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Pegasus: Equine-Assisted Therapy for therapy-resistant adolescents with autism spectrum disorders, a multiple baseline AB-study

Pegasus: Equine-Assisted Therapy for therapy-resistant adolescents with autism spectrum disorders, a multiple baseline AB-study - Pegasus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54442
Enrollment
35
Registered
2021-10-12
Start date
2022-02-14
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autism emotion dysregulation

Interventions

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.

Sponsors

Karakter
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)