NCT06968351

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

June 2, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

May 5, 2025

Last Update Submit

July 29, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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).

    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

    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

    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

    Before treatment, within a week after treatment, and one month after treatment

  • Change in empathy as measured with the Brief Interpersonal Reactivity Index

    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

    Before treatment, within a week after treatment, and one month after treatment

  • Change in psychological flexibility as measured with the Multidimensional Psychological Flexibility Inventory

    Before treatment, within a week after treatment, and one month after treatment

  • +3 more secondary outcomes

Study Arms (1)

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.

Behavioral: Animal-Assisted Intervention

Interventions

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.

Also known as: AAI, Dog Therapy
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • persons-in-custody
  • aged 18 or older
  • understand Cantonese

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Correctional Services Department

Hong Kong, 00000, Hong Kong

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 13, 2025

Study Start

June 2, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Sensitive data are collected and no authorization is obtained from study participants.

Locations