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Trial registered on ANZCTR


Registration number
ACTRN12624001462572p
Ethics application status
Submitted, not yet approved
Date submitted
18/11/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Sexual and Reproductive Health Screening in a Child and Youth Mental Health Service
Scientific title
Implementing Routine Sexual and Reproductive Health Screening into a Child and Youth Mental Health Service: A Cluster Randomised Controlled Trial
Secondary ID [1] 312960 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual health 335487 0
Reproductive health 335872 0
Condition category
Condition code
Reproductive Health and Childbirth 332046 332046 0 0
Contraception
Public Health 332456 332456 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is to be developed as a part of the study. The sexual and reproductive health education and training module (intervention) will be developed by the study team in consultation with clinicians and young people. The consultation process will involve a half-day workshop with the study investigators and experts in SRH, as well as external input via group meetings with the child and youth mental health service (CYMHS) clinicians consumers and parents/guardians.

The final draft of the intervention will be trialed by the study investigator with volunteer child and youth mental health clinicians and the wider study team.

Once the intervention has been finalised, the education intervention will be delivered to clinicians in Cluster 1 (three randomly selected community CYMHS sites; intervention cluster/arm) first, along with nursing staff at each community site in both Clusters 1 and 2, and the Forensic CYMHS site. Clinical staff in Cluster 2 (remaining three randomly selected community CYMHS sites; control cluster/arm) will continue as care as usual without receiving the intervention.

Once sufficient numbers of clinicians in Cluster 1 have received the training, completed pre- and post-intervention surveys, and the intervention has been in practice for approximately 6 months, clinicians and nurses in Cluster 2 will be invited to participate in the study.

The intervention will take form as a one hour, face to face education and training session delivered to clinical staff working within a CYMHS community clinic setting. Participants will receive the intervention as a one-time dose. The intervention will be delivered by two study PIs with extensive experience in sexual and reproductive health and child and youth psychiatry and will cover aspects of sexual and reproductive health such as sexually transmitted diseases, sexual dysfunction (related to mental health medication side effects), consent, healthy relationships and contraception.

The intervention aims to increase clinician knowledge, confidence and skills to engage in brief conversations with young people with mental health problems to screen for sexual and reproductive health issues. Nursing staff (1 to 2 per clinic) will receive an extended version of this intervention comprising additional training to support the nurse-led intervention and will address areas such as STI testing and referral pathways for specialised and/or ongoing care. This extended version of the training for nurses will be delivered around the same time that clinicians receive the standard one-hour education module. Nursing staff across both Cluster 1 and Cluster 2 will receive the intervention (nursing education and training) at baseline.

Clinical staff working with adolescent clients across the community clinics will be provided with resources to implement the intervention immediately following the delivery by way of conducting screening with their adolescent clients who attend these clinics attend weekly to fortnightly appointments on average, although this varies depending on individual need.
Intervention code [1] 329769 0
Early detection / Screening
Comparator / control treatment
The control arm of this study will be 'Cluster 2', which will comprise three community sites whose staff will not receive the education session intervention and will continue with care as usual for an initial 6-month period. Care as usual will entail standard mental health care in which clinicians may also ask about sexual and reproductive health, however, currently this is infrequently and inconsistently addressed.
Control group
Active

Outcomes
Primary outcome [1] 339649 0
Comparison between intervention and control sites in the number of referrals for a nurse led consultation
Timepoint [1] 339649 0
Six-months post-intervention commencement
Primary outcome [2] 339650 0
Comparison of staff knowledge, skills and confidence of SRH screening of young people (composite measure)
Timepoint [2] 339650 0
Within one week pre-intervention (Baseline), Post intervention (up to one-week post intervention) and at 3-months post intervention completion.
Secondary outcome [1] 440736 0
The level of adolescent (14-17-years) acceptability of SRH screening in a mental health setting.
Timepoint [1] 440736 0
Continuously throughout the study from the three-month post intervention time-point until target numbers are reached or data saturation is achieved, whichever comes first.
Secondary outcome [2] 442248 0
The level of parent/caregiver acceptability of SRH screening in a mental health setting.
Timepoint [2] 442248 0
Continuously throughout the study from the three-month post intervention time-point until target numbers are reached or data saturation is achieved, whichever comes first.
Secondary outcome [3] 442251 0
The level of staff acceptability of SRH screening in a mental health setting.
Timepoint [3] 442251 0
Continuously throughout the study from the three-month post intervention time-point until target numbers are reached or data saturation is achieved, whichever comes first.

Eligibility
Key inclusion criteria
CYMHS Staff
Surveys: All clinicians at CHQHHS CYMHS community clinics and Forensics CYMHS will be eligible to participate in the intervention. We will seek to recruit these staff to participate in the pre- and post-intervention surveys, with consent being sought prior to participation.
Qualitative interviews: Any clinician from the above sample who consented to a qualitative interview and completed both pre- and post-intervention surveys, and who received the intervention in full (SRH education session).
Adolescent clients, and parents/caregivers of adolescent clients
Qualitative interviews:
a. Adolescent CYMHS clients aged 14-years and over who attended a CYMHS clinic and received mental health care will be eligible to participate in a qualitative interview.
b. Parents or guardians of adolescent CYMHS clients who attended a CYMHS clinic and received mental health care will be eligible to participate in a qualitative interview.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Qualitative interviews:
1. Adolescent clients of CYMHS younger than 14 years of age.
2. Insufficient understanding of the English language.
3. Clinicians who are not employed by CHQ CYMHS.
4. Adolescent clients, or parents/caregivers of adolescent clients who are not a patient of CHQHHS.
5. CYMHS clinicians who did not complete all study components; the pre- and post-intervention surveys, and completion of the SRH education session.
4. Any staff, consumers or parents of consumers who are not a patient of CHQHHS.
5. Any consumer who is in state care (foster, residential care etc.).
6. Staff who did not complete all three components of the study; the pre-survey, training and post-survey.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cluster 2 will act as a comparator for cluster 1, and the clusters will receive the same intervention in a step-wise fashion. For the first 6 months, cluster 2 is usual care and cluster 1 receives the intervention, and outcomes will be compared between the two clusters. Following this, cluster 2 will receive the intervention.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
5/01/2026
Actual
Date of last data collection
Anticipated
27/03/2026
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317395 0
Other
Name [1] 317395 0
Sexual Health Research Fund. The Sexual Health Research Fund is administered by the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM).
Country [1] 317395 0
Australia
Primary sponsor type
Hospital
Name
Children's Health Queensland CYMHS service
Address
Country
Australia
Secondary sponsor category [1] 319683 0
None
Name [1] 319683 0
Address [1] 319683 0
Country [1] 319683 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316120 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 316120 0
Ethics committee country [1] 316120 0
Australia
Date submitted for ethics approval [1] 316120 0
18/11/2024
Approval date [1] 316120 0
Ethics approval number [1] 316120 0

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

Contacts
Principal investigator
Name 136854 0
Prof James Scott
Address 136854 0
Centre for Children's Health Research (Children's Health QLD), 62 Graham St, South Brisbane QLD 4101
Country 136854 0
Australia
Phone 136854 0
+617 3069 7398
Fax 136854 0
Email 136854 0
james.scott@health.qld.gov.au
Contact person for public queries
Name 136855 0
James Scott
Address 136855 0
Centre for Children's Health Research (Children's Health QLD), 62 Graham St, South Brisbane QLD 4101
Country 136855 0
Australia
Phone 136855 0
+617 3069 7000
Fax 136855 0
Email 136855 0
james.scott@health.qld.gov.au
Contact person for scientific queries
Name 136856 0
James Scott
Address 136856 0
Centre for Children's Health Research (Children's Health QLD), 62 Graham St, South Brisbane QLD 4101
Country 136856 0
Australia
Phone 136856 0
+617 3069 7398
Fax 136856 0
Email 136856 0
james.scott@health.qld.gov.au

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.