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Trial registered on ANZCTR


Registration number
ACTRN12611000902998
Ethics application status
Approved
Date submitted
23/08/2011
Date registered
24/08/2011
Date last updated
24/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treating children with post-traumatic stress disorder (PTSD) following an accidental injury
Scientific title
Treating children who have clinical or sub-clinical PTSD following an accidental or unintentional injury (e.g., car accident, sporting injury) with trauma focused cognitive behavioural therapy for children and their parents.
Secondary ID [1] 262844 0
Current Controlled Trials ISRCTN79049138
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical and sub-clinical levels of posttraumatic stress disorder as identified by the DSM TR IV. 270564 0
Condition category
Condition code
Mental Health 270729 270729 0 0
Anxiety
Injuries and Accidents 270812 270812 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children were screened with the Child Trauma Screening Questionnaires following their accidental injury and 1 month post to determine whether they are at high risk for post-traumatic stress symptoms. If high risk they are then further assessed for PTSD via the Clinically Administered PTSD Scale for children (CAPS-CA). If a clinical or sub-clinical diagnosis is apparent the child and parent are then invited to participate in the intervention stage of the trial. The intervention consists of 2 integrated but distinct programs - one for parents ("My child and the accident: A story with a good ending") and one for children/adolescents ("Me and the accident: A story with a good ending"), developed by Vanessa Cobham, Peta Lilley, Justin Kenardy, Sue Spence and Brett McDermott in 2007. Both programs are based on trauma focused cognitive behavioural theory and strategies as well as a strength based resilience building approach. The intervention will be delivered via 2 conditions; child-focussed over 6X1.5 hour individual sessions (6 weeks) and family-focused (parent and child) over 10X1.5 hour individual sessions (4 parent, 6 child; 10 weeks).
Intervention code [1] 269194 0
Early detection / Screening
Intervention code [2] 269200 0
Treatment: Other
Intervention code [3] 269263 0
Diagnosis / Prognosis
Comparator / control treatment
The control condition is an active waitlist group. Following assessment the families are randomised into the intervention or waitlist condition. On allocation the waitlist families are notified of their condition. Those in the waitlist group will be monitored and assessed. Following a 10 week wait (max intervention time), the families will be reassessed and invited to receive therapy if necessary (i.e., still presenting with clinical or sub-clinical levels of PTSD).
Control group
Active

Outcomes
Primary outcome [1] 269432 0
Loss of PTSD diagnosis as measured by the Clinically Administered PTSD Scale for Children (CAPS-CA). This is semi-structured interview delivered to children
Timepoint [1] 269432 0
The CAPS is used at 4 assessment time points; 6 weeks post accident (pre treatment), post treatment, 6 months post treatment and 12 months post treatment.
Secondary outcome [1] 287630 0
Child trauma symptoms as assess by the Child Trauma Screening Questionnaire (CTSQ)
Timepoint [1] 287630 0
at 2 weeks post accident and pre treatment.
Secondary outcome [2] 287631 0
Child PTSD symptom scale (CPSS)
Timepoint [2] 287631 0
at pre-treatment, mid treatment, post treatment, 6 months post treatment and 12 months post treatment.
Secondary outcome [3] 287632 0
General anxiety as assessed by the Spence Child Anxiety Scale (SCAS)
Timepoint [3] 287632 0
at pre treatment, post treatment, 6 months post treatment and 12 months post treatment.
Secondary outcome [4] 287633 0
Depression assessed by the Child Depression Inventory - Short Version (CDI-S)
Timepoint [4] 287633 0
at pre treatment, post treatment, 6 months post treatment and 12 months post treatment.
Secondary outcome [5] 287634 0
Quality of Life as assess by the Pediatric Quality of Life Inventory (Peds QL)
Timepoint [5] 287634 0
at pre treatment, post treatment, 6 months post treatment and 12 months post treatment
Secondary outcome [6] 287635 0
Parental report of their own depression and anxiety assessed by the Depression Anxiety and Stress Scale (DASS)
Timepoint [6] 287635 0
pre treatment, post treatment, 6 months post treatment and 12 months post treatment
Secondary outcome [7] 287636 0
General levels of parental anxiety as measured by the State Trait Anxiety Inventory (STAI)
Timepoint [7] 287636 0
pre treatment, post treatment, 6 months post treatment and 12 months post treatment
Secondary outcome [8] 287637 0
Child emotional and behavioural state as measured by the parents via the Child Behaviour Checklist (CBCL)
Timepoint [8] 287637 0
at pre treatment, post treatment, 6 months post treatment and 12 months post treatment
Secondary outcome [9] 287638 0
Paediatric quality of life as measured by the parents assessed by the parent version of the Pediatric Quality of LIfe Inventory
Timepoint [9] 287638 0
at pre treatment, post treatment, 6 months post treatment and 12 months post treatment
Secondary outcome [10] 287639 0
Parental posttraumatic stress as measured by the Posttraumatic Stress Diagnostic Scale (PDS)
Timepoint [10] 287639 0
at pre treatment, mid treatment, post treatment, 6 months post treatment and 12 months post treatment

Eligibility
Key inclusion criteria
Admitted to either the Emergency Department or the wards following an accidental or unintentional injury
Admitted overnight
Endorsment of CTSQ items indicating 'at-risk' status within 2 weeks of admission
Clinical or sub-clinical diagnosis of PTSD as identified via the CAPS-CA
Minimum age
7 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents english insufficient to complete questionnaires
Developmental delay or mental retardation in the child
Moderate to severe head injury or post traumatic amnesia following the accident
Severe depression or suicide risk in the child
Alcohol, substance abuse or psychosis in the caregiver
Child under the care of the Department of Child Safety
Injury due to physical or sexual abuse

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 to the intervention was randomised and concealed. The allocation was centrally randomised by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation is determined using a computer program which generates a list of random numbers and allocation to one of the three conditions
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
Recruiting
Date of first participant enrolment
Anticipated
6/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4358 0
4069
Recruitment postcode(s) [2] 4401 0
4101
Recruitment postcode(s) [3] 4359 0
5001

Funding & Sponsors
Funding source category [1] 269664 0
Government body
Name [1] 269664 0
National Health and Medical Research Council
Country [1] 269664 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia QLD 4067
Country
Australia
Secondary sponsor category [1] 266701 0
University
Name [1] 266701 0
Flinders University
Address [1] 266701 0
Sturt Road, Bedford Park 5042
Adelaide, SA
Country [1] 266701 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269617 0
Royal Children's Hospital
Ethics committee address [1] 269617 0
Herston Rd, Herston, 4069, QLD
Ethics committee country [1] 269617 0
Australia
Date submitted for ethics approval [1] 269617 0
Approval date [1] 269617 0
Ethics approval number [1] 269617 0
HREC/09/QRCH/41
Ethics committee name [2] 269618 0
Children Youth and Women's Health Services
Ethics committee address [2] 269618 0
77 King William Road
North Adelaide SA 5006
Ethics committee country [2] 269618 0
Australia
Date submitted for ethics approval [2] 269618 0
Approval date [2] 269618 0
Ethics approval number [2] 269618 0
REC2149/2/2112
Ethics committee name [3] 269619 0
The Mater Health Service
Ethics committee address [3] 269619 0
Raymond Terrace, South Brisbane Qld 4101
Ethics committee country [3] 269619 0
Australia
Date submitted for ethics approval [3] 269619 0
Approval date [3] 269619 0
Ethics approval number [3] 269619 0
protocol number 1305C

Summary
Brief summary
Very little research has examined the potential interventions for the treatment of post-traumatic stress disorder in children following accidental injury. This trial aims to evaluate and compare child only and child plus parent versions of a cognitive-behavioural early intervention. It is hypothesised that children within the treatment conditions will significantly reduce in their post-trauma symptoms compared to those children who do not receive any therapeutic intervention. Furthermore, it is hypothesised that children in the child plus parent condition will reduce in their post-trauma symptoms at a greater rate than those children who receive the intervention without parental assistance.

The principal clinical question under investigation is the efficacy of an early, trauma-focused cognitive-behavioural intervention for the treatment of PTSD in children following accidental injury. Specifically, we compare the efficacy of two active treatments (child-focused and family-focused CBT) and a waitlist control (no therapy) to determine which is associated with greater reductions in psychological and health-related outcome measures over time. The primary outcome will be a reduction in trauma symptoms on a diagnostic interview in the active treatments compared to the waitlist control and greater reductions in the family- compared to the child-focused condition. In doing so, this project will also trial a method of stepped screening and assessment to determine those children requiring early intervention for PTSD following accidental injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33023 0
Address 33023 0
Country 33023 0
Phone 33023 0
Fax 33023 0
Email 33023 0
Contact person for public queries
Name 16270 0
Professor Justin Kenardy
Address 16270 0
Centre of National Research on Disability and Rehabilitation Medicine
Level 1, Edith Cavell Building
Royal Brisbane and Women's Hospital
Herston, 4029 QLD
Country 16270 0
Australia
Phone 16270 0
+61 07 3365 5560
Fax 16270 0
+61 07 3346 4603
Email 16270 0
j.kenardy@uq.edu.au
Contact person for scientific queries
Name 7198 0
Professor Justin Kenardy
Address 7198 0
Centre of National Research on Disability and Rehabilitation Medicine
Level 1, Edith Cavell Building
Royal Brisbane and Women's Hospital
Herston, 4029 QLD
Country 7198 0
Australia
Phone 7198 0
+61 7 3365 5560
Fax 7198 0
+61 07 3346 4603
Email 7198 0
j.kenardy@uq.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

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