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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001232325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/09/2026
Date registered
Help: Date registered
8/10/2026
Date last updated
Help: Date last updated
8/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
8/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Kick Start Trial: Advancing Childhood Anxiety Treatment with Intensive Exposure Therapy
Scientific title
Effect of Intensive Exposure Therapy Compared with Standard CBT on Anxiety Disorder Severity in Children Aged 7 to 12 Years: A Randomised Non-Inferiority Trial
Additional trial identifiers [1] 317279 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Anxiety 341907 0
Condition category
Condition code
Mental Health 337964 337964 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The study involves a pragmatic, non-inferiority 2 (Treatment: Transdiagnostic Two Session Treatment (TST) vs. Traditional Cognitive Behavioural Therapy (CBT)) by 3 (Time: Baseline, 6-week, 14-week) randomised controlled trial. Children will be randomly assigned to Transdiagnostic Two Session Treatment (TST) or traditional Cognitive Behaviour Therapy (CBT).

Transdiagnostic TST comprises two three-hour individual face-to-face exposure sessions delivered one week apart over two consecutive weeks (e.g., 1 week and 2 weeks). During the two prolonged exposure sessions children will be encouraged to face their fears. The use of relaxation strategies or distraction will be discouraged. Parents will be involved in treatment and receive training in the use of rewards to encourage at-home exposure practice and strategies to reduce family accommodation.

Clinicians will be registered psychologists and clinical psychologists trained in both treatment conditions (to control for therapist effects) using a structured training protocol and supervised weekly by a senior clinician and CIs. To ensure adherence to treatment protocols all treatment sessions will be recorded and a random 25% from each treatment condition will be reviewed against a checklist by an independent clinician to assess for treatment fidelity and adherence as per our previous trials.
Intervention code [1] 334053 0
Treatment: Other
Description of the comparator or control
Traditional CBT will use the Cool Kids manualised program. This program has more than 20 years of established efficacy in comparison to placebo and active treatments. Cool Kids comprises 10 x 60-minute individual face-to-face sessions with a trained psychologist delivered over 10 weeks. It incorporates CBT skills of: psychoeducation, cognitive restructuring, graduated exposure, and optional skills in problem solving, communication, relaxation and assertiveness. Parents participate in treatment sessions to support home practice, comprehension and implementation, as well as receiving parenting skills to reduce overinvolvement, accommodation, and encourage brave behaviour.

Clinicians will be registered psychologists and clinical psychologists trained in both treatment conditions (to control for therapist effects) using a structured training protocol and supervised weekly by a senior clinician and CIs. To ensure adherence to treatment protocols all treatment sessions will be recorded and a random 25% from each treatment condition will be reviewed against a checklist by an independent clinician to assess for treatment fidelity and adherence as per our previous trials.
Control group
Active

Outcomes
Primary outcome [1] 345398 0
Severity of the primary anxiety or obsessive compulsive disorder
Timepoint [1] 345398 0
1-month post-completion of treatment program
Secondary outcome [1] 465972 0
Severity of the primary anxiety or obsessive compulsive disorder
Timepoint [1] 465972 0
6-week and 14-week post-baseline assessment
Secondary outcome [2] 465973 0
Remission of primary anxiety diagnosis
Timepoint [2] 465973 0
6-week and 14-week post-baseline assessment
Secondary outcome [3] 465974 0
Remission of all anxiety diagnoses
Timepoint [3] 465974 0
6-week and 14-week post-baseline assessment
Secondary outcome [4] 465975 0
Clinical severity of all anxiety diagnoses
Timepoint [4] 465975 0
6-week and 14-week post-baseline assessment
Secondary outcome [5] 465976 0
Idiosyncratic Target Symptoms Parent
Timepoint [5] 465976 0
6-week and 14-week post-baseline assessment
Secondary outcome [6] 465977 0
Parent rated anxiety symptoms
Timepoint [6] 465977 0
6-week and 14-week post-baseline assessment
Secondary outcome [7] 465978 0
Parent rated anxiety related impairment
Timepoint [7] 465978 0
6-week and 14-week post-baseline assessment
Secondary outcome [8] 465979 0
Parent rated symptoms of depression
Timepoint [8] 465979 0
6-week and 14-week post-baseline assessment
Secondary outcome [9] 465981 0
Client satisfaction post treatment
Timepoint [9] 465981 0
1-month post-completion of treatment program
Secondary outcome [10] 465982 0
Therapeutic Alliance
Timepoint [10] 465982 0
1-month post-completion of treatment program
Secondary outcome [11] 465983 0
Treatment credibility
Timepoint [11] 465983 0
Following psychoeducation Session 1
Secondary outcome [12] 465984 0
Parent rated Quality of Life
Timepoint [12] 465984 0
6-week and 14-week post-baseline assessment
Secondary outcome [13] 465985 0
Healthcare utilisation
Timepoint [13] 465985 0
6-week and 14-week post-baseline assessment
Secondary outcome [14] 465986 0
Costs of attending care
Timepoint [14] 465986 0
6-week and 14-week post-baseline assessment
Secondary outcome [15] 465987 0
Costs of providing care
Timepoint [15] 465987 0
Cost logs will be completed for all assessment and treatment appointments.
Secondary outcome [16] 468532 0
Idiosyncratic Target Symptoms Child
Timepoint [16] 468532 0
6-week and 14-week post-baseline assessment
Secondary outcome [17] 468533 0
Child rated anxiety symptoms
Timepoint [17] 468533 0
6-week and 14-week post-baseline assessment
Secondary outcome [18] 468534 0
Child rated anxiety related impairment
Timepoint [18] 468534 0
6-week and 14-week post-baseline assessment
Secondary outcome [19] 468535 0
Child rated symptoms of depression
Timepoint [19] 468535 0
6-week and 14-week post-baseline assessment
Secondary outcome [20] 468631 0
Child rated Quality of Life
Timepoint [20] 468631 0
6-week and 14-week post-baseline assessment
Secondary outcome [21] 468632 0
Quality of Life - Parent self report
Timepoint [21] 468632 0
6-week and 14-week post-baseline assessment
Secondary outcome [22] 468644 0
Threat expectancies
Timepoint [22] 468644 0
6-week and 14-week post-baseline assessment

Eligibility
Key inclusion criteria
(1) Primary DSM-5 anxiety disorder or Obsessive Compulsive Disorder (OCD), based on a structured diagnostic interview (equal to or greater than 4 on the Anxiety Disorders Interview Schedule for Children [ADIS-C/P; Silverman & Albano, 1996]).
(2) Aged 7-12 years
(3) Children and their parents/guardians must be proficient in reading and writing in English.
(4) Comorbidity with other internalizing and externalizing disorders is permissible, provided these are secondary diagnoses and/or not excluded diagnoses.
(5) Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
(1) Current clinically significant suicidality or suicidal behaviours
(2) Concurrent psychological treatment
(3) Pharmacotherapy: Initiation of an antidepressant within 12 weeks of study enrolment or any changes in established psychotropic medication within 8 weeks of study enrolment.
(4) Diagnosis of selective mutism, conduct, bipolar or substance use disorder, psychosis, autism spectrum disorder, intellectual impairment or pervasive developmental disorder.
(5) Considered at risk due to physical abuse, sexual abuse or extended school refusal.

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 using a password protected electronic system and revealed sequentially and after eligibility has been determined and treatment consent received.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be determined prior to study start by the study biostatistician, who will be independent and have no contact with participants.The randomisation sequence will be created by a computer generated system in permutated blocks.
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
One hundred and fifty-six children randomized equally into the two study groups will provide statistical power 0.8 at the 0.05 level of statistical significance for a non-inferiority (NI) test of means where the true difference between groups is zero and the NI margin is set to a Cohen’s d value of 0.4. The margin was determined as being less than the conventional minimum clinically important difference of d=0.5, per Food and Drug Administration (FDA) guidelines for the design of NI clinical trials and in line with other similar non-inferiority trials that had effect sizes of more than 0.3.

All quantitative measures will be reported as mean and standard deviation (SD) or median and interquartile range. All categorical measures will be reported as count and percentage. Evaluation of statistical hypotheses will be by intention-to-treat and where the assumption of normality if required but violated, formal statistical inference will employ the nonparametric bootstrap with 2000 iterations. The study’s primary and secondary hypotheses will be evaluated using tests for non-inferiority with the NI margin set as described under sample size and power. Tests will be one-tailed and evaluated at the 0.05 level of statistical significance. Evaluation of factors measured at baseline that are predictive of subsequent treatment response will be made regardless of the treatment to which participants are randomized. Modelling will employ simple and multiple linear regression for each study endpoint. Where numerous potential response predictors are identified, a bootstrapped model selection procedure [17] will be used to minimise the potential for over-optimism bias that is known to be prevalent in predictive models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/10/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 45840 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 318657 0
Government body
Name [1] 318657 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 318657 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 321078 0
None
Name [1] 321078 0
Address [1] 321078 0
Country [1] 321078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317271 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 317271 0
Ethics committee country [1] 317271 0
Australia
Date submitted for ethics approval [1] 317271 0
15/09/2025
Approval date [1] 317271 0
23/12/2025
Ethics approval number [1] 317271 0
520251881666094

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

Contacts
Principal investigator
Name 140522 0
Dr Ella Oar
Address 140522 0
Emotional Health Clinic, Level 1, South Side, Australian Hearing Hub.16 University Avenue. Macquarie University NSW 2109. Wallumattagal Campus
Country 140522 0
Australia
Phone 140522 0
+61 2 9850 8596
Fax 140522 0
Email 140522 0
[email protected]
Contact person for public queries
Name 140523 0
Ella Oar
Address 140523 0
Emotional Health Clinic, Level 1, Australian Hearing Hub. 16 University Avenue. Macquarie University NSW 2109. Wallumattagal Campus
Country 140523 0
Australia
Phone 140523 0
+61 2 9850 8596
Fax 140523 0
Email 140523 0
[email protected]
Contact person for scientific queries
Name 140524 0
Ella Oar
Address 140524 0
Emotional Health Clinic, Level 1, South Side, Australian Hearing Hub.16 University Avenue. Macquarie University NSW 2109. Wallumattagal Campus
Country 140524 0
Australia
Phone 140524 0
+61 2 9850 8596
Fax 140524 0
Email 140524 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Ethical approval prevents the sharing of individual patient data



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected] Letter of Approval 01_26.pdf


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.