Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000120279
Ethics application status
Approved
Date submitted
8/01/2018
Date registered
29/01/2018
Date last updated
6/05/2022
Date data sharing statement initially provided
6/05/2022
Date results provided
6/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A controlled evaluation of an “arts in health” program designed to enhance psychosocial health in Mater Young Adults Health Centre patients
Scientific title
A controlled evaluation of an “arts in health” program designed to enhance psychosocial health in Mater Young Adults Health Centre patients
Secondary ID [1] 293726 0
RA-17-263 research agreement between University of QLD and Mater Hospital and Health Services
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 306089 0
anxiety disorders 306090 0
addiction 306091 0
Condition category
Condition code
Mental Health 305214 305214 0 0
Depression
Mental Health 305215 305215 0 0
Anxiety
Mental Health 305216 305216 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a two arm controlled evaluation in which patients of the Mater Young Adults Health Centre (YAHC) aged 18 to 25 years will be offered their choice of three arts based group interventions designed to enhance their psychosocial well-being and engagement with health services: art therapy group; vocal group; and make-your-own-podcast group. Participants who are placed in an arts group immediately will continue to receive treatment-as-usual at the Mater YAHC (condition TAU+ARTS). Their data will be compared with participants who are receiving treatment as usual only during the six weeks period (condition TAU).
a) Art Therapy group
Educators: Kate Palmer and an intern psychologist or art therapist
Kate Palmer, Social Worker (7 years) and Art Therapist (1 year) is well qualified and experienced to be the lead educator of this group. Kate will be joined by a provisionally registered clinical psychology postgraduate student, or postgraduate art therapy student, as part of their supervised practice program (under the supervision of Kate and Dr Genevieve Dingle). These students will have already completed several courses in mental health and therapy and have completed about 100 hours of client contact so they are well prepared to work as co-facilitators of this group. They will comply with the requirements for students on placement at the Mater in terms of confidentiality agreements, vaccinations, and workplace orientations.
Content: The six session art therapy program involves a range of art activities including fluid painting, bridge drawing, and mask making. There is growing demand for Art Therapy within the Mater YAHC, and both groups have yet to be empirically evaluated. The art therapy component runs for approximately two hours each session, and encourages group members to explore sense of self, self-identity, independence and life goals through art. There is evidence to support art therapy decreasing social isolation in young people with medical conditions and creating an opportunity to meet others with similar experiences and learn from such experiences and works (Bitonte & Santa, 2014; Rubin, 2005). Positive group experiences are also related to a successful transition to adulthood from adolescence more generally (Riley, 2001). For young people with complex experiences like medical illness, art therapy is a powerful tool for emotional expression, processing and supports social, cognitive and physical development (Kline, 2016). Mallay (2002) and Kline (2016) propose that art therapy is ideal for working with young people when sensory, cognitive or physical capabilities are impaired as it does not rely on verbal output in the way that other psychotherapies do. In this field, it is common for the young person to have either one or more of the following impairments: speech, language, cognitive, physical, social and psychological. Art Therapy also supports physical and fine motor rehabilitation (Kline, 2016).

b) Vocal Group
Educators: Malcolm Hume (Brisbane State High School teacher and choral director) and Kate Palmer. Malcolm has degrees in both music and education, and he directs Bella Voce, the premier senior vocal ensemble at Brisbane State High School. He is familiar with musical repertoire and techniques suitable for working with young people. He will be joined in the group face-to-face sessions by Kate Palmer, in order to have a clinician on hand if the need arises. This six session program will be offered in both face-to-face or virtual modes so that young people who are able to attend the choir in person may do so, while young people who experience barriers in terms of their immunity level or location may attend online. After each session, Malcolm will post song conducting instructions online and the participants will record themselves singing and send their recording to Malcolm to merge into a soundtrack which all participants can hear. In this way we expect that group benefits will be experienced by all participants even if they are participating virtually.
Content: There is both quantitative and qualitative evidence to support the use of group singing interventions to increase emotion regulation, mental health, and wellbeing (Dingle, Brander, Ballantyne & Baker, 2013; Dingle, Williams, Jetten, Welch, 2017). When participants sing together they have an important role in creating the choral sound, and there is no reference being made to their psychological health status. It has been found that engagement in such choir groups increases social connection, social functioning, employment capacity, self-perception, emotion regulation and positive emotions (Dingle et al, 2013; 2017). Despite young adults with health problems reporting similar concerns around social functioning (Zebrack, 2011) the use of group choir singing has not yet been evaluated in a young adult health context.
c) Make Your Own Podcast group
Educators: 2 MentalMusic team members and Kate Palmer and/or Alan Heady (Mater YAHC Health Psychologist)
www.MentalMusic.org is a group of Brisbane young people who make podcasts about mental health and social issues that affect young people (Hinchcliffe, 2017). They will be responsible for providing education in the sessions, while a clinician (Kate and/or Alan) will also be present at all sessions. The role of the educators from MentalMusic is focused on skills instruction – this is in keeping with the arts programs being more like ‘courses’ than ‘therapy’ groups per se. The groups will be kept small in number (ie., 4-6 participants, with 2 MentalMusic educators and at least 1 clinical facilitator) so participant behaviour, emotions and interpersonal dynamics are expected to be readily managed. It should be noted that the MentalMusic educators will not be responsible for managing mental health issues (or health issues) experienced by participants during the podcast making program – instead the Mater clinical facilitator/s who will be present in all of the sessions will take on that role. These staff members are experienced group facilitators and able to manage any group dynamics or other issues arising, and for debriefing with the educators after each group session.
Content: In the current project, we expect that participants will select topics related to their medical experiences and associated social and developmental issues. The topics and preparation for interviews will be conducted in the group sessions, and the educators will assist participants to select topics, and also the participants will conduct their interviews with each other (ie. other participants in the podcast making group) for the purpose of skills building during the program. This means that the topics, interview questions, and editing of recorded material for the podcasts can be carefully monitored by the project team. The MentalMusic.org members will show small groups of MYAHCB participants how to conduct research on the topic, microphone and interviewing technique, how to set up and conduct interviews, and how to edit the podcasts and make them available online.
All three programs will be offered in groups, face-to-face at the Dome, on level 4 of the Mater Salmon Building. The vocal group will also be offered in virtual format for participants who are unable to attend sessions face to face. Typically the programs will be delivered over six weeks, 90 minutes per session; however, there may be some groups conducted in intensive mode (i.e. 3 x 3 hour sessions over three weeks). Participants will be allowed to enrol in more than one arts based program however only their first program will be evaluated at pre-and post-program; subsequent programs will be evaluated at post-program only.
Intervention code [1] 299981 0
Treatment: Other
Comparator / control treatment
Treatment as usual: these young people are not opting to join an arts based group but are receiving medical and allied health treatment as usual at the Mater YAHC. Typically this consists of regular appointments with their treating medical team, and allied health appointments as required at the Young Adults Support Unit.
Control group
Active

Outcomes
Primary outcome [1] 304376 0
The primary outcomes of this study will be the change in scores on quality of life measured by the AQuOL (Moodie, Richardson, Rankin, Iezzi, & Sinha, 2010). The AQuOL has 20 items and yields several subscales: Independent Living, Mental Health, Coping, Relationships, Pain, and Senses.
Timepoint [1] 304376 0
Pre-program (T1); Post-program (T2 = +6 weeks) and follow up (T3 = +10 weeks). The post-program assessment (T2) is considered to be the primary endpoint.
Primary outcome [2] 304379 0
Scores on a measure of emotion regulation, the Difficulties in Emotion Regulation Scale - 16 item version (Bjureberg et al., 2016)
Timepoint [2] 304379 0
Pre-program (T1); post-program (T2 = +6 weeks ); and six weeks post-program (T3 = +10 weeks). The post-program (T2) assessment is considered the primary endpoint.
Primary outcome [3] 304451 0
Social Identification with arts group, and with family, measured on the 4-item social identification measure (Doosje, Ellemers, & Spears, 1995). This is a single measure with the content of items varied according to the social group of interest (in this study, family and arts based group will be written into the items, e.g. "I identify with other members of...[my family]"
Timepoint [3] 304451 0
The new study design has only two time points, T1 (pre-program) and T2 (+6 weeks)
Secondary outcome [1] 341776 0
Secondary outcomes include participants’ ratings of engagement with each arts program in the post-program survey. These items have been designed specifically for this study (e.g. 'I found this arts based group enjoyable' rated on a scale of agreement / disagreement)
Timepoint [1] 341776 0
Post-program ratings (T2 = +6 weeks)
Secondary outcome [2] 342009 0
Verbal feedback on each of the interventions given by participants in the end of project focus groups. The questions for the focus groups are below:
Can you reflect on the following elements of the arts program/s you attended and comment on your experience of them?
a) The content of the program – what activities did you find helpful? (encourage discussion of the four programs separately)
b) The content of the program – what activities did you find unhelpful or difficult? (is there anything we could do to make it better?)
c) How did you find the format of the program – e.g. face to face vs online?
d) How was your experience of sharing your music, art or podcast recordings with others in the group?
e) Did you feel a sense of belonging and connectedness with others in the group?
f) Did your participation in the arts group/s affect your social connections with others outside of the group (e.g. family, friends, house-mates?)
g) Did you participation in the arts group affect your attendance and feelings about coming to the Mater Young Adults Health Centre for other aspects of health services here?
h) Did your participation in the arts group affect your physical health? (if yes, in what way?)
i) Did your participation in the arts group affect your mental health and wellbeing? (If yes, in what way?)
Timepoint [2] 342009 0
Focus groups will be held towards the end of 2018, which will represent a range of times since each participant was engaged in an arts based group as part of the project.
Secondary outcome [3] 342010 0
Engagement with other aspects of health care at the Mater Young Adults Health Centre, measured by the number of 'did not attend' appointments recorded in the young person's medical chart for the three months prior to their engagement in the arts based group; compared with three months after their first attendance at an arts based health program.
Timepoint [3] 342010 0
3 months before compared with 3 months after the participants' attendance at their first arts based group session.

Eligibility
Key inclusion criteria
The participants will be patients of the Mater YAHC ranging in age from 18 to 25 and of all genders, as this is the age group of particular interest to the researchers. The study is not diagnosis specific. Clinicians from the Mater YAHC clinics Thrive, Young Adults Support Unit, Diabetes, Cystic Fibrosis, Irritible Bowel Disease, Clarence Street Alcohol and Drug Service, and others will be made aware of the project and will identify patients who they think might benefit from the arts programs and be suitable for group work.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
An ability to attend (in person or virtually) five out of the six intervention sessions, as to derive benefit from the program it is expected that the majority of sessions need to be attended.

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will check for any Time 1 differences between arts groups (which we are not expecting) and assuming there aren’t any, the data will be pooled across arts groups to form a single “intervention” sample for statistical comparison with the control sample. The main analyses planned were 2 x 2 mixed analyses of variance. A power analysis for a 2 groups (TAU; TAU + arts group intervention) x 2 times (pre-program, post-program +6 weeks) indicated that a sample size of 52 would be required to detect a significant difference between groups with a medium effect size (f = .20) on measured variables.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
5/03/2018
Actual
5/03/2018
Date of last participant enrolment
Anticipated
21/12/2018
Actual
21/12/2018
Date of last data collection
Anticipated
28/02/2019
Actual
Sample size
Target
105
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9700 0
Mater Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 18469 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 298341 0
Charities/Societies/Foundations
Name [1] 298341 0
Brain Injured Childrens Aftercare Recovery Endeavours (BICARE)
Country [1] 298341 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
c/- Dr Genevieve Dingle
School of Psychology
University of QLD
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 297459 0
Hospital
Name [1] 297459 0
Mater Misericordiae Hospital and Health Services, Brisbane
Address [1] 297459 0
Raymond Terrace, South Brisbane Qld 4101
Country [1] 297459 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299333 0
Mater HREC
Ethics committee address [1] 299333 0
Ethics committee country [1] 299333 0
Australia
Date submitted for ethics approval [1] 299333 0
26/09/2017
Approval date [1] 299333 0
30/11/2017
Ethics approval number [1] 299333 0
HREC/17/MHS/107
Ethics committee name [2] 299344 0
UQ HREC
Ethics committee address [2] 299344 0
Ethics committee country [2] 299344 0
Australia
Date submitted for ethics approval [2] 299344 0
05/12/2017
Approval date [2] 299344 0
06/12/2017
Ethics approval number [2] 299344 0
2017002023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2314 2314 0 0
/AnzctrAttachments/374258-Clean version_Mater Arts in Health Protocol v2 21112017.docx (Protocol)
Attachments [2] 2315 2315 0 0
/AnzctrAttachments/374258-17 107 HREC approval.pdf (Ethics approval)
Attachments [3] 2316 2316 0 0
/AnzctrAttachments/374258-2017002023 - UQ Ethics Approval Form.pdf (Ethics approval)

Contacts
Principal investigator
Name 80090 0
Dr Genevieve Dingle
Address 80090 0
School of Psychology
University of QLD
St Lucia QLD 4072
Country 80090 0
Australia
Phone 80090 0
+617 3365 7295
Fax 80090 0
Email 80090 0
[email protected]
Contact person for public queries
Name 80091 0
Genevieve Dingle
Address 80091 0
School of Psychology
University of QLD
St Lucia QLD 4072
Country 80091 0
Australia
Phone 80091 0
+617 3365 7295
Fax 80091 0
Email 80091 0
[email protected]
Contact person for scientific queries
Name 80092 0
Genevieve Dingle
Address 80092 0
School of Psychology
University of QLD
St Lucia QLD 4072
Country 80092 0
Australia
Phone 80092 0
+617 3365 7295
Fax 80092 0
Email 80092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The final cleaned data set that is used for any publications
When will data be available (start and end dates)?
Uncertain
Available to whom?
Other researchers by request
Available for what types of analyses?
Reviews with meta analyses
How or where can data be obtained?
Data on the UQ Research Data Management system will be made available by emailing the principal investigator: [email protected]


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.