Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001089325
Ethics application status
Approved
Date submitted
18/07/2017
Date registered
27/07/2017
Date last updated
27/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treating Post-traumatic stress disorder (PTSD) in Lockyer Valley youth following the 2011 Queensland floods
Scientific title
An evaluation of a cognitive-behavioural protocol with a trauma focus in the treatment of PTSD among children and adolescents living in the Lockyer Valley following the 2011 Queensland flood disaster.
Secondary ID [1] 292455 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PTSD 304067 0
Anxiety disorders 304068 0
Depression 304069 0
Condition category
Condition code
Mental Health 303400 303400 0 0
Anxiety
Mental Health 303401 303401 0 0
Depression
Mental Health 303403 303403 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The intervention evaluated was a cognitive-behavioural manualized intervention with a trauma focus ("My story of the floods", Cobham & McDermott, 2011). It consisted of 2 parent/caregiver sessions (1.5 hours duration each), followed by up to 8 individually administered child/adolescent sessions (1.5 hours duration each). Within the 8 child/adolescent sessions, there was an optional session (focusing on grief) which the majority of children did not require. A brief (~30 minutes) booster session was offered between 2 and 4 weeks after the completion of the intervention. All children were provided with a therapy workbook. The intervention was delivered by therapists who were either Clinical Psychology trainees completing a partial externship on this project under the supervision of Dr. Cobham, or experienced mental health clinicians (clinical psychologists and one psychiatrist - all with more than 5 years experience). All therapists completed training in the manualized protocol, delivered by Dr. Cobham. Treatment was conducted at children's schools in a face to face format. Sessions were weekly over a 12-14 week period (including the booster session). Only the trauma narrative component of each session was routinely recorded, however, each child's workbook was photocopied, so some measure of treatment adherence will be able to be extrapolated from this.
Intervention code [1] 298681 0
Early Detection / Screening
Comparator / control treatment
No control group - this evaluation was conducted in the context of a state government public health initiative.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302785 0
Diagnostic outcomes as measured using the Anxiety Disorders Interview Schedule for Children - specifically, the % of children free of PTSD.
Timepoint [1] 302785 0
Post-treatment (completed after the booster session), ~ 4 weeks after the final active treatment session.
Primary outcome [2] 302804 0
Diagnostic outcomes - specifically % of children free of other comorbid conditions met at pre-treatment. This was assessed using the Anxiety Disorders Interview Schedule for Children (ADIS-C-IV).
Timepoint [2] 302804 0
Diagnostic interview completed at post-treatment (primary time point). Also completed at 6 and 12 months following completion of treatment.
Secondary outcome [1] 336996 0
Youth self-report questionnaires - specifically, the Posttraumatic Stress Reaction Index (PTSD-RI).
Timepoint [1] 336996 0
Questionnaires were administered post-treatment, 6-months after the completion of treatment and 12 months after the completion of treatment.
Secondary outcome [2] 337075 0
Youth self-report questionnaires - specifically, the Spence Children's Anxiety Scale (SCAS).
Timepoint [2] 337075 0
Post-treatment and 6 and 12 months following completion of treatment.
Secondary outcome [3] 337317 0
Youth self-report questionnaires - specifically, the Children's Depression Inventory - Short Version (CDI-S).
Timepoint [3] 337317 0
Post treatment, and 6- and 12-months following completion of treatment.

Eligibility
Key inclusion criteria
Children who received the evaluated intervention were part of the 2011 Queensland Child and Youth Disaster Response, the overarching public health initiative funded by the Federal government, under which this intervention was delivered and evaluated.
Eligible youth were those living in disaster affected areas in the Lockyer Valley of Queensland, Australia during the floods of January 2011. Eligible youth had parental consent to participate in a 2-stage screening process which was conducted in their schools. Eligible youth had to have proceeded to the second stage of screening (the diagnostic interview) and to have met criteria for flood-related PTSD on the diagnostic interview in order to be included in the intervention.
Minimum age
7 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Youth were excluded if their parents/caregivers did not consent for them to participate in treatment; if they did not meet criteria on the diagnostic interview for flood-related PTSD; or if they had a pre-existing trauma history that indicated that more intensive treatment might be required.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Timing
Prospective
Statistical methods / analysis
This trial was an open, uncontrolled evaluation of a cognitive-behavioural, trauma-focused manualized intervention. Treatment was offered in the context of a larger public health service initiative following the 2011 Queensland floods. It was not intended as a piece of research. No power calculations were conducted. Children and adolescents who required treatment were all offered the manualized intervention, and their outcomes were evaluated.
Outcome data have been examined in a preliminary fashion only at this point.
Primary outcomes (diagnostic status) will be examined using chi square analyses. Secondary outcomes (questionnaire data) will be examined using repeated measures ANOVAs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/04/2011
Date of last participant enrolment
Anticipated
Actual
29/07/2011
Date of last data collection
Anticipated
Actual
19/12/2012
Sample size
Target
10
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 16649 0
4347 - Grantham
Recruitment postcode(s) [2] 16650 0
4347 - Ma Ma Creek
Recruitment postcode(s) [3] 16651 0
4347 - Mount Whitestone
Recruitment postcode(s) [4] 16652 0
4352 - Murphys Creek
Recruitment postcode(s) [5] 16653 0
4341 - Laidley
Recruitment postcode(s) [6] 16654 0
4352 - Withcott

Funding & Sponsors
Funding source category [1] 297023 0
Government body
Name [1] 297023 0
Queensland Health
Country [1] 297023 0
Australia
Primary sponsor type
Individual
Name
Vanessa Cobham
Address
School of Psychology
University of Queensland
St. Lucia, 4067, Queensland,
Australia.
Country
Australia
Secondary sponsor category [1] 296022 0
Individual
Name [1] 296022 0
Brett McDermott
Address [1] 296022 0
School of Medicine and Dentistry,
James Cook University,
1 James Cook Drive, Townsville, QLD 4811
Country [1] 296022 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298208 0
Royal Children's Hospital HREC, Brisbane, Queensland
Ethics committee address [1] 298208 0
At the time of application, this HREC was based at the Royal Children's Hospital (RCH), then located in Herston, Brisbane.
Herston Road, Herston, QLD, 4006.
The RCH was merged with the Mater Children's Hospital (MCH) in 2014, resulting in a new hospital and health service - Children's Health Queensland (CHQ) with a new HREC (CHQ).
Ethics committee country [1] 298208 0
Australia
Date submitted for ethics approval [1] 298208 0
10/11/2011
Approval date [1] 298208 0
14/11/2011
Ethics approval number [1] 298208 0
HREC/11/QRCH/153

Summary
Brief summary
The TraumaFocused Cognitive Behavioural Therapy (TF-CBT) manualized protocol is a component of the QLD Health child and adolescent mental health stepped care response to the 2011 flood and cyclone disasters. This intervention is only being offered to children identified through a two stage screening process as experiencing a posttraumatic mental health problem following the 2011 QLD disasters. The protocol consists of 2 parent sessions
and 8 sessions of individual therapy with children. Sessions are conducted in children’s schools during school hours in order to minimize the inconvenience experienced by families.
The followup assessments (to be conducted posttreatment, 6 and 12 months following completion of treatment) consist of the same tools used to identify children in the first instance through screening. These consist of the Spence Children's Anxiety Scale, the UCLA PTSDReaction Index, the Children's Depression Inventory, and the Anxiety Disorders Interview Schedule for Children (parent and child versions).
The broad aims of the intervention are to improve parents’ confidence and competence in managing their children’s posttraumatic mental health problems; and to reduce children’s symptomatology. TF-CBT has the strongest evidence base of any psychological therapy with children experiencing posttraumatic mental health problems.
Trial website
Trial related presentations / publications
Cobham, V.E., & McDermott, B. (2013). “My Story of the Flood”: Piloting a trauma-focused CBT protocol with youth experiencing PTSD following a natural disaster. Paper presented at the World Congress of Behavioural and Cognitive Therapies, Lima, Peru.
Public notes
The children referred to in this application received an intervention because they were part of the Statewide Child and Youth Disaster Response following the 2011 QLD floods. We are seeking to retrospectively register this evaluation in order to be able to publish the outcomes and contribute to the very small body of research examining children's mental health post-disaster. It is important to stress that the intervention (and evaluation of same) were delivered as part of the wider disaster response.

Contacts
Principal investigator
Name 76342 0
Dr Vanessa Cobham
Address 76342 0
School of Psychology,
University of Queensland,
St. Lucia, Queensland, 4067
Country 76342 0
Australia
Phone 76342 0
+61 7 33469911
Fax 76342 0
Email 76342 0
[email protected]
Contact person for public queries
Name 76343 0
Dr Vanessa Cobham
Address 76343 0
School of Psychology,
University of Queensland,
St. Lucia, Queensland, 4067
Country 76343 0
Australia
Phone 76343 0
+61 7 33469911
Fax 76343 0
Email 76343 0
[email protected]
Contact person for scientific queries
Name 76344 0
Dr Vanessa Cobham
Address 76344 0
School of Psychology,
University of Queensland,
St. Lucia, Queensland, 4067
Country 76344 0
Australia
Phone 76344 0
+61 7 33469911
Fax 76344 0
Email 76344 0
[email protected]

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

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