Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001014640
Ethics application status
Approved
Date submitted
27/08/2023
Date registered
19/09/2023
Date last updated
19/09/2023
Date data sharing statement initially provided
19/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Horse Programs for Autistic Children
Scientific title
Equine-assisted therapy for autistic children: An exploration of effectiveness and mechanisms of change.
Secondary ID [1] 310442 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 331226 0
Condition category
Condition code
Mental Health 327988 327988 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will use a single subject, multiple cross-over (N-of-1) study design with multiple baseline across participants. Different treatment conditions will consist of treatment with horse present (A; intervention condition), and treatment without horse present (B; control condition). Participants will be assigned randomly to a randomly generated sequence of multiple episodes (individual therapy sessions) of both treatment conditions.

A 2-week baseline condition will commence at the same time for all participants. The baseline period will consist of the participants usual routine, with no additional interventions or changes.

Through random assignment, 2 participants will then commence the intervention. A further 2 participants will commence treatment after 4 weeks from baseline, and the last two after 6 weeks from baseline.

Treatment adherence will be monitored through a session attendance checklist, and reasons for non attendance will be recorded.

Intervention:
A mindfulness-based, cognitive-behavioural therapy intervention (MCBT) will be provided in a farm setting and will be adapted to allow for the inclusion of a horse in some of the scheduled activities. The intervention will consist of 60-minute therapy sessions, provided on a weekly basis for 8 consecutive weeks. The intervention will be provided by a PhD candidate./ student researcher.

The student researcher is currently enrolled in the Clinical Psychology Doctorate program at Curtin University and has completed all clinical training of this program, is a registered psychologist and has completed the AHPRA practice requirement of the clinical psychology registrar program (endorsement pending completion of the Doctorate Program). Through their training and experience working as a psychologist in private practice, the student researcher has obtained knowledge and experience in providing psychological interventions to a variety of clients from different age groups and cultural backgrounds. The research student also has over 10 years experience of volunteering and working in equine- assisted therapy programs providing services to autistic children. The student researcher will be supervised by Dr Trevor Mazzuchelli who has extensive experience in working with children with a range of disabilities. Dr Trevor Mazzucchelli held a position as clinical psychologist with the Disability Services Commission for 14 years, specialising in working with children with developmental disabilities (including ASD) and their families.

A standardised treatment program will be manualised and documented in detail, including clear description of comparable activities in the control and intervention conditions. The treatment activities will be based on a mindfulness based CBT program, Participants will interact with the horse through observing the horse, brushing the horse, groundwork/ leading/ walking the horse, and being led on horseback). Examples of specific activities in the treatment condition (with the horse) will include : mindful breathing while standing with the horse (control: mindful breathing while standing in nature), mindful walking/ focussing on movement in the body and rhythm while leading the horse (control condition: mindful walking without horse);noticing/ observing body sensations and linking it to emotions and states of arousal using observations of the horse as a metaphor/ comparison (control: noticing and observing feelings while in nature); noticing and engaging the 5 senses while grooming the horse (control: noticing the 5 senses in nature).


Target behaviour will be monitored by the parent during each phase of the study via daily completion of the Parent Daily Report checklist (PDR; Chamberlain & Reid, 1987). A web-based version of the PDR will be used. Parents will receive reminders, prompting completion in line with the observation schedule. During the initial 2-week baseline phase, the PDR will be completed daily, to ascertain target behaviour stability. Subsequently, the PDR will be collected 3 times per week, to reduce participant burden.

Idiosyncratic indices of happiness will be identified for each participant in line with protocols suggested by Parson et al. (2012) and replicated by Ramey et al., 2022 and observed and scored based on the recording of sessions. A rater blind to the session number will view videos of treatment sessions and use a scatter plot to code for indices of happiness and participation.

The standardised measures are intended to be completed online but can also be requested as paper and pen version by the participant. If necessary, the independent rater could also complete these measures with the participants via phone, if neither the online nor paper- pen version is appropriate for a particular participant.
All standardised self-report measures will be administered at the beginning of the baseline phase, after the 8 weeks of overall intervention, and at 3- and 6-month follow-up. Child participants will complete therapeutic alliance measures on an iPad provided at the end of each session.
Intervention code [1] 326844 0
Treatment: Other
Intervention code [2] 326970 0
Behaviour
Comparator / control treatment
The study will use a single subject, multiple cross-over (N-of-1) study design with multiple baseline across participants. Participants will be acting as their own control by random assignment to a sequence of multiple episodes (individual therapy sessions) of both treatment and control conditions. The treatment episodes for the control condition consist of comparable mindfulness-based activities that are conducted in a farm setting, but without the direct presence of the horse., e.g. mindful breathing while standing in nature, mindful walking/ focussing on movement in the body and rhythm, noticing/ observing body sensations and linking it to emotions and states of arousal while in nature, noticing and engaging the 5 senses while observing nature.
Control group
Active

Outcomes
Primary outcome [1] 335853 0
Internalising and externalising behaviours will be assessed using the composite overall difficulties score of the Strengths and Difficulties Questionnaire (child self-report and parent self-report) pre- and post intervention.
Timepoint [1] 335853 0
All standardised self-report measures will be administered for all participants on day 1 of the baseline phase (same timepoint for all participants), 7 days after the last intervention session has been concluded (different timepoint for each participant due to staggered treatment commencement) and as a follow up measure at 3- and 6-month post last intervention session (different timepoint for each participant).

Child participants will complete therapeutic alliance measures on an iPad provided at the end of each session prior to leaving the premisses..
Primary outcome [2] 335871 0
Social/ communication skills (Social Responsiveness Scale (SRS-2); parent report) pre- and post intervention
Timepoint [2] 335871 0
All standardised self-report measures will be administered at the beginning of the baseline phase, after the 8 weeks of overall intervention, and at 3- and 6-month follow-up. Child participants will complete therapeutic alliance measures on an iPad provided at the end of each session.
Primary outcome [3] 335872 0
Problem behaviour- Parent Daily Report checklist for target behaviour, during baseline, intervention phase and post intervention
Timepoint [3] 335872 0
Target behaviour will be monitored by the parent during each phase of the study via daily completion of the Parent Daily Report checklist (PDR; Chamberlain & Reid, 1987). A web-based version of the PDR will be used. Parents will receive reminders, prompting completion in line with the observation schedule. During the initial 2-week baseline phase, the PDR will be completed daily, to ascertain target behaviour stability. Subsequently, the PDR will be collected 3 times per week, to reduce participant burden.
Secondary outcome [1] 425946 0
Measures of happiness/ participation in session
Behavioural observations of indices of happiness during therapy sessions, independent rater (protocol suggested by parson et al., 2012 and replicated by Ramey et al., 2022); Therapy Process Observational Coding System-Alliance Scale (TPOCS-A), independent rater;
Timepoint [1] 425946 0
Idiosyncratic indices of happiness will be identified for each participant in line with protocols suggested by Parson et al. (2012) and replicated by Ramey et al., 2022 and observed and scored based on the recording of sessions. A rater blind to the session number will view videos of treatment sessions and use a scatter plot to code for indices of happiness and participation.
Secondary outcome [2] 425947 0
Quality of life/ general wellbeing (Family Quality of life Survey (FQOLS-2006), parent self- report;
Timepoint [2] 425947 0
All standardised self-report measures will be administered for all participants on day 1 of the baseline phase (same timepoint for all participants), 7 days after the last intervention session has been concluded (different timepoint for each participant due to staggered treatment commencement) and as a follow up measure at 3- and 6-month post last intervention session (different timepoint for each participant).
Secondary outcome [3] 425948 0
Standardised measures for child mindfulness (Five-Facet Mindfulness: Mindfulness Questionnaire-child and adolescent version short form (FFMQ-A-SF)
Timepoint [3] 425948 0
All standardised self-report measures will be administered for all participants on day 1 of the baseline phase (same timepoint for all participants), 7 days after the last intervention session has been concluded (different timepoint for each participant due to staggered treatment commencement) and as a follow up measure at 3- and 6-month post last intervention session (different timepoint for each participant).

The standardised measures are intended to be completed online but can also be requested as paper and pen version by the participant. If necessary, the independent rater could also complete these measures with the participants via phone, if neither the online nor paper- pen version is appropriate for a particular participant.
Secondary outcome [4] 426545 0
Child Treatment satisfaction
Child self- report of session satisfaction therapeutic alliance will be measures using the Child Session Rating Scale-
Timepoint [4] 426545 0
The Child Session Rating Scale will be completed as child self-report immediately after completion of the session, prior to leaving the premisses.
Secondary outcome [5] 426546 0
Pediatric Quality of Life Inventory (PedsQL), child self- report) pre- and post intervention
Timepoint [5] 426546 0
All standardised self-report measures will be administered for all participants on day 1 of the baseline phase (same timepoint for all participants), 7 days after the last intervention session has been concluded (different timepoint for each participant due to staggered treatment commencement) and as a follow up measure at 3- and 6-month post last intervention session (different timepoint for each participant).

Eligibility
Key inclusion criteria
6 children between the age of 9- to 14-years with a diagnosis of ASD, and their parents (no age limit for parents).
Minimum age
9 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Only participants that are not simultaneously engaged in any other psychological treatment and if receiving pharmacological treatment, with a minimum of 3 months of medication stability will be recruited. To monitor potential confounding effects, parents will be asked to inform of medication changes over the course of the study and information about participation in adjunct therapies will be collected.

Exclusion criteria for the child participants are very high levels of anxiety or sensory sensitivities that would prevent participants from comfortably interacting with the horses and farm setting, extreme externalising behaviours and being completely non-verbal or unable to communicate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Multiple episodes (individual therapy sessions) of both treatment conditions will be provided to each participant. The sequencing of treatment episodes was generated through computerised sequence generation, and participants will be allocated to one of the different treatment sequences through simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study will use a single subject, multiple cross-over (N-of-1) study design with multiple baseline across participants.

For this study, the different treatment conditions will consist of treatment with horse present (A; intervention condition), and treatment without horse present (B; control condition). Multiple episodes (individual therapy sessions) of both treatment conditions will be provided to each participant. The sequencing of treatment episodes was generated through randomisation, and participants will be randomly allocated to one of the different treatment sequences.

The 2-week baseline condition will commence at the same time for all participants. Through random assignment, 2 participants will then commence the intervention. A further 2 participants will commence treatment after 4 weeks from baseline, and the last two after 6 weeks from baseline
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Collection/ Outcome measures:
All sessions will be video recorded to allow for coding of observed behaviour by an independent rater.

Data will be collected from a range of standardised parent and child self-report measures as well as behavioural observations, using the following measures:
- standardised measures for internalising and externalising behaviours, strengths and difficulties (Strengths and Difficulties Questionnaire child self-report and parent self-report) pre- and post intervention
- standardised measure for social/ communication skills (Social Responsiveness Scale (SRS-2); parent report) pre- and post intervention
- Parent Daily Report checklist for target behaviour, during baseline, intervention phase and post intervention
- Standardised Measures of Quality of life/ general wellbeing (Family Quality of life Survey (FQOLS-2006), parent self- report; Pediatric Quality of Life Inventory (PedsQL), child self- report) pre- and post intervention
- Standardised measures for child mindfulness (Five-Facet Mindfulness Questionnaire-child and adolescent version short form (FFMQ-A-SF) pre- and post intervention
- Measures of happiness/ participation in session (Behavioural observations of indices of happiness during therapy sessions, independent rater (protocol suggested by parson et al., 2012 and replicated by Ramey et al., 2022); Therapy Process Observational Coding System-Alliance Scale (TPOCS-A), independent rater;
- Child self- report of session satisfaction therapeutic alliance (Child Session Rating Scale- child self-report) after each session



A total daily problem behaviour score for each completed PDR, a total score for observed indices of happiness and session satisfaction will be calculated for each session. Scores will be analysed visually by using a line graph to detect trends in the data. As weak effects may not be detected by visual analysis, statistical tests will also be performed. Tau- U (Parker et al., 2011) will be used to calculate effect sizes, as this measure can account for both the change across phases and as well as positive baseline trend (Rakap 2015). Tau U is selected, as this non- parametric measure does not show artificial ceiling effects and performs reasonably well even with autocorrelated data (Parker et al., 2011)

Total (and subscale scores where applicable) will be calculated for pre- and post-measurements of questionnaires used. Total scores will be calculated for the Pediatric Quality of Life Inventory (Varni et al., 1999). A reliable change index will be calculated to assess clinically significant change on these measures, using the methods proposed by Jacobson and Truax (1991).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2023
Actual
Date of last participant enrolment
Anticipated
1/10/2023
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 41196 0
6271 - Capel
Recruitment postcode(s) [2] 41197 0
6230 - Bunbury
Recruitment postcode(s) [3] 41198 0
6280 - Busselton

Funding & Sponsors
Funding source category [1] 314651 0
University
Name [1] 314651 0
Curtin University
Country [1] 314651 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street Bentley 6102 Western Australia
Country
Australia
Secondary sponsor category [1] 316613 0
None
Name [1] 316613 0
Address [1] 316613 0
Country [1] 316613 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313668 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 313668 0
Ethics committee country [1] 313668 0
Australia
Date submitted for ethics approval [1] 313668 0
03/07/2023
Approval date [1] 313668 0
24/08/2023
Ethics approval number [1] 313668 0
HRE2023-0480

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

Contacts
Principal investigator
Name 128950 0
Mr Trevor Mazzucchelli
Address 128950 0
Curtin UniversityKoorliny Way, Bentley WA 6102
Country 128950 0
Australia
Phone 128950 0
+61 8 9266 7182
Fax 128950 0
Email 128950 0
[email protected]
Contact person for public queries
Name 128951 0
Trevor Mazzucchelli
Address 128951 0
Curtin UniversityKoorliny Way, Bentley WA 6102
Country 128951 0
Australia
Phone 128951 0
+61 8 9266 7182
Fax 128951 0
Email 128951 0
[email protected]
Contact person for scientific queries
Name 128952 0
Trevor Mazzucchelli
Address 128952 0
Curtin UniversityKoorliny Way, Bentley WA 6102
Country 128952 0
Australia
Phone 128952 0
+61 8 9266 7182
Fax 128952 0
Email 128952 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


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.