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Trial registered on ANZCTR


Registration number
ACTRN12618002049257
Ethics application status
Approved
Date submitted
18/12/2018
Date registered
21/12/2018
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Arts On Our Mind - the effectiveness of creative activities in promoting mental wellbeing and reducing psychopathological symptoms in children of families with a mental illness
Scientific title
Arts On Our Mind - the effectiveness of creative activities in promoting mental wellbeing and reducing psychopathological symptoms in children of families with a mental illness
Secondary ID [1] 282926 0
Nil
Universal Trial Number (UTN)
U1111-1146-1695
Trial acronym
AOOM (Arts On Our Mind)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental wellbeing 289744 0
Condition category
Condition code
Mental Health 290075 290075 0 0
Depression
Mental Health 290076 290076 0 0
Anxiety
Mental Health 290077 290077 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research explores the effectiveness of creative activities in promoting mental wellbeing and reducing the psychopathological symptoms of children of parents/families with a mental illness (COPMI). The research is a mixed method, randomised experimental and control group design to explore changes in psychopathological symptoms, as well as levels of resiliency and mindfulness in the COPMI population.Participants of the research will be young
people identified to have a family member with a mental illness, living in the Metro South Health catchment region. Referrals may include self-referrals, referrals from mental health clinicians or other stakeholders such as youth workers, school staff or primary healthcare providers. Participants may or may not be currently experiencing a mental illness themselves. Exclusion criteria applies to those who are currently at risk of harming themselves or others, experiencing a psychotic episode or abusing illicit substances, as they may not be able to participate safely in the group. Participants with severe cognitive impairment are also excluded as they may have difficulties following directions and participate fully and meaningfully in the group.

Eligible participants will be randomised into either the Experimental Group that will take part in the ‘Arts On Our Mind’ (AOOM) creative arts group (which is the research intervention) or the Waitlist Control Group, in which the participants will not be taking part in AOOM during the initial research period. However, they will be offered the opportunity to take part in AOOM after the initial research period to ensure equal access to the program. Therefore, there will be two sets of data collected for the Waitlist Control Group, which includes the initial data set collected when acting as a control for the experimental group, as well as the subsequent data set collected when engaged in the AOOM after the waitlist period is over.
For the purpose of this study, participants will be exposed to simple, accessible, inexpensive and common creative activities usually deemed to be fun and engaging to young people. Such activities may include: drawing, role plays, sound/music creation, mask making, collage, painting, mosaic, pastels and printmaking. The focus of the research intervention is exposure to a variety of creative activities over a 5-week period, with quantitative data collected at the start, at the end and post-one-months of the 5-week intervention period.

Art materials and instructions used includes a number of creative activities taken from The Expressive Arts Activity Book (Darley and Heath, 2008), using common art materials such as colour pencils, paper, cardboards, acrylic paints etc. The five sessions conducted over five weeks will involve an assortment of creative activities ranging from writing to painting, drawing and printmaking. Each session is about three hours long. There will be a maximum of 12 participants. There will be at least two facilitators, who do not have to be a mental health professional, but should have ready access to one for supervision, referral and debriefing purposes. All facilitators will need to undergo a brief workshop prior to their participation for familiarisation of the group program and to promote uniformity in the approach. The chief investigator can be a mental health professional supervising the facilitators and be one of the facilitators. The sessions are delivered face-to-face.
The location and setting of the group will be in an appropriate community health facility with access to air conditioning, water and toileting facilities. A Facilitator Self-Assessment form will be completed by facilitators after each session to report on their perception of their adherence. All facilitators would also have completed a familiarisation workshop (with assessable criteria) prior to their participation to promote uniformity of approach.
Intervention code [1] 287701 0
Prevention
Intervention code [2] 287702 0
Treatment: Other
Comparator / control treatment
Pre and post measurement of engaging in a creative arts/activities group - with randomised control and intervention groups.

The treatment (intervention) involves exposure to creative activities in a group situation over a five-week period, once a week, for three hours.

Each session will consist of two to three icebreaker activities and one or two media based
and/or themed activities. Participants are encouraged to participate as much as
possible in accordance with their comfort levels. At the start of each session, there
will be a standard greeting message to be recited by the facilitators and at the start of
each subsequent creative activity, a set of instructions for the activity will be
provided. Facilitators can provide general guidance and support to the participants
and manage any problematic behaviours or crises situations as required but should
always ensure that the focus of the group is the engagement of participants with the
prescribed creative arts activities. Whilst the activities are pre-determined, how
participants engage with the activities and associated materials are non-directive.
All activities are taken from the following resource - Darley, S., & Heath, W. (2008). The Expressive Arts Activity Book, London: Jessica
Kingsley Publishers.

The waitlist control group will also receive the same intervention, but after being on a 'waitlist' where they will complete the research measurement tools (quantitative) without engaging in the interventions initially, followed by engagement in the intervention afterwards. This will commence within two weeks of the post-one-month data being collected from the initial intervention group period. This means that the waitlist control group will commence with the creative arts group after 9-10 weeks behind the commencement date of the intervention group.

Control group
Active

Outcomes
Primary outcome [1] 290198 0
The levels of mental resilience as assessed by the RSCA - Resiliency Scales for Children and Adolescents (quantitative measure) and a semi structured-interview (qualitative measure).
Timepoint [1] 290198 0
The RSCA will be administered before the intervention at Week One, after the final session of the intervention at Week Five and one month post Week Five. The qualitative semi-structured interviews will be conducted at Week Five and one month post Week Five.
Primary outcome [2] 308485 0
Another primary outcome is the level of psychopathological symptoms in the participants, which include the levels of depression, anxiety, anger, disruptive behaviour and poor self concept, as assessed by the BYI-2 - Beck Youth Inventories 2nd Edition (quantitative measure) and a semi structured-interview (qualitative measure)..


Timepoint [2] 308485 0
The Beck Youth Inventories 2nd Edition will be administered before the intervention at Week One, after the final session of the intervention at Week Five and one month post Week Five. The qualitative semi-structured interviews will be conducted at Week Five and one month post Week Five.
Secondary outcome [1] 304088 0
A secondary outcome is the level of mindfulness in participants as measured by the CAMM - Child Acceptance and Mindfulness Measure (quantitative measure) and a semi structured-interview (qualitative measure).
Timepoint [1] 304088 0
The CAMM will be administered before the intervention at Week One, after the final session of the intervention at Week Five and one month post Week Five. The qualitative semi-structured interviews will be conducted at Week Five and one month post Week Five.

Eligibility
Key inclusion criteria
1. Participants will be from families with parental mental illness, or a sibling/close relative with mental illness living in the household.

2. Participants will be between the ages 8-12 years.
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Actively psychotic
2. Unable to participate in a group situation due to violence or other disruptive behaviours
3. Intellectual disability making it difficult for participant to understand/comprehend the group content and materials.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is done by the QuickCalcs randomisation calculator available online.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be a 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data will be gathered before (pre) and after (post) the intervention using three assessment measures. Three other ultra-brief measures will also be used during each session to measure the participant’s perceived psychosocial outcomes, the feedback on the different art forms used in each session and the group process itself. Qualitative information will also be obtained through semi-structured interviews and facilitator self-reports. The qualitative feedback will provide further insight into the unique and subjective perspectives and experiences of the group participants. The quantitative data will be analysed using a repeated measures model with potential covariates being investigated - such as gender, age, types of mental illness within the family and the types of creative activities used. Deductive direct content analysis will be conducted to explore any common or significant themes gathered from the qualitative measures, particularly in relation to the yielded quantitative data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2019
Actual
Date of last participant enrolment
Anticipated
17/02/2020
Actual
Date of last data collection
Anticipated
26/06/2020
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 301472 0
Government body
Name [1] 301472 0
Metro South Health
Country [1] 301472 0
Australia
Primary sponsor type
Government body
Name
Metro South Health
Address
Child and Youth Mental Health Service
51 Wembley Road, Logan Central
Metro South Addiction and Mental Health Services
Metro South Health, Brisbane, Queensland, Australia 4114
Country
Australia
Secondary sponsor category [1] 301164 0
None
Name [1] 301164 0
Address [1] 301164 0
Country [1] 301164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302217 0
Metro South HHS HREC
Ethics committee address [1] 302217 0
Ethics committee country [1] 302217 0
Australia
Date submitted for ethics approval [1] 302217 0
13/04/2018
Approval date [1] 302217 0
20/04/2018
Ethics approval number [1] 302217 0
HREC/13/QPAH/499

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

Contacts
Principal investigator
Name 41838 0
Mr Adam Lo
Address 41838 0
Child and Youth Mental Health Service,
51 Wembley Road, Logan Central QLD 4114
Metro South Addiction and Mental Health Services,
Metro South Health, Queensland Government, Australia
Country 41838 0
Australia
Phone 41838 0
+61730894100
Fax 41838 0
Email 41838 0
adam.lo@health.qld.gov.au
Contact person for public queries
Name 41839 0
Adam Lo
Address 41839 0
Child and Youth Mental Health Service,
51 Wembley Road, Logan Central QLD 4114
Metro South Addiction and Mental Health Services,
Metro South Health, Queensland Government, Australia
Country 41839 0
Australia
Phone 41839 0
+61730894100
Fax 41839 0
Email 41839 0
adam.lo@health.qld.gov.au
Contact person for scientific queries
Name 41840 0
Adam Lo
Address 41840 0
Child and Youth Mental Health Service,
51 Wembley Road, Logan Central QLD 4114
Metro South Addiction and Mental Health Services,
Metro South Health, Queensland Government, Australia
Country 41840 0
Australia
Phone 41840 0
+61730894100
Fax 41840 0
Email 41840 0
adam.lo@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
Privacy reasons


What supporting documents are/will be available?




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.