Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000688482p
Ethics application status
Not yet submitted
Date submitted
6/06/2025
Date registered
30/06/2025
Date last updated
30/06/2025
Date data sharing statement initially provided
30/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Animal-Assisted Therapy with Children in Out of Home Care.
Scientific title
A Multi-site, Single Case, Withdrawal Design Evaluating the Effect of Dog Presence on Comfort and Distress Indicators in Children Receiving Therapy Who Are Living in Whanau or Out of Home Care.
Secondary ID [1] 314510 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 337584 0
Post-traumatic stress disorder 337810 0
Condition category
Condition code
Mental Health 333927 333927 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 334152 334152 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Animal-Assisted Therapy will be implemented with children who are undergoing trauma-focused cognitive behavioural therapy (TF-CBT) while in out-of-home care and have active cases with the National Child Protection Service (CPS). The primary objective of this intervention is to measure resting heart rate, blood pressure, and subjective units of distress (SUDs) during the last five minutes of therapy sessions, both with and without the presence of a dog, to determine whether the dog's presence influences physiological and subjective measures of calmness.

Heart rate will be tracked using a Polar H10 chest strap, while blood pressure will be assessed with an Omron device. The children's visual ratings of SUDs will be collected by a registered psychologist with six years of experience working with children.

TF-CBT therapy sessions will be conducted individually and face-to-face, once a week for 45 minutes; only the first ten sessions are part of the study. The therapy dog will be present during five of these sessions. Sessions will be personalized for each participant following the phases of TF-CBT to address trauma. TF-CBT is a phase-based, components-based model that follows a sequential, manualized programme to ensure fidelity and is time-limited, usually delivered within a maximum treatment length of six months (Cohen et al., 2017). The phases are delivered in the following order 1) Stabilization Skills, 2) Trauma Narrative and Processing, 3) Integration/Consolidation with the components described in the acronym PRACTISE: Psychoeducation and Parenting Skills, Relaxation Skills, Affective Modulation Skills, Cognitive Coping Skills, Trauma Narration and Processing, In Vivo Mastery, Conjoint Child-Parent Sessions, and Enhancing Safety and Developmental Trajectory. The child works through these phases at their own pace, e.g., during psychoeducation general information about their specific trauma is shared, during relaxation skills coping stratigies such as breathing are learnt.

Adherence to TF-CBT is measured by implementing the four core principles, duration and proportionailty relates to session duration and topic - Complex trauma may take 16-25 sessions to address, with a longer duration on the stabilisation phase. The second principle relates to the correct sequence of phases and components, they must be delivered sequentially as they build on from each other. The third principle is gradual exposure which aims to support the child and caregiver in successfully working through issues of avoidance of the trauma and finally including caregivers whenever possible. These four principles can be recorded on the fidelity checklist avaliable from the TF-CBT therapist certification website. Each participant will have a copy of this checklist in their file.

Therapy dog activities will be written into each participants therapy plan. For example during the relaxation skills component, coaching the dog through breathing skills may help the child learn them and use them. Teaching the dog a new skill/trick may help the child learn how to break skills down and understand that learning new skills takes time, including learning how to process their own trauma. The therapy dog has recieved training with a Dogs NZ trainer and achieved the Canine Good Citizen Gold Award. It is intended that sessions will occur in three CPS sites in Northland, New Zealand, all are urban based sites that serve large rural communities.

Intervention code [1] 331152 0
Treatment: Other
Intervention code [2] 331153 0
Behaviour
Comparator / control treatment
A single case withdrawal, non-concurrent design shall be used with the participants acting as their own control. Therefore each participant will recieve TF-CBT across 10 sessions during the study, they will be randomly allocated to have the dog attend either the first session or the second session. Resulting in the dog being present in every alternate session. For example if the child is randomly allocated to have the dog present in their first session, then the dog will also be present in their third, fifth, seventh and ninth sessions for a total of 5 sessions with the dog present. If the child is randomly allocated to have the dog present in their second session then the dog will also be present in their fourth, sixth, eighth and tenth sessions. The children will recieve TF-CBT throughout following the phases as noted in the description of intervention.
Control group
Active

Outcomes
Primary outcome [1] 341601 0
To compare resting heart rate data in children receiving TF-CBT with or without a dog present in session.
Timepoint [1] 341601 0
Measures will be collected at baseline (one - two weeks prior to first session) and then weekly at each therapy session for 10 weeks in the last five minutes of session.
Primary outcome [2] 341805 0
Blood pressure readings will be compared in children receiving TF-CBT across 10 sessions. To ascertain if there is a difference in readings if a dog is present or not present in session.
Timepoint [2] 341805 0
Measures will initially be collected at baseline (one-two weeks prior to the first session and then weekly during each therapy session. Blood pressure measures will be collected from children on the day of therapy in the last ten minutes to ascertain systolic (SBP) and diastolic (DBP) blood pressure. Three blood pressure readings will be collected while the children are sitting quietly. The average of the readings will be taken to ascertain the resting SBP and DBP variables.
Primary outcome [3] 341806 0
To compare subjective units of distress (SUDS) in children receiving TF-CBT across 10 sessions with or without a dog present in session.
Timepoint [3] 341806 0
An initial SUDS will be collected at baseline (one to two weeks prior to the first session) and then again in the first and last five minutes of each session for 10 sessions.
Secondary outcome [1] 448049 0
To compare caregiver ratings of their child's feelings of calm across 10 sessions with or without a dog present.
Timepoint [1] 448049 0
Caregivers will be phoned/text the morning after session to record this outcome. This should take no longer than five minutes each time.
Secondary outcome [2] 448747 0
Compare caregivers ratings of child motivation to attend therapy sessions with or without the dog present.
Timepoint [2] 448747 0
When caregivers bring their child in for the session, immediately prior to the start of each session. This should take no longer than five minutes each time.
Secondary outcome [3] 448748 0
Change in child trauma symptomology.
Timepoint [3] 448748 0
Completed at baseline (one to two weeks prior to first session) and then again at the end of the tenth session. The assessment should take the caregiver approximately 15 mins to complete.
Secondary outcome [4] 448749 0
Childs perception of their trauma symtomology
Timepoint [4] 448749 0
Completed in the first and tenth sessions only.
Secondary outcome [5] 448911 0
Change in child's trauma symptomology
Timepoint [5] 448911 0
Completed at baseline (one to two weeks prior to first session) and then again at the end of the tenth session. The assessment should take the caregiver approximately 15 mins to complete.
Secondary outcome [6] 448912 0
Change in child trauma symptomology.
Timepoint [6] 448912 0
Completed at baseline (one to two weeks prior to first session) and then again at the end of the tenth session. The assessment should take the caregiver approximately 15 mins to complete.

Eligibility
Key inclusion criteria
Children will be invited to participate in the research if:
they are aged between eight and sixteen years of age
they are no longer residing with their parents – but are in out-of-home care
they have been referred to Clinical Services Te Tai Tokerau/Northland for therapy
Minimum age
8 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who have allergies or fear dogs
Children who have previously intentionally harmed an animal
Children who would be younger than eight at the first therapy session

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
Crossover
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
28/07/2025
Actual
Date of last participant enrolment
Anticipated
2/11/2026
Actual
Date of last data collection
Anticipated
11/01/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 27082 0
New Zealand
State/province [1] 27082 0
Northland

Funding & Sponsors
Funding source category [1] 319053 0
Government body
Name [1] 319053 0
Oranga Tamariki
Country [1] 319053 0
New Zealand
Funding source category [2] 319072 0
University
Name [2] 319072 0
Joanne Hona
Country [2] 319072 0
New Zealand
Funding source category [3] 319315 0
University
Name [3] 319315 0
University of Canterbury
Country [3] 319315 0
New Zealand
Primary sponsor type
University
Name
Joanne Hona - Oranga Tamariki/University of Canterbury
Address
Country
New Zealand
Secondary sponsor category [1] 321738 0
Government body
Name [1] 321738 0
Oranga Tamariki
Address [1] 321738 0
Country [1] 321738 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317656 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 317656 0
Ethics committee country [1] 317656 0
New Zealand
Date submitted for ethics approval [1] 317656 0
01/07/2025
Approval date [1] 317656 0
Ethics approval number [1] 317656 0

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

Contacts
Principal investigator
Name 141718 0
Mrs Joanne Hona
Address 141718 0
Oranga Tamariki, 4 Albert Street, Whangarei, 0110, Northland
Country 141718 0
New Zealand
Phone 141718 0
+64274430331
Fax 141718 0
Email 141718 0
[email protected]
Contact person for public queries
Name 141719 0
Joanne Hona
Address 141719 0
Oranga Tamariki, 4 Albert Street, Whangarei, 0110, Northland
Country 141719 0
New Zealand
Phone 141719 0
+64274430331
Fax 141719 0
Email 141719 0
[email protected]
Contact person for scientific queries
Name 141720 0
Joanne Hona
Address 141720 0
Oranga Tamariki, 4 Albert Street, Whangarei, 0110, Northland
Country 141720 0
New Zealand
Phone 141720 0
+64274430331
Fax 141720 0
Email 141720 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Due to confidentiality and the planned low number of participants sharing individual data publicly will not occur. Personal data will be shared with individual participants.



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.