Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000914167
Ethics application status
Approved
Date submitted
31/05/2019
Date registered
28/06/2019
Date last updated
28/06/2019
Date data sharing statement initially provided
28/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of Coping with Accident REactions (CARE) screen and-treat early intervention for improving recovery from trauma reactions in young injured children and their parents
Scientific title
Pragmatic Randomised Control Trial of the Coping with Accident REactions (CARE) screen and-treat early intervention for facilitating faster recovery from acute traumatic stress reactions in young injured children and their parents
Secondary ID [1] 295722 0
None
Universal Trial Number (UTN)
U1111-1218-4830
Trial acronym
CARE pRCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 309116 0
Injury 309117 0
Posttraumatic Stress Disorder 313398 0
Condition category
Condition code
Mental Health 307993 307993 0 0
Other mental health disorders
Injuries and Accidents 307994 307994 0 0
Burns
Injuries and Accidents 311916 311916 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CARE intervention consists of a 2 session manualised treatment protocol, with Session 1 providing (1) psychoeducation to normalise parent and child reactions, (2) coping strategies to manage distress, and (3) resources to help parents and children develop an accurate narrative about the accident and medical treatment. Session 2 consists of (1) monitoring child and parent distress; (2) educating how parenting and parent-child relationships can change following an accident, helping parents identify unhelpful behaviours and discuss goals for change; and (3) teaching parents how to manage their child’s symptoms. The sessions are conducted following the baseline diagnostic assessment approximately 2-4 weeks post injury. Sessions are 45-60 minutes in duration and conducted 1 week apart. A brief follow-up phone session at 6-weeks is offered to check in with families and provide referral information if needed. Resources developed for the intervention include information booklets, Max the Brave (a storybook about a boy who goes to hospital after an injury), LuLu the Owl toy, and a personal storybook template.

In running the efficacy trials and following protocol such that all families completed all sessions and modules, we discovered that many families did not require all modules of the intervention, and children often preferred one resource over another (e.g. liked Max the Brave, didn’t use LuLu the Owl). Using this information to inform the current trial, therapists will now choose the most appropriate treatment modules and resources on a case-by-case basis, tailoring the intervention to each family. The intervention will be delivered up to a maximum equivalent of two 90-minute sessions conducted with the primary caregiver(s), delivered via telephone, skype or face-to-face, as preferred by the family to facilitate access.

Fidelity: Clinical psychologists (with a minimum of master’s level training) from the Queensland Children's Hospital will be the therapists delivering the intervention. They will undergo a full-day training workshop on trauma during early childhood, paediatric medical traumatic stress, and the CARE intervention by the co-developer of the intervention. Clinical supervision will be held at the completion of each intervention session. As this intervention is been delivered by hospital staff as part of routine clinical care it will not be possible to record (audio or video) and review sessions. However, therapists will be required to complete treatment adherence checklists at the end of each session.
Intervention code [1] 302043 0
Prevention
Intervention code [2] 302044 0
Early detection / Screening
Intervention code [3] 302045 0
Behaviour
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] 306972 0
Child posttraumatic stress symptom severity.. This will be assessed using the Diagnostic Infant Preschool Assessment (PTSD Module)
Timepoint [1] 306972 0
3 months post-injury
Secondary outcome [1] 350290 0
Child emotional and behavioural problems. Total emotional and behavioural problems will be assessed using the Pediatric Emotional Distress Scale-Early Screener (PEDS-ES)
Timepoint [1] 350290 0
3 and 6 months post-injury
Secondary outcome [2] 350291 0
Child Health Related Quality of Life (HRQOL). HRQOL will be assessed using the CHU9D (young child version)
Timepoint [2] 350291 0
3 and 6 months post-injury
Secondary outcome [3] 350292 0
Parent post-traumatic stress symptoms. Parent symptoms of distress will be assessed using the International Trauma Questionnaire (ITQ).
Timepoint [3] 350292 0
3 months and 6 months post-injury
Secondary outcome [4] 350293 0
Parent psychological distress symptoms. Parental anxiety and depression will be assessed using the Kessler Psychological Distress Scale (K6).
Timepoint [4] 350293 0
3 months and 6 months post-injury
Secondary outcome [5] 350493 0
Cost-effectiveness of the CARE Intervention. This will be assessed by calculating intervention costs vs TAU costs and child and adolescent service use for the 6-months following the injury. Service use will be assessed via accessing medicare records and study specific questionnaire i.e. CHU9D
Timepoint [5] 350493 0
6-months post injury
Secondary outcome [6] 350494 0
Child functional impairment (i.e. relationships, daily activities, day-care) from their PTSD symptoms will be assessed using the questions on the DIPA.
Timepoint [6] 350494 0
3 & 6 months post injury
Secondary outcome [7] 368236 0
CARE Intervention Acceptability. This will be assessed using the CARE Acceptability Questionnaire (study-specific questionnaire).
Timepoint [7] 368236 0
Pre-intervention and 3-months post injury
Secondary outcome [8] 368237 0
Parental satisfaction of the CARE intervention. This will be assessed using the CARE Satisfaction Questionnaire (study-specific questionnaire).
Timepoint [8] 368237 0
6-months post injury
Secondary outcome [9] 371826 0
Child PTSD diagnosis. This will be assessed using the Diagnostic Infant Preschool Assessment (PTSD Module)
Timepoint [9] 371826 0
3 and 6 months

Eligibility
Key inclusion criteria
Children will be considered eligible if (1) the child presents to the Queensland Children's Hospital (QCH) Brisbane following an unintentional traumatic injury, and (2) the child aged 1-6 years.
Minimum age
1 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if (1) their English is insufficient for completing surveys and the intervention (2) if family situation is assessed to be too complex (i.e. risk to child's safety).

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)
Randomisation will occur after consent has been taken and the baseline diagnostic interview completed. The research team will email the independent statistician the
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomisation with random selected block sizes of 4, 6 and 8 will be generated in R by a statistician (independent from the research team) considering an allocation ratio of 1:1. The statistician will email the randomization sequence to a research assistant not involved in the study. Third-party concealment of group allocation will occur using a numbered series of opaque, sealed envelopes prepared in advance and given to the psychology team. Following the baseline assessment, the interviewer (psychologist) will open the sealed envelope to reveal assignment of the participant to the CARE intervention or to TAU.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Our analysis of the main outcome will be performed using generalised linear mixed modelling to determine the effect of treatment, time, and their interaction on symptom severity. The ‘patient’ will be considered as a random effect. We will explore change over time and between groups for primary and secondary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/04/2019
Date of last participant enrolment
Anticipated
3/01/2022
Actual
Date of last data collection
Anticipated
1/11/2022
Actual
Sample size
Target
120
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13408 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 26010 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 300313 0
Charities/Societies/Foundations
Name [1] 300313 0
Australian Rotary Mental Health Grant
Country [1] 300313 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Children's Health Research Centre (UQ-CHRC)
Centre for Children's Health Research
62 Graham Street
South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 299747 0
None
Name [1] 299747 0
Address [1] 299747 0
Country [1] 299747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301124 0
Children's Health Queensland Hospital and Health Services Human Research Ethics Comittee
Ethics committee address [1] 301124 0
Ethics committee country [1] 301124 0
Australia
Date submitted for ethics approval [1] 301124 0
30/04/2018
Approval date [1] 301124 0
05/06/2018
Ethics approval number [1] 301124 0
HREC/18/QRCH/126
Ethics committee name [2] 301128 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 301128 0
Ethics committee country [2] 301128 0
Australia
Date submitted for ethics approval [2] 301128 0
05/06/2018
Approval date [2] 301128 0
18/06/2018
Ethics approval number [2] 301128 0
2018001197

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

Contacts
Principal investigator
Name 85938 0
Dr Alexandra De Young
Address 85938 0
Centre for Children's Burns and Trauma Research
Level 7, UQ-CHRC
62 Graham Street
South Brisbane, QLD 4101
Country 85938 0
Australia
Phone 85938 0
+617 3069 7002
Fax 85938 0
Email 85938 0
[email protected]
Contact person for public queries
Name 85939 0
Alexandra De Young
Address 85939 0
Centre for Children's Burns and Trauma Research
Level 7, UQ-CHRC
62 Graham Street
South Brisbane, QLD 4101
Country 85939 0
Australia
Phone 85939 0
+617 3069 7002
Fax 85939 0
Email 85939 0
[email protected]
Contact person for scientific queries
Name 85940 0
Alexandra De Young
Address 85940 0
Centre for Children's Burns and Trauma Research
Level 7, UQ-CHRC
62 Graham Street
South Brisbane, QLD 4101
Country 85940 0
Australia
Phone 85940 0
+617 3069 7002
Fax 85940 0
Email 85940 0
[email protected]

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.