NCT07811479

Brief Summary

Child maltreatment is common and encompasses various forms, including psychological, physical, and sexual abuse, exposure to domestic violence, neglect, and sexual exploitation. Each year, French police and gendarmerie services record more than 50,000 child victims of intrafamilial violence, according to data from the Ministerial Statistical Service for Internal Security (SSMSI). Approximately two-thirds of these children are victims of physical violence and one-third are victims of sexual violence. These figures have increased steadily over recent years, particularly for sexual violence, in the context of greater disclosure by victims. Violence against children constitutes a major public health issue because of its short- and long-term physical, psychological, and developmental consequences, as well as the increased risk of involvement in future violence during adolescence or adulthood, either as victims or perpetrators. Children presumed to be victims of abuse are managed in Child Advocacy and Pediatric Assessment Units (Unités d'Accueil Pédiatrique Enfance en Danger, UAPEDs) by multidisciplinary teams comprising physicians, psychologists, nurses, and social workers, following judicial referral or concerns raised by parents or caregivers. Depending on the circumstances, the child may undergo a forensic interview conducted on-site by law enforcement officers (police or gendarmerie), followed by a medico-legal and/or psychological assessment to evaluate the impact of the alleged abuse. This model enables comprehensive care to be delivered in a single location and within a limited timeframe, with professionals working around the child, thereby minimizing repeated disclosures and reducing the risk of retraumatization. The vast majority of forensic interviews are conducted by investigators trained in the National Institute of Child Health and Human Development (NICHD) protocol for interviewing children. It has been hypothesized that the involvement of a Judicial Assistance Dog (JAD) may provide benefits to children during forensic interviews, a key stage of the judicial process that can be highly stressful for child victims of abuse who are asked to recount traumatic experiences to an unfamiliar investigator. For centuries, dogs have been domesticated to accompany humans. Since the late twentieth century, they have been specifically trained to assist vulnerable individuals, support people with chronic conditions, and participate in animal-assisted interventions. The role of dogs as part of healthcare and psychosocial support has been extensively studied in recent years. Animal-assisted interventions have been used in a variety of clinical settings with the aim of reducing anxiety, pain, and stress-related symptoms through mechanisms involving emotional regulation and attentional processes. Several studies have reported benefits among children with mental health conditions, including post-traumatic stress disorder (PTSD), depression, attention-deficit/hyperactivity disorder (ADHD), anxiety disorders, and problematic video gaming behaviors. Assistance dogs are also frequently incorporated into interventions for children with autism spectrum disorder to promote prosocial behaviors, with beneficial interactions observed regardless of the child's verbal communication abilities. In pediatric hospital settings, animal-assisted therapy has been associated with reductions in both blood pressure and pain levels. These effects may be mediated by physiological mechanisms. Exposure to a dog for 15 minutes has been associated with significant reductions in cortisol levels (13), while human-dog interactions have also been linked to changes in electroencephalographic activity and heart rate, potentially enhancing shared attention and emotional regulation. The concept of the Judicial Assistance Dog first emerged in the United States in the early 2000s within court settings. In France, following a model similar to that developed in North America, the first Judicial Assistance Dog, named Lol, joined the Cahors Court of Justice in 2019 to support victims throughout judicial proceedings. Orko, the second Judicial Assistance Dog trained in France, joined the Child Advocacy and Pediatric Assessment Unit of Orléans University Hospital in 2020. Several potential benefits of Judicial Assistance Dogs during forensic interviews have been suggested, including reductions in signs of distress and anxiety among child victims. A study conducted in the United States demonstrated significant decreases in heart rate and blood pressure among presumed child victims of sexual abuse who were accompanied by an assistance dog during the forensic process.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress1%
Oct 2026Apr 2028

First Submitted

Initial submission to the registry

September 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 3, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

Judicial Assistant DogAnxietyChild victimForensic interview

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect of the presence of a Judicial Assistance Dog on the chil's anxiety level prior to the forensic interview.

    Comparison of the change in STAI-C scores between T1 (after 10 min of waiting) and T0 (baseline assessment upon arrival) between the intervention group (10-minute exposure to the Judicial Assistance Dog) and the control group (10 minutes in a standard waiting room)

    At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting

Secondary Outcomes (2)

  • To evaluate the effect of the presence of a Judicial Assistance Dog on heart rate

    At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting

  • To evaluate the effect of the presence of a Judicial Assistance Dog on perceived anxiety

    At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting

Study Arms (2)

Judicial Assistance Dog group

EXPERIMENTAL

Children assigned to this group will have contact with the Judicial Assistance Dog before the forensic interview.

Behavioral: Judicial Assistance Dog

Standard waiting room group

NO INTERVENTION

Children assigned to this group will undergo the standard pre-interview waiting period without contact with the Judicial Assistance Dog.

Interventions

After randomization, the Judicial Assistance Dog will be introduced to the child in the waiting room, and the child will remain in contact with the dog for 10 minutes.

Judicial Assistance Dog group

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • First-time interview in a child advocacy and pediatric assessment unit (UAPED)
  • Age ≥ 7 years
  • Ability to understand and complete the Stat-trait Anxiety Inventory for Children (STAI-C)
  • Written informed consent obtained from the child's legal guardian

You may not qualify if:

  • Previous contact with the Judicial Assistant Dog
  • Known dog allergy
  • Lack of informed consent from the legal guardian
  • Lack of assent from the child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire d'Orléans

Orléans, 45067, France

Location

Related Publications (3)

  • Maoz I, Zubedat S, Dolev T, Aga-Mizrachi S, Bloch B, Michaeli Y, Eshed Y, Grinstein D, Avital A. Dog training alleviates PTSD symptomatology by emotional and attentional regulation. Eur J Psychotraumatol. 2021 Nov 19;12(1):1995264. doi: 10.1080/20008198.2021.1995264. eCollection 2021.

  • Norman RE, Byambaa M, De R, Butchart A, Scott J, Vos T. The long-term health consequences of child physical abuse, emotional abuse, and neglect: a systematic review and meta-analysis. PLoS Med. 2012;9(11):e1001349. doi: 10.1371/journal.pmed.1001349. Epub 2012 Nov 27.

  • Gilbert R, Widom CS, Browne K, Fergusson D, Webb E, Janson S. Burden and consequences of child maltreatment in high-income countries. Lancet. 2009 Jan 3;373(9657):68-81. doi: 10.1016/S0140-6736(08)61706-7. Epub 2008 Dec 4.

MeSH Terms

Conditions

Human-Animal BondAnxiety Disorders

Condition Hierarchy (Ancestors)

Human-Animal InteractionBehaviorMental Disorders

Study Officials

  • Sarah EID, Doctor

    Centre Hospitalier Universitaire d'Orléans

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah EID, Doctor

CONTACT

Camille PRIMA - - CROKAERT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 10, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

September 10, 2026

Record last verified: 2026-09

Locations