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Trial registered on ANZCTR


Registration number
ACTRN12618000299202
Ethics application status
Approved
Date submitted
16/02/2018
Date registered
28/02/2018
Date last updated
12/02/2020
Date data sharing statement initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Electronic risky health behaviour and mental health screening for New Zealand youth aged 12 - 24 years in primary health care.
Scientific title
Evaluating the implementation of YouthCHAT: a primary care e-screening tool for mental health issues among Te Tai Tokerau Youth
Secondary ID [1] 294076 0
None
Universal Trial Number (UTN)
U1111-1206-6830
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
risky health behaviours 306634 0
Mental Health 306635 0
Sexual Health and identity 306636 0
Substance abuse 306683 0
problematic gambling 306684 0
Abuse 306685 0
physical inactivity 306686 0
anger management 306687 0
Eating disorder 306688 0
Condition category
Condition code
Mental Health 305736 305736 0 0
Anxiety
Mental Health 305783 305783 0 0
Depression
Mental Health 305784 305784 0 0
Eating disorders
Mental Health 305785 305785 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
YouthCHAT is a rapid (5-15 min) self-report screening tool that covers smoking, drinking, recreational drug use, problematic gambling, depression, anxiety, sexual health and identity, exposure to abuse, conduct and eating issues, anger management and physical inactivity. Positive screens lead to branching logic linking users to validated assessment tools. A key feature is the help question, which enables youth to indicate areas where they would like help and prioritise issues where they have problems in more than one domain. Young people self-administer YouthCHAT electronically prior to their consultation a clinical summary report is generated immediately on completion of a YouthCHAT screen and is sent straight to the clinician before they meet with the young person. YouthCHAT provides the clinician with a guide to effective evidence-based interventions using a stepped-care management model ranging from self-help, to GP or primary care nurse brief interventions or provision of relevant medication, to referral to community agencies, and services, and finally referral to secondary care.
YouthCHAT is being implemented into participating sites and all youth meeting the clinic's screening criteria will complete a YouthCHAT screen irrespective of participation in the study. YouthCHAT data will be stored using an electronic data management system and from this the number of YouthCHAT screens completed at each site can be compared to deidentified historical data retrieved from the clinics' practice management systems as a means of monitoring adherence to YouthCHAT screening
Clinicians using YouthCHAT will be invited to take part in an anonymous survey and/or an semi-structured interview to provide feasibility and acceptability data of the implementation process. Youth attending the clinics who have undergone a YouthCHAT screen will be invited to participate in a focus group to discuss acceptability of YouthCHAT processes. Utility measures, such as changes in screening and help-seeking behaviour, will be gathered via comparison with retrospective deidentified data collection.

The project will run for three years and it is anticipated that data collection will be completed by the beginning of the third year. This study is using a co-design approach, in which the research team will work with primary healthcare organisations, clinic staff, local agencies, cultural and community groups to determine optimal processes for conducting the study which will include duration/frequency of observation at each participating clinic.
Intervention code [1] 300347 0
Early detection / Screening
Comparator / control treatment
Comparison of screening rates for mental health issues and risky health behaviours; early identification of emerging problems and delivery of brief interventions before and after YouthCHAT implementation (via 12-months of retrospective screening data from the clinics'practice management system ) will be made.
Control group
Historical

Outcomes
Primary outcome [1] 304812 0
Asses the feasibility of implementing YouthCHAT by determining satisfaction of the tool amongst clinics by means of semistructured interviews with clinical staff
Timepoint [1] 304812 0
At 3 months post implementation of YouthCHAT at each site
Primary outcome [2] 304813 0
Asses the utility of YouthCHAT in nurse-led youth clinics, school-based clinics and general practice in Te Tai Tokerau by identifying changes in youth screening rates for youth mental health and health risk behavioural issues.

Comparison of screening rates for mental health issues and risky health behaviours; before and after YouthCHAT implementation (via 12-months of retrospective deidentified collated screening data from the computerised practice management system) will be made.
Timepoint [2] 304813 0
one year after the initial implementation of YouthCHAT
Primary outcome [3] 304814 0
Asses the acceptability of implementing YouthCHAT in nurse-led youth clinics, school-based clinics and general practice in Te Tai Tokerau

This will be assessed from the analysis of data collected from Semi- structured interviews and follow-up surveys (using questions designed for this study) with clinic staff and focus groups with a subset of youth from the clinic (using questions based on those used in a previous YouthCHAT study assessing acceptability of the tool amongst disadvantaged youth)

Timepoint [3] 304814 0
At 3 months post implementation
Secondary outcome [1] 343274 0
Identify changes in brief intervention delivery ranging from self-help (for example helpline numbers, handouts and web addresses for psychoeducation and e-therapy such as SPARX), to GP or primary care nurse brief interventions or provision of relevant medication (such as nicotine replacement), to referral to community agencies, and services, and finally referral to secondary care (mental health and drug and alcohol services)
for example for mental health issues and health risk behaviours in youth

Comparison of brief ntervention delivery for mental health issues and risky health behaviours; before and after YouthCHAT implementation (via 12-months of retrospective deidentified collated screening data from the computerised practice management system) will be made.
Timepoint [1] 343274 0
one year after implementation
Secondary outcome [2] 343605 0
Asses the utility of YouthCHAT in nurse-led youth clinics, school-based clinics and general practice in Te Tai Tokerau by identifying changes in detection rates of youth mental health and health risk behavioural issues.

Comparison of detection rates for mental health issues and risky health behaviours; before and after YouthCHAT implementation (via 12-months of retrospective deidentified collated screening data from the computerised practice management system) will be made.
Timepoint [2] 343605 0
at one year post implementation

Eligibility
Key inclusion criteria
Youth enrolled at the clinic who have undertaken a YouthCHAT screen , clinic staff who use the YouthCHAT tool and the Clinical Educator who provides training and support in the use of YouthCHAT
Minimum age
16 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria other than not meeting the inclusion criteria -

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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9592 0
New Zealand
State/province [1] 9592 0
Auckland

Funding & Sponsors
Funding source category [1] 298706 0
Government body
Name [1] 298706 0
The Global Alliance for Chronic Diseases. (GACD). via the Health Research Council NZ
Address [1] 298706 0
The Health Research Council of New Zealand
PO Box 5541
Wellesley Street
Auckland 1141
Country [1] 298706 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019,
Auckland
1142
NZ
Country
New Zealand
Secondary sponsor category [1] 297876 0
None
Name [1] 297876 0
Address [1] 297876 0
Country [1] 297876 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299654 0
Health and Disability Research Committee NZ
Ethics committee address [1] 299654 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 299654 0
New Zealand
Date submitted for ethics approval [1] 299654 0
26/02/2018
Approval date [1] 299654 0
05/05/2018
Ethics approval number [1] 299654 0
18/CEN/31

Summary
Brief summary
YouthCHAT is an electronic screening tool developed in 2016 to assess mental health and risky health behaviours among youth attending primary care. Many young people in New Zealand are affected by depression and anxiety but the majority do not access help. For Maori, the burden of morbidity and mortality associated with mental health is considerably higher. This study aims to explore the utility, feasibility, and acceptability of YouthCHAT when tailored for use in primary care settings with large Maori populations. The objectives of the study are: to evaluate the use of YouthCHAT in nurse-led youth clinics, school-based clinics, and general practice in rural New Zealand; to develop a framework for the scaling up of YouthCHAT across further settings; to assess health provider and youth acceptability of the tool; and to identify changes in screening rates for mental health, help-seeking behaviour, early identification of emerging problems and brief intervention delivery.
This study will use an implementation, co-design participatory research approach, with a mixed method design to evaluate the use of the YouthCHAT programme in primary health clinics in Te Tai Tokerau. The roll out of YouthCHAT by a rural primary health organisation (PHO) will be pragmatic, starting with five nurse-led clinics, scaling up to school-based clinics and general practices over three years. The YouthCHAT programme is being implemented into the youth screening policies and procedures across all Northland clinics participating in this study. The evaluation of this process will involve consultation and partnership between researchers, clinicians, young people, support staff, community stakeholders, managers and policymakers in research planning and adaptation of YouthCHAT processes and resources in response to user feedback. Acceptability and feasibility data will be gathered via surveys and focus groups. Utility measures, such as changes in screening and help-seeking behaviour, will be gathered via comparison with retrospective deidentified data collection.
Inherent in the design of this project is the iterative evaluation of the utility, feasibility, and acceptability of the implementation of YouthCHAT, with the aim of creating a framework for wider scale rollout and implementation. It is anticipated that YouthCHAT will be a culturally acceptable, cost-effective and time-saving screening tool within primary care settings, increasing youth mental health screening and improving access to care. The systematic approach of screening and provision of algorithms for stepped care intervention will lead to early and more comprehensive intervention of youth mental health, substance misuse and other lifestyle issues, which will have a large impact on subsequent physical, mental and social health and well-being.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81186 0
Prof Felicity Goodyear-Smith
Address 81186 0
Department of General Practice & Primary Health Care,
Room 378, Building 730 School of Population Health,
Tamaki Campus
University of Auckland,
261 Morrin Rd,
Glen Innes,
Auckland 1142


Country 81186 0
New Zealand
Phone 81186 0
+64 (0) 9 923 2357
Fax 81186 0
Email 81186 0
f.goodyear-smith@auckland.ac.nz
Contact person for public queries
Name 81187 0
Mrs Rhiannon Martel
Address 81187 0
Department of General Practice & Primary Health Care,
Room 378, Building 730 School of Population Health,
Tamaki Campus
University of Auckland,
261 Morrin Rd,
Glen Innes,
Auckland 1142
Country 81187 0
New Zealand
Phone 81187 0
+64 (0) 27 4461683
Fax 81187 0
Email 81187 0
rmar156@aucklanduni.ac.nz
Contact person for scientific queries
Name 81188 0
Prof Felicity Goodyear-Smith
Address 81188 0
Department of General Practice & Primary Health Care,
Room 378, Building 730 School of Population Health,
Tamaki Campus
University of Auckland,
261 Morrin Rd,
Glen Innes,
Auckland 1142
Country 81188 0
New Zealand
Phone 81188 0
+64 (0) 9 923 2357
Fax 81188 0
Email 81188 0
f.goodyear-smith@auckland.ac.nz

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?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6871 0
Ethical approval
Citation [1] 6871 0
Link [1] 6871 0
Email [1] 6871 0
Other [1] 6871 0
Attachment [1] 6871 0
Type [2] 6872 0
Study protocol
Citation [2] 6872 0
Link [2] 6872 0
Email [2] 6872 0
rmar156@aucklanduni.ac.nz
Other [2] 6872 0
Attachment [2] 6872 0
Summary results
No Results