Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000456550
Ethics application status
Approved
Date submitted
20/02/2024
Date registered
15/04/2024
Date last updated
15/04/2024
Date data sharing statement initially provided
15/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Finding the right balance of ‘support’: Testing a new digital model of care for child and adolescent anxiety in regional communities
Scientific title
A Randomised Controlled Trial of the Efficacy of Internet-Based Cognitive Behaviour Therapy plus messaging support for managing child and adolescent anxiety in regional communities
Secondary ID [1] 311025 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 332142 0
Condition category
Condition code
Mental Health 328865 328865 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two intervention conditions in this study: (1) standard self-help internet-based cognitive-behaviour therapy + brief coaching and messaging support (iCBT Plus) and (2) standard self-help internet-based cognitive-behaviour therapy (iCBT-Std)

Intervention Arm 1- iCBT Plus

Participants in this condition will receive a standard self-help iCBT program for anxiety + brief coaching and messaging support. The standard self-help iCBT program will be delivered via the Momentum platform, which is an up-to-date web platform adapted from existing iCBT web platforms, to provide evidence-informed, scalable and openly accessible iCBT programs. The standard self-help iCBT program is comprised of 7 online sessions of approximately 45-minute duration, completed once per week. The Momentum anxiety program includes evidence-based anxiety management strategies such as recognition of physiological symptoms, relaxation, coping self-talk, cognitive restructuring, graded exposure, and self-reinforcement. Sessions comprise visually appealing pages, reading material, question/answer exercises, games, quizzes and homework. Young people will be given 1-2 homework tasks per week that will take approximately 15-30 minutes to complete. Homework tasks will include the following: recording anxiety-provoking situations, practising relaxation techniques, identifying avoidance, working on graded exposure exercises, and engaging in cognitive restructuring exercises. Homework will be assigned for each of the 7 sessions, and SMS reminders will refer to these tasks (see below).

There are different versions of the program for children (aged 7-12 years) and adolescents (aged 13-17 years). Young people progress through sessions at the rate of one session per week. Participants receive automated email reminders of session availability, reminding of overdue sessions and reinforcing progress.

In addition to the online program, participants will have consultations with a Momentum Coach via videoconferencing or teleconferencing - depending on availability at location and client preferences. A Momentum Coach will conduct two 30 minute individual consultation sessions via video/teleconferencing with the child and their parent. The first Momentum Coach consultation will be conducted prior to participants commencing session 1 of their Momentum program. The aim of the consultation will be to establish rapport, set expectations, identify goals and explain the program. A Momentum Coach will provide the second consultation with the participant after the completion of session 3 of their Momentum program (treatment mid-point and at a critical exposure hierarchy point) to provide clarification of techniques and to assist understanding and implementation of the exposure hierarchy. Each consultation session will be completed with parents and children at a convenient time.

The participants in the iCBT plus group will also receive two types of additional messaging support over 7 weeks for the duration of the program. The first messaging support will be in the form of one weekly message from a Momentum Coach. Momentum Coaches will review user responses in the Momentum session material and curate a message (email within platform) based on templates to provide assistance to the young person. Messages will be personalised by the Coach (based on their responses to session activities and homework) and aim to reinforce effort, redirect incorrect responses and set additinoal practice tasks. The weekly messages will be delivered via the internal Momentum program message system and can only be viewed when logged into the program.

The second type of messaging support will be two weekly coach tips focused on the implementation of anxiety strategies (skills tips) and completion of homework activities (practice reminders) sent via SMS (or email if preferred). These messages will assist with real-time implementation of skills. These messages have been designed by the research team based on results from previous trials, and qualitative research with young people, parents and clinicians previously using our programs. The messages aim to complement the skills that will be being learnt/practised during that session. The coach tips will be sent out to prompt skill rehearsal; one message will be sent 1-day after session completion and one message sent 4 days after session completion, each week unitl the end of the program.

In terms of treatment fidelity, therapists are required to keep a record of the number of minutes spent each week on viewing responses and sending emails, to provide a check of the treatment provided. Further, a random sample of 10% of email responses will be examined by the lead investigator to check adherence to template email responses.

Participants will be able to access the online program beyond the 12-week assessment, although no therapist support will be provided beyond this point. Session completion will be tracked at each time point.
Intervention code [1] 327474 0
Treatment: Other
Intervention code [2] 327475 0
Behaviour
Comparator / control treatment
Intervention Arm 2- Standard, self-help internet-based cognitive-behaviour therapy (iCBT-Std).

Participants allocated to the iCBT-Std condition will access the standard 7 session self-help iCBT program for anxiety situated on the Momentum platform. Program content will mirror that of the iCBT-Plus condition, but participants will complete sessions on their own and will not receive any coaching and messaging support.

Participants will be able to access the online program beyond 12-week assessment and session completion will be tracked at each time point.
Control group
Active

Outcomes
Primary outcome [1] 336663 0
The primary outcome is the clinician severity rating relating to the primary anxiety disorder, at 9-months after the start of treatment.
Timepoint [1] 336663 0
9 months after the start of treatment (primary endpoint)
Data also gathered at:
Pre-treatment
12 weeks after the start of treatment
Secondary outcome [1] 429246 0
Diagnostic status: free of primary anxiety disorder.
Timepoint [1] 429246 0
Pre-treatment
12 weeks after the start of treatment
9 months after the start of treatment
Secondary outcome [2] 429247 0
Diagnostic status: free of all anxiety disorders
Timepoint [2] 429247 0
Pre-treatment
12 weeks after the pre-treatment
9 months after the pre-treatment
Secondary outcome [3] 429248 0
Spence Children's Anxiety Scale- Child and Parent Version (SCAS-C&P)
Timepoint [3] 429248 0
Pre-treatment
12 weeks after the start of treatment
9 months after the start of treatment
Secondary outcome [4] 429249 0
Health-related Quality of life will be measured by the Child Health Utility 9 Index (CHU9D)
Timepoint [4] 429249 0
Pre-treatment
12 weeks after the start of treatment
9 months after the start of treatment
Secondary outcome [5] 429250 0
Children's Anxiety Scale-8 (CAS-8)
Timepoint [5] 429250 0
This measure is completed as a standard part of the online program at the beginning of each session, to measure changes in anxiety symptoms.
Secondary outcome [6] 429251 0
The Child Anxiety Life Interference Scale (The CALIS)
Timepoint [6] 429251 0
Pre-treatment
12 weeks after the start of treatment
9 months after the start of treatment
Secondary outcome [7] 429253 0
Children's global functioning will be measured by the Children's Global Assessment Scale (CGAS) - clinician rated based on data obtained in the ADIS-C&P
Timepoint [7] 429253 0
Pre-treatment
12 weeks after the pre-treatment
9 months after the pre-treatment
Secondary outcome [8] 429254 0
Treatment expectancy by children and parents
Timepoint [8] 429254 0
At end of session 1 of the intervention.
Secondary outcome [9] 429255 0
Treatment adherence - number of sessions completed
Timepoint [9] 429255 0
12 weeks after the start of treatment
9 months after the start of treatment
Secondary outcome [10] 429256 0
Treatment Satisfaction scale - child and parent satisfaction with treatment.
Timepoint [10] 429256 0
After session 3
12 weeks after the start of treatment

Eligibility
Key inclusion criteria
Children and adolescents will be invited to participate in the study if they meet the following criteria at initial registration for the Momentum platform;
(1) if they present with elevated levels of anxiety on the Spence Children’s Anxiety Scale (equal or greater than 84th percentile or T-score of 60);
(2) are residents of regional/rural areas (as classified by areas 2-7 of the Modified Monash Model, identified via postcode);
(3) do not demonstrate clinically interfering depression levels on the Centre for Epidemiological Studies Depression Scale for Children. Clinically interfering levels are defined as meeting the 'elevated' cut-off on this scale AND rating the degree of interference from the depression at a minimum of 5 or higher on an 8-point scale;
(4) have access to the Momentum online platform via a computer or mobile device with an Australian IP address;
(5) aged 7-17 years;

Additional inclusion criteria (ascertained via interview):

(1) a primary diagnosis of social anxiety disorder (SAD), generalised anxiety disorder (GAD), separation anxiety (SEP), or specific phobia (SP) on the Anxiety Disorders Interview Schedule for Children – Child and Parent version (ADIS-C/P; Silverman and Albano, 1996);
(2) willingness to be randomised to one of the two conditions.

Children and adolescents with a primary diagnosis of obsessive-compulsive disorder (OCD), posttraumatic disorder (PTSD) or panic disorder (PD) will not be eligible for participation. However, these diagnoses will be permitted if secondary. Participants with secondary mood disorders will be included, provided that their mood disturbance had a clinician severity rating (CSR) of <5 on the ADIS-C/P.
Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children and adolescents with current suicidal ideation, self-harm tendencies, substance abuse issues, significant behavioural disorders, pervasive developmental disorders, learning disorders, or those currently receiving professional help, as well as those who initiated or altered medication for anxiety or sleep within the six weeks leading up to the baseline assessment, will be excluded from the study.

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)
Allocation will be concealed by using sealed opaque envelopes. The randomisation sequence will be determined usign a computer-generated sequence in blocks of 30. This will be generated by the first investigator who will provide the sealed envelopes to the project manager. The project manager will only open the envelope after the participant is accepted into the study and agrees to participate in either condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified random assignment will be used controlling for participant age (child, teen), and an allocation ratio of 1:1 to treatment conditions.
Simple randomisation will be employed using a randomisation table created by computer 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
We will aim to recruit between 50-75 participants per condition, which will provide sufficient power for a feasibility test of the primary outcome variable.

The data collected through surveys and interviews will undergo analysis using both an intent-to-treat (ITT) and per-protocol (PP) approach. Primary anxiety diagnoses at each timepoint will be examined and reported through chi-square analyses. Continuous secondary outcome data will be analysed using mixed model, hierarchical linear modelling, nested within treatment groups, with time as a within-subject factor and condition (iCBT-Std vs iCBT-Plus) as the between-subject effect. Effect sizes will be computed for each measure and condition to assess the level of clinically significant change at 12-weeks (post-treatment) and 9 months. All analyses will be carried out using SPSS, Mplus, and R.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/01/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315287 0
Charities/Societies/Foundations
Name [1] 315287 0
HCF Research Foundation
Country [1] 315287 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
USQ Springfield 37 Sinnathamby Blvd, Springfield Central QLD 4300
Country
Australia
Secondary sponsor category [1] 318018 0
None
Name [1] 318018 0
Address [1] 318018 0
Country [1] 318018 0
Other collaborator category [1] 282958 0
University
Name [1] 282958 0
Griffith University
Address [1] 282958 0
Country [1] 282958 0
Australia
Other collaborator category [2] 282959 0
University
Name [2] 282959 0
The Australian National University
Address [2] 282959 0
Country [2] 282959 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314210 0
University of Southern Queensland Human Research Ethics Committee
Ethics committee address [1] 314210 0
Ethics committee country [1] 314210 0
Australia
Date submitted for ethics approval [1] 314210 0
25/04/2023
Approval date [1] 314210 0
08/06/2023
Ethics approval number [1] 314210 0
ETH2023-0216

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

Contacts
Principal investigator
Name 130794 0
Prof Sonja March
Address 130794 0
Centre for Health Research & School of Psychology and Wellbeing & Institute for Resilient Regions University of Southern Queensland Springfield Campus 37 Sinnathamby Blvd, Springfield Central QLD 4300
Country 130794 0
Australia
Phone 130794 0
+61 7 3470 4434
Fax 130794 0
Email 130794 0
sonja.march@unisq.edu.au
Contact person for public queries
Name 130795 0
Sonja March
Address 130795 0
Centre for Health Research & School of Psychology and Wellbeing & Institute for Resilient Regions University of Southern Queensland Springfield Campus 37 Sinnathamby Blvd, Springfield Central QLD 4300
Country 130795 0
Australia
Phone 130795 0
+61 7 3470 4434
Fax 130795 0
Email 130795 0
sonja.march@unisq.edu.au
Contact person for scientific queries
Name 130796 0
Sonja March
Address 130796 0
Centre for Health Research & School of Psychology and Wellbeing & Institute for Resilient Regions University of Southern Queensland Springfield Campus 37 Sinnathamby Blvd, Springfield Central QLD 4300
Country 130796 0
Australia
Phone 130796 0
+61 7 3470 4434
Fax 130796 0
Email 130796 0
sonja.march@unisq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data pertaining to primary and secondary outcomes may be shared. De-identified data will be shared with researchers under circumstances where the researchers have appropriate ethics approvals and appropriate research questions.
When will data be available (start and end dates)?
Data will only become available after all data has been analysed and results published from the trial. This includes both primary research questions, secondary research questions and those arising from the study later. These dates are to be determined.
Available to whom?
This de-identified data may be available to other researchers who hold suitable ethical clearance and wish to collaborate with the investigator team.
Available for what types of analyses?
The de-identified data may be available for review and meta-analytic purposes or other anlayses on request.
How or where can data be obtained?
The data can be obtained from the primary investigator at sonja.march@unisq.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21020Informed consent form  sonja.march@unisq.edu.au
21021Ethical approval  sonja.march@unisq.edu.au
21695Study protocol  sonja.march@unisq.edu.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.