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Trial registered on ANZCTR


Registration number
ACTRN12616001065482
Ethics application status
Approved
Date submitted
29/07/2016
Date registered
9/08/2016
Date last updated
29/06/2021
Date data sharing statement initially provided
23/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Cognitive Behavioural Treatment for Socially Anxious Youth
Scientific title
Efficacy of cognitive behavioural treatment for socially anxious youth with theoretically derived modifications.
Secondary ID [1] 289797 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety 299702 0
Condition category
Condition code
Mental Health 299637 299637 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1: 10 sessions of CBT over 12 weeks – Cool Kids Program

Condition 2: 10 sessions of CBT over 12 weeks – Cool Kids Program with amended skills directly derived from models of the maintenance of social anxiety. The program includes the same cognitive and behavioural strategies as condition 1 and has been amended to also include exposure to subtle avoidance, attention processes, and target self-perception biases.

CBT sessions include psychoeducation about anxiety and social anxiety, and skills to manage anxiety. Skills focus on thinking styles and behavioural responses to anxiety. Sessions include both children and parents (less parental involvement for adolescents) and are delivered individually (to each family). 10 sessions are ideally delivered weekly, except for weeks 9 and 11 where there is a break from CBT sessions. Sessions are approximately 50 minutes in duration.

Participants are provided with a parent and child workbook.
Therapists are provisional psychologists completing postgraduate training in clinical psychology with prior experience treating anxiety, registered psychologists or clinical psychologists.
Treatment will be delivered at the Centre for Emotional Health Clinic at Macquarie University, Sydney Australia

Treatment integrity will be assessed by independent raters by watching therapy sessions and coding for adherence or violations from the treatment manuals.
Intervention code [1] 295252 0
Treatment: Other
Comparator / control treatment
Standard, generic, CBT program for child anxiety – Cool Kids will be delivered as an active control treatment.
Control group
Active

Outcomes
Primary outcome [1] 299102 0
Proportion of participants in remission of DSM-5 social anxiety disorder as assessed by semi-structured clinical interview (ADIS-C/P)
Timepoint [1] 299102 0
Post-treatment and 6 month follow-up
Secondary outcome [1] 326171 0
Proportion of participants in remission of other DSM-5 anxiety disorders as assessed by semi-structured clinical interview (ADIS-C/P)
Timepoint [1] 326171 0
Post-treatment and 6 month follow-up
Secondary outcome [2] 326172 0
Change in Clinician Severity Ratings on social diagnosis using ADIS 0 - 8 scale.
Timepoint [2] 326172 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [3] 326173 0
Change in Clinician Severity Ratings on primary diagnosis using ADIS 0 - 8 scale.
Timepoint [3] 326173 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [4] 326174 0
Changes on fear and avoidance of social situations (from ADIS-C/P)
Timepoint [4] 326174 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [5] 326175 0
Changes on Children’s Anxiety Life Interference Scale (parent report)
Timepoint [5] 326175 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [6] 326176 0
Changes on Spence Children’s Anxiety Scale (parent report)
Timepoint [6] 326176 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [7] 326177 0
Changes on Brief Depression and Anxiety Scale for Children (parent report)
Timepoint [7] 326177 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [8] 326178 0
Changes on quality of life (CHU-D9) child report
Timepoint [8] 326178 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [9] 326179 0
Changes on social threat and failure subscale of Children’s Automatic Thoughts Scale (child report)
Timepoint [9] 326179 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [10] 326180 0
Changes on Social Phobia Anxiety Inventory for Children (parent report)
Timepoint [10] 326180 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [11] 326181 0
Changes on Children’s Anxiety Life Interference Scale (self report)
Timepoint [11] 326181 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [12] 326182 0
Changes on Spence Children’s Anxiety Scale (self report)
Timepoint [12] 326182 0
Pre-Treatment, Post-Treatment and 6 month follow-up
Secondary outcome [13] 326183 0
Changes on Brief Depression and Anxiety Scale for Children (self report)
Timepoint [13] 326183 0
Pre-Treatment, Post-Treatment and 6 month follow-up

Eligibility
Key inclusion criteria
DSM-5 diagnosis of social anxiety disorder
Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.. Social anxiety that is more than 2 CSR point less severe than another DSM-5 anxiety diagnosis or an unwillingness by family to work primarily on the social anxiety.
2. Primary disorder is not an anxiety disorder
3. Current risk (active suicidal risk, abuse/neglect, unmanaged psychotic symptoms, 2 weeks of consistent school refusal with no intention or plan to return to school)
4. Concurrent psychological therapy or not on a stable dose of psycho-pharmacological medication (i.e. stable for 2 months prior to assessment and intent to stay on same dose)
5. Diagnosis of Autism Spectrum Disorder
6. Child requires significant assistance within the classroom or child is not in mainstream schooling
7. Inpatient

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)
Participants self-refer to the clinic or research team, are sent information about the research trial, provide screening information and if determined to meet inclusion but not exclusion criteria from this information, attend a diagnostic assessment and complete research measures and tasks.
Suitability is determined from the diagnostic interview and if suitable participants make payment for treatment and are then randomly allocated after diagnosis and completion of baseline measures to condition and booked in for their treatment sessions/appointments.
Randomisation list is held by an investigator who is not involved in the assessment or treatment of clients.
Allocation to conditions will be done by the project co-ordinator who will remain blind to the next condition in the sequence until after the participant has completed baseline assessment and consented to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based random number generator.
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
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be conducted using intention-to-treat and completer models. Multiple imputation will be used to impute missing data when necessary. Categorical data will be analysed via chi-squared tests, and continuous data with parametric or equivalent non-parametric tests including mixed linear models. For all quantitative outcomes a sample of 100 individuals per study group is required to achieve statistical power 0.8 at the 0.05 level of statistical significance (two-tailed) for the predicted effect size (Cohen’s d=0.4). This sample size will also provide sufficient power (80%) to detect a difference between treatments on the secondary dichotomous measure, remission of social anxiety disorder of 40% versus 60% at the 0.05 level of statistical significance (two-tailed).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2016
Actual
13/10/2016
Date of last participant enrolment
Anticipated
31/03/2020
Actual
27/03/2020
Date of last data collection
Anticipated
18/12/2020
Actual
18/12/2020
Sample size
Target
200
Accrual to date
Final
194
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13852 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 294179 0
Government body
Name [1] 294179 0
National Health and Medical Research Council
Country [1] 294179 0
Australia
Primary sponsor type
Individual
Name
Professor Ronald Rapee
Address
Department of Psychology
Macquarie University
Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 293007 0
None
Name [1] 293007 0
NA
Address [1] 293007 0
NA
Country [1] 293007 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295582 0
Macquarie University Human Research Ethics Committee (HREC (Medical Sciences))
Ethics committee address [1] 295582 0
Ethics committee country [1] 295582 0
Australia
Date submitted for ethics approval [1] 295582 0
12/05/2016
Approval date [1] 295582 0
01/06/2016
Ethics approval number [1] 295582 0
5201600388

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

Contacts
Principal investigator
Name 67282 0
Dr Lauren McLellan
Address 67282 0
Department of Psychology
Macquarie University
Macquarie University NSW 2109
Country 67282 0
Australia
Phone 67282 0
+61298501463
Fax 67282 0
+61298508062
Email 67282 0
lauren.mclellan@mq.edu.au
Contact person for public queries
Name 67283 0
Ronald Rapee
Address 67283 0
Department of Psychology
Macquarie University
Macquarie University NSW 2109
Country 67283 0
Australia
Phone 67283 0
+61 2 98508032
Fax 67283 0
+61298508062
Email 67283 0
ron.rapee@mq.edu.au
Contact person for scientific queries
Name 67284 0
Ronald Rapee
Address 67284 0
Department of Psychology
Macquarie University
Macquarie University NSW 2109
Country 67284 0
Australia
Phone 67284 0
+61298508032
Fax 67284 0
+61298508062
Email 67284 0
ron.rapee@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We did not obtain permission from individual participants to make their data publicly available


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
SourceTitleYear of PublicationDOI
EmbaseComparison of Transdiagnostic Treatment and Specialized Social Anxiety Treatment for Children and Adolescents With Social Anxiety Disorder: A Randomized Controlled Trial.2023https://dx.doi.org/10.1016/j.jaac.2022.08.003
N.B. These documents automatically identified may not have been verified by the study sponsor.