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Personalised Anxiety Treatment for CHildren (PATCH)

Examining the clinical efficacy and acceptability of personalised treatment for childhood anxiety disorders based on children's cognitive-learning risk markers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001467527
Acronym
PATCH
Enrollment
26
Registered
2024-12-17
Start date
2025-07-01
Completion date
2028-03-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Anxiety disorders are the earliest emerging, most common and debilitating mental illnesses, yet 40-45% of anxious children do not respond to best-practice psychological treatment, cognitive behavioural therapy (CBT). For the past two decades, we have been examining fear conditioning and extinction (CON-EXT) markers of anxious children’s underlying threat sensitivity, positive valence, and cognitive control systems, and the markers that predict who will recover following CBT. We have developed a CON-EXT Profile to assess markers at the individual patient level and conducted studies of CBT enhancements that allow for personalised treatment. The next and most important step is to examine outcomes from personalised CBT relative to standard CBT. The primary aim of this project is to conduct a Phase III randomised controlled trial, in which anxious children, 7-12 years of age, are randomised to Stratified CBT, in which CBT is personalised to their CON-EXT markers (right CBT for each anxious child), compared to Standard CBT, in which anxious children receive standard CBT (one size fits all). It is hypothesised that a higher proportion of children will be in remission, and acceptability ratings and treatment completions will be higher, in Stratified CBT than Standard CBT at the post-treatment primary endpoint and 6-month follow-up.

Interventions

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 th

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.

Sponsors

Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
7 Years to 12 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026