Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001320943
Ethics application status
Approved
Date submitted
29/10/2019
Date registered
7/12/2020
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Inpatient psychiatric services for children and adolescents in New Zealand: an exploratory case study
Scientific title
Inpatient psychiatric services for children and adolescents in New Zealand: an exploratory case study
Secondary ID [1] 299576 0
Nil
Universal Trial Number (UTN)
U1111-1242-2292
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health disorders 314867 0
Condition category
Condition code
Mental Health 313207 313207 0 0
Anxiety
Mental Health 313208 313208 0 0
Depression
Mental Health 313209 313209 0 0
Psychosis and personality disorders
Mental Health 313572 313572 0 0
Other mental health disorders
Public Health 317539 317539 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This qualitative observational case study will take place at the Regional Rangatahi Adolescent Inpatient Service (RRAIS) - the acute adolescent inpatient mental health unit for the central region of New Zealand. The purpose is to explore the view/experiences on the services provided of: current IPs; their whanau; and staff. Interviews will provide a single cross-sectional opportunity to gather data. Participants in the research will be required to complete the consent process and to participate in an interview; there will be no requirement to access health records or for participants to undergo any other assessments. All research will be undertaken by a PhD student from the University of Otago. The student is an experienced health service manager and researcher, with over 25 years of work experience in the UK and NZ health systems, and within a private research consultancy.

Group 1: Service users
- Participants:
Current child and adolescent IPs of the mental health unit.
- Focus:
Service user views/ patient experience of the IP service.
- Method:
Face-to-face semi-structured interviews held on the unit lasting approximately 45-60 minutes with a maximum of 15 participants. Interviews will either be conducted on a one-to-one basis or in small groups (if this is the preference of participants).
- Supporting information and research tools:
Service user topic guide and interview questions;
Service user information sheet – to provide tailored information on the study purpose, requirements of participants, eligibility, the consent process and where to go for further information;
Consent forms - Service user consent form (to record participant consent where the lead clinician has confirmed the service user is able to provide informed consent); Service user assent form (to record permission to approach a parent/caregiver to provide consent for the service user to participate where the lead clinician has assessed that the service user is not able to provide informed consent); and Parental consent form and information sheet (to confirm their consent for the service user to participate where required).

Group 2: Whanau/ family members
- Participants: Whanau/ family members of current IP service users.
- Focus: Whanau/ family members’ views/ experience of their child/adolescent admission.
- Method: Semi-structured interviews lasting approximately 30-45 minutes with up to eight participants either by telephone or face-to-face on the unit.
- Supporting information and research tools: Whanau topic guide and interview questions; - Whanau participant information sheet; and Whanau participant consent form (relating to their own participation).

Group 3: Staff
- Participants: Staff currently working at the mental health unit.
- Focus: Staff members’ views/ experience of working within the service.
- Method: Face-to-face semi-structured interviews lasting approximately 60 minutes conducted with small groups (up to a maximum of 15 participants in total).
- Supporting information and research tools: Staff member topic guide and interview questions; Staff member participant information sheet; and Staff member consent form.
Intervention code [1] 315926 0
Not applicable
Comparator / control treatment
Qualitative case study - no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321817 0
The composite primary outcome is the views/experiences: of people (both service users and their family members/whanau) who have received IP mental health services within a specialist child and adolescent unit in New Zealand; and of staff working within services.
This qualitative study has an exploratory focus and the range of views is likely to cover a broad scope and to be multi-faceted. Areas of interest include: views on key positive/negative features of services provided (e.g. the ward environment, staffing and care planning); identification of barriers/enablers of access (e.g. location of services; referral processes; admission criteria; and influence of whanau/peers); and values/cultural influences on the model of service delivery and the impact on patient experience.
Data relating to the views/experiences of participants will be collected during a series of semi-structured interviews.
Timepoint [1] 321817 0
Interviews will be conducted once only (during the time of admission for the service user cohort) providing a single cross-sectional perspective on stakeholder views.
Secondary outcome [1] 388446 0
Nil
Timepoint [1] 388446 0
Nil

Eligibility
Key inclusion criteria
Child and adolescent service users must:
- Be 19-years or under at time of admission
- Be a current IP of RRAIS at the time of interview
- Be able to give informed consent or (if assessed by clinical staff as not being able to give informed consent) provide assent for parental consent to be granted on their behalf
Group 2: Whanau/ family members must:
- Be a family member of a current RRAIS IP aged 19-years or under at time of admission
- Provide informed consent relating to their own participation
Group 3: Staff participants must:
- Be a current staff member of RRAIS
- Provide informed consent relating to their own participation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any service user assessed by clinical staff as not being able to give informed consent and who will not provide assent for parental consent to be granted on their behalf, will be not be eligible for participation.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
This is a qualitative case study design involving small group/individual interviews assessed using a reflexive thematic analysis framework (Braun and Clarke, 2006).
The researcher will seek saturation of themes within each group of interviews across the sample. The primary researcher (JA) will independently read and code interview transcripts; codes will be examined and iteratively collated into groups that capture similar themes, each with a number of sub themes. These themes and sub themes will be considered and validated by the study primary supervisor (GJ).
NVivo Software will be employed to assist with data organisation and analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/12/2020
Actual
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
31/03/2021
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment outside Australia
Country [1] 21967 0
New Zealand
State/province [1] 21967 0
Wellington

Funding & Sponsors
Funding source category [1] 304060 0
Charities/Societies/Foundations
Name [1] 304060 0
Marsden Fund
Country [1] 304060 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington
Address
Suicide and Mental Health Research Group,
Department of Psychology,
University of Otago Wellington,
23 Mein Street,
Newtown,
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 307697 0
None
Name [1] 307697 0
Address [1] 307697 0
Country [1] 307697 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304551 0
NZ Health and Disability Ethics Committee
Ethics committee address [1] 304551 0
Ethics committee country [1] 304551 0
New Zealand
Date submitted for ethics approval [1] 304551 0
10/10/2019
Approval date [1] 304551 0
06/03/2020
Ethics approval number [1] 304551 0

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

Contacts
Principal investigator
Name 97354 0
Ms Julie Artus
Address 97354 0
Suicide and Mental Health Research Group,
Department of Psychological Medicine,
University of Otago Wellington,
23 Mein St,
Newtown,
Wellington 6242
Country 97354 0
New Zealand
Phone 97354 0
+64 212066667
Fax 97354 0
Email 97354 0
[email protected]
Contact person for public queries
Name 97355 0
Julie Artus
Address 97355 0
Suicide and Mental Health Research Group,
Dean's Department,
University of Otago Wellington,
23 Mein St,
Newtown,
Wellington 6242
Country 97355 0
New Zealand
Phone 97355 0
+64 212066667
Fax 97355 0
Email 97355 0
[email protected]
Contact person for scientific queries
Name 97356 0
Julie Artus
Address 97356 0
Suicide and Mental Health Research Group,
Department of Psychological Medicine,
University of Otago Wellington,
23 Mein St,
Newtown,
Wellington 6242
Country 97356 0
New Zealand
Phone 97356 0
+64 212066667
Fax 97356 0
Email 97356 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
This is a qualitative research study undertaken as part of a PhD programme. No individualised data will be available on completion of the study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9609Informed consent form  [email protected]



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.