Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Change from baseline on the Emotion dysregulation Index (EDI) after start of the intervention
研究概览
简要总结
The purpose of this study is to assess the (cost)effectivity of Equine assisted Therapy in adolescents with Autism Spectrum disorders.
详细描述
The study has a 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). After obtaining written informed consent, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 11-18 years old;
- •a clinical diagnosis of autism spectrum disorders according the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) as diagnosed by a Beroepen in de Individuele Gezondheidszorg (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.
排除标准
- •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 intelligence quotient (IQ) equal to or below 80 on the Wechsler Intelligence Scale for Children (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.
研究组 & 干预措施
EAT Intervention
15 sessions of EAT
干预措施: Equine assisted Therapy (EAT) (Behavioral)
结局指标
主要结局
Change from baseline on the Emotion dysregulation Index (EDI) after start of the intervention
时间窗: 3 times a week during 23 weeks from baseline
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 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 will be converted into t-scores.
次要结局
- Change from baseline of Goal attainment as measured on the Outcome Rating Scale (ORS) after 15 weeks(The therapist will assess the SRS/ORS each session (week 3-23).)
- Change from baseline of family functioning as measured on the VGFO on T3(This questionnaire will be assessed at the baseline (T0) and at week 25 (T3).)
- Change from baseline of Global functioning as measured on the Teachers Report Form (TRF) after 15 weeks and 1 year(The whole version will be assessed at baseline, short version at week 2-6 (T1), at week17-23 (T2), week 25 (T3) and after 1 year (T4).)
- Change from baseline of Global functioning as measured on the Youth Self Report (YSR) after 15 weeks and 1 year(The whole version will be assessed at baseline, short version at week 2-6 (T1), at week17-23 (T2), week 25 (T3) and after 1 year (T4).)
- Change from baseline of adherence as measured on the SRS after 15 weeks(The therapist will assess the SRS each session (week 3-23).)
- Change from baseline of severity of autism spectrum symptoms as measured on the Social Responsiveness Scale (SRS-2) after 15 weeks and 1 year(The SRS-2 (parents) will be assessed at baseline (T0), at week 2-6 (T1), at week17-23 (T2), week 25 (T3) and after 1 year (T4).)
- Change from baseline on the Goal Attainment Scale (GAS) after the intervention after 15 weeks(The GAS will be assessed in the fifth (week 7-11), tenth (week12-16) en fifteenth (week 17-23) sessions.)
- Change from baseline of self-esteem as measured on the The Rosenberg Self-Esteem Scale (RSES) after 15 weeks and 1 year(Rosenberg Self-Esteem Scale will be assessed at the baseline (T0), at week 2-6 (T1), at week17-23 (T2), week 25 (T3) and after 1 year.)
- Change from baseline of Global functioning as measured on the Child Behavior Checklist (CBCL) after 15 weeks and 1 year(The whole version will be assessed at baseline, short version at week 2-6 (T1), at week17-23 (T2), week 25 (T3) and after 1 year (T4).)
- Change from baseline of Quality of life as scored on the KIDSCREEN after 15 weeks and 1 year(The KIDSCREEN-27 will be assessed at baseline (T0), at week 2-6 (T1), at week17-23 (T2), week 25 (T3) and after 1 year (T4))