ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

1111-1207-1125

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

Behaviour

Intervention code [2]

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]

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]

Post-treatment (i.e., immediately following treatment - primary endpoint) and 3- and 6- months post end of treatment.

Primary outcome [2]

Questionnaire measure of anxiety (the SCARED) completed by adolescents (about their own anxiety).

Timepoint [2]

Post-treatment (i.e., immediately following treatment - primary endpoint) and 3- and 6- months post end of treatment.

Primary outcome [3]

Questionnaire measure of mood (the Mood and Feelings Questionnaire) completed by adolescents (about their own mood).

Timepoint [3]

Post-treatment (i.e., immediately following treatment - primary endpoint) and 3- and 6- months post end of treatment.

Secondary outcome [1]

Participants' behavioural avoidance, as measured by the Checklist of Avoidance Strategy Engagement for Adolescents and an Avoidance Hierarchy.

Timepoint [1]

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]

Participants' ability to tolerate distress, as measured by the Distress Tolerance Scale (completed by both adolescents and parents/caregivers).

Timepoint [2]

3- and 6-month follow-up points - that is, 3 and 6 months following the completion of the intervention.

Secondary outcome [3]

Questionnaire measure of anxiety (the SCARED) completed by parents/caregivers (about their adolescent's anxiety).

Timepoint [3]

3- and 6-months post end of treatment.

Secondary outcome [4]

Questionnaire measure of mood (the Mood and Feelings Questionnaire) completed by parents/caregivers (about their adolescent's mood).

Timepoint [4]

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]

4104 - Yeronga

Recruitment postcode(s) [2]

4077 - Inala

Recruitment postcode(s) [3]

4122 - Mount Gravatt

Recruitment postcode(s) [4]

4012 - Nundah

Recruitment postcode(s) [5]

4500 - Strathpine

Recruitment postcode(s) [6]

4054 - Keperra

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Children's Hospital Foundation

Address [1]

494 Stanley Street,
South Brisbane, QLD, 4101.

Country [1]

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]

Hospital

Name [1]

Children's Health Queensland Child and Youth Mental Health Service

Address [1]

199 Grey St.,
South Brisbane, QLD, 4101.

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Jill Ehrenreich-May

Address [1]

Department of Psychology,
University of Miami,
5665 Ponce De Leon Blvd, Coral Gables, FL 33124

Country [1]

United States of America

Other collaborator category [2]

Individual

Name [2]

Stephen Stathis

Address [2]

Children's Health QLD Child and Youth Mental Health Service
199 Grey St.,
South Brisbane, QLD, 4101.

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health QLD Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

09/05/2017

Approval date [1]

23/05/2017

Ethics approval number [1]

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

A/Prof Vanessa Cobham

Address

School of Psychology
University of Queensland
St. Lucia, QLD, 4072.

Country

Australia

Phone

+61 7 33469911

Fax

[email protected]

Contact person for public queries

Name

Vanessa Cobham

Address

School of Psychology
University of Queensland
St. Lucia, QLD, 4072.

Country

Australia

Phone

+61 7 33469911

Fax

[email protected]

Contact person for scientific queries

Name

Vanessa Cobham

Address

School of Psychology
University of Queensland
St. Lucia, QLD, 4072.

Country

Australia

Phone

+61 7 33469911

Fax

[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

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Results not available at this time.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Validation of the Child version of the Perseverative Thinking Questionnaire of repetitive negative thinking in young people with diagnosed depressive and anxiety disorders	2021	https://doi.org/10.1111/bjc.12336

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically