Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000333213
Ethics application status
Approved
Date submitted
18/02/2018
Date registered
6/03/2018
Date last updated
6/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating adolescent anxiety and depression within the Child and Youth Mental Health Service, Children's Health QLD.
Scientific title
Evaluating the Unified Protocol for Adolescents experiencing anxiety and/or depressive disorders within the Child and Youth Mental Health Service, Children's Health QLD.
Secondary ID [1] 293702 0
None
Universal Trial Number (UTN)
1111-1207-1125
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 306048 0
Depression 306049 0
Condition category
Condition code
Mental Health 305188 305188 0 0
Anxiety
Mental Health 305189 305189 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 a one-on-one face-to-face consultation format. It consists of 8-21 weekly sessions (i.e., if 8 sessions of the intervention are delivered, this would generally occur across an 8-week period; if 14 sessions are delivered, this would generally occur across a 14-week period), 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 a clinician within one of 4 'active' community clinic treatment sites within Children's Health QLD's (CHQ) Child and Youth Mental Health Service (CYMHS). Supervision will be provided to clinicians implementing the intervention on a weekly basis by Dr. Cobham. Sessions will be audio recorded for treatment adherence. It should be noted that, because this evaluation is occurring in a real world clinical service setting, it is likely that participant adolescents and their families will receive other services over and above the UP-A as individual therapy - for example, medication and/or family therapy.
Intervention code [1] 299957 0
Behaviour
Intervention code [2] 300436 0
Treatment: Other
Comparator / control treatment
The comparator is 'Treatment as Usual' (TAU) at the remaining 2 community clinics within CHQ CYMHS (Inala and Yeronga). Treatment as Usual will be defined as whatever interventions are used with each individual participant (including the type of individual therapy they receive; case management sessions; family therapy sessions; parenting sessions; medication). Thus, 'treatment as usual' will look slightly different for each participant. This information will be collected for each participant from both their principal service provider and via their CYMHS records.
Control group
Active

Outcomes
Primary outcome [1] 304342 0
The primary outcome is the presence and severity of any anxiety or depressive disorder at follow-up points (post-treatment and 3- and 6-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] 304342 0
Post-treatment (i.e., immediately following treatment - primary endpoint) and 3- and 6- months post end of treatment.
Primary outcome [2] 304344 0
Questionnaire measure of anxiety (the SCARED) completed by adolescents (about their own anxiety).
Timepoint [2] 304344 0
Post-treatment (i.e., immediately following treatment - primary endpoint) and 3- and 6- months post end of treatment.
Primary outcome [3] 304346 0
Questionnaire measure of mood (the Mood and Feelings Questionnaire) completed by adolescents (about their own mood).
Timepoint [3] 304346 0
Post-treatment (i.e., immediately following treatment - primary endpoint) and 3- and 6- months post end of treatment.
Secondary outcome [1] 341649 0
Participants' behavioural avoidance, as measured by the Checklist of Avoidance Strategy Engagement for Adolescents and an Avoidance Hierarchy.
Timepoint [1] 341649 0
Post-treatment and 3- and 6-month follow-up points - that is, 3 and 6 months following the completion of the intervention.
Secondary outcome [2] 341652 0
Participants' ability to tolerate distress, as measured by the Distress Tolerance Scale (completed by both adolescents and parents/caregivers).
Timepoint [2] 341652 0
3- and 6-month follow-up points - that is, 3 and 6 months following the completion of the intervention.
Secondary outcome [3] 343894 0
Questionnaire measure of anxiety (the SCARED) completed by parents/caregivers (about their adolescent's anxiety).
Timepoint [3] 343894 0
3- and 6-months post end of treatment.
Secondary outcome [4] 343895 0
Questionnaire measure of mood (the Mood and Feelings Questionnaire) completed by parents/caregivers (about their adolescent's mood).
Timepoint [4] 343895 0
Post-treatment and 3- and 6-months post treatment completion.

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 experiencing high levels of suicidal ideation or who have engaged in suicidal behaviors within the past 3 months will be excluded from the trial.
2. 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.
3. 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.
4. 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)
Allocation is not concealed. Eligible participants at 4 of the 6 community CYMHS clinics will be offered the UP-A if they agree to participate in the trial. Eligible participants at 2 of the 6 community CYMHS clinics will be offered Treatment as Usual. UP-A and TAU clinics have been pre-determined.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There is little literature comparing treatment as usual in Child and Youth Mental Health Services with a manualized intervention deemed to be efficacious. At this point, there is no literature comparing the Unified Protocol for Adolescents (UP-A) with treatment as usual in this setting. Although it is hypothesised that youth receiving the UP-A will experience better outcomes than youth receiving treatment as usual, this trial has been designed based on the more conservative assumption of equivalence between the two conditions in terms of the % of youth who recover from their primary anxiety or depressive diagnosis from the 3-month follow-up point onwards. The study is planned to be powered to provide 85% power at the 5% (2-sided) significance level. The sample size required using G*Power is 52 families per group. Allowing for 20% loss to follow-up, it is planned to enrol 125 families in the trial.
Primary outcomes (diagnostic status) will be examined using chi square analyses. Secondary outcomes (questionnaire data) will be examined using repeated measures ANOVAs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/03/2018
Actual
Date of last participant enrolment
Anticipated
30/11/2018
Actual
Date of last data collection
Anticipated
31/05/2019
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18672 0
4104 - Yeronga
Recruitment postcode(s) [2] 18673 0
4077 - Inala
Recruitment postcode(s) [3] 18674 0
4122 - Mount Gravatt
Recruitment postcode(s) [4] 18675 0
4012 - Nundah
Recruitment postcode(s) [5] 18676 0
4500 - Strathpine
Recruitment postcode(s) [6] 18677 0
4054 - Keperra

Funding & Sponsors
Funding source category [1] 298321 0
Charities/Societies/Foundations
Name [1] 298321 0
Children's Hospital Foundation
Country [1] 298321 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St. Lucia, QLD, 4072.
Country
Australia
Secondary sponsor category [1] 297436 0
Hospital
Name [1] 297436 0
Children's Health Queensland Child and Youth Mental Health Service
Address [1] 297436 0
199 Grey St.,
South Brisbane, QLD, 4101.
Country [1] 297436 0
Australia
Other collaborator category [1] 279915 0
Individual
Name [1] 279915 0
Jill Ehrenreich-May
Address [1] 279915 0
Department of Psychology,
University of Miami,
5665 Ponce De Leon Blvd, Coral Gables, FL 33124
Country [1] 279915 0
United States of America
Other collaborator category [2] 279916 0
Individual
Name [2] 279916 0
Stephen Stathis
Address [2] 279916 0
Children's Health QLD Child and Youth Mental Health Service
199 Grey St.,
South Brisbane, QLD, 4101.
Country [2] 279916 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299314 0
Children's Health QLD Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 299314 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham St.,
South Brisbane, QLD, 4101.
Ethics committee country [1] 299314 0
Australia
Date submitted for ethics approval [1] 299314 0
09/05/2017
Approval date [1] 299314 0
23/05/2017
Ethics approval number [1] 299314 0
HREC/17/QRCH/90

Summary
Brief summary
The current project aims to:
" Use principles of Implementation Science to promote uptake of, and confidence in using the Unified Protocol for Adolescents (UP-A) by CYMHS clinicians with anxious and/or depressed adolescents in the real world setting of a CYMHS community clinic.
" Evaluate the UP-A compared to treatment as usual (TAU).
It is hypothesised that by the end of the proposed project:
" The confidence of CYMHS clinicians in the utility and delivery of the UP-A with anxious and/or depressed adolescents will have increased following a sequence of targeted implementation processes to support uptake of the EBT in community Clinic A; and
" The UP-A will produce superior outcomes on measures of adolescent anxiety and depressive symptomatology compared to TAU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80022 0
A/Prof Vanessa Cobham
Address 80022 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country 80022 0
Australia
Phone 80022 0
+61 7 33469911
Fax 80022 0
Email 80022 0
[email protected]
Contact person for public queries
Name 80023 0
Vanessa Cobham
Address 80023 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country 80023 0
Australia
Phone 80023 0
+61 7 33469911
Fax 80023 0
Email 80023 0
[email protected]
Contact person for scientific queries
Name 80024 0
Vanessa Cobham
Address 80024 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country 80024 0
Australia
Phone 80024 0
+61 7 33469911
Fax 80024 0
Email 80024 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23588Study protocol  [email protected]
23589Informed consent form  [email protected]

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Results not available at this time.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIValidation of the Child version of the Perseverative Thinking Questionnaire of repetitive negative thinking in young people with diagnosed depressive and anxiety disorders2021https://doi.org/10.1111/bjc.12336
N.B. These documents automatically identified may not have been verified by the study sponsor.