2023-505253-41-00撤回3 期
Enhancing social attunement in autism via interpersonal sensorimotor synchronization therapy combined with single-dose intranasal oxytocin administration
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- UZ Leuven
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The primary endpoint of this project is the change from baseline treatment effects on dyadic attunement in children with ASD and the experimenter, determined by multimodal measures of neurophysiological and behavioral responses as defined in the study protocol, during screen-based and real-life social interaction paradigms
研究概览
简要总结
The primary objective of this project is to determine the change from baseline treatment effects on dyadic attunement between children with autism spectrum disorder and the experimenter
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Voluntary written informed asent of the participant if possible and voluntary informed consent of their legally authorized representative has been obtained prior to any screening procedures
- •Participants participating in the ASD group must have a formal ASD diagnosis, established by a multidisciplinary team of experienced clinicians as defined by the DSM-IV-TR or DSM-5- criteria (Diagnostic and Statistical Manual of Mental Disorders)
- •Male participants within an age-range of 8 to 12 years old; only female participants at pre-puberty within this age-range on the day of the study visit
- •Intelligence Quotient above 70
- •Stable background treatment during four weeks prior to screening and in the period from intake to study visit
- •No planned changes in psychosocial interventions in the period from intake to study visit
排除标准
- •Participant has a (history of) neurological (stroke, concussion, epilepsy, etc.), psychiatric or developmental disorder (other than ASD or comorbid ADHD in participants with ASD) or a first-degree relative has this disorder
- •Known hypersensitivity to active substance or excipients in nasal sprays
- •Participants participating in the NT group must not have a total SRS T-score of ≥ 60
- •Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- •Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- •Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- •Significant hearing or vision impairments
- •Non-Dutch native speaker
- •Regular nasal obstruction or nosebleeds
- •Active medical problems: unstable seizures, significant physical illness (e.g., serious liver, renal, or cardiac pathology)
- •Subjects who recently have had previous chronic treatment with oxytocin
结局指标
主要结局
The primary endpoint of this project is the change from baseline treatment effects on dyadic attunement in children with ASD and the experimenter, determined by multimodal measures of neurophysiological and behavioral responses as defined in the study protocol, during screen-based and real-life social interaction paradigms
The primary endpoint of this project is the change from baseline treatment effects on dyadic attunement in children with ASD and the experimenter, determined by multimodal measures of neurophysiological and behavioral responses as defined in the study protocol, during screen-based and real-life social interaction paradigms
次要结局
- The secondary endpoint of this project is the change from baseline treatment effects on post-intervention endogenous oxytocin and cortisol levels measured in saliva samples
研究者
Professor of the Study team
Scientific
UZ Leuven
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Enhancing social attunement in autism via interpersonal sensorimotor synchronization therapy combined with single-dose intranasal oxytocin administration2023-505253-41-01UZ Leuven140
招募中
1 期
Enhancing social attunement in autism via interpersonal sensorimotor synchronization therapy combined with single-dose intranasal oxytocin administratioAutism Spectrum Disorder (ASD)CTIS2023-505253-41-01Z Leuven140
进行中（未招募）
1 期
Enhancing social attunement in autism via interpersonal sensorimotor synchronization therapy combined with single-dose intranasal oxytocin administratioCTIS2023-505253-41-00Z Leuven140
已完成
2 期
Intranasal Oxytocin Treatment for Social Deficits in Children With AutismAutismNCT01624194Stanford University54
已完成
不适用
Sensory-Friendly Physical Activity for Sleep in Autistic ChildrenAutism Spectrum DisorderNCT07277101Xili Wen106