Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000325606
Ethics application status
Approved
Date submitted
5/03/2014
Date registered
26/03/2014
Date last updated
9/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an Early Intervention to Prevent Traumatic Stress Reactions in Young Injured Children and their Parents.
Scientific title
Prevention of Post Trauma Reactions in Young Injured Children and their Parents:A Randomised Control Trial of the Early Psychological Intervention in Children after Psychological Trauma (EPICAP).
Secondary ID [1] 284189 0
None
Universal Trial Number (UTN)
U1111-1154-0244
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder (PTSD) 291285 0
Anxiety 291286 0
Maladaptive Behaviour 291287 0
Unintentional traumatic injuries 291479 0
Condition category
Condition code
Mental Health 291639 291639 0 0
Anxiety
Injuries and Accidents 291640 291640 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves a screen-and-treat design. All eligible families will be screened approximately 1 week after the accident. Families who screen at 'high-risk' will then be randomly allocation to intervention or treatment as usual conditions. Families who screen at 'low-risk' will not need to participate in the intervention. However, these parents will be invited to fill in some brief questionnaires at 2 weeks and 6 months after the accident to monitor the progress of their child over this period.

The intervention will consist of 2 face-to-face sessions (60 min) and 2 follow-up calls or short follow-up face-to-face meetings (5-15 min), respectively. All sessions will be conducted with parents and with children participating when developmentally appropriate. Treatment Session 1 will begin approximately 2 weeks post accident. Follow-up phone-call 1 will be 3 days after Session 1. Session 2 will be conducted 1 week after Session 1 and follow-up call 2 will occur 4 weeks after Session 1.

The treatment will be conducted according to a manual that will specify the treatment procedures and timing. The first session aims to: (1) obtain the parent’s story about their child’s accident and medical treatment to normalise experiences and to convey empathy and understanding and to assess level of parental distress (2) provide psychoeducation materials to help parents understand and normalize their own reactions and to promote positive coping (3) provide psychoeducation materials to help parents to understand and normalize the reactions of their child and to identify signs that indicate risk for ongoing problems (4) provide parents with general coping strategies to prevent or manage their child’s distress (5) provide parents with a storybook (‘Max the brave’) to help them talk to their child about accident related experiences and to show how the character successfully copes with the experience (6) give children an Owl Toy “Lu Lu” that they can use for comfort and to feel brave in scary situations and (7) teach parents how to help their child to create an accurate story about the accident and medical treatment and to provide exposure to these memories. The second session aims to (1) educate and normalise how parenting behaviours and the parent-child relationship can change following a child’s accident and help parents to identify any unhelpful behaviours and discuss goals for change and (2) teach parents how to effectively manage their child’s traumatic stress reactions (i.e. Fear and avoidance, Separation anxiety, Tantrums, aggression and disobedience and Sleeping problems).
Intervention code [1] 288884 0
Prevention
Intervention code [2] 289046 0
Behaviour
Intervention code [3] 289049 0
Early detection / Screening
Comparator / control treatment
Treatment as usual: Treatment as usual consists of the social worker (SW) initiating contact with families to offer services. If problems are identified (i.e. parental guilt, distress, concerns regarding child coping, external stressors) the SW interventions would include: acknowledgement and normalisation of these concerns, reactions, feelings, psychoeducation around responses to injury, trauma, coping and adjustment and referrals to appropriate services if needed. SW will continue to follow-up with the family at the next appointment/s and further explore adjustment and coping if necessary. From there, if significant issues are present appropriate referrals are made. Occupational therapists (OTs) use social stories and medical play to help children prepare for medical procedures. They also provide psychoeducation on concerns parents may have related to sleeping and behaviour.
Control group
Active

Outcomes
Primary outcome [1] 291611 0
Child PTSD symptoms. This will be assessed using the PTSD module from the Diagnostic Infant Preschool Assessment (DIPA).
Timepoint [1] 291611 0
3 and 6 months post accident
Secondary outcome [1] 307159 0
Child emotional and behavioural distress. Total emotional and behavioural problems will be assessed using the Child Behavior Checklist 1/5-5 (CBCL/1.5-5). Separation Anxiety Disorder and Oppositional Behaviour Disorder will be assessed using the relevant modules on the Diagnostic Infant Preschool Assessment (DIPA).
Timepoint [1] 307159 0
3 and 6 months post accident
Secondary outcome [2] 307440 0
Child Health Related Quality of Life (HRQOL). HRQOL will be assessed using the TNO-AZL Preschool Children Quality of Life (TAPQOL)
Timepoint [2] 307440 0
3 and 6 months post accident
Secondary outcome [3] 307441 0
Parent PTSD symptoms. Parent PTSD symptoms will be assessed using the Posttraumatic Diagnostic Scale (PDS).
Timepoint [3] 307441 0
3 and 6 months post accident
Secondary outcome [4] 307442 0
Parent anxiety and depression. This will be assessed using the Depression Anxiety and Stress Scale (DASS-21).
Timepoint [4] 307442 0
3 and 6 months post injury
Secondary outcome [5] 307443 0
Changes in parenting stress levels. This will be assessed using the Parenting Stress Index (PSI).
Timepoint [5] 307443 0
3 and 6 months post injury
Secondary outcome [6] 307444 0
Wound healing. This will be assessed by using number of days till wound re-epithelialization.
Timepoint [6] 307444 0
3 and 6 months post burn.

Eligibility
Key inclusion criteria
(1) child is admitted to the Royal Children’s Hospital (RCH) Brisbane following an unintentional traumatic injury and (2) child is aged between 1-6 years.
Minimum age
1 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if (1) parents’ English is insufficient to complete interviews or questionnaires, (2) child has a Glasgow Coma Scale < 12, (3) injury was a result of suspected child abuse or neglect, and/or (4) child has a pervasive developmental disorder.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/04/2014
Actual
3/06/2014
Date of last participant enrolment
Anticipated
Actual
26/07/2016
Date of last data collection
Anticipated
Actual
16/01/2017
Sample size
Target
260
Accrual to date
Final
464
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 288835 0
Other
Name [1] 288835 0
Queensland Children's Medical Research Institute
Country [1] 288835 0
Australia
Primary sponsor type
University
Name
CONROD, University of Queensland
Address
Level 1 Edith Cavell Building
Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 287529 0
None
Name [1] 287529 0
Address [1] 287529 0
Country [1] 287529 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290675 0
QLD Children's Health Services (RCH) Human Research Ethics Committee
Ethics committee address [1] 290675 0
Ethics committee country [1] 290675 0
Australia
Date submitted for ethics approval [1] 290675 0
03/03/2014
Approval date [1] 290675 0
01/06/2014
Ethics approval number [1] 290675 0
HREC/14/QRCH/14

Summary
Brief summary
In Australia, accidental injury represents the most common type of traumatic event experienced by children under the age of 6 years. Recent research has shown that around 10-30% of young injured children will go on to develop chronic posttraumatic stress disorder (PTSD). Parents of injured children are also at risk of PTSD and this is associated with short and long-term consequences for their child’s physical and psychological recovery. PTSD is a complex and serious disorder that is associated with a range of adverse psychiatric and health outcomes; poorer adherence to medical treatment; reduced wound healing; diminished health-related quality of life; impaired parent-child relationships; and can significantly impact psychological, cognitive, social and neurobiological development. Despite the significance of this problem, to date, the mental health needs of injured young children have been neglected. One reason for this is due to the uncertainty and considerable debate around how to best provide early psychological intervention to traumatised children and adults. In particular, there are currently no published studies on early intervention for young traumatised children. The proposed research therefore aims to evaluate the effectiveness and feasibility of a screening and indicated prevention program for injured young children (1-6 years) and their parents. The study will employ a randomised control trial design and children who are screened as ‘high-risk’ for PTSD and their parents will be randomised to either (1) 2-session face-to-face child and family focused intervention or (2) treatment as usual. Assessment will be completed at baseline (2 weeks), 3 and 6 months post injury. The development, evaluation and dissemination of effective indicated prevention programs for young children and parents have the potential for enormous national and international benefit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46574 0
Dr Alexandra De Young
Address 46574 0
CONROD
Level 1 Edith Cavell Building
Herston, QLD, 4029
Country 46574 0
Australia
Phone 46574 0
61 7 3346 4890
Fax 46574 0
61 7 3346 5289
Email 46574 0
adeyoung@uq.edu.au
Contact person for public queries
Name 46575 0
Dr Alexandra De Young
Address 46575 0
CONROD
Level 1 Edith Cavell Building
Herston, QLD, 4029
Country 46575 0
Australia
Phone 46575 0
61 7 3346 4890
Fax 46575 0
Email 46575 0
adeyoung@uq.edu.au
Contact person for scientific queries
Name 46576 0
Dr Alexandra De Young
Address 46576 0
CONROD
Level 1 Edith Cavell Building
Herston, QLD, 4029
Country 46576 0
Australia
Phone 46576 0
61 7 3346 4890
Fax 46576 0
Email 46576 0
adeyoung@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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePreventive intervention for trauma reactions in young injured children: results of a multi-site randomised controlled trial.2020https://dx.doi.org/10.1111/jcpp.13193
EmbaseScreening for PTSD and functional impairment in trauma-exposed young children: evaluation of alternative CBCL-PTSD subscales.2022https://dx.doi.org/10.1007/s10862-022-09985-5
EmbaseCoping with Accident Reactions (CARE) early intervention programme for preventing traumatic stress reactions in young injured children: Study protocol for two randomised controlled trials.2016https://dx.doi.org/10.1186/s13063-016-1490-2
N.B. These documents automatically identified may not have been verified by the study sponsor.