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Trial registered on ANZCTR


Registration number
ACTRN12619001675112
Ethics application status
Approved
Date submitted
9/10/2019
Date registered
29/11/2019
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Yawardani Jan-ga (Horses helping healing in Yawuru language): Using equine-assisted learning to improve the social and emotion wellbeing of Aboriginal young people and prevent suicide
Scientific title
Yawardani Jan-ga: Equine Assisted Learning with Aboriginal community co-design as in intervention into causal pathways into incarceration and suicide.
Secondary ID [1] 299510 0
nil known
Universal Trial Number (UTN)
U1111-1241-7349
Trial acronym
YGEAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol spectrum disorder 314758 0
Social and emotional wellbeing issues 314759 0
Condition category
Condition code
Mental Health 313086 313086 0 0
Suicide
Public Health 313182 313182 0 0
Health promotion/education
Mental Health 313183 313183 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 313184 313184 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Yawardani Jan-ga is an equine-assisted experiential learning program delivered weekly by a trained Aboriginal EAL Practitioners utilizing horses as facilitators to assist Aboriginal young people to develop life-transferable skills such as self-awareness, healthy boundaries, self-regulation, persistence and improved social and emotional wellbeing.
A standard dose will be a curriculum of 10 sessions of 45 minutes to 1 hour delivered one-on-one at the field site, with the final two sessions being delivered in pairs or small groups. It is intended that sessions be delivered weekly. However, the intervention will be personalised. For each session, activities within the curriculum are selected depending on the emotional state and preference of the young person on the day. Depending on how quickly the young person acquire each skill, they may need to repeat sessions before they progress to the next and, therefore, require more (or less) than the expected standard 10 sessions. A young person may re-join the research at any time after they have graduated if they feel the need for another dose, provided there is the capacity to accommodate them.
Voice-recordings, videos, and photos of participant's progress are taken during sessions and kept in a clinical file. Attendance and progress through the curriculum is monitored weekly to track progress of young people as they move through the program.
Aboriginal EAL Practitioners have receive a minimum of 3 x 1-week blocks of training in EAL by a recognized Equine Psychotherapy Training provider co-facilitated by an Aboriginal Equine Psychotherapist with more than 8 years experience. As part of their ongoing continuing professional development, practitioners will be required to engage in discussion about issues arising in their sessions with PI Coffin.
Intervention code [1] 315765 0
Behaviour
Intervention code [2] 315766 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321629 0
Changes in self-awareness as observed in primary participants during EAL sessions. Observations may be documented by EAL-Practitioners:

1. During EAL-sessions as part of field notes.
2. After EAL-sessions in reflective notes of the EAL session/participant.
3. After EAL-sessions on review of photo-sequences / video footage taken during the EAL sessions. Photo-sequences may consist of 4-30 photos per session (depending on activity), while video footage may be made up of one or multiple videos per session, ranging from 30 seconds to three-minutes in length (depending on activity).
Timepoint [1] 321629 0
At the end of ten sessions
Primary outcome [2] 321862 0
Changes in self-regulation as observed in primary participants during EAL sessions and as reported by parent/carer and referrers.

Observations may be documented by EAL-Practitioners:
1. During EAL-sessions as part of field notes.
2. After EAL-sessions in reflective notes of the EAL session/participant.
3. After EAL-sessions on review of photo-sequences / video footage taken during the EAL sessions. Photo-sequences may consist of 4-30 photos per session (depending on activity), while video footage may be made up of one or multiple videos per session, ranging from 30 seconds to three-minutes in length (depending on activity).

Reports on self regulation will be collected through one-on-one interviews (open ended ‘check-ins’) with parent/carers and referrers (school/ police/ other). Interviews (open ended ‘check-ins’) are expected to be between 5 and 20 minutes, and will be conducted either face-to-face, via telephone, depending on the preference / availability of the interviewee.
Interviews will be audio-recorded if consent is given and the transcribed verbatim, otherwise detailed notes will be taken.
Timepoint [2] 321862 0
At the end of ten sessions
Primary outcome [3] 321863 0
Changes in pro-social behaviours (e.g. giving, sharing, helping, obeying rules) as observed in primary participants during EAL sessions and as reported by parent/carer and referrers.
Pro-social behaviours refer to a broad range of voluntary actions intended to help or benefit another individual or group of individuals.

Observations may be documented by EAL-Practitioners:
1. During EAL-sessions as part of field notes.
2. After EAL-sessions in reflective notes of the EAL session/participant.
3. After EAL-sessions on review of photo-sequences / video footage taken during the EAL sessions. Photo-sequences may consist of 4-30 photos per session (depending on activity), while video footage may be made up of one or multiple videos per session, ranging from 30 seconds to three-minutes in length (depending on activity).

Pro-social behaviours will be assessed in one-on-one interviews (open ended ‘check-ins’) with parent/carers and referrers (school/ police/ other). Interviews (open ended ‘check-ins’) are expected to be between 5 and 20 minutes, and will be conducted either face-to-face, via telephone, depending on the preference / availability of the interviewee.
Interviews will be audio-recorded if consent is given and the transcribed verbatim, otherwise detailed notes will be taken.
Timepoint [3] 321863 0
At the end of ten sessions
Secondary outcome [1] 375671 0
Retention of changes in self-awareness among primary participants as assessed through one-on-one semi-structured interviews (open ended) with participant, parents/carers and referrers (school/ police/ other).

Semi-structured interviews with participant, parents/carers and referrers (school/ police/ other) are expected to be up 30-minutes in length, and will be conducted either face-to-face, via telephone, depending on the location, preference, and availability of the interviewee.
Interviews will be audio-recorded if consent is given and the transcribed verbatim, otherwise detailed notes will be taken.
Timepoint [1] 375671 0
At the end of 6 months post-intervention
Secondary outcome [2] 376521 0
Retention of changes in self-regulation among primary participants as assessed through one-on-one semi-structured interviews (open ended) with participant, parents/carers and referrers (school/ police/ other).

Semi-structured interviews with participant, parents/carers and referrers (school/ police/ other) are expected to be up 30-minutes in length, and will be conducted either face-to-face, via telephone, depending on the location, preference, and availability of the interviewee.
Interviews will be audio-recorded if consent is given and the transcribed verbatim, otherwise detailed notes will be taken.
Timepoint [2] 376521 0
At the end of 6 months post-intervention
Secondary outcome [3] 376522 0
Retention of changes in pro-social behaviours (e.g. giving, sharing, helping, obeying rules). Pro-social behaviours refer to a broad range of voluntary actions intended to help or benefit another individual or group of individuals.

Retention of pro-social gains among primary participants will be assessed in one-on-one semi-structured interviews (open-ended) with participant, parents/carers and referrers (school/ police/ other) are expected to be up 30-minutes in length, and will be conducted either face-to-face, via telephone, depending on the location, preference, and availability of the interviewee.
Interviews will be audio-recorded if consent is given and the transcribed verbatim, otherwise detailed notes will be taken.
Timepoint [3] 376522 0
At the end of 6 months post-intervention

Eligibility
Key inclusion criteria
Aboriginality
6-25 years
local service referral
Minimum age
6 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-Aboriginal
below 5 years of age
Over 25 years of age

Study design
Purpose of the study
Prevention
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)
Efficacy
Statistical methods / analysis
Qualitative (analysis will be qualitatively led)

Recruitment
Recruitment status
Not yet recruiting
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 in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 28208 0
6725 - Broome
Recruitment postcode(s) [2] 28209 0
6728 - Derby

Funding & Sponsors
Funding source category [1] 304004 0
Charities/Societies/Foundations
Name [1] 304004 0
Telethon Kids Institute
Address [1] 304004 0
15 Hospital Avenue
Nedlands, WA, 6009
Country [1] 304004 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kids Institute
Address
15 Hospital Avenue
Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 304249 0
None
Name [1] 304249 0
Address [1] 304249 0
Country [1] 304249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304496 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 304496 0
450 Beaufort Street
Highgate, WA, 6003
Ethics committee country [1] 304496 0
Australia
Date submitted for ethics approval [1] 304496 0
02/07/2019
Approval date [1] 304496 0
23/07/2019
Ethics approval number [1] 304496 0
926

Summary
Brief summary
Yawardani Jan-ga means horses doing healing in Yawuru (local Broome) language. It is a direct response to community concerns over youth social and emotional wellbeing, and requests for research programs that are strengths-based and focused on building resilience among youth. Yawardani Jan-ga will investigate the effects of using equine-assisted learning (EAL) to increase the social and emotional wellbeing among Aboriginal youth as an alternative approach to traditional Western models of mental health service provision.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97154 0
Prof Julianne (Juli) Coffin
Address 97154 0
Telethon Kids Institute
Kimberley Office
12 Napier Street,
Broome WA 6725
Country 97154 0
Australia
Phone 97154 0
+61 409377891
Fax 97154 0
Email 97154 0
juli.coffin@telethonkids.org.au
Contact person for public queries
Name 97155 0
Prof Julianne (Juli) Coffin
Address 97155 0
Telethon Kids Institute
Kimberley Office
12 Napier Street,
Broome WA 6725
Country 97155 0
Australia
Phone 97155 0
+61 409377891
Fax 97155 0
Email 97155 0
juli.coffin@telethonkids.org.au
Contact person for scientific queries
Name 97156 0
Prof Julianne (Juli) Coffin
Address 97156 0
Telethon Kids Institute
Kimberley Office
12 Napier Street,
Broome WA 6725
Country 97156 0
Australia
Phone 97156 0
+61 409377891
Fax 97156 0
Email 97156 0
juli.coffin@telethonkids.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5259 0
Ethical approval
Citation [1] 5259 0
Link [1] 5259 0
Email [1] 5259 0
Other [1] 5259 0
Summary results
No Results