Psychological WellbeingNCT06968351
A Pilot Study on Animal-Assisted Intervention in Correctional Settings
A study testing Animal-Assisted Intervention in people with Psychological Wellbeing and Animal-assisted Intervention, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Mental health concerns such as depression, anxiety, and post-traumatic stress are particularly prevalent among incarcerated individuals and are considered risk factors for recidivism. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Wellbeing, Animal-assisted Intervention
- What is being tested?
- Animal-Assisted Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- persons-in-custody
- aged 18 or older
- understand Cantonese
Who cannot join
- an allergy, a fear, or a dislike toward dogs
- a history of aggression toward animals
- a criminal history involving animals
- a history of neurodevelopmental disorders
- active psychosis or mania
- active suicidality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Correctional Services Department
Hong Kong, 00000
Senior Clinical Psychologist (PSS1), +852-25981936, email@csd.gov.hk
About this study
Official title: Animal-Assisted Intervention: An Effectiveness Study Using Qualitative and Quantitative Measures on Offenders With Mental Illnesses in Hong Kong
Mental health concerns such as depression, anxiety, and post-traumatic stress are particularly prevalent among incarcerated individuals and are considered risk factors for recidivism. Leveraging the natural human-animal bond, animal-assisted intervention (AAI) offers a less threatening alternative to engage incarcerated individuals and address their mental health needs. As an initial effort to help promote rehabilitative security in Hong Kong, the current study examines the acceptability and effectiveness of a brief animal-assisted program among offenders in local secured facilities.
- Being tested
- Animal-Assisted Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-Assisted InterventionBehavioural
Also called AAI, Dog Therapy
A brief animal-assisted intervention is offered on a group basis across four sessions. Each session lasts approximately 60 minutes and covers the same themes but through different exercises. These themes include effective communication, behavioral principles, problem-solving, and teamwork. The first part of a session involves learning to give effective single-component commands to a rehabilitative dog under the guidance of a professional dog handler. The second part of a session involves the applications of two or more of these single-component commands to an interactive group activity. Project staff are present at each session to facilitate discussions among participants on any challenges encountered, learning, and intra- as well as inter-personal experiences during the session.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants are assigned to a brief animal-assisted intervention that is offered on a group basis across four sessions. Each of the four sessions lasts approximately 60 minutes. In addition to questionnaire data prior to and after the treatment, participants will provide physiological and questionnaire data at both the beginning and the end of each session. Receives: Behavioral: Animal-Assisted Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in common psychopathology as measured with the Depression, Anxiety, and Stress Scale - 21 Items
Depression, Anxiety, and Stress Scale - 21 Items (DASS21; Lovibond \& Lovibond, 1995) is a self-report measure of common mental health concerns. The three subscales are each measured with seven items, using a 4-point Likert scale from 0 = Did not apply to me at all to 3 = Applied to me very much or most of the time. Scores are summed for each subscale, with higher scores indicating more severe levels of emotional symptoms.
Measured: At the beginning of each sessions, approximately one week after completion of the treatment, and one month after the treatment
Change in emotional state as measured with the International Positive and Negative Affect Schedule Short Form
International Positive and Negative Affect Schedule Short Form (I-PANAS-SF; Thompson, 2007) is an adapted version of the PANAS-SF (Watson et al., 1988) and designed specifically for non-English speaking individuals. Using a 5-point Likert scale from 1 = Never to 5 = Always, individuals rate on their experience of five positive affect and five negative affect in the present moment. Scores are summed for each subscale, with higher scores indicating higher levels of positive or negative affect.
Measured: At the beginning and at the end of each session, up to a total of four sessions
Change in heart rate variability
Heart rate data are collected via photoplethysmogram signals and then transformed into heart rate variability with artifacts corrected through automated detection using the Kubios HRV Scientific software (Kubios, 2024).
Measured: At the beginning and at the end of each session, up to a total of four sessions
Change in skin conductance
Both phasic and tonic skin conductance data are captured with a galvanic skin response sensor
Measured: At the beginning and at the end of each session, up to a total of four sessions
Secondary outcomes (8)
Change in disciplinary offences and privileges during incarceration
To track PIC's conduct and interpersonal behaviors during incarceration, official correctional records on disciplinary offences and privileges received in the week prior to each AAI session, including counts and associated behaviors, are collected.
Measured: At each session, up to a total of four sessions, and within a week after the treatment
Change in trauma-related psychopathology as measured with the Posttraumatic Stress Disorder Checklist for DSM-5
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a self-report measure of posttraumatic stress disorder (PTSD) symptom severity, based on its diagnostic criteria in DSM-5 (Blevins et al., 2015). Each of the 20 items is rated on a 5-point Likert scale of 0 = Not at all to 4 = Extremely.
Measured: Before treatment, within a week after treatment, and one month after treatment
Change in empathy as measured with the Brief Interpersonal Reactivity Index
Brief Interpersonal Reactivity Index (B-IRI) measures empathy by four subscales, namely Perspective Taking, Empathic Concern, Fantasy, and Personal Distress. Each subscale is measured by four items, using a 5-point Likert scale from 1 = Does not describe me at all to 5 = Describes me very well and with higher sum scores indicating higher levels in the corresponding aspect of empathy.
Measured: Before treatment, within a week after treatment, and one month after treatment
Change in self-efficacy as measured with the New General Self-Efficacy Scale
New General Self-Efficacy Scale (NGSES) is designed to measure self-efficacy across contexts. Using a 5-point Likert scale from 1 = Strongly disagree to 5 = Strongly agree, individuals rate on a total of eight items about their self-perceived ability to perform across different contexts. Scores are summed across all items, with higher scores indicating greater self-efficacy.
Measured: Before treatment, within a week after treatment, and one month after treatment
Change in psychological flexibility as measured with the Multidimensional Psychological Flexibility Inventory
The Multidimensional Psychological Flexibility Inventory (MPFI; Rolffs et al., 2018) measures an individual's flexibility in responding to difficult experiences. Its short form consists of 12 items, which uses a 6-point Likert scale from 1 = Never True to 6 = Always True, and demonstrates psychometric soundness when used among Chinese (Li, 2024). Scores are summed across items, with higher scores indicate greater level of psychological flexibility.
Measured: Before treatment, within a week after treatment, and one month after treatment
Change in openness to treatment as measured with the Attitudes Toward Seeking Professional Psychological Help
Attitudes Toward Seeking Professional Psychological Help (ATSPPH) measures an individual's help seeking preferences as indicated by three subscales, namely Openness to seeking professional help, Value in seeking professional help, and Preference to cope on one's own. Its short form contains 10 items, each rated on a 4-point Likert scale from 0 = Disagree to 3 = Agree. Scores are summed across items for each subscale, with higher scores indicating greater levels in each of the measured domains.
Measured: Before treatment, within a week after treatment, and one month after treatment if feasible
Change in social interactions
Participants' behaviors during each AAI session and across the sessions are rated by independent observers on six items, using 3- to 5-point Likert scales (Koda et al., 2015). These items ask for ratings on a participant's general facial expression in terms of its affective valence, tenderness toward the animal, amount of talking, willingness to have contact with the animal, interest in the animal, and ease of interaction with the animal.
Measured: At each session, up to a total of four sessions, and within a week after the treatment
Subjective experience with the treatment
Four open-ended questions are used to help understand participants' experience with the AAI descriptively. These items include one on overall psychological wellbeing on the day of measurement, one on feelings toward the animal, one on feelings toward peers in the assigned AAI, and one on overall psychological wellbeing throughout the past week.
Measured: Within a month after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start2 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological WellbeingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Correctional Services Department
- Responsible party
- Principal investigator, Amanda Kingsze CHEUNG, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968351
- Sponsor's protocol ID
- EA240679
- Status last verified
- Jul 2025
- First submitted
- 5 May 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sensitive data are collected and no authorization is obtained from study participants.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal-Assisted Intervention: An Effectiveness Study Using Qualitative and Quantitative Measures on Offenders With Mental Illnesses in Hong Kong
- ClinicalTrials.gov ID
- NCT06968351
- Acronym / sponsor ID
- EA240679
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Correctional Services Department
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mental health concerns such as depression, anxiety, and post-traumatic stress are particularly prevalent among incarcerated individuals and are considered risk factors for recidivism. Leveraging the natural human-animal bond, animal-assisted intervention (AAI) offers a less threatening alternative to engage incarcerated individuals and address their mental health needs. As an initial effort to help promote rehabilitative security in Hong Kong, the current study examines the acceptability and effectiveness of a brief animal-assisted program among offenders in local secured facilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Animal-Assisted InterventionParticipants are assigned to a brief animal-assisted intervention that is offered on a group basis across four sessions. Each of the four sessions lasts approximately 60 minutes. In addition to questionnaire data prior to and after the treatment, participants will provide physiological and questionnaire data at both the beginning and the end of each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- persons-in-custody
- aged 18 or older
- understand Cantonese
Key exclusion criteria (6 listed)
- an allergy, a fear, or a dislike toward dogs
- a history of aggression toward animals
- a criminal history involving animals
- a history of neurodevelopmental disorders
- active psychosis or mania
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-Assisted InterventionAlso: AAI, Dog TherapyA brief animal-assisted intervention is offered on a group basis across four sessions. Each session lasts approximately 60 minutes and covers the same themes but through different exercises. These themes include effective communication, behavioral principles, problem-solving, and teamwork. The first part of a session involves learning to give effective single-component commands to a rehabilitative dog under the guidance of a professional dog handler. The second part of a session involves the applications of two or more of these single-component commands to an interactive group activity. Project staff are present at each session to facilitate discussions among participants on any challenges encountered, learning, and intra- as well as inter-personal experiences during the session. | Behavioural | Treatment |
Primary outcome
Change in common psychopathology as measured with the Depression, Anxiety, and Stress Scale - 21 Items
Time frame: At the beginning of each sessions, approximately one week after completion of the treatment, and one month after the treatment
Depression, Anxiety, and Stress Scale - 21 Items (DASS21; Lovibond \& Lovibond, 1995) is a self-report measure of common mental health concerns. The three subscales are each measured with seven items, using a 4-point Likert scale from 0 = Did not apply to me at all to 3 = Applied to me very much or most of the time. Scores are summed for each subscale, with higher scores indicating more severe levels of emotional symptoms.
Change in emotional state as measured with the International Positive and Negative Affect Schedule Short Form
Time frame: At the beginning and at the end of each session, up to a total of four sessions
International Positive and Negative Affect Schedule Short Form (I-PANAS-SF; Thompson, 2007) is an adapted version of the PANAS-SF (Watson et al., 1988) and designed specifically for non-English speaking individuals. Using a 5-point Likert scale from 1 = Never to 5 = Always, individuals rate on their experience of five positive affect and five negative affect in the present moment. Scores are summed for each subscale, with higher scores indicating higher levels of positive or negative affect.
Change in heart rate variability
Time frame: At the beginning and at the end of each session, up to a total of four sessions
Heart rate data are collected via photoplethysmogram signals and then transformed into heart rate variability with artifacts corrected through automated detection using the Kubios HRV Scientific software (Kubios, 2024).
Change in skin conductance
Time frame: At the beginning and at the end of each session, up to a total of four sessions
Both phasic and tonic skin conductance data are captured with a galvanic skin response sensor
8 secondary outcomes
Change in disciplinary offences and privileges during incarceration
Time frame: At each session, up to a total of four sessions, and within a week after the treatment
Change in trauma-related psychopathology as measured with the Posttraumatic Stress Disorder Checklist for DSM-5
Time frame: Before treatment, within a week after treatment, and one month after treatment
Change in empathy as measured with the Brief Interpersonal Reactivity Index
Time frame: Before treatment, within a week after treatment, and one month after treatment
Change in self-efficacy as measured with the New General Self-Efficacy Scale
Time frame: Before treatment, within a week after treatment, and one month after treatment
Change in psychological flexibility as measured with the Multidimensional Psychological Flexibility Inventory
Time frame: Before treatment, within a week after treatment, and one month after treatment
Change in openness to treatment as measured with the Attitudes Toward Seeking Professional Psychological Help
Time frame: Before treatment, within a week after treatment, and one month after treatment if feasible
Change in social interactions
Time frame: At each session, up to a total of four sessions, and within a week after the treatment
Subjective experience with the treatment
Time frame: Within a month after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No. Sensitive data are collected and no authorization is obtained from study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-Assisted Intervention in people with Psychological Wellbeing and Animal-assisted Intervention, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director (+852-39175889, idpclab@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in common psychopathology as measured with the Depression, Anxiety, and Stress Scale - 21 Items (time frame: At the beginning of each sessions, approximately one week after completion of the treatment, and one month after the treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025; AzTrials last refreshed its copy on 29 Oct 2026.