- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Camille PRIMA - - CROKAERT
- Número de telefone: +33238744292
- E-mail: camille.prima@chu-orleans.fr
Estude backup de contato
- Nome: Sarah EID, Doctor
- Número de telefone: +33238651544
- E-mail: sarah.eid@chu-orleans.fr
Locais de estudo
-
-
-
Orléans, França, 45067
- Centre Hospitalier Universitaire d'Orléans
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Judicial Assistance Dog group
Children assigned to this group will have contact with the Judicial Assistance Dog before the forensic interview.
|
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.
|
|
Sem intervenção: Standard waiting room group
Children assigned to this group will undergo the standard pre-interview waiting period without contact with the Judicial Assistance Dog.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To evaluate the effect of the presence of a Judicial Assistance Dog on the chil's anxiety level prior to the forensic interview.
Prazo: At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To evaluate the effect of the presence of a Judicial Assistance Dog on heart rate
Prazo: At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting
|
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)
|
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
Prazo: At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting
|
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).
|
At T0: Baseline assessment upon arrival At T1: After 10 minutes of waiting
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sarah EID, Doctor, Centre Hospitalier Universitaire d'Orléans
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CHUO-2026-06
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .