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Trial registered on ANZCTR


Registration number
ACTRN12619001541190
Ethics application status
Approved
Date submitted
20/09/2019
Date registered
8/11/2019
Date last updated
8/11/2019
Date data sharing statement initially provided
8/11/2019
Date results provided
8/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a family-focused cognitive-behaviour therapy relative to treatment as usual for anxiety-disordered children and adolescents.
Scientific title
Effectiveness of a family-focused, cognitive-behaviour relative to treatment as usual for anxiety-disordered children and adolescents.
Secondary ID [1] 298576 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 313417 0
Condition category
Condition code
Mental Health 311852 311852 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study compared 2 experimental conditions, namely (1) treatment as usual at the Mater Day Program; and (2) treatment as usual plus the family-oriented CBT anxiety intervention (further details below). The family-oriented CBT intervention was offered in alternating terms to enable quasi-randomisation. All families who attended the Day Program with a child (aged 6 - 18) who met criteria for an anxiety diagnosis on the parent version of the Anxiety Disorders Interview Schedule for Children (ADIS-C; Silverman and Nelles, 1988) with a severity level of 4 or greater were invited to participate in the study.

Day Program staff were trained in administration of the ADIS-C by the principal investigator, who had extensive experience with the interview and numerous teaching videos which were used in the training. 20% of all interviews were videotaped and judged independently to determine inter-rater reliability for pre-treatment diagnoses.

Attendance was monitored informally by clinicians, however, adherence was not consistently monitored throughout the intervention (identified limitation).

Families were randomly assigned to one of the two treatment condition based on the term in which the patient began in the Day Program. Families in the treatment as usual condition received the treatment that all Day Program patients routinely receive. This typically incorporated a combination of case management sessions, individual therapy sessions, parent support sessions, family therapy sessions, and a program of group work for the patient.

Families in the family-oriented CBT condition received all of the abovementioned TAU services, in addition to the 'Do as I do' (Cobham, 2006) parent-focused programme and the 'Facing your Fears' (Cobham, 2006a) child/adolescent-focused programme. The FCBT intervention was delivered in parallel to TAU (however TAU extended beyond the 12-week CBT intervention). Both the 'Do As I Do' and 'Facing Your Fears' programmes are manualised programs which have been evaluated in prior efficacy trials. In these programs, parents and children are given workbooks that are used in session and for home-based tasks. The family-oriented CBT intervention consisted of weekly face-to-face groups which were facilitated at the Day Program at the Mater Children's Hospital in Brisbane, Queensland. The intervention programme consisted of 12 weekly sessions, with each session lasting 60-90 minutes. The first 6 sessions were devoted to teaching parents the basic cognitive behavioural principles of anxiety management, as well as strategies for managing their children's anxiety. The subsequent 6 sessions focused on teaching children and adolescents cognitive behavioural principles for managing their own anxiety (focusing on exposure to address anxious avoidance and a "scientific approach" to evaluating the validity of anxiety-provoking thoughts). Approximately 1-month post-intervention, children were invited to return for a booster session where strategies and skills learned within the family intervention were collaboratively reviewed and areas of concern were addressed using cognitive-behavioural strategies. Each booster session lasted for 60 - 90 minutes.

The intervention was facilitated by the Principal Investigator (Clinical Psychologist) and one other Day Program staff member who was trained in the treatment of complex mental health conditions in child and adolescent populations.
Intervention code [1] 314836 0
Treatment: Other
Comparator / control treatment
Families in the treatment as usual condition received the treatment that all Day Program patients routinely receive, being treatment-as-usual (TAU). This typically incorporated a combination of case management sessions, individual therapy sessions, parent support sessions, family therapy sessions, and a program of group work for the patient.
Control group
Active

Outcomes
Primary outcome [1] 320605 0
Change in diagnostic status as assessed by the ADIC-C.
Timepoint [1] 320605 0
There will be three time-points: immediately post intervention (primary endpoint), 6-months post intervention, and 12-months post intervention.
Secondary outcome [1] 372177 0
Change in children's self-reported anxiety as assessed by the Revised Children's Manifest Anxiety Scale (RCMAS).
Timepoint [1] 372177 0
Immediately post-intervention, 6-month post-intervention and 12-month post-intervention.
Secondary outcome [2] 372178 0
Change in parental reports of their children's overall level of functional impairment as measured on the Columbia Impairment Scale (CIS).
Timepoint [2] 372178 0
Immediately post-intervention, 6-month post-intervention and 12-month post-intervention.
Secondary outcome [3] 372179 0
Change in parental reports of their children's symptoms of anxiety as measured by the Child Behaviour Checklist Internalising raw score (CBCL Int.).
Timepoint [3] 372179 0
Immediately post-intervention, 6-months post-intervention, and 12-month post-intervention.
Secondary outcome [4] 375991 0
Change in children's self-reported anxiety as assessed by the Spence Children's Anxiety Scale (SCAS)
Timepoint [4] 375991 0
Immediately post-intervention, 6-months post-intervention and 12-months post-intervention.
Secondary outcome [5] 375993 0
Change in children's self-reported depression as assessed by the Child Depression Inventory - Short form (CDI-S).
Timepoint [5] 375993 0
Immediately post-intervention, 6-months post-intervention and 12-months post-intervention.

Eligibility
Key inclusion criteria
All children and adolescents aged 6-18 years who met criteria for an anxiety diagnosis (on the parent version of the ADIS-C) with a severity level of 4 or greater, and their parents, were invited to participate in the project. The anxiety disorder was not required to be the patient's primary diagnosis, rather a significant component of their overall presentation. Indeed, almost 75% of participants met criteria for secondary, non-anxiety diagnosis.
Minimum age
6 Years
Maximum age
62 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The sole exclusion criterion was if the patient had potential for adverse consequences, specifically, if the patients' case manager deemed them to be at risk of being adversely effected by participation in the anxiety group (which required a relatively stable and low average to average level of cognitive functioning). Examples of such patients may include intellectually impaired or actively psychotic young people.

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)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Participants were quasi-randomly assigned to received either treatment as usual (TAU) or TAU in combination with a family-oriented anxiety intervention based on the term within which they began in the Mater Day Program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Chi square analysis of association to assess the relationship between treatment condition and remission of anxiety diagnosis at pre-post, 6-month, and 12-month post intervention.
Mixed factorial ANOVA using repeated measures were completed for the analysis of all continuous variables.
Completer and intention-to-treat analyses were conducted to deal with missing data due to drop-out or incompleteness.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/02/2002
Date of last participant enrolment
Anticipated
Actual
20/03/2009
Date of last data collection
Anticipated
Actual
6/04/2009
Sample size
Target
40
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14404 0
Mater Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 27413 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 303115 0
Hospital
Name [1] 303115 0
Mater Child and Youth Mental Health Service
Country [1] 303115 0
Australia
Primary sponsor type
Hospital
Name
Mater Child and Youth Mental Health Service
Address
Mater Child & Youth Mental Health Service
Management and Service Development Unit
Level 2, Mater Community Services Building, Annerley Road,
South Brisbane, Queensland 4101 Australia
Country
Australia
Secondary sponsor category [1] 303111 0
None
Name [1] 303111 0
Address [1] 303111 0
Country [1] 303111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303668 0
Mater Misericordiae Ltd HREC
Ethics committee address [1] 303668 0
Ethics committee country [1] 303668 0
Australia
Date submitted for ethics approval [1] 303668 0
Approval date [1] 303668 0
07/02/2002
Ethics approval number [1] 303668 0
469C
Ethics committee name [2] 304075 0
The University of Queensland Human Ethics Research Committee A & B
Ethics committee address [2] 304075 0
Ethics committee country [2] 304075 0
Australia
Date submitted for ethics approval [2] 304075 0
31/05/2019
Approval date [2] 304075 0
04/06/2019
Ethics approval number [2] 304075 0
2019001320

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

Contacts
Principal investigator
Name 94434 0
A/Prof Vanessa Cobham
Address 94434 0
Level 4
School of Psychology
Faculty of Health and Behavioural Sciences
University of Queensland
St Lucia
QLD, 4072
Country 94434 0
Australia
Phone 94434 0
+61 7334 69911
Fax 94434 0
Email 94434 0
vanessa@psy.uq.edu.au
Contact person for public queries
Name 94435 0
Vanessa Cobham
Address 94435 0
Level 4,
School of Psychology
Faculty of Health and Behavioural Sciences
University of Queensland
St Lucia
QLD, 4072
Country 94435 0
Australia
Phone 94435 0
+61 7334 69911
Fax 94435 0
Email 94435 0
vanessa@psy.uq.edu.au
Contact person for scientific queries
Name 94436 0
Vanessa Cobham
Address 94436 0
Level 4,
School of Psychology
Faculty of Health and Behavioural Sciences
University of Queensland
St Lucia
QLD, 4072
Country 94436 0
Australia
Phone 94436 0
+61 7334 69911
Fax 94436 0
Email 94436 0
vanessa@psy.uq.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


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.