Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000211460p
Ethics application status
Not yet submitted
Date submitted
8/01/2025
Date registered
21/02/2025
Date last updated
21/02/2025
Date data sharing statement initially provided
21/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Effectiveness and Implementation of Psychosocial Assessment of Adolescents and Young Adults in Emergency Departments
Scientific title
Psychosocial Assessment of Adolescents and Young Adults in Emergency Departments: Protocol for a Type II Hybrid Effectiveness-Implementation Study
Secondary ID [1] 313648 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosocial wellbeing 336216 0
Mental health 336415 0
Condition category
Condition code
Mental Health 332936 332936 0 0
Other mental health disorders
Public Health 332935 332935 0 0
Health service research
Emergency medicine 332750 332750 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A well-regarded psychosocial assessment for adolescents and young adults (12 - 25 years) is the HEEADSSS assessment. The HEEADSSS captures patient strengths and risks relevant to apects of their life including Home, Education and Employment, Eating and Exercise, Activities, Drugs and Alcohol, Sexuality and Gender, Suicide, Depression and Self-harm, and Safety. A digital self-assessment version of the HEEADSSS (the eHEEADSSS) has recently been developed and implemented at the Sydney Children's Hospitals Network.

Hosted on the Tickit® digital platform, the eHEEADSSS enables clinicians to conduct recommended psychosocial assessments, with results integrating into hospital Electronic Medical Records systems. The e-HEEADSSS features a grade-4 literacy level and allows young people to complete a self-assessment via a digital device (e.g. smartphone, tablet) with privacy and at their own pace. A summary report of their responses to the assessment are uploaded and available to clinicians in real-time in a secure password-protected application available via the internet. On average, the eHEEADSSS takes a young person less than 15 minutes to complete. Pilot research at the Sydney Children's Hospitals Network indicates that the eHEEADSSS is more sensitive and acceptable to young people than the traditional HEEADSSS interview.

The eHEEADSSS will now be implemented within the Emergency Departments of three new Hospitals outside of the Sydney Children's Hospitals Network. The research project will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to evaluate the effectiveness and implementation of this change. This will involve quantitative analyses of 24-months of routine administrative data from the new Hospital sites. The administrative data to be analysed will include data from the eHEEADSSS assessments and data from the Hospital Electronic Medical Records systems. Participant consent will be waived for the use of this administrative data. The eHEEADSSS will be implemented within these new sites regardless of the commencement of this study.
Intervention code [1] 330246 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340285 0
The primary outcome measure will be the number of eHEEADSSS assessments completed during the 12-month implementation period.
Timepoint [1] 340285 0
The measurement timepoint will be at the conclusion of the 12-month implementation period.
Secondary outcome [1] 443620 0
A secondary outcome measure will be the number of suicide concerns identified by eHEEADSSS during the implementation period. Suicide concerns are captured through specific items in the eHEEADSSS such as "I have tried to or thought about harming myself" and "Ending my life has been on my mind lately".
Timepoint [1] 443620 0
The measurement timepoint will be at the conclusion of the 12-month implementation period.
Secondary outcome [2] 444184 0
A secondary outcome measure will be the number of sexual concerns identified by eHEEADSSS during the implementation period. Sexual concerns are captured through specific items in the eHEEADSSS such as "I have been forced to do something sexual against my will before".
Timepoint [2] 444184 0
The measurement timepoint will be at the conclusion of the 12-month implementation period.
Secondary outcome [3] 444183 0
A secondary outcome measure will be the number of safety concerns identified by eHEEADSSS during the implementation period. Safety concerns are captured through specific items in the eHEEADSSS such as "I don’t feel safe at home" and "I would like to talk more about feeling safe".
Timepoint [3] 444183 0
The measurement timepoint will be at the conclusion of the 12-month implementation period.

Eligibility
Key inclusion criteria
Patients between 12 and 25 years presenting to Emergency Departments at research sites (n=3) during the 12-month implementation period.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318115 0
Government body
Name [1] 318115 0
NSW Health Translational Research Grant Scheme
Country [1] 318115 0
Australia
Primary sponsor type
Government body
Name
New South Wales Health
Address
Country
Australia
Secondary sponsor category [1] 320494 0
University
Name [1] 320494 0
Western Sydney University
Address [1] 320494 0
Country [1] 320494 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316760 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 316760 0
Ethics committee country [1] 316760 0
Australia
Date submitted for ethics approval [1] 316760 0
31/03/2025
Approval date [1] 316760 0
Ethics approval number [1] 316760 0

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

Contacts
Principal investigator
Name 138926 0
Dr Daniel Waller
Address 138926 0
The Academic Department of Adolescent Medicine at the Children's Hospital at Westmead Cnr Hawkesbury Rd & Hainsworth St, Westmead NSW 2145
Country 138926 0
Australia
Phone 138926 0
+612 8204 4459
Fax 138926 0
Email 138926 0
[email protected]
Contact person for public queries
Name 138927 0
Daniel Waller
Address 138927 0
The Academic Department of Adolescent Medicine at the Children's Hospital at Westmead Cnr Hawkesbury Rd & Hainsworth St, Westmead NSW 2145
Country 138927 0
Australia
Phone 138927 0
+612 8204 4459
Fax 138927 0
Email 138927 0
[email protected]
Contact person for scientific queries
Name 138928 0
Daniel Waller
Address 138928 0
The Academic Department of Adolescent Medicine at the Children's Hospital at Westmead Cnr Hawkesbury Rd & Hainsworth St, Westmead NSW 2145
Country 138928 0
Australia
Phone 138928 0
+612 8204 4459
Fax 138928 0
Email 138928 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.