Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000653965
Ethics application status
Approved
Date submitted
14/05/2020
Date registered
5/06/2020
Date last updated
15/10/2021
Date data sharing statement initially provided
5/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psychological Stepped Care for Anxious Adolescents in Community Mental Health Services: A Pilot Effectiveness Trial
Scientific title
Psychological Stepped Care for Anxious Adolescents in Community Mental Health Services: A Pilot Effectiveness Trial
Secondary ID [1] 301292 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 317473 0
Condition category
Condition code
Mental Health 315575 315575 0 0
Anxiety
Public Health 315703 315703 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stepped Care of cognitive behavioural therapy.
Step 1 will consist of the Chilled Out cognitive behavioural therapy internet program delivered over 14 weeks and supported by 4 x 30 minute structured phone calls from a community mental health intake officer or youth access worker (at CYMHS and HeadSpace). The Chilled Out program (from the Cool Kids anxiety management program suite) teaches cognitive behavioural therapy skills in eight modules (goal setting, psychoeducation, cognitive restructuring, graded exposure, coping skills) that take approximately 30 minutes each week. All modules are accessible from first log in, and participants are recommended to complete one module per week. Each module contains educational videos, text and worksheets.

Step 1 support telephone calls are provided by intake officers and youth access clinicians trained in the Chilled Out program by the lead CI. These calls check program adherence and homework exercises, skills understanding, risk management, and problem solve challenges to skill implementation. Program adherence is checked via session attendance checklists and website analytics monitoring log ins.

At the end of Step 1, the participant and clinician will discuss whether or not they need to progress to Step 2. Progression will be based on a clinical review of current symptoms and preference by the participant.

Step 2 consists of up to 10 face-to-face (1 hour) sessions over 14 weeks delivered individually at CYMHS/HeadSpace by a psychologist using the Chilled manualised cognitive behavioural therapy program (from the Cool Kids anxiety management suite of programs). This manualised program uses the same core cognitive behavioural skills (goal setting, psychoeducation, cognitive restructuring, graded exposure) as Chilled Out (step one), however, in more detail, and with more one-on-one therapist time to apply skills to the participant (up to 10 x 1 hours). Treatment goals are collaboratively set between participant and clinician and therapy skills are extended as needed to address remaining anxiety symptoms. Clinicians are trained in the Chilled program by the lead CI.
Intervention code [1] 317600 0
Behaviour
Intervention code [2] 317672 0
Treatment: Other
Comparator / control treatment
Treatment as usual. Usual care at CYMHS/HeadSpace consisting of up to 10 x 1 hours face-to-face sessions. Usual care practices are based on HeadSpace and CYMHS services protocols.
Control group
Active

Outcomes
Primary outcome [1] 323816 0
Change in anxiety symptom severity on the Clinical Global Impressions Scale - Severity (clinician reported)
Timepoint [1] 323816 0
Final treatment session. Due to the nature of these health services and the participant population in which participants can stop attending appointments prematurely (e.g. circumstances change, symptoms improve, get help elsewhere), we collected session by session data. The data for the final session attended by the participant was recorded as the final treatment session.
Secondary outcome [1] 382975 0
Change in anxiety symptom improvement on the Clinical Global Impressions Scale - Improvement (clinician reported).
Timepoint [1] 382975 0
Final treatment session. Due to the nature of these health services and the participant population in which participants can stop attending appointments prematurely (e.g. circumstances change, symptoms improve, get help elsewhere), we collected session by session data. The data for the final session attended by the participant was recorded as the final treatment session.
Secondary outcome [2] 382976 0
Change in functioning as assessed on the Clinician Global Assessment Scale (clinician reported)
Timepoint [2] 382976 0
Final treatment session. Due to the nature of these health services and the participant population in which participants can stop attending appointments prematurely (e.g. circumstances change, symptoms improve, get help elsewhere), we collected session by session data. The data for the final session attended by the participant was recorded as the final treatment session.
Secondary outcome [3] 382977 0
Spence Children’s Anxiety Scale (8 item) - self report (participant) measure of anxiety symptoms.
Timepoint [3] 382977 0
Final Treatment Session. Due to the nature of these health services and the participant population in which participants can stop attending appointments prematurely (e.g. circumstances change, symptoms improve, get help elsewhere), we collected session by session data. The data for the final session attended by the participant was recorded as the final treatment session.
Secondary outcome [4] 382978 0
Change in Child Health Utility Index 9D (CHU9D) scores- self-report measure of health related quality of life.
Timepoint [4] 382978 0
Final treatment session. Due to the nature of these health services and the participant population in which participants can stop attending appointments prematurely (e.g. circumstances change, symptoms improve, get help elsewhere), we collected session by session data. The data for the final session attended by the participant was recorded as the final treatment session.
Secondary outcome [5] 382979 0
Service Use. Hospital records will be used to determine data regarding: waiting time from intake to treatment, number of sessions attended, and the number of clinician hours used. The qualifications of clinicians administering interventions will come from a clinician based survey.
Timepoint [5] 382979 0
Final treatment session. Due to the nature of these health services and the participant population in which participants can stop attending appointments prematurely (e.g. circumstances change, symptoms improve, get help elsewhere), we collected session by session data. The data for the final session attended by the participant was recorded as the final treatment session.
Secondary outcome [6] 382981 0
User Experience. Adolescents will be asked to rate their experience with treatment via three questions (How much did X service assist you? 0-10; How much did the service improve your symptoms? 0-10, How much would you recommend this service to others? 0-10).
Timepoint [6] 382981 0
One month post final treatment session
Secondary outcome [7] 382982 0
Staff Experience. At project end, CYMHS/HeadSpace staff will be asked to provide confidential feedback on the benefits and barriers to the stepped care approach. This will be collected via an online survey and via focus groups.
Timepoint [7] 382982 0
After last participant has completed treatment.

Eligibility
Key inclusion criteria
Aged 12 years to 18 years.
Assessed by clinicians at the participating Child & Youth Mental Health Services (CYMHS) and HeadSpace sites. Participants determined to have a clinically relevant anxiety problem as their main interfering problem via the usual clinical assessment processes.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary clinical problem that is not anxiety. e.g. depression, psychosis.
Current self-harm, active suicidal risk,bipolar disorder, psychosis, unsafe family circumstance, and insufficient literacy as determine by usual intake procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation occurred at the site level prior to the study beginning. Each site was randomised to one condition or the other such that all participants at those sites were into the same treatment condition.

There were two Child & Youth Mental Health Services (CYMHS) and two HeadSpace sites that are paired together in the local area (as they cross refer between each other). The CYMHS/HeadSpace pairs are randomly allocated to either the Stepped Care intervention or the Treatment as Usual intervention at the beginning of the trial. All participants enrolled at each of the paired sites were then allocated to the intervention matching that site. Because all participants at each site were allocated to the same condition, the intake officer enrolling the participants into the trial were not blind to allocation. However, the participant data was deidentified such that researchers conducting the analyses were blind to condition allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was conducted using a computerized randomizer www.randomisation.org conducted by a research assistant independent of the research team.

There were two Child & Youth Mental Health Services (CYMHS) and two HeadSpace sites that are paired together in the local area (as they cross refer between each other). The CYMHS/HeadSpace pairs are randomly allocated to either the Stepped Care intervention or the Treatment as Usual intervention at the beginning of the trial. Prior to the start of the trial, each paired site was randomised to one condition or the other such that all participants at those sites were enrolled into the treatment condition allocated to that site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on large effect (d>0.8) differences between standard Cool Kids (face to face) and the same stepped care intervention (with two treatment steps) in our university clinic trial, we predict moderate to large effect differences between stepped care and Treatment as Usual. Based on recruitment of 80 participants we will have the statistical power to detect a large effect (d=0.6) with 80% power and alpha at 0.05. We plan for enrollment of 20 participants per site (40 in each intervention arm).

As a pilot effectiveness trial, analyses will be based on intent-to-treat. Analyses will utilise multilevel mixed models (controlling for any differences in demographics at baseline) to evaluate group differences over time. All participants allocated to treatment will be included in the analyses. Mixed model analyses will be used for all linear variables. Chi-squared will be used to compare user satisfaction with the interventions at one-month follow-up, and also user level data (such as total therapist time, waiting time etc)..

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/11/2017
Date of last participant enrolment
Anticipated
Actual
14/10/2019
Date of last data collection
Anticipated
30/06/2020
Actual
19/04/2020
Sample size
Target
80
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 30280 0
2067 - Chatswood
Recruitment postcode(s) [2] 30281 0
2100 - Brookvale
Recruitment postcode(s) [3] 30282 0
2096 - Queenscliff

Funding & Sponsors
Funding source category [1] 305736 0
Charities/Societies/Foundations
Name [1] 305736 0
Australian Rotary Health
Country [1] 305736 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 306160 0
None
Name [1] 306160 0
Address [1] 306160 0
Country [1] 306160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306011 0
Northern Sydney Local Health District Human Ethics Committee
Ethics committee address [1] 306011 0
Ethics committee country [1] 306011 0
Australia
Date submitted for ethics approval [1] 306011 0
Approval date [1] 306011 0
09/10/2017
Ethics approval number [1] 306011 0
HREC/17/HAWKE/23
Ethics committee name [2] 306012 0
Macquarie University Human Research Ethics Committee
Ethics committee address [2] 306012 0
Ethics committee country [2] 306012 0
Australia
Date submitted for ethics approval [2] 306012 0
Approval date [2] 306012 0
08/12/2016
Ethics approval number [2] 306012 0
HREC Approval: 5201600931

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102414 0
Prof Viviana Wuthrich
Address 102414 0
Department of Psychology
Macquarie University
Balaclava Rd, Macquarie Park NSW 2109
Country 102414 0
Australia
Phone 102414 0
+61 2 9850 4866
Fax 102414 0
Email 102414 0
[email protected]
Contact person for public queries
Name 102415 0
Viviana Wuthrich
Address 102415 0
Department of Psychology
Macquarie University
Balaclava Rd, Macquarie Park NSW 2109
Country 102415 0
Australia
Phone 102415 0
+61 2 9850 4866
Fax 102415 0
Email 102415 0
[email protected]
Contact person for scientific queries
Name 102416 0
Viviana Wuthrich
Address 102416 0
Department of Psychology
Macquarie University
Balaclava Rd, Macquarie Park NSW 2109
Country 102416 0
Australia
Phone 102416 0
+61 2 9850 4866
Fax 102416 0
Email 102416 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is public health data that cannot be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.