- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03369769
Wellness Effects of Animal-assisted Activities With Autism Spectrum Disorder Youth in a Specialized Psychiatric Hospital
Physiological Wellness Effects of Animal-assisted Activities in Children With Autism Spectrum Disorder in a Specialized Psychiatric Hospital Program
Background: Children with Autism Spectrum Disorder (ASD) are at higher risk for developing co-existing mental health conditions and consequently experiencing psychiatric hospitalization, compared to the general pediatric population. However, hospital environments can be exceptionally stressful for this population, given their social-communication deficits, ineffective emotional regulation skills and heightened physiological arousal. While the use of animal-assisted activities (AAA) show potential for various improvements in children with ASD in community settings, these "stress-reducing" and "social-buffering" benefits have not yet been studied within a psychiatric hospital setting for youth with ASD.
Objectives: Evaluate whether an AAA with canines can lead to reduced physiological arousal and improvements in social-communication as well as aberrant behaviors in children and adolescents diagnosed with ASD in a specialized psychiatric hospital setting.
Methods: Participants were recruited from the Neuropsychiatric Special Care (NSC) program's inpatient and/or partial day-treatment program. Prior to study participation, baseline demographic measures were acquired from caregivers and participants' ASD diagnosis was confirmed. Participants experienced two, randomly assigned 35-minute sessions (AAA and Control Condition) with a minimum two-day washout period between groups. Each session included a baseline 20-minute social skills group immediately followed by a 10 minute experimental or control condition. The AAA condition introduced a canine and volunteer handler for free interaction time while the control condition introduced a novel toy and a volunteer for free interaction. Participants' physiological arousal was continuously assessed throughout all conditions via the Empatica E-4 wristbands (Empatica Inc. 2014). All sessions were videotaped for behavioral coding using the Observation of Human Animal Interaction for Research - Modified, v.1.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background: Children with ASD are at higher risk for developing co-existing mental health conditions and consequently experiencing psychiatric hospitalization, compared to the general pediatric population. However, hospital environments can be exceptionally stressful for this population, given their social-communication deficits, ineffective emotional regulation skills and heightened physiological arousal. While the use of animal-assisted activities (AAA) show potential for various improvements in children with ASD in community settings, these "stress-reducing" and "social-buffering" benefits have not yet been studied within a psychiatric hospital setting for youth with ASD.
Objectives: Evaluate whether an AAA with canines can lead to reduced physiological arousal and improvements in social-communication as well as aberrant behaviors in children and adolescents diagnosed with ASD in a specialized psychiatric hospital setting.
Methods: Participants were recruited from the Neuropsychiatric Special Care (NSC) program's inpatient and/or partial day-treatment program. Prior to study participation, baseline demographic measures were acquired from caregivers and participants' ASD diagnosis was confirmed. Participants experienced two, randomly assigned 35-minute sessions (AAA and Control Condition) with a minimum two-day washout period between groups. Each session included a baseline 20-minute social skills group immediately followed by a 10 minute experimental or control condition. The AAA condition introduced a canine and volunteer handler for free interaction time while the control condition introduced a novel toy and a volunteer for free interaction. Participants' physiological arousal was continuously assessed throughout all conditions via the Empatica E-4 wristbands (Empatica Inc. 2014). All sessions were videotaped for behavioral coding using the Observation of Human Animal Interaction for Research - Modified, v.1.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Admitted to a specialized psychiatric unit for children with developmental disabilities
- Meeting standard cut-off scores for ASD on the Social Communication Questionnaire Screener (> 12) and Autism Diagnostic Observation Schedule-2nd Ed
- English speaking
Exclusion Criteria:
- Unwillingness to wear wristband & be videotaped
- Allergies or phobias to canines
- Inability to attend to and participate in a social group
- Prisoner status or ward of the state
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Canine & Adult Handler Activity
Unstructured 10-minute small group interaction with canine & handler
|
10 minutes interaction with therapy dog and adult handler in small group (2-4 participants).
Autres noms:
|
|
Comparateur actif: Toy and Adult Handler Activity
Unstructured 10-minute small group interaction with toy & handler
|
10 minutes interaction with therapy dog and adult handler in small group (2-4 participants).
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in physiological measurements with the wristband device from baseline through 90 minutes.
Délai: Baseline; 90 minutes
|
The Wristband device is worn by the participant for 90 minutes during the day of the experimental condition.
Physiological measure of Galvanic skin response, heart rate, heart rate variability will be assessed at baseline through 90 minutes.
Collection points during this day includes comparison from baseline, social group, and experimental condition.
|
Baseline; 90 minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Observation of Human Animal Interaction for Research (OHAIRE-modified)
Délai: Two 10-minute conditions (experimental and control) on two separate days.
|
The Observation of Human-Animal Interaction for Research (OHAIRE) is a timed interval coding system intended to capture the unique interactions between humans and animals.
It was originally developed and piloted with children with autism spectrum disorder (ASD) interacting with typically-developing peers in a small group school setting with guinea pigs compared to toys.
|
Two 10-minute conditions (experimental and control) on two separate days.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Robin L Gabriels, Psy.D., University of Colorado, Denver
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15-1227
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Activity
-
University of MiamiPas encore de recrutement
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI); University of Rochester; University of Massachusetts...ComplétéCancer du sein | Survivante du cancer du sein | Traqueurs de condition physiqueÉtats-Unis
-
University Hospital, ToulouseActif, ne recrute pasAccident vasculaire cérébralFrance
-
Enes SucularComplétéEn bonne santéTurquie (Türkiye)
-
Pacific UniversityComplété
-
St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences OrganizationComplétéCancer du poumon, non à petites cellulesCanada
-
Universiteit AntwerpenUniversity Hospital, Antwerp; Cliniques universitaires Saint-Luc- Université...ComplétéHémophilie A | Hémophilie BBelgique