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Trial registered on ANZCTR


Registration number
ACTRN12616001243404
Ethics application status
Approved
Date submitted
30/08/2016
Date registered
6/09/2016
Date last updated
11/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability and utility of electronic screener, YouthCHAT (Youth Version Case-finding Help Assessment Tool), and its comparison with the Home, Education, Eating, Activities, Drugs and Alcohol, Sexuality, Suicide/Depression, Safety (HEEADSSS) assessment. for young people with long-term physical conditions and high school students.
Scientific title
.Acceptability and utility of electronic screener, YouthCHAT (Youth Version Case-finding Help Assessment Tool), and its comparison with the Home, Education, Eating, Activities, Drugs and Alcohol, Sexuality, Suicide/Depression, Safety (HEEADSSS) assessment. for young people with long-term physical conditions and high school students.
Secondary ID [1] 290068 0
Nil
Universal Trial Number (UTN)
U1111-1187-0848
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 300132 0
Depression 300144 0
Substance Abuse 300145 0
Condition category
Condition code
Mental Health 300011 300011 0 0
Anxiety
Mental Health 300023 300023 0 0
Depression
Mental Health 300024 300024 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will use a 2 stage, mixed methods participatory action research approach to development and validation of a YouthCHAT (an electronic case finding tool) mapped to all HEEADSSS (face to face psychosocial assessment) domains, and assessment of acceptability of its use at the Starship and Tamaki College settings in Auckland, New Zealand.. YouthCHAT stands for Youth version Case Finding and Help Assessment Tool. Designed in Auckland, New Zealand. It is a self-report screening tool that covers 10 domains: smoking, drinking, recreational drug use, problematic gambling, depression, anxiety, sexual health, exposure to abuse, anger management, physical activity and takes between 5-10 minutes to complete. Positive screens lead to branching logic linking users to validated assessment tools. HEEADSSS assessment (Home, Education, Eating, Activities, Drugs and Alcohol, Sexuality, Suicide/Depression, Safety) is a clinician-administered interview-based assessment of youth that can identify mental health and substance use problems. Currently, all Year nine (Yr 9) students in decile 1-3 schools, and some attendees at primary care and paediatric services in NZ are screened for wellbeing via HEEADSSS. While HEEADSSS offers a straightforward, holistic, and gradual approach to assessing young people across many domains, it is a face-to-face assessment, not a screening tool. Drawbacks include its lack of validation cost of resourcing and time required for administration (up to 45 minutes).

Stage 1
The acceptability and utility of YouthCHAT will be evaluated at two settings: with 30 young people aged 13 to 18 years with long-term conditions attending outpatients at Starship Hospital, and 48 Year 9 students attending Tamaki College in 2017 (a sub-set of the 150 students who will participate in the RCT below). A separate focus group will be undrtaken with Maori young people to ascertain and culturally-specific preferences, issues or concerns. Feedback from consenting young people undertaking YouthCHAT will be sought as well as from attending paediatricians and specialist nurses at Starship and from school nurses at Tamaki College.

Stage 2
A randomised controlled trial of YouthCHAT with HEEADSSS with be conducted with 150 participants at Tamaki College using a counterbalanced design in which one group receives YouthCHAT and then HEEADSSS assessment (Condition 1), and the other HEEADSSS and then YouthCHAT (Condition 2) on the same day.
Intervention code [1] 295792 0
Early detection / Screening
Comparator / control treatment
The comparison of YouthCHAT with HEEADSSS with be conducted at Tamaki College using a counterbalanced design in which one group receives YouthCHAT and then HEEADSSS assessment (Condition 1), and the other HEEADSSS and then YouthCHAT (Condition 2). So, both groups will receive the same interventions, but in a different order.
Control group
Active

Outcomes
Primary outcome [1] 299493 0
1. Detection rates for each domain for HEADSSS and YouthCHAT as measured by mental health or lifestyle issue ‘present’ or ‘absent’ (Tamaki sample only). Validated scales for anxiety (based on the GAD 7), depression (based on the PHQ9 9) and substance abuse (based on the SACS) are included in YouthCHAT. HEEADSSS assessment identifies these issues using the clinical judgement of the assessor.
Timepoint [1] 299493 0
Once all assessments are completed.
Primary outcome [2] 299506 0
Time taken to complete YouthCHAT and HEEADSSS screening (Tamaki sample only). Quantitative data will include HEEADSSS and YouthCHAT findings and administrative data such as time to complete assessments.
Timepoint [2] 299506 0
Once all assessments are completed.
Primary outcome [3] 299507 0
Acceptability and Utility of YouthCHAT as assessed via feedback from staff and students / patients (Starship and Tamaki participants). A general inductive approach will be used to analyse focus group data.

Quantitative data will include survey data (Likert scales) on acceptability and utility of YouthCHAT by Starship patients and Tamaki College students

Qualitative data will include:
1. One taped and transcribed student focus group to advise on the wording of the newly added YouthCHAT modules
2. Free text survey responses on acceptability and utility of YouthCHAT by Starship patients
3. Taped and transcribed semi-structured interviews with Starship and hospital staff
4. Four taped and transcribed student focus groups that address acceptability and utility of the assessments as well as face validity of newly added YouthCHAT questions
Timepoint [3] 299507 0
Once all assessments are completed.
Secondary outcome [1] 327330 0
Differences in YouthCHAT vs HEEADSSS screening outcomes by gender.
Timepoint [1] 327330 0
Once all assessments are completed.
Secondary outcome [2] 327360 0
Differences in YouthCHAT vs HEEADSSS screening outcomes by ethnicity.
Timepoint [2] 327360 0
Once all assessments are completed.

Eligibility
Key inclusion criteria
30 young people aged 13 to 18 years with long-term physical conditions attending outpatients at Starship Hospital in Auckland New Zealand, and 150 Year 9 students (aged 13 years) of varying ethnicity, attending Tamaki College in Auckland, New Zealand will be included.
Minimum age
13 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to consent or lack of parental assent for young people's participation will lead to them being excluded from the study. Lack of long-term physical condition (lasting 3 or more months) will be an additional exclusion criterion for participants at Starship Hospital.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be undertaken using central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For the RCT component of the study, Tamaki has an estimated 150 Yr 9 students in 2017 who will be randomly allocated to either Condition 1 (n = 75) or Condition 2 (n = 75). A power calculation shows that given 144 participants there will be 90% power to detect differences between the two assessments assuming a mean duration of 15 minutes for YouthCHAT (SD = 30) and 45 minutes for HEEADSSS (SD = 90).

Quantitative data will be analysed using Microsoft Excel and SPSS (Statistical Software Package). Analyses will include basic descriptive statistics (e.g., number of youth screened, YouthCHAT summary data; HEEADSSS summary data, demographic characteristics of the sample). t Tests and repeated measures ANOVA will compare differences between the two groups. Qualitative data will be analysed using a general inductive approach with collated text analysed to identify emerging themes, which are then independently coded by two researchers with consensus reached by adjudication. Data analysis will be conducted at the end of Term 4, 2017.

Recruitment
Recruitment status
Completed
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] 8171 0
New Zealand
State/province [1] 8171 0
Auckland

Funding & Sponsors
Funding source category [1] 294430 0
Self funded/Unfunded
Name [1] 294430 0
Address [1] 294430 0
Country [1] 294430 0
Primary sponsor type
University
Name
University of Auckland
Address
c/o Department of Psychological Medicine, Level 12 Support Block, Auckland Hospital, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 293304 0
None
Name [1] 293304 0
Address [1] 293304 0
Country [1] 293304 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295858 0
HDEC
Ethics committee address [1] 295858 0
Ethics committee country [1] 295858 0
New Zealand
Date submitted for ethics approval [1] 295858 0
12/09/2016
Approval date [1] 295858 0
31/10/2016
Ethics approval number [1] 295858 0

Summary
Brief summary
Context
Psychosocial problems such as depression, anxiety and substance abuse are common and burdensome in young people, particularly those with long-term physical conditions such asthma and diabetes. ‘Screening’ for such problems is currently only undertaken routinely using an unvalidated, time-consuming HEEADSSS interview with Year 9 students in decile 1-3 schools and opportunistically in paediatric settings. YouthCHAT (Youth version, Case-finding and Help Assessment Tool) is a relatively new, locally-developed, ipad-based composite screener for identifying similar psychosocial issues to HEEADSSS. Based individually validated screening instruments, it is self-administered within minutes. Preliminary testing has revealed its acceptability to young people, but further research is required to expand its modules to cover all HEEADSSS domains, to evaluate its acceptability for young people with and without long-term physical conditions, and compare its effectiveness against HEEADSSS.

Objectives
1. Ascertain acceptability and utility of YouthCHAT for children with long-term physical illness and high school students
2. Validate three additional YouthCHAT domains against comparable HEEADSSS domains
3. Compare the performance of YouthCHAT and HEEADSSS in the high school setting
Methods
Additional YouthCHAT domains will be co-designed with young people at Tamaki College at the end of 2016. YouthCHAT will then be administered to 30 young people at Starship Hospital, and 150 students at Tamaki College, either before or after HEEADSSS (randomised trial with counter-balanced design) during the 2017 school year.

Potential clinical benefits
YouthCHAT could be an exciting, innovative, efficient means of routine screening for common psychosocial health issues in young people with and without long-term physical conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68746 0
Dr Hiran Thabrew
Address 68746 0
Department of Psychological Medicine, University of Auckland, Level 12 Support Block, Auckland Hospital, Park Road, Grafton, Auckland 1142, New Zealand.
Country 68746 0
New Zealand
Phone 68746 0
+64 21404080
Fax 68746 0
Email 68746 0
hiran.thabrew@gmail.com
Contact person for public queries
Name 68747 0
Dr Hiran Thabrew
Address 68747 0
Department of Psychological Medicine, University of Auckland, Level 12 Support Block, Auckland Hospital, Park Road, Grafton, Auckland 1142, New Zealand.
Country 68747 0
New Zealand
Phone 68747 0
+64 21404080
Fax 68747 0
Email 68747 0
hiran.thabrew@gmail.com
Contact person for scientific queries
Name 68748 0
Dr Hiran Thabrew
Address 68748 0
Department of Psychological Medicine, University of Auckland, Level 12 Support Block, Auckland Hospital, Park Road, Grafton, Auckland 1142, New Zealand.
Country 68748 0
New Zealand
Phone 68748 0
+64 21404080
Fax 68748 0
Email 68748 0
hiran.thabrew@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary