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Trial registered on ANZCTR


Registration number
ACTRN12622000874718
Ethics application status
Approved
Date submitted
7/06/2022
Date registered
21/06/2022
Date last updated
21/06/2022
Date data sharing statement initially provided
21/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Antenatal Art Therapy Wellbeing Program
Scientific title
Antenatal Art Therapy Wellbeing Program: An exploratory pilot study
Secondary ID [1] 307290 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 326576 0
antenatal health 326577 0
postnatal health 326659 0
Condition category
Condition code
Public Health 323820 323820 0 0
Health promotion/education
Reproductive Health and Childbirth 323821 323821 0 0
Antenatal care
Mental Health 323900 323900 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Antenatal art therapy wellbeing program.

Materials used: The materials used in the intervention include visual art materials as provided to participants in Art in Pregnancy packs and a theme-based art therapy protocol.

Procedures: The pilot program is a brief, group-based art therapy intervention aimed at supporting wellbeing during pregnancy. The pilot has been designed based on a thematic review of peer reviewed research, pertaining to art-based programs delivered in the period of pregnancy (Crane, Buultjens & Fenner, 2021). Session one (individual) aims to facilitate self reflection and exploration of emotion. Session two and three aim to consider themes relating to psychosocial health and developing identity. The final session aims to examine resourcefulness and support networks in the perinatal period. The themes will be used flexibly throughout the duration of the pilot with the aim of supporting individual expression and peer connection. A mix of visual art materials will be utilised in each session.

Who will deliver the intervention: The intervention will be delivered by a Masters level qualified art therapist (and PhD candidate). The art therapist and graduate researcher has clinical experience in group art therapy, adult and perinatal mental health.

Modes of delivery: In line with the general health recommendations during the global pandemic the pilot study will be conducted mostly online. If appropriate session one will be facilitated face-to-face. This will be an individual session between each research participant and the art therapist/graduate researcher. The subsequent group art therapy sessions (a maximum of ten participants in attendance for each group) will be conducted via videoconferencing.

Location: Individual face-to-face research activities will occur at La Trobe University. The group component of the intervention (three sessions) will occur via video conferencing.

Intervention delivery: The intervention consists of four, sixty minute art therapy sessions (one individual and three groups). Women will be eligible for enrollment at 28 weeks gestation and will progress through the study until follow-up at four to six weeks postnatal.

Intervention Adherence: Adherence to the intervention will be monitored by members of the research team, in the form of an attendance check-list.
Intervention code [1] 323735 0
Lifestyle
Intervention code [2] 323736 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331611 0
In-depth, individual interview.
A thirty minute interview will be conducted between a member of the research team and each participant. Interviews will be conducted in accordance to an interview schedule. Key themes include:

Interview 1: Expectations of mothering; wellbeing in pregnancy; understandings of wellbeing and social support; level of familiarity with the creative arts.
Interview 2: Program impact on wellbeing, social support and anticipated role adjustment in the antenatal period; exploration of the therapeutic factors of art therapy; participant feedback on intervention utility.
Interview 3: Program impact on wellbeing, social support and role adjustment in the postnatal period; exploration of the therapeutic factors of art therapy; participant feedback on intervention utility.
Timepoint [1] 331611 0
At baseline: Prior to the first session of the intervention.
Post-intervention: After the final session of the intervention and before childbirth.
Follow-up: Approximately one month after childbirth.
Secondary outcome [1] 410524 0
Wellbeing in Pregnancy Scale (WiP)
Timepoint [1] 410524 0
At baseline: Prior to the first session of the intervention.
Post-intervention: After the final session of the intervention and before childbirth.
Secondary outcome [2] 410526 0
Depression, Anxiety, Stress Scale - 21 (DASS - 21)
Timepoint [2] 410526 0
At baseline: Prior to the first session of the intervention.
Post-intervention: After the final session of the intervention and before childbirth.
Follow-up: Approximately one month after childbirth.

Eligibility
Key inclusion criteria
A pregnant woman who is becoming a mother for the first time
Currently accessing any chosen model of pregnancy care at the industry partner hospital (inclusive of shared care)
Proficient in English
Uncomplicated/low risk pregnancy
Third trimester (from 28 weeks gestation)
Aged 18 years or over
Not currently seeking or receiving treatment (pharmacological or psychotherapeutic) for a diagnosed mental health condition
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
If a participant is considered medically high-risk and unable to participate due to medical intervention.
If a participant scores in the severe range on the Depression, Anxiety, Stress Scale (DASS-21).

Study design
Purpose of the study
Educational / counselling / training
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
Not yet recruiting
Date of first participant enrolment
Anticipated
18/07/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310935 0
University
Name [1] 310935 0
La Trobe University
Country [1] 310935 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road and Kingsbury Drive
Bundoora
Victoria
3086
Country
Australia
Secondary sponsor category [1] 312229 0
None
Name [1] 312229 0
Address [1] 312229 0
Country [1] 312229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310490 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 310490 0
Ethics committee country [1] 310490 0
Australia
Date submitted for ethics approval [1] 310490 0
Approval date [1] 310490 0
05/05/2022
Ethics approval number [1] 310490 0
2022-002
Ethics committee name [2] 311033 0
La Trobe University Human Research Ethics Committee
Ethics committee address [2] 311033 0
Ethics committee country [2] 311033 0
Australia
Date submitted for ethics approval [2] 311033 0
Approval date [2] 311033 0
23/05/2022
Ethics approval number [2] 311033 0

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

Contacts
Principal investigator
Name 117854 0
Dr Melissa Buultjens
Address 117854 0
La Trobe University,
Department of Public Health, School of Psychology and Public Health
Plenty Road and Kingsbury Drive,
Bundoora,
Victoria,
3086
Country 117854 0
Australia
Phone 117854 0
+61 3 94796502
Fax 117854 0
Email 117854 0
m.buultjens@latrobe.edu.au
Contact person for public queries
Name 117855 0
Tess Crane
Address 117855 0
La Trobe University,
Department of Public Health, School of Psychology and Public Health
Plenty Road and Kingsbury Drive,
Bundoora,
Victoria,
3086
Country 117855 0
Australia
Phone 117855 0
+61 3 94795773
Fax 117855 0
Email 117855 0
t.crane@latrobe.edu.au
Contact person for scientific queries
Name 117856 0
Tess Crane
Address 117856 0
La Trobe University,
Department of Public Health, School of Psychology and Public Health
Plenty Road and Kingsbury Drive,
Bundoora,
Victoria,
3086
Country 117856 0
Australia
Phone 117856 0
+61 3 94795773
Fax 117856 0
Email 117856 0
t.crane@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants will not be providing consent for data to be available in this way.


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.