Promoting Social Perceptual Learning With Oxytocin in Autism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)
研究概览
简要总结
The main objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when paired with a computer game intervention that is designed to enhance face perception skills.
详细描述
Recognizing faces is critical to social functioning, and can be improved for individuals with ASD by using intervention software in the form of appropriately designed computer games. The effects of this type of social intervention may be amplified with the concurrent use of oxytocin. Furthermore, these learning effects may impact social skills in general and translate to the level of the individual's everyday social behavior. Thus, the objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with ASD when paired with a computer game intervention that is designed to enhance face perception skills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants aged 12-17 years, Mental age ≥ 10
- •Gender: males
- •Diagnosis of an Autism Spectrum Disorder
- •Consent: parent/guardian permission and child assent.
- •Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English (and English as a first language).
- •Study participant needs to be clinically stable, in the opinion of the study clinicians. Stability will be assessed by the clinicians based on information from and conversations with the parent, if necessary. The parent needs to commit verbally to not making any changes to his or her child's current treatments for the duration of this study.
排除标准
- •History of traumatic brain injury, epilepsy/seizure disorder (except febrile seizures), or other significant medical, genetic, or neurological abnormality affecting growth, development, or motor or higher cortical functioning. Sensory impairments (e.g., significant vision/hearing loss).
- •Patients with one or more of the following: Human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder, or severe depression.
- •Sensory impairments (e.g., significant vision/hearing loss).
- •Gestational age below 35 weeks and/or perinatal injury.
- •Profound mental retardation (e.g., Intelligence quotient (IQ) < 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments.
- •Lack of impairment in face recognition as determined by average or above average performance on the Benton Face Recognition Task.
- •Female participants.
- •Patients who are sensitive to Syntocinon or any components of its formulation.
- •Fever at the time of the baseline visit, defined as temperature above 37.5 degrees Celsius or 99.5 degrees Fahrenheit.
- •Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues.
结局指标
主要结局
Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)
时间窗: Baseline and Post-testing (after max. 12 days)
This test measures the extent to which the participant employed a featural or holistic face recognition strategy. A sample face is presented, followed by a test face composed of either two whole faces or two face parts.
Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)
时间窗: Baseline and Post-testing (after max. 12 days)
This is a test of emotion recognition. This test asks children to pick the best word out of four options to describe the mental state of a set of eyes. The test includes 28 photographs of eyes with both affective (e.g., upset) and cognitive (e.g., thoughtful) mental state words as choices.
次要结局
- Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention(Baseline and Post-testing (after max. 12 days))
研究者
Robert Schultz
Robert T. Schultz, PhD, Director of the Center for Autism Research
Children's Hospital of Philadelphia