Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000064404p
Ethics application status
Submitted, not yet approved
Date submitted
18/12/2024
Date registered
22/01/2025
Date last updated
22/01/2025
Date data sharing statement initially provided
22/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
CON-EXT Study: Examining the feasibility and acceptability of personalised treatment for childhood anxiety disorders based on children's cognitive-learning markers
Scientific title
Examining the feasibility and acceptability of personalised treatment for childhood anxiety disorders based on children's cognitive-learning markers
Secondary ID [1] 313587 0
None
Universal Trial Number (UTN)
Trial acronym
CON-EXT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 336116 0
Condition category
Condition code
Mental Health 332667 332667 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be 62 anxious children of any sex and racial and ethnic background who provide assent and their parent/carer who provides consent.

The CON-EXT Predictive Marker Task. (approximately 1 - 2 weeks before CBT begins)

The fear conditioning and extinction task (CON-EXT) Predictive Marker Task involves two-steps; (1) Identify CON-EXT Markers at the individual patient level and (2) Profile them against the CON-EXT Marker (+) Reference Sample of responders to Cognitive Behavioural Therapy (CBT). Clinicians will follow detailed instructions provided in the CON-EXT Predictive Marker Task Manual and video-recorded training resources which describe and demonstrate all procedures in administering, scoring, and profiling the CON-EXT Predictive
Marker Task. All CON-EXT Predictive Marker Task assessments will be audiotaped and 20% will undergo masked review to confirm fidelity and compliance

1. Identify: All children’s CON-EXT markers will be assessed at baseline using computer-based Presentation and Biopac systems. The CON-EXT Predictive Marker Task is based on the fear conditioning and extinction task used in our prior studies and involves habituation (2 trials per stimulus), conditioning (12 trials per stimulus) and extinction (12 trials per stimulus). The Conditioned Stimulus (CSs) are shapes presented for 8-sec each and the US is a 3-sec sound of metal on slate (95dB) presented through headphones on CS+ trials during conditioning and omitted during habituation and extinction. The clinician attaches electrodes to the child’s hand to record skin conductance response scores (SCRs) trial-by-trial and instructs the child how to provide CS evaluations (ratings 1-9 scale) on the keyboard before and after each phase. Headphones are fitted and children are instructed to focus attention on the computer screen and provide responses when prompted. After the task, SCRs are scored by the clinician using Acqknowledge software, converted to microsiemens and averaged across blocks of 2 trials using our scoring programs. Blocked SCR and CS evaluation data are summarised on individual Participant Scoring Forms.

2. Profile: The clinician will then use the summarised SCR and CS evaluation scores from the Participant Scoring Form and plot them on the CON-EXT Profile relative to the CON-EXT Marker (+) Reference Sample who responded to CBT and whose scores are represented by the green bands for CS valence ratings and SCR responses. The orange band represents one standard deviation from the CBT responder range and the red band represents one standard deviation above the CBT responder range. If a child’s scores fall within the green bands for CS valence and SCR responses, they are identified as CON-EXT Marker (+). If a child’s scores fall within the orange or red bands for CS valence and SCR responses, they are identified as CON-EXT Marker (-).

Treatment with CBT.
All anxious children will receive 10 weekly sessions of CBT, including 10 child sessions and 6 parent sessions (with a duration of approximately 1 hour per session), using the Take Action Program, which is the evidence-based program completed by the 129 anxious children forming the current CON-EXT Marker (+) Reference Sample. CBT will be delivered by provisionally registered psychologists completing Master of Clinical Psychology Training. They will be trained in manualised CBT for anxiety disorders via a two-day training workshop and weekly supervision by CIA-Waters, CIB-Farrell, and CIC-Sluis, as in past trials.

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
Intervention code [1] 330180 0
Behaviour
Intervention code [2] 330181 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340183 0
Anxiety diagnosis
Timepoint [1] 340183 0
Post intervention and 1 month follow up
Primary outcome [2] 340184 0
Anxiety rating
Timepoint [2] 340184 0
Post treatment and 1 month follow up
Secondary outcome [1] 443203 0
Illness Severity
Timepoint [1] 443203 0
Post treatment and 1 month follow up
Secondary outcome [2] 443202 0
Global functioning
Timepoint [2] 443202 0
Post Intervention and 1 month follow up
Secondary outcome [3] 443204 0
Anxiety Symptoms
Timepoint [3] 443204 0
Post Treatment and 1 month follow up

Eligibility
Key inclusion criteria
Inclusion:
(a) children 7-12 years old;
(b) meets criteria for a principal DSM-5 anxiety disorder,
(c) parent/carer consent for child to cease concurrent psychotherapy (if relevant),
(d) parent/carer consent for child to stabilise medication (if relevant) at the same dose for 12 weeks prior to baseline diagnostic assessment.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion: children with
(a) non-anxiety principal diagnosis,
(b) autism, pervasive developmental disorder or intellectual disability, gross developmental delay,
(c) medical contraindications, and
(d) prior child-focused CBT treatment as reported by parents. Depressive or externalizing disorders secondary to an anxiety disorder will be allowed and will not be exclusion criteria.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
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
27/01/2025
Actual
Date of last participant enrolment
Anticipated
25/09/2026
Actual
Date of last data collection
Anticipated
18/12/2026
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318055 0
Government body
Name [1] 318055 0
Department of Health and Aged Care Medical Research Future Fund - Childhood Mental Health Research Grant,
Country [1] 318055 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 320408 0
None
Name [1] 320408 0
Address [1] 320408 0
Country [1] 320408 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316706 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316706 0
Ethics committee country [1] 316706 0
Australia
Date submitted for ethics approval [1] 316706 0
18/12/2024
Approval date [1] 316706 0
Ethics approval number [1] 316706 0

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

Contacts
Principal investigator
Name 138734 0
Prof Allison Waters
Address 138734 0
Griffith University, Parklands Dr, Southport, Qld, 4222
Country 138734 0
Australia
Phone 138734 0
+61 07 37353351
Fax 138734 0
Email 138734 0
[email protected]
Contact person for public queries
Name 138735 0
Allison Waters
Address 138735 0
Griffith University, Parklands Dr, Southport, Qld, 4222
Country 138735 0
Australia
Phone 138735 0
+61 07 37353351
Fax 138735 0
Email 138735 0
[email protected]
Contact person for scientific queries
Name 138736 0
Allison Waters
Address 138736 0
Griffith University, Parklands Dr, Southport, Qld, 4222
Country 138736 0
Australia
Phone 138736 0
+61 07 37353351
Fax 138736 0
Email 138736 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.