1. Introduction
The current paper describes a process evaluation of a randomized controlled trial (RCT) on the effectiveness of dog-assisted therapy aimed at reducing psychosocial problems, such as stress, depression, and anxiety, and improving social communication and self-esteem in adults with autism spectrum disorder (ASD) [
1]. Although adults with ASD show high levels of comorbid problems [
2,
3], psychosocial interventions have been highly understudied [
4], and effective treatments remain limited for these patients.
The RCT is considered the gold standard for providing evidence on the effectiveness of a therapy [
5]. However, poor internal and external validity might render the RCT results meaningless for clinical practice. For example, poor internal validity may be the result of inadequate screening, recruitment, or randomization procedures (further addressed as sampling quality). This may also result in a non-representative study sample that undermines the external validity of the RCT results. Furthermore, both internal and external validity can be compromised when not all of the intervention elements are executed properly in an RCT. The study results should, then, be attributed to only several elements of the intervention, rather than the whole intervention. When therapists and patients are not satisfied with the intervention (e.g., due to severe side effects in patients and procedures that are not clear for the therapists) or when they find the intervention irrelevant for the target population, the poor intervention quality experienced may result in poor implementation in health care practice.
A process evaluation provides insight into the aspects that determine the internal and external validity of an RCT. It can also reveal potential barriers and facilitators to implementing an intervention [
6]. This information is important for health professionals and stakeholders for both interpretation of study results and choosing the most suitable and effective interventions for clinical practice. Furthermore, via thorough process evaluations, rich and specific data can be collected and reported, which provide a good understanding of the variables involved in the relationship between the intervention and study outcomes in the RCT. This information can help understand why an intervention has worked, or why not, and can contribute to theoretical discussions about its working mechanisms. In the past decades, the importance of a process evaluation alongside an RCT has been acknowledged in medical and health care research. For example, guidelines have been published to establish an adequate process evaluation [
7], and the growing number of process evaluation reports has even resulted in systematic reviews on process evaluations to provide information for refining existing and developing new interventions [
8,
9].
To the best of our knowledge, besides our RCT on dog-assisted therapy [
10], the literature regarding adults with ASD describes only two non-pharmacological interventions. These are cognitive behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR). Both interventions showed favorable effects on comorbid problems, such as anxiety [
11]. Although no process evaluations were reported, several adjustments of the original intervention protocols were recommended to increase the feasibility of the interventions [
4]. For example, Spek et al. adjusted the MBSR protocol of Segal, Williams, and Teasdale (2002) [
12] to make it suitable for the ASD target group [
13]. Because adults with ASD may have information processing problems, Spek et al. proposed avoiding metaphors and exercises in which the participant observes his or her own thoughts. In general, adults with ASD have difficulties in communication, representation, information processing, and generalization of learned techniques into daily life [
14,
15]. Such difficulties may pose real challenges for a strict execution of an intervention protocol, resulting in poor program fidelity (the extent to which the intervention is delivered in accordance with the protocols) [
16]. However, even excellent feasibility during an RCT does not guarantee that the feasibility of the intervention will be suitable in clinical practice. Different external factors (e.g., financial aspects, such as insurance coverage) can jeopardize program fidelity of the total intervention or its specific components. Moreover, factors related to the ASD population can influence the feasibility of an intervention and the generalizability of previously reported effects. For example, patients with ASD may experience difficulties in representation and imagination of a future perspective. Therefore, patients with ASD may not be motivated to execute exercises that do not lead to immediate results or changes in their daily lives.
Animal-assisted therapy (AAT) in patients with ASD is an intervention that includes both a trained animal and pre-established therapeutic goals guided by a therapist certified in health care [
17]. In children with ASD, positive effects were found on social impairments, social communication, and stress reduction after an animal-assisted intervention (AAI) [
18,
19]. To the best of our knowledge, to date, our study is the only AAI study that has been conducted in adults with ASD. The results showed decreased self-reported stress and agoraphobia and improved proxy-reported social awareness and social communication after a ten-week dog-assisted therapy program [
10]. Although these effects look promising, health professionals and researchers also need information on aspects that can affect internal and external validity, such as sampling quality, program fidelity, and appraisal of the therapy program by the patients and health care professionals. Alongside estimated effects of an intervention, information on potential barriers and facilitators to AAT is needed to help research consumers (e.g., professionals in clinical practice and decisionmakers involved in financing care) make informed decisions.
The aim of this process evaluation was to investigate study quality and program relevance and feasibility of an AAT program tested in adults with ASD and to gain insight into barriers and facilitators to implementing the intervention within health care organizations. The results of this process evaluation can help place the study effects in context and provide guidelines to facilitate the transition from research evidence to clinical health practice.
4. Discussion
The aim of this study was to explore the feasibility and relevance of, as well as barriers and facilitators to implementing, an animal-assisted therapy (AAT) in adults with ASD and to evaluate the credibility of the results of a previously conducted RCT.
With regard to reach, process evaluation may suggest selection bias with some consequences for external validity of the results. On the one hand, the process data showed that recruitment of participants was challenging: although potential participants responded positively to the information letter, only about 50% of approached patients enrolled in the study. On the other hand, females and dog owners seemed over-represented in our sample when compared with the worldwide population of females with ASD and dog owners within the Dutch population [
22,
23]. This could have influenced the external validity of the effect study.
Regarding the recruitment challenges, potential participants suggested limiting travel time to therapy locations, because this was the main reason the other 50% declined to participate in the study. Sensory sensitivity in people with ASD can make traveling a burden, and this aspect is relevant for other therapies as well. Offering a therapy at multiple locations might be a solution, but offering AAT at multiple locations poses logistical challenges: several conditions, such as suitable therapy rooms and eligible therapy dogs and therapists, must be met in order to perform AAT. Regarding the under-representation of male participants and non-dog-owners, the effect analyses were controlled for gender and dog ownership without influencing the estimated effects [
10]. Nevertheless, future research on this topic should consider that selection bias might occur in this population, because males might not be reached easily. It is important to gain more insight into the effects of AAT in our under-represented groups and to explore whether larger sample sizes show the same results and effects when controlled for gender and dog ownership. Professionals in clinical practice and researchers need to improve information transfer about the intervention to attract more male patients and to involve those who do not own a dog.
Only two (external) factors were reported for missing a therapy session (i.e., participant illness and preplanned vacation); no motivational factors were reported. This seems to suggest that the participants were highly motivated to participate in research and receive AAT. This is also underlined by an adherence rate in the intervention condition, which was higher than in other studies in the adult ASD population [
20,
24]. All the participants attended at least nine out of 10 therapy sessions. It can be suggested that researchers and health professionals should focus more on providing information that attracts a larger proportion of those who might be interested in receiving the intervention than on improving adherence to the protocol, which seems a less important issue for those who are willing to follow the program.
Both the therapists and participants evaluated the intervention as feasible and relevant, and both reported being satisfied with the intervention program content. The participants were slightly more positive when appraising AAT for themselves than when appraising it for other people with ASD, which may reflect some inability to see the intervention from the perspective of others. A safe, joyful, and relaxing environment, the opportunity to touch another living being during therapy, concrete exercises, and direct feedback were cited by the participants and therapists as important determinants of their positive appraisal. These reported aspects are in line with the significant effects found in the effect study—namely, decreased self-reported stress and agoraphobia and increased proxy-reported social self-awareness and social communication [
10]. The positive appraisal of touching the therapy dog is noteworthy, because many people with ASD experience sensory overstimulation when being touched by another person [
25]. Physical contact with a therapy dog is possibly less overstimulating than physical contact with a human being. This may be related to difficulties in social communication experienced by people with ASD. Human–human interactions are often logically more complicated than human–animal interactions. It can be argued that the therapy dogs fulfill a need for proximity—a determinant that is challenging to fulfill in many therapist–participant therapies due to ethical restrictions and social–communicative impairments of the patient with ASD. Furthermore, the participants specifically reported AAT as being a joyful experience. The therapy might be experienced as less invasive when compared with other therapies.
Regarding program fidelity, no major deviations from the therapy protocol were reported. The literature shows that most interventions require substantial adjustments for people with ASD. For example, Spain et al. [
11] reviewed six effect studies on cognitive behavioral therapy in adults with ASD. Although overall positive preliminary results were reported, Spain et al. recommended a prolonged assessment phase and an increased number of treatment sessions to ameliorate engagement with the therapist, enhance emotional literacy, and practice and improve generalization. The participants and therapists in our study suggested that the experience-based character of AAT is one of the main reasons for its high feasibility.
The role play exercise where the participant invents a character who interacts with the animal was evaluated as challenging. It is important to consider that this exercise might pose challenges for adults with ASD due to impairments in imagination and pretend play [
26]. For future clinical execution of the therapy protocol, therapists may consider eliminating this exercise when a participant experiences difficulty in performing it.
This process evaluation revealed that potential barriers jeopardizing program fidelity might include aspects such as negative attitude towards therapy in general, stressful contextual factors in participants’ lives, and problems with generalization of learned behavior skills. Although these were reported by only four participants, health professionals should take these factors into consideration before starting the AAT program. Involving partners or other family members in the therapy process or assigning homework for the participants may help increase program fidelity.
In spite of AAT’s overall feasibility, optimal performance of the protocol requires several basic elements, such as well-trained, tested, and socialized dogs; certified health care professionals; knowledge of animal behavior by the health care professionals or animal handlers who are providing the AAT; and suitable therapy rooms with non-slippery floors. For these reasons, implementation of AAT might be more logistically challenging compared with therapies such as CBT. To facilitate implementation in the mental health care setting, it is important to provide information and share the positive effects of AAT. Practitioners should be aware that other health professionals or patients might not be used to having animals present in a clinical health care setting and may experience anxiety or have an aversion and/or allergy to animals.
Notably, none of the participants or therapists reported concerns about animal welfare (e.g., maximum number of working hours and relaxation for the therapy dogs) or hygiene (e.g., zoonosis) as barriers to implementation of AAT in clinical practice. Although studies on dog welfare during AAT sessions are very limited, Glenk’s recent review of animal welfare offers guidelines, such as the therapy dog’s familiarity with the therapist and environment and access to water and a quiet place to rest between sessions [
27]. It is also important to note that not all animals are suited to be involved in therapy sessions. The International Association of Human Animal Interaction Organizations (IAHAIO) has produced a white paper providing guidelines for specific species that can be employed as therapy animals [
17]. Furthermore, we highly recommend that each individual animal should be physically and mentally evaluated before being involved in a therapy program and have regular check-ups by an animal behavior expert or veterinarian to protect the well-being of the animal involved. Additionally, because the therapists in our therapy program were working in the role of both therapist and dog handler, it will be useful in future research to gain more insight into the barriers and facilitators to performing this dual role and into their experiences regarding monitoring the welfare of both the humans and animals involved in the therapy.
5. Conclusions
In our RCT on the effectiveness of dog-assisted therapy, results showed decreased self-reported stress and agoraphobia and improved proxy-reported social awareness and social communication in adults with ASD. The current process evaluation showed that besides the positive intervention effects, the intervention program was experienced as satisfying, feasible, and relevant for the target population by both the participants and therapists. Due to the positive intervention effects and the positive evaluation of the program, AAT can be considered a valuable addition to an existing (limited) treatment repertoire for adults with ASD. Improved self-insight, joy, relaxation, and physical contact were reported as important determinants of positive therapy appraisal. These determinants match with the study effects on reduction of self-perceived stress and agoraphobia and improved social awareness and social communication reported by proxies. To increase possible therapy effects, health professionals should consider abilities for generalization of learned skills and severity of contextual aspects. Additional efforts can be made to involve male patients and non-dog owners, and further research on these subgroups is welcomed.
To date, AAT interventions have not been regulated worldwide, and for this reason, it is very important when implementing AAT programs to consider the safety of all participants, including patients, health professionals, and animals. Sufficient education/training of therapists and animal handlers and animal welfare including veterinarian check-ups and regulated working hours must be carefully observed. Future research should focus on these factors, and professionalization of this field should include formulating international quality guidelines and certification of therapy animals and therapists.