The Effectiveness of Animal Assisted Therapy in Adults with Autism Spectrum Disorder: Study Protocol for a Randomized Controlled Trial Carolien Wijker 1,2* , Annelies A Spek 3 , Roeslan Leontjevas 2,4 , Theo Verheggen 2 and Marie-Jose Enders-Slegers 2 1 GGZ Oost Brabant, Netherlands 2 Department of Psychology and Educational Sciences, Open University of the Netherlands, Netherlands 3 Autism Center of Expertise, Eemnes, Netherlands 4 Department of Primary and Community Care, Center for Family Medicine, Geriatric Care and Public Health, Radboud University Nijmegen, Medical Centre, Netherlands *Corresponding author: Carolien Wijker, MD, GGZ Oost Brabant, Oss, Noord Brabant, Netherlands, Tel: +31412848325; E-mail: c.wijker@ggzoostbrabant.nl Received date: September 27, 2017; Accepted date: November 06, 2017; Published date: November 15, 2017 Copyright: © 2017 Wijker C, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. Abstract Introduction: Comorbid problems are common in adults with autism spectrum disorder (ASD). The number of studies on the effects of behavioural interventions in adults with ASD is limited, the needs of adults with ASD differ from individual to individual, and the numbers of ASD diagnoses are on the rise worldwide. For this reason, it is of great importance to develop new interventions for adults with ASD and to examine the effectiveness of those interventions on reducing comorbid symptoms. In children with ASD, preliminary positive results are found in interaction with an animal. The effects of Animal Assisted Therapy (AAT) have not yet been studied in adults with ASD. Therefore, this study is focused on the effects of AAT in adults with ASD, without intellectual disability. Methods: The explorative study will be conducted in adults with ASD and aims to provide insight into the effects and feasibility of AAT. The intervention consists of ten weekly one-on-one sessions conducted in the presence of a dog. Participants in this study will be randomized after the baseline measurement and equally distributed towards the AAT or waiting-list control condition. The study outcome measures are self-reported stress, psychological distress, self-confidence, levels of autistic traits, heart rate variability, salivary cortisol, and α-amylase. Data will be analysed with mixed models. A comprehensive process evaluation will be conducted for more insight into barriers and facilitators and into feasibility of the intervention. The medical ethics committee CMO region Arnhem-Nijmegen, the Netherlands, approves this study. Written informed consent will be obtained from all participants before enrolment. Discussion: This study protocol describes a research designed to explore the effects and feasibility of Animal Assisted Therapy in adults with autism spectrum disorder. Keywords: Autism spectrum disorder; Animal Assisted Terapy; Service dog; Adults Abbreviations AAA: Animal Assisted Activities; AAE: Animal Assisted Education; AAI: Animal Assisted Interventions; AAT: Animal Assisted Terapy; ADI-R: Autistic Disorder Interview-Revised; ASD: autism spectrum disorder; CBT: Cognitive Behavioural Terapy; DSM-5: Diagnostic and Statistical Manual of Mental Disorders 5th edition; IAHAIO: International Association of Human-Animal Interaction Organizations; MBSR: Mindfulness-Based Stress Reduction; PSS: Perceived Stress Scale; RCT: Randomized Controlled Trial; RSES: Rosenberg Self-Esteem Scale; SCL-90-R: Symptom Checklist-90-Revised; SRS-A: Social Responsiveness Scale for Adults; T0-T2: Data Collection Time Points 0-2; t0, t30, t60: Data Collection Time Points (in min) Introduction Autism spectrum disorder (ASD) is characterized by two main criteria: (A) persistent defcits in social communication and social interaction across multiple contexts and (B) restricted, repetitive patterns of behaviour, interests, or activities according to the DSM-5 criteria [1]. Te prevalence of childhood ASD is estimated at 1% [2,3]. A similar prevalence is found in the adult population in England [4]. Over the past 30 years, the prevalence of ASD has increased substantially, which has been attributed in part to the increased awareness and recognition of ASD and the change of diagnostic concepts and criteria [5,6]. In addition to the problems experienced by people with ASD as described in the diagnostic criteria of the DSM-5, many comorbid problems have also been reported, the most common of which are anxiety and mood disorders. Research has shown that around 50% of adults with ASD meet the criteria of an anxiety or mood disorder [7-9]. In adults with ASD, a positive correlation is found between levels of anxiety and stress and in particular, with a decreased ability to cope with change, anticipation, sensory stimuli and unpleasant events [10]. Also common in people with ASD are sleeping problems, low self- esteem, a negative self-image, and rumination [11,12]. A u t i s m : O p e n A c c e s s ISSN: 2165-7890 Autism-Open Access Wijker et al., Autism-Open Access 2017, 7:5 DOI: 10.4172/2165-7890.1000221 Short Communication Open Access Autism-Open Access, an open access journal ISSN:2165-7890 Volume 7 • Issue 5 • 1000221