Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001068752
Ethics application status
Approved
Date submitted
27/07/2022
Date registered
2/08/2022
Date last updated
18/09/2023
Date data sharing statement initially provided
2/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility, acceptability and effectiveness of integrating mentalization principles into cognitive behavioural treatment for childhood anxiety disorders.
Scientific title
Evaluating the feasibility, acceptability and effectiveness of integrating mentalization principles into cognitive behavioural treatment for childhood anxiety disorders.
Secondary ID [1] 307648 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Anxiety Disorders 327152 0
Condition category
Condition code
Mental Health 324289 324289 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Integrating mentalization principles into cognitive behavioural treatment for childhood anxiety disorders.
The integrated therapeutic intervention consists of 7 online therapy sessions delivered by supervised clinical psychology university students to parents (with their child attending three of the 7 sessions) over a 12 week period. This includes access to the program website and intervention materials designed specifically for this study. The website includes psychoeducation, worksheets on child anxiety, parent-focused cognitive behavioural therapy skills, reflective parenting, promoting independence, attachment and graded exposure. Sessions occur for approximately 1 hour weekly or fortnightly from the participants home via telehealth. Compliance checklist have been designed for the clinicians to complete each week, which cover each of the sessions materials and interventions to monitor adherence.
Intervention code [1] 324117 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332115 0
Child anxiety symptoms as measured by the Spence Children's Anxiety Scale - Parent Report (SCAS-P).
Timepoint [1] 332115 0
Baseline, completion of treatment (primary timepoint) and 12 weeks post-intervention completion.
Primary outcome [2] 332117 0
Parent self-efficacy as measured using an adapted version of the Brief Parental Self-Efficacy Scale (BPSES)
Timepoint [2] 332117 0
Baseline, completion of treatment (primary time-point) and 12 weeks post-intervention completion.
Secondary outcome [1] 412289 0
Parent mentalization as measured by the Parental Reflective Functioning Questionnaire (PRFQ).
Timepoint [1] 412289 0
Baseline, completion of treatment and 12 weeks post-intervention completion.
Secondary outcome [2] 412290 0
Feasibility as measured by the number of participants recruited (number of participants recruited as assessed by study recruitment logs), participant retention and participant drop out (number of participants who completed the program and the number of participants who ceased treatment before completion as per the participant logs).
Timepoint [2] 412290 0
Baseline and completion of treatment
Secondary outcome [3] 412291 0
Accessibility as measured by the 5-item impact/impairment score on the Strengths and Difficulties Questionnaire (SDQ)
Timepoint [3] 412291 0
Baseline, completion of treatment and 12 week post-intervention completion.

Eligibility
Key inclusion criteria
Parents with a child aged 6-11 years of age with an elevated anxiety score (T-Score equal to or greater than 60) in one or more anxiety disorder on the parent reported Spence’s Children’s Anxiety Scale - Parent Report (SCAS-P) and anxiety disorder diagnosis on the MINI Psychiatric Interview for children.
Minimum age
6 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria includes children with a current primary diagnosis of PTSD/Conduct/Depression.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study should have adequate power with a sample size of around 15 – 20 participants. Clinical studies in mental health using a single group design tend to display large effect sizes (Cohen, 1988: Peters et al., 2021).
- Descriptive statistics including age and sex of the child, principal and secondary diagnoses and subscale and total scores on each measure at pre, post and follow up intervention phase will be generated and evaluated (including means and standard deviations).
- Missing data at pre or post intervention phases will be managed by multiple imputation methods (expectation maximisation) (Ng, 2013).
- Intervention efficacy will be assessed using one way, within subjects, repeated measures ANOVA, with the independent variable being time. Violation of assumptions will be reviewed and discussed and post-hoc Bonferroni adjustments will be conducted to highlight any group differences. Effect size will be calculated using Omega squared (Olejink & Algina, 2003).
- Further analysis will include reliable change (Jacobson and Traux, 1991) and clinically significant change (Jacobson, Follete, and Revenstof, 1984) indexes.
- Feasibility and acceptability analysis of the intervention will be conducted using retention and dropout rates and item responses from questionnaires.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/08/2022
Actual
29/08/2022
Date of last participant enrolment
Anticipated
23/12/2022
Actual
23/12/2022
Date of last data collection
Anticipated
31/08/2023
Actual
31/08/2023
Sample size
Target
20
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311909 0
University
Name [1] 311909 0
Swinburne University of Technology
Country [1] 311909 0
Australia
Primary sponsor type
University
Name
Swinburne Univeristy of Technology
Address
John St, Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 313416 0
None
Name [1] 313416 0
Address [1] 313416 0
Country [1] 313416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311345 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 311345 0
Swinburne University of Technology
John Street, Hawthorn
Victoria 3122
Ethics committee country [1] 311345 0
Australia
Date submitted for ethics approval [1] 311345 0
04/05/2022
Approval date [1] 311345 0
02/06/2022
Ethics approval number [1] 311345 0
20225850-9844

Summary
Brief summary
The primary purpose of this research is to evaluate the feasibility, acceptability, and efficacy of integrating mentalization principles into a cognitive behavioural intervention for childhood anxiety. In light of the evidence that reflective functioning enhances parenting self-efficacy, coupled with the evidence on the effectiveness of CBT in reducing and managing anxiety in children, it is hypothesized that this integrated cognitive behavioural intervention will demonstrate:
(a) feasibility, acceptability, safety and tolerability
(b) a reduction in clinical levels of anxiety and anxiety symptoms in children and,
(c) an increase in self-reported parental self-efficacy in managing their child’s anxiety.
Trial website
Trial related presentations / publications
Public notes
Student Investigator: James Morello

Contacts
Principal investigator
Name 120790 0
Dr Chris Ludlow
Address 120790 0
Swinburne University of Technology
John Street, Hawthorn
Victoria 3122
Country 120790 0
Australia
Phone 120790 0
+61 0435 048 799
Fax 120790 0
Email 120790 0
[email protected]
Contact person for public queries
Name 120791 0
Chris Ludlow
Address 120791 0
Swinburne University of Technology
John Street, Hawthorn
Victoria 3122
Country 120791 0
Australia
Phone 120791 0
+61 0435 048 799
Fax 120791 0
Email 120791 0
[email protected]
Contact person for scientific queries
Name 120792 0
Chris Ludlow
Address 120792 0
Swinburne University of Technology
John Street, Hawthorn
Victoria 3122
Country 120792 0
Australia
Phone 120792 0
+61 0435 048 799
Fax 120792 0
Email 120792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual line by line data
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Researchers who provide a sound proposal
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
Contact principal investigator by email: [email protected]


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.