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Trial registered on ANZCTR


Registration number
ACTRN12624001467527p
Ethics application status
Not yet submitted
Date submitted
20/11/2024
Date registered
17/12/2024
Date last updated
17/12/2024
Date data sharing statement initially provided
17/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalised Anxiety Treatment for CHildren (PATCH)
Scientific title
Examining the clinical efficacy and acceptability of personalised treatment for childhood anxiety disorders based on children's cognitive-learning risk markers
Secondary ID [1] 313372 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
PATCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 335742 0
Condition category
Condition code
Mental Health 332297 332297 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of Intervention:
Children will be aged between 7 - 12 years, they will be recruited because their parents will be concerned with their anxiety.
Master level clinical psychologists will assess the child using the Anxiety Disorders Interview Schedule (ADIS-5) interview and other surveys. If they are deemed by consensus of the clinical team to have a principal anxiety disorder diagnosis, they will complete a fear conditioning and extinction task (CON-EXT), that will identify their theragnostic markers using a CON-EXT profile. This will indicate which cognitive Behavioural Therapy (CBT) intervention/treatment condition the child is placed.
The CON-EXT markers are of children’s underlying threat sensitivity, positive valence, and cognitive control systems, and the markers that predict who will recover from anxiety following standard CBT which targets the threat sensitivity systems.

The two arm or conditions will be randomly assigned, however within the treatment arm, the participant will be placed in one of three conditions based on the CON-EXT profile.

The therapy will be conducted by registered psychologists overseen by members of the team. The treatments will be offered in the University clinic or online, or a mixture of both, dependent on the family’s requirements.
Arm 1 is the control arm, which is standard CBT, delivered as a 10 session Take Action Program .

The treatment (Intervention) arm is Stratified CBT.

Children in Stratified CBT with all CON-EXT Profile markers in the green band will receive standard CBT – the Take Action Program.
Children with negative valence CON-EXT markers will receive Take Action augmented with positive valence strategies to activate the positive valence system during CBT. The positive valence strategies, involve working on a computer program called positive search training (PST) that will take approximately 30 mins to complete. It involves the child viewing a wide variety of pictures (such as growling dogs, angry faces and thunderstorms), and learning to focus their attention on the good and calm pictures among them (such as happy children, playful animals and healthy food). PST also includes games, verbalisations and animations so it is interactive for children. The pictures used in PST are no more fear provoking then pictures or images the children see and hear about on the television or part of their everyday life. Computer-based positive search training will take approximately 20-30 mins and will be completed at the start of each Take Action session, children will learn positive search catch phrases and jingles to facilitate attention broadening, positive stimulus selection and responsivity to mastery experiences during sessions 1-4. They will apply these strategies during exposure trials (sessions 5-10), augmented with positive background music to improve positive mood. Therapists will follow a manual and reinforce how well children attend to positive stimuli, use positive catch phrases, and exhibit positive mood. Between sessions, partipants will be encouraged to practice what they learnt that week, and continue to use the catch phrases, "Look for good, look for calm, use both options and never give up"

Children with generalisation CON-EXT markers will complete cognitive control training at the start of each Take Action session, involving verbalisation strategies to narrow and maintain attention to target stimuli (same images as described above for PST) and inhibit attention shifting to surrounding stimuli to prevent generalisation. The verbalisation strategies, include " Lock it in" and "Look and Learn". These sessions will take about 20-30 mins and will be completed at the start of each Take Action session. Children will apply cognitive control strategies during sessions 1-4 and during exposure trials in sessions 5-10 to enhance the processing of feared stimuli and limit attention avoidance. Therapists will follow a manual and reinforce how well children maintain attention on target stimuli, use cognitive control strategies, and inhibit attention to other stimuli during exposure therapy.. Between sessions, partipants will be encouraged to practice what they learnt that week, and continue to use the catch phrases, "Lock it in" and "Look and Learn".

The Take Action program takes 60 mins each session.

To assess adherence to the intervention, Session attendance, duration and content completion will be recorded via the therapist in CBT and CCT and PST are computer-based tasks that return output files and thus session completion is tracked by the returned sessions and via therapist recording as they are completed right before CBT sessions, whether in person or online.
Intervention code [1] 329955 0
Behaviour
Intervention code [2] 330082 0
Treatment: Other
Comparator / control treatment
1.Standard CBT.
All children in Standard Cognitive Behavioural Therapy individually receive the 10-session Take Action Program, an evidence-based program. These sessions take 60 mins each.

The therapy will be conducted by registered psychologists overseen by members of the team. The treatments will be offered in the University clinic or online, or a mixture of both, dependent on the family’s requirements.

Sessions 1-4 focus on psychoeducation, relaxation strategies and cognitive therapy. Within-session exposure therapy is conducted from sessions 5-10 using individualised exposure hierarchies. Exposure therapy involves developing an exposure hierarchy ladder collaboratively with the participant to identify graded exposure tasks relevant to their specific anxiety/fears. Completion of exposure tasks occurs both within and between sessions. The exposure tasks identified are dependent on the participants specific fears/anxiety and so will vary from person to person.

Between-session exposure activities are completed at home. These will depend on the child's fear but could include gradually approaching a dog, giving a talk in front of class, going to a birthday party, going in an elevator, going to the doctor or dentist, going into a dark room in the house, sleeping with the light off as examples.

Take Action includes a 1-month booster session and 6 parent sessions. The parent sessions alongside the child sessions - so the child completes a session, and then the parent completes their session straight after (so they are back-to-back) where possible. Sometimes they occur at a different time to the child sessions dependent on parent and child availability to attend sessions, but they always occur within the same week.

For assessing adherence to the intervenion, session attendance, duration and content completion will be recorded via the therapist in CBT
Control group
Active

Outcomes
Primary outcome [1] 339938 0
Anxiety
Timepoint [1] 339938 0
Baseline (0 week) Post treatment (12 weeks from baseline) and 6 months post treatment
Secondary outcome [1] 441987 0
Global Functioning
Timepoint [1] 441987 0
Baseline (0 week) Post treatment (12 weeks from baseline) and 6 months post treatment
Secondary outcome [2] 441988 0
Illness Severity
Timepoint [2] 441988 0
Baseline (0 week) Post treatment (12 weeks from baseline) and 6 months post treatment

Eligibility
Key inclusion criteria
1. Children aged 7-12 years
2. Meet criteria for a principle DSM-5 anxiety disorder
3. Parent/carer consent for chidl to cease concurrent psychotherapy (if relevent)
4. Parent/carer consent for child to stablise medication (if relevant) at teh same dose for 12 weeks prior to assessment
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with a non-anxiety 'principal' diagnosis. Depression, ADHD and Oppositional Defiant Disorder that are "secondary" diagnoses to a principal anxiety disorder diagnosis will not be exclusions given high comorbidity and the inclusion of these comorbid "secondary" disorders in our prior trials

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
1/03/2028
Actual
Date of last data collection
Anticipated
30/09/2028
Actual
Sample size
Target
358
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317813 0
Charities/Societies/Foundations
Name [1] 317813 0
Wellcome Trust
Country [1] 317813 0
United Kingdom
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 320201 0
None
Name [1] 320201 0
Address [1] 320201 0
Country [1] 320201 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316497 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316497 0
Ethics committee country [1] 316497 0
Australia
Date submitted for ethics approval [1] 316497 0
18/12/2024
Approval date [1] 316497 0
Ethics approval number [1] 316497 0

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

Contacts
Principal investigator
Name 138082 0
Prof Allison Waters
Address 138082 0
Griffith University, Parklands Dr, Southport Gold Coast,Queensland, 4222
Country 138082 0
Australia
Phone 138082 0
+61 07 37353434
Fax 138082 0
Email 138082 0
a.waters@griffith.edu.au
Contact person for public queries
Name 138083 0
Allison Waters
Address 138083 0
Griffith University, Parklands Dr, Southport Gold Coast, Queensalnd, 4222
Country 138083 0
Australia
Phone 138083 0
+61 07 37353434
Fax 138083 0
Email 138083 0
a.waters@griffith.edu.au
Contact person for scientific queries
Name 138084 0
Allison Waters
Address 138084 0
Griffith University, Parklands Dr, Southport Gold Coast, Queensland, 4222
Country 138084 0
Australia
Phone 138084 0
+61 07 37353434
Fax 138084 0
Email 138084 0
a.waters@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.