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Trial registered on ANZCTR


Registration number
ACTRN12612000351819
Ethics application status
Approved
Date submitted
23/03/2012
Date registered
27/03/2012
Date last updated
29/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An Evaluation of Stepped Care for Child Anxiety
Scientific title
A Randomised Controlled Trial of Standard Care versus Stepped Care for Children and Adolescents with Anxiety Disorders
Secondary ID [1] 280204 0
Nil
Universal Trial Number (UTN)
U1111-1129-3972
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 286144 0
Condition category
Condition code
Mental Health 286338 286338 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stepped Care: consist of 3 treatment steps. Participants and their parents in this condition will first receive the least intensive intervention followed by more intensive interventions if required. Step 1 will involve completion of the validated self-help program Helping your Anxious Child (primary school participants) or Cool Teens (high school participants). The program will be available in both online and workbook formats and consists of 10 modules each taking 30-90 minutes to complete. A period of 12 weeks is allocated for completion of the self-help program during which time families will receive 4, 30 minute contacts with a CBT therapist (by telephone or email self-selected by families). Based on our previous work, scheduled sessions will involve checking of progress, motivational prompts, and assistance with difficulties Therapists will also be available for client-initiated contact between sessions. Step 2 will involve the same program and treatment length as offered in standard care. Step 3 will involve an intensive intervention for treatment non-responders. This is a 12x 50 minute session individual program, held weekly over a 12 week period, for children/adolescents and their primary caregiver with content based on a functional assessment of barriers and limitations to the previous treatment. It continues skills from the Cool Kids program in a more intensive fashion, incorporates motivational features and has a strong focus on parenting factors and parent-child interaction. Sessions in step 3 are conducted by clinical psychologists or clinical psychology interns.
Intervention code [1] 284533 0
Treatment: Other
Intervention code [2] 284534 0
Behaviour
Comparator / control treatment
Standard Care: 10x 50 minute individual sessions attended by the child/adolescent and their primary caregiver over a 12 week period. Treatment is implemented by psychologists, clinical psychologists and psychology interns using the manualised Cool Kids Anxiety Management Program.
Control group
Active

Outcomes
Primary outcome [1] 286804 0
Changes in diagnostic status and severity according to the Anxiety Disorders Interview Schedule
Timepoint [1] 286804 0
Pre treatment compared to one year after randomisation
Secondary outcome [1] 296699 0
Changes on self and primary caregiver report measure:
Spence Children's Anxiety Scale
Timepoint [1] 296699 0
Pre treatment compared to 14, 27, 40 and 52 weeks after randomisation
Secondary outcome [2] 296737 0
Changes on self and primary caregiver report measure:
Short Mood and Feelings Questionnaire
Timepoint [2] 296737 0
Pre treatment compared to 14, 27, 40 and 52 weeks after randomisation
Secondary outcome [3] 296738 0
Changes on self and primary caregiver report measure:
Strengths and Difficulties Questionnaire
Timepoint [3] 296738 0
Pre treatment compared to 14, 27, 40 and 52 weeks after randomisation
Secondary outcome [4] 296739 0
Changes on self and primary caregiver report measure:
Diagnostic Interview Schedule for Children IV
Timepoint [4] 296739 0
Pre treatment compared to 14, 27, 40 and 52 weeks after randomisation
Secondary outcome [5] 296741 0
Changes on self and primary caregiver report measure:
Child Anxiety Life Interference Scale
Timepoint [5] 296741 0
Pre treatment compared to 14, 27, 40 and 52 weeks after randomisation
Secondary outcome [6] 296742 0
Self and primary caregiver report of resource use since last assessment
Timepoint [6] 296742 0
Pre treatment, 14, 27, 40 and 52 weeks after randomisation

Eligibility
Key inclusion criteria
Primary Anxiety Disorder in Child/Adolescent
(No criteria for parents)
Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Life-threatening suicidal ideation or self harm
At risk due to abuse or neglect
Current psychological treatment elsewhere
Significant intellectual impairment
Unmanaged psychotic symptoms

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 concealment involves contacting the holder of the allocation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2012
Actual
27/05/2013
Date of last participant enrolment
Anticipated
Actual
10/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
281
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284955 0
Government body
Name [1] 284955 0
National Health and Medical Research Council
Country [1] 284955 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 283826 0
None
Name [1] 283826 0
Address [1] 283826 0
Country [1] 283826 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286965 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 286965 0
Ethics committee country [1] 286965 0
Australia
Date submitted for ethics approval [1] 286965 0
09/04/2012
Approval date [1] 286965 0
30/09/2012
Ethics approval number [1] 286965 0
5201200208
Ethics committee name [2] 294700 0
Departmental Ethics Committee - Dept of Health & Aging
Ethics committee address [2] 294700 0
Ethics committee country [2] 294700 0
Australia
Date submitted for ethics approval [2] 294700 0
Approval date [2] 294700 0
08/01/2013
Ethics approval number [2] 294700 0
20/2012

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

Contacts
Principal investigator
Name 33969 0
Prof Ronald Rapee
Address 33969 0
Dept of Psychology
Macquarie University
Sydney. NSW. 2109
Country 33969 0
Australia
Phone 33969 0
61 2 9850 8032
Fax 33969 0
Email 33969 0
Ron.Rapee@mq.edu.au
Contact person for public queries
Name 17216 0
Heidi Lyneham
Address 17216 0
Department of Psychology
Macquarie University
North Ryde
NSW 2109
Country 17216 0
Australia
Phone 17216 0
+61298509433
Fax 17216 0
Email 17216 0
heidi.lyneham@mq.edu.au
Contact person for scientific queries
Name 8144 0
Ron Rapee
Address 8144 0
Department of Psychology
Macquarie University
North Ryde
NSW 2109
Country 8144 0
Australia
Phone 8144 0
+61298508032
Fax 8144 0
Email 8144 0
ron.rapee@mq.edu.au

No information has been provided regarding IPD availability


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
EmbaseEconomic evaluation of stepped care for the management of childhood anxiety disorders: Results from a randomised trial.2019https://dx.doi.org/10.1177/0004867418823272
EmbaseLow intensity treatment for clinically anxious youth: a randomised controlled comparison against face-to-face intervention.2021https://dx.doi.org/10.1007/s00787-020-01596-3
N.B. These documents automatically identified may not have been verified by the study sponsor.