Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000772448
Ethics application status
Approved
Date submitted
18/06/2025
Date registered
22/07/2025
Date last updated
22/07/2025
Date data sharing statement initially provided
22/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Strengthening Memory and Anxiety Reduction Trial (SMART)
Scientific title
Making it stick: The effect of memory rehearsal on exposure therapy outcomes for childhood anxiety disorders.
Secondary ID [1] 314593 0
None
Universal Trial Number (UTN)
Trial acronym
SMART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 337755 0
Condition category
Condition code
Mental Health 334085 334085 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children will complete six weekly one-hour exposure therapy sessions targeting anxiety, along with between-session memory rehearsal training activities.

Exposure therapy tasks will be tailored to each participants' specific anxiety disorder. For example, children with a primary fear of public speaking may engage in exposure tasks such as delivering a speech in front of their parents, presenting to one unfamiliar adult, or speaking in front of a small group of unfamiliar adults. In contrast, a child with a phobia of the dark might participate in activities such as playing with glowsticks in a dark room, playing hide-and-seek in a dimly lit environment, or taking a nighttime walk with a torch. Children will be guided through exposure tasks in a gradual, step-by-step manner at their own pace. Sessions will be delivered by Provisional, Registered and Clinical Psychologists with specialist training in conducting exposure therapy with children.

The memory rehearsal training is designed to help children recall specific memories of completing their exposure tasks and strengthen recall for the safety learning they have gained during the session. Children will complete a brief (~10minute) online questionnaire three times per week between exposure sessions, which will involve answering a set of standardised questions focsued on recalling the exposure tasks they completed during the session, their original threat expectancies, whether the negative events happened, and what they learned by doing the exposure task(s). Parents will be sent a link to the child's memory rehearsal questionnaire via SMS and will asssit children to answer the standardised questions. Adherence will be monitored via online survey completion.
Intervention code [1] 331244 0
Treatment: Other
Comparator / control treatment
Children will complete six weekly one-hour exposure therapy sessions targeting anxiety, along with between-session generic memory training games.

Exposure tasks will be tailored to each participant’s specific anxiety disorder and will be delivered by Provisional, Registered and Clinical Psychologists with specialist training in conducting exposure therapy with children.

Children in the comparison condition will complete a variety of generic memory training games via an online questionnaire sent to the parent's phone. These memory games will match the experimental condition in terms of frequency and duration (i.e., 3 times per week for approximately 10 minutes). Adherence will be monitored via online survey completion.
Control group
Active

Outcomes
Primary outcome [1] 341743 0
Severity of the primary anxiety or obsessive compulsive disorder
Timepoint [1] 341743 0
Baseline, Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up.
Secondary outcome [1] 448576 0
Remission of primary anxiety diagnosis
Timepoint [1] 448576 0
Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up
Secondary outcome [2] 448613 0
Remission of all anxiety diagnoses
Timepoint [2] 448613 0
Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up
Secondary outcome [3] 448614 0
Clinical severity of all anxiety diagnoses
Timepoint [3] 448614 0
Baseline, Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up
Secondary outcome [4] 448615 0
Clinical severity of all anxiety diagnoses relative to baseline
Timepoint [4] 448615 0
Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up
Secondary outcome [5] 448616 0
Idiosyncratic problem severity
Timepoint [5] 448616 0
Baseline, Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up
Secondary outcome [6] 448617 0
Self-reported anxiety symptoms
Timepoint [6] 448617 0
Baseline, Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up
Secondary outcome [7] 448618 0
Anxiety-related impairment
Timepoint [7] 448618 0
Baseline, Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up
Secondary outcome [8] 448619 0
Self-reported depression
Timepoint [8] 448619 0
Baseline, Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up
Secondary outcome [9] 448620 0
Threat expectancy
Timepoint [9] 448620 0
Baseline, Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up
Secondary outcome [10] 448621 0
Self Efficacy
Timepoint [10] 448621 0
Baseline, Post-treatment (after completion of the 6-week exposure therapy intervention) and three-month follow-up
Secondary outcome [11] 448625 0
Client satisfaction at post-treatment
Timepoint [11] 448625 0
Post-treatment (after completion of the 6-week exposure therapy intervention)
Secondary outcome [12] 448700 0
Therapeutic alliance
Timepoint [12] 448700 0
Post-treatment (after completion of the 6-week exposure therapy intervention)
Secondary outcome [13] 448701 0
Treatment credibility and expectancies
Timepoint [13] 448701 0
After session 1
Secondary outcome [14] 449881 0
Memory ability
Timepoint [14] 449881 0
Baseline and post-treatment (after completion of the 6-week exposure therapy intervention).

Eligibility
Key inclusion criteria
(1) Primary DSM-5 anxiety disorder or Obsessive Compulsive Disorder (OCD), based on a structured diagnostic interview (greater than or equal to 4 on the Anxiety Disorders Interview Schedule for Children [ADIS-C/P; Silverman & Albano, 1996]).
(2) Aged 8-12 years
(3) Children and their parents 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
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Current clinically significant suicidality or suicidal behaviours
(2) Concurrent psychological treatment
(3) Pharmacotherapy: Current use of antidepressant or benzodiazepine medication. Other psychotropic medications are permitted provided the child has been on a stable dose for at least 8 weeks prior to 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 created by a computer generated system in permutated blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of N=164 will provide 80% power to detect a small effect size difference between groups of f = 0.14 across 3 timepoints (pre-treatment, post-treatment, 3-month follow-up), with p<.05 and r=.5 between repeated measures (G*Power). This will also allow 80% power to detect mediation based on small-moderate relationships between treatment group, memory for safety learning and anxiety outcomes (ß = .26; NNT =158).

Intention to treat analyses will be conducted with all randomised participants included in analyses. Linear mixed models using restricted maximum likelihood will be used to compare groups on continuous outcomes. Cognitive tests of memory will be included as covariates. Multiple imputation will be used to estimate missing data and results from the imputed model will be compared to mixed model analyses without imputed data. Causal mediation analysis will be used to test the mediating effect of memory for safety learning on anxiety outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
164
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 44238 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 319140 0
Government body
Name [1] 319140 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 319140 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 321606 0
None
Name [1] 321606 0
Address [1] 321606 0
Country [1] 321606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317733 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 317733 0
Ethics committee country [1] 317733 0
Australia
Date submitted for ethics approval [1] 317733 0
17/02/2025
Approval date [1] 317733 0
15/04/2025
Ethics approval number [1] 317733 0
520251878862289

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

Contacts
Principal investigator
Name 141970 0
A/Prof Carly Johnco
Address 141970 0
Room 807, Level 3, South Side, Australian Hearing Hub.16 University Avenue. Macquarie University NSW 2109. Wallumattagal Campus
Country 141970 0
Australia
Phone 141970 0
+61 2 9850 8053
Fax 141970 0
Email 141970 0
[email protected]
Contact person for public queries
Name 141971 0
SMART
Address 141971 0
Australian Hearing Hub. 16 University Avenue. Macquarie University NSW 2109. Wallumattagal Campus
Country 141971 0
Australia
Phone 141971 0
+61 2 9850 8596
Fax 141971 0
Email 141971 0
[email protected]
Contact person for scientific queries
Name 141972 0
Carly Johnco
Address 141972 0
Room 807, Level 3, South Side, Australian Hearing Hub.16 University Avenue. Macquarie University NSW 2109. Wallumattagal Campus
Country 141972 0
Australia
Phone 141972 0
+61 2 9850 8053
Fax 141972 0
Email 141972 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 data about patients in this trial who are minors.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected] Approval.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.