BACKGROUND: For people with autism spectrum disorder (ASD), daily life is highly stressful and traumatic with many unpredictable events that can evoke emotion dysregulation (ED): a strong difficulty with appropriately regulating negative affect. Heightened levels of ED may aggravate social dysfunctioning in ASD and vice versa. For a part of the patients with ASD, treatment as usual does not have any effect at all on ED. As ASD with severe levels of ED can be considered to have an ultra-high risk profile for developing other disorders (psychosis, anxiety, eating disorders, depression), this treatment-resistant subgroup of patients may end up needing life-long psychiatric treatment. Particularly problematic is that these patients often lack motivation for typically initiated forms of therapy, thereby further limiting their chances for a more favorable outcome. A highly promising method that may prove effective for therapy-resistant individuals with ASD is Equine-Assisted Therapy (EAT). While often met with prejudgment and skepticism, reports from parents and therapists as well as a recent systematic review suggest that EAT may have beneficial effects in youths with ASD. We further argue that an ideal (and perhaps last?) ‘window of opportunity’ for intervention in treatment-resistant patients with ASD is adolescence, because of the major genetically pre-programmed neurological changes occurring in this period that heighten the sensitivity for environmental input. EAT targeting severe ED offered within this timeframe may improve clinical outcomes both in the short and in the long term in otherwise treatment-resistant adolescents with ASD.
OBJECTIVE: To quantify the short-term (15 weeks) and long-term (1 year) (cost-)effectiveness of Equine-Assisted Therapy (EAT) in adolescents with therapy-resistant ASD (aged 11-18) and, when proven (cost-) effective, implement EAT in clinical practice.
HYPOTHESES: In a therapy-resistant group (N=35) of youths with ASD, a 15-week treatment with EAT significantly improves:
1. the primary outcome measure emotion dysregulation in
(a) the short term (15 weeks) and
(b) the long term (1 year).
2. secondary outcome measures of ASD symptom severity, quality of life, self-esteem, global and family functioning and goal attainment as well as qualitative outcomes in (a) the short term (15 weeks) and (b) the long term (1 year).
3. is more cost-effective on the long term (1 year) when compared to a scenario including continued CAU.
STUDY DESIGN: Mixed-methods strategy consisting of three elements: a randomized, multiple-baseline single-case design (n=35), a qualitative study (n=8-10) and a cost-effectiveness study (n=6). Participants will be randomly assigned to one of the five pre-defined baseline lengths (2-6 weeks) to increase the internal validity of the design with a 1:1 allocation using permuted blocks of random sizes.
STUDY POPULATION(S)/DATASETS: Treatment-resistant adolescents with ASD (11-18 years), with clinical levels of emotion dysregulation despite receiving care as usual (CAU) for at least 18 months.
INTERVENTION: 15 weekly sessions of 60 minutes EAT using a standardized protocol (ORS, homework discussion, activity, feedback, rehearsal of activity, SRS, new homework) by certified EAT therapists.
TIME SCHEDULE: Preparation 6 months; recruitment, intervention and follow-up four years (inclusion between months 6-36, follow-up between months 11-48); reporting between months 48-60.
FEASIBILITY: All relevant stakeholders have offered their participation in this project. Recruiting n=35 participants within four years is highly feasible, since recruitment is done both from within Karakter (where n=3200 patients with ASD are yearly treated) as from other sources (EAT centers, social media, patient organizations). We offer several locations for treatment to accommodate for travel distance for participants. The burden of assessments for participants is within acceptable limits (15 minutes for adolescents and 25 minutes for parents).
PATIENT INVOLVEMENT: Patient representatives from the Dutch