The second aim is to investigate when and how reductions in symptoms of emotional disorders and presenting problems (i.e., symptoms of anxiety and depression, severity of presenting problems) occur throughout treatment.

Conditions

Anxiety Disorders; Depression; Obsessive-Compulsive Disorder; Adolescent - Emotional Problem; Emotional Disorder

Keywords

Transdiagnostic Treatment; Emotional Disorders; Adolescence; Psychotherapy

Outcome Measures

Primary Outcomes (6)

• Change in DSM-5 Anxiety and Depressive Disorder Diagnoses and Severity in Accordance with Anxiety Disorders Interview Schedule for the DSM-5, Child and Parent Versions (ADIS-5-C/P)

  measure of change in diagnostic severity of internalizing disorders pre- to post- treatment

  administered pre-baseline (prior to treatment initiation), post-baseline (after 2, 3, or 4 week waitlist period), and post-treatment (after 16 sessions of weekly treatment)

• Session to Session Change in a measure of emotion regulation in youth, Emotion Regulation Questionnaire-Child and Adolescent Form (ERQ-CA)

  measure of change in cognitive flexibility throughout baseline and treatment conditions

  to be completed by adolescents weekly throughout baseline and treatment phases consisting of one assessment prior to initiating study, once weekly assessments during 2, 3, or 4 week baseline period, and assessments every week for 16 weeks

• Session to Session Change in a measure of distress tolerance in youth, Distress Tolerance Scale (DTS)

  measure of change in distress tolerance throughout baseline and treatment conditions

  to be completed by adolescents weekly throughout baseline and treatment phases consisting of one assessment prior to initiating study, once weekly assessments during 2, 3, or 4 week baseline period, and assessments every week for 16 weeks

• Session to Session Change in a measure of avoidance behaviors in youth associated with emotional disorders, Emotional Avoidance Strategy Inventory for Adolescents (EASI-A)

  measure of change in experiential avoidance throughout baseline and treatment conditions

  to be completed by adolescents weekly throughout baseline and treatment phases consisting of one assessment prior to initiating study, once weekly assessments during 2, 3, or 4 week baseline period, and assessments every week for 16 weeks

• Session to Session Change in a measure of anxiety and depressive symptoms in youth (self-report), Revised Children's Anxiety and Depression Scale-Short Form (RCADS-Short Form)

  indicates change in levels of anxiety and depressive symptoms reported by adolescents throughout baseline and treatment conditions

  to be completed by adolescents weekly throughout baseline and treatment phases consisting of one assessment prior to initiating study, once weekly assessments during 2, 3, or 4 week baseline period, and assessments every week for 16 weeks

• Session to Session Change in a measure of anxiety and depressive symptoms in youth reported by parents, Revised Children's Anxiety and Depression Scale-Parent Report-Short Form (RCADS-P-Short Form)

  indicates change in levels of anxiety and depressive symptoms experienced by adolescents as reported by parents of adolescents throughout baseline and treatment conditions

  to be completed by adolescents weekly throughout baseline and treatment phases consisting of one assessment prior to initiating study, once weekly assessments during 2, 3, or 4 week baseline period, and assessments every week for 16 weeks

Secondary Outcomes (2)

• Session to Session Change in a measure of severity of presenting problems in youth, Top Problems

  assessed weekly throughout the study (approximately 18-20 weeks)

• Session to Session Change in Score on a measure of youth distress tolerance, The Behavioral Indicator of Resiliency to Distress (BIRD)

  administered pre-baseline (prior to treatment initiation), at mid-treatment (after 7th session of weekly therapy), post-treatment (after 16 sessions of weekly treatment)

Study Arms (4)

2 Week Waitlist

NO INTERVENTION

Participants assessed weekly (via self- and parent-report questionnaires administered on the internet) for symptom change during waitlist (baseline) period. At the end of waitlist and prior to treatment phase, symptom/disorder change assessed via clinical interview conducted by independent evaluator.

3 Week Waitlist

NO INTERVENTION

Participants assessed weekly (via self- and parent-report questionnaires administered on the internet) for symptom change during waitlist (baseline) period. At the end of waitlist and prior to treatment phase, symptom/disorder change assessed via clinical interview conducted by independent evaluator.

4 Week Waitlist

NO INTERVENTION

Participants assessed weekly (via self- and parent-report questionnaires administered on the internet) for symptom change during waitlist (baseline) period. At the end of waitlist and prior to treatment phase, symptom/disorder change assessed via clinical interview conducted by independent evaluator.

16 Sessions of Therapeutic Intervention

EXPERIMENTAL

Participants receive 50 minute sessions weekly of therapeutic intervention (Unified Protocol for the Treatment of Emotional Disorders in Adolescents). Symptom change assessed weekly on the internet or before each session (via self- and parent-report questionnaires). At the end of treatment phase, symptom/disorder change assessed via clinical interview conducted by independent evaluator.

Behavioral: Unified Protocol for Emotional Disorders in Adolescents (UP-A)

Interventions

Unified Protocol for Emotional Disorders in Adolescents (UP-A) BEHAVIORAL

The Unified Protocol for Emotional Disorders in Adolescents (UP-A), is a transdiagnostic therapeutic intervention employing core dysfunction approaches, defined as such due to their attendance to features of various (emotional) disorders. The treatment may work to ameliorate symptoms more broadly by targeting cross-cutting features common to the range of disorders targeted. Specifically, the UP-A might lead to the successful treatment of an array of emotional disorders in youth by targeting processes common across these frequently co-occurring problems including poor distress tolerance, limited cognitive flexibility, and heightened avoidance.

16 Sessions of Therapeutic Intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents must be between 13 and 17 years of age
• Adolescents must have a primary DSM-5 anxiety or depressive disorder based on results of a diagnostic interview administered by a trained clinician at intake within protocol 20130139
• Adolescents must indicate elevated symptoms of depression via adolescent and/or parent report of symptoms (RCADS and/or RCADS-P Depression Subscale Index T-Score ≥ 60) and anxiety (RCADS and/or RCADS-P Total Anxiety Subscale Index T-Score ≥ 60) at intake
• If relevant, adolescents must be on a stable dose of any SSRI/SNRI medication
• Adolescents must self-report the ability to speak/read English sufficiently (and have at least one parent who can) to complete all study measures in English
• Adolescents must have a legal guardian available to sign study consents, remain present during assessments, and fill out study questionnaires.

You may not qualify if:

• Adolescents obtain a Full Scale IQ score below 80 on the Vocabulary and Matrix Reasoning subtests of an abbreviated IQ test
• Adolescents indicate possible cognitive delays that could interfere with successful completion of study procedures
• Adolescents currently receiving psychotherapy elsewhere.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (2)

• Ehrenreich-May J, Rosenfield D, Queen AH, Kennedy SM, Remmes CS, Barlow DH. An initial waitlist-controlled trial of the unified protocol for the treatment of emotional disorders in adolescents. J Anxiety Disord. 2017 Mar;46:46-55. doi: 10.1016/j.janxdis.2016.10.006. Epub 2016 Oct 17.

  PMID: 27771133 BACKGROUND

• Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18.

  PMID: 22697453 BACKGROUND

Related Links

• Department of Psychology, Child and Adolescent Mood and Anxiety Treatment Program (currently recruiting study participants)

MeSH Terms

Conditions

Anxiety Disorders; Depression; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jill Ehrenreich-May, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators to conduct post-treatment evaluations.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are randomly assigned to one of three baseline conditions (2, 3, or 4 week waitlist) and all participants are subsequently treated using the active study intervention (UP-A).

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: April 5, 2017
• Study Start: January 12, 2017
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)