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…
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be emotion dysregulation measured by the Emotion
Dysregulation Inventory (EDI). The EDI is an informant report measure of
emotion dysregulation rated on a five-point scale.
Emotion Dysregulation Inventory (EDI) is specifically designed to measure
emotion regulation impairments in youths and adolescents with ASD. The
EDI-short form is a validated, change-sensitive, 13-item caregiver report
measure of emotion regulation impairment for individuals who are at least 6
years of age. The EDI was developed using the item response theory (IRT)
analysis and none of the final items had evidence of differential item
functioning (e.g., psychometric biases) by gender, age, intellectual ability
and verbal ability, making it suitable for use across heterogeneous
populations. Items on the EDI measure how problematic behaviors have been
during the past day. The scale used is Not at all=0, Mild=1, Moderate=2,
Severe=3, or Very Severe=4. The EDI short form includes two scales: a 7-item
Reactivity Index and a 6-item Dysphoria Index. Index raw scores can be
converted into t-scores or theta scores based on a sample of 1755 individuals
with ASD or based on a sample of 1000 youths matching the US census as general
population norms [27]. For the purposes of this study we will administer the
13-item EDI short form three times a week (for 23 weeks).
Secondary outcome
Secondary outcomes will be assessed by multiple informants (adolescents,
parents, teachers) and include quality of life, communication and social
functioning (SRS-2), self-esteem, global functioning and goal attainment.
Before and after each session, the Outcome Rating Scale (ORS) and Session
Rating Scale (SRS) will be used to assess the well-being of the child and the
way the child is experiencing the intervention. Furthermore, general
information on medical history, level of education of parents/caregivers and
medication will be included, as well as prior beliefs/satisfaction and family
function.
Background summary
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.
Study objective
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.
Study design
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.
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.
Study burden and risks
During the baseline, intervention and post-intervention phases, parents will
be asked to fill in the EDI items three times a week. This will take one to two
minutes to complete. In multiple baseline design studies it is common to
include multiple data points. Although the time involved for each measurement
is limited, the number of measurements is substantial and therefore the burden
for participants is estimated as being moderate. Patients can choose if they
prefer to complete the EDI through an app or by pen or pencil. None of the
parents in the pilot felt completing these questions as a burden. Although the
participants found the time (less than a minute) completely acceptable we will
build an application for filling out the assessments on-line and also allow
using pen and pencil in conformity with their recommendation to take the
preference of the participants into account. We will further support parents to
complete their questionnaires by regular contact.
For all other assessments by questionnaires (baseline (T0), at the end of phase
A (T1), after completion of phase B (T2), after the end of phase C (T3) and
after one year (T4)) we will use the questionnaire platform (CASTOR). We have
performed a pilot and the participants found the time (25 minutes for parents
and 15 minutes for participants) completely acceptable.
Horalaan 5
Ede 6717LX
NL
Horalaan 5
Ede 6717LX
NL
Listed location countries
Age
Inclusion criteria
- between 11-18 years old;
- a clinical diagnosis of autism spectrum disorders according the DSM 5 as
diagnosed by a BIG registered healthcare
professional;
- insufficient emotion regulation after regular therapy for at least 1,5 years
as indicated by a score above clinical cut-off
(T-score = 65) on the EDI;
- comorbidities are allowed except for those interfering with safety.
Exclusion criteria
- unable to respond to questions (parents or adolescents);
- no access to an Internet connection;
- insufficient mastery of Dutch language in parents or adolescents;
- physically incapable to work with the horses;
- unstable medication use;
- total IQ equal to or below 80 on the WISC-III-R or WISC-V;
- allergic or phobic to horses;
- insufficient regulation to safely handle the horses;
- therapy with horses within the last two years.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77902.091.21 |