- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07811479
Benefits of Judicial Assistance Dogs for Child Victims in Child Advocacy and Pediatric Assessment Units (UAPEDs) (AudiCAJ)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study aims to measure the anxious state of the minor when he first arrives at the unit (T0) and 10 minutes later (T1) with or without the presence of a Judicial Assistance Dog (JAD).
The minor is randomized in one of the two groups of the study:
- the interventional group (minor in the dedicated waiting room with the JAD for 10min)
- or the control group (minor in the dedicated waiting room without the JAD for 10min).
Then an anxiety measure occurs. Two time point are evaluated: at arrival (T0) and after waiting 10min (T1):
- Anxiety questionnaire: STAI-C translated in French answered with the help of a registered nurse trained for psychometric tests (10 min)
- Anxiety level self-assessment (2 min)
- Cardiac frequency measure by the registered nurse in charge of the minor (5 min): an average of 3 measures will be taken
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Camille PRIMA - - CROKAERT
- Número de teléfono: +33238744292
- Correo electrónico: camille.prima@chu-orleans.fr
Copia de seguridad de contactos de estudio
- Nombre: Sarah EID, Doctor
- Número de teléfono: +33238651544
- Correo electrónico: sarah.eid@chu-orleans.fr
Ubicaciones de estudio
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Orléans, Francia, 45067
- Centre Hospitalier Universitaire d'Orléans
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous contact with the Judicial Assistant Dog
- Known dog allergy
- Lack of informed consent from the legal guardian
- Lack of assent from the child
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Judicial Assistance Dog group
Children assigned to this group will have contact with the Judicial Assistance Dog before the forensic interview.
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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.
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Sin intervención: Standard waiting room group
Children assigned to this group will undergo the standard pre-interview waiting period without contact with the Judicial Assistance Dog.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To evaluate the effect of the presence of a Judicial Assistance Dog on the chil's anxiety level prior to the forensic interview.
Periodo de tiempo: At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting
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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)
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At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To evaluate the effect of the presence of a Judicial Assistance Dog on heart rate
Periodo de tiempo: At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting
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Comparison of the change in heart rate (beats per minute, bpm) between T1 (after 10 minutes of waiting) and T0 (baseline assessment upon arrival) between the intervention group (10-minute exposure to the judicial assistant dog) and the control group (10 minutes in a standard waiting room)
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At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting
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To evaluate the effect of the presence of a Judicial Assistance Dog on perceived anxiety
Periodo de tiempo: At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting
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Comparison of the change in score on the Anxiety Level Self-Assessment Scale between T1 (after 10 minutes of waiting) and T0 (baseline assessment upon arrival) between the intervention group (10-minute exposure to the judicial assistant dog) and the control group (10 minutes in a standard waiting room).
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At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sarah EID, Doctor, Centre Hospitalier Universitaire d'Orléans
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHUO-2026-06
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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