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Trial registered on ANZCTR


Registration number
ACTRN12616001686493p
Ethics application status
Submitted, not yet approved
Date submitted
6/12/2016
Date registered
8/12/2016
Date last updated
30/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a unified protocol of emotion focussed therapy for the treatment of anxiety and depression in adolescents: A case series.
Scientific title
The Unified Protocol for Adolescents: A case series addressing mechanisms of change in anxious and depressed adolescents.
Secondary ID [1] 290696 0
Nil known
Universal Trial Number (UTN)
U1111-1190-6238
Trial acronym
UP-A Case series
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 301244 0
Depressive disorders 301245 0
Condition category
Condition code
Mental Health 301003 301003 0 0
Anxiety
Mental Health 301004 301004 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A): 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. The number of sessions received by adolescents and their parents/guardians is based on the clinician's perception of the young person's treatment needs. Sessions are approximately 60 minutes in duration.
Topics covered include: psychoeducation about anxiety, depression and emotions; behavioural and emotional exposure; emotion regulation; and cognitive challenging.
A parent or primary guardian is asked to attend all sessions of the UP-A, although the degree of involvement varies based on clinical need. At a maximum, clinicians may elect to use optional parenting materials throughout treatment and for up to three parent-alone sessions. These sessions use the guiding acronym ICE (Independence, Consistency and Empathy) to reinforce youth session materials and problem-solve concerns common in the parenting of youth with emotional disorders (e.g., overprotection, conflict, etc.).
The person running the sessions in this trial will be either a qualified Clinical Psychologist (the Chief Investigator) or postgraduate clinical psychology student interns within the University of QLD Clinical Psychology training program (under supervision from Dr. Cobham). Sessions will be video or audio recorded for treatment adherence.
Intervention code [1] 296580 0
Treatment: Other
Intervention code [2] 296588 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300420 0
The primary outcome is the presence and severity of any anxiety or depressive disorder at follow-up points (post-treatment and 3-month follow-up). In other words, it is a composite primary outcome based on a single diagnostic interview (the Anxiety Disorders Interview Schedule for Children - ADIS-C). A Clinical Severity Rating of 4 or greater (out of 8) is regarded as representing a diagnosable disorder.
Timepoint [1] 300420 0
Post-treatment (i.e., immediately following treatment) and 3-months post end of treatment.
Primary outcome [2] 300421 0
Participants' emotional regulation strategies, as measured by the parent version of the CHildren's Emotion Management Scales (CEMS), the Emotional Avoidance Strategy Inventory for Adolescents and the Distress Tolerance Scale.
Timepoint [2] 300421 0
3-month follow-up - that is 3 months after the final treatment session.
Primary outcome [3] 300422 0
Participants' behavioural avoidance, as measured by the Checklist of Avoidance Strategy Engagement for Adolescents and an Avoidance Hierarchy.
Timepoint [3] 300422 0
3-month follow-up - that is 3 months after the final treatment session.
Secondary outcome [1] 329929 0
Participants' affect as measured by the Positive and Negative Affect Scale for Children.
Timepoint [1] 329929 0
3-month follow-up - that is 3 months after the final treatment session.
Secondary outcome [2] 329930 0
Parental psychopathology, as measured by the Patient Health Questionnaire-9, and the Generalized Anxiety Disorder-7.
Timepoint [2] 329930 0
3-month follow-up - that is, 3 months after treatment is completed.
Secondary outcome [3] 329956 0
Parental emotion regulation, as measured by the Coping with Children's Negative Emotions Scales, and the Distress Tolerance Scale.
Timepoint [3] 329956 0
3-month follow up - that is 3 months after treatment is completed.

Eligibility
Key inclusion criteria
Male or female adolescents aged 12-18 years with clinically significant symptoms of anxiety or depression (evidence of clinically significant symptom will be defined as a Clinical Severity Rating - CSR - greater than or equal to 4 on any DSM-5 defined anxiety disorder or depressive disorder).
The adolescent lives with a legal guardian and this guardian is willing to attend treatment sessions and participate in study assessments.
Adolescents and their parents/guardians are able to complete all study procedures in English.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Adolescents who are currently receiving psychological treatment for their anxiety / depressive symptoms (Note: the use of psychopharmacologic treatments for anxiety or depression is allowable under the following conditions: the adolescent must be on a stable dosage for months for SSRI medication, or 1 month for benzodiazepine medication prior to consenting to the study).
2. 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. The short version of the Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to screen for suicidality at baseline. The C-SSRS allows the Chief Investigator to gather information on suicidal behavior, suicide attempts, and presence and intensity of suicidal ideation. The information will be used to identify adolescents possessive or active suicidal ideation, intent or plan.
3. Adolescents with a substance abuse problem within the last 6 months, as assessed by the ADIS-5-C/P, will be excluded.
4. Youth with primary conditions not specified for exclusion (e.g., eating disorders, schizophrenia) will be screened. As long as an emotional disorder treatment focus is appropriate, these youth will be included.
5. 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 will be excluded.
6. Given additional complexities obtaining informed consent, adolescents who are currently placed in the foster care system will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Modified Brinley plots will be used to allow visual analysis of data for all participants. These plots can also show group/phase means, variance, confidence intervals, effect sizes, clinical cut-offs, reliable change and percentage of reliable change. A 95% confidence interval will be used during data analysis, displayed in brackets. Cohens D will be used in
the analysis to indicate effect size in the comparison of pre, post and follow-up means.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/04/2017
Actual
Date of last participant enrolment
Anticipated
27/10/2017
Actual
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 14804 0
4067 - St Lucia

Funding & Sponsors
Funding source category [1] 295120 0
University
Name [1] 295120 0
University of Queensland
Country [1] 295120 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St. Lucia
Queensland 4067.
Country
Australia
Secondary sponsor category [1] 293941 0
None
Name [1] 293941 0
Address [1] 293941 0
Country [1] 293941 0
Other collaborator category [1] 279343 0
Individual
Name [1] 279343 0
Jill Ehrenreich-May
Address [1] 279343 0
Department of Psychology
University of Miami,
Miami, Florida.
P.O. Box 248185
Coral Gables, FL 33124-0751
USA
Country [1] 279343 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296472 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 296472 0
Ethics committee country [1] 296472 0
Australia
Date submitted for ethics approval [1] 296472 0
13/12/2016
Approval date [1] 296472 0
Ethics approval number [1] 296472 0

Summary
Brief summary
The Unified Protocol for Adolescents (UP-A) is a transdiagnostic intervention for the treatment of anxiety and/or depressive disorders. The aim is to examine possible mechanisms by which the intervention produces change in participants (12-18 year olds with a primary anxiety or depressive diagnosis). 6-8 participants will be recruited and treated using the UP-A. Hypothesised mechanisms of change (e.g., improved emotion regulation) will be measured from session to session for each adolescent. Expected outcomes include: symptom reductions in participants and information about which treatment targets are associated with symptom reduction (i.e., mechanisms by which the intervention is working).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70978 0
Dr Vanessa Cobham
Address 70978 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4067
Country 70978 0
Australia
Phone 70978 0
+61 7 33469911
Fax 70978 0
Email 70978 0
[email protected]
Contact person for public queries
Name 70979 0
Vanessa Cobham
Address 70979 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4067
Country 70979 0
Australia
Phone 70979 0
+61 7 33469911
Fax 70979 0
Email 70979 0
[email protected]
Contact person for scientific queries
Name 70980 0
Vanessa Cobham
Address 70980 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4067
Country 70980 0
Australia
Phone 70980 0
+61 7 33469911
Fax 70980 0
Email 70980 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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