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临床试验/NCT01912378
NCT01912378撤回1 期

Phase 1 Study of Intranasal Oxytocin on Parents' Behavioral and Physiological Responses to Children With Autism

University of California, San Francisco1 个研究点 分布在 1 个国家开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
撤回
试验地点
1
主要终点
Parental social behavior

研究概览

简要总结

The study will investigate the effects of an intranasal administration of oxytocin (OT) to parents of children with autism spectrum disorders (ASD) on the quality of mother-father-child interactions. Physiological and behavioral measures of parent-child triadic interaction quality will be assessed.

H1: Parents who receive OT will demonstrate greater parental engagement and nonverbal prosocial behaviors compared to parents who receive placebo.

H2: Children with ASD whose parents receive OT will have increased nonverbal prosocial behaviors during the discussion and play tasks compared to children whose parents' receive placebo.

H3: Parents who receive OT will demonstrate increased behavioral and physiological synchrony with their child during the discussion and play tasks compared to parents who receive placebo and their child.

详细描述

Autism spectrum disorder (ASD) is a continuum of neurodevelopmental disorders associated with significant communication, social, and behavioral deficits including impairments in verbal and nonverbal communication and excessive attachments to routine. These deficits can impede parent-child bonding, increase parental stress, and lead to dysfunctional parent-child interactions. While there has been progress into understanding the neurobiology and neuropsychology of schizophrenia and autism spectrum disorder, treatment options remain inadequate. Psychosocial interventions such as family therapy aimed at promoting affection, praise, and communication reduce oppositional behavior, but are time consuming and costly. A safe and cost-effective pharmacological intervention given to non-affected family members could augment current psychosocial therapies, improve the functioning of the family, and favorably influence the course of the illness in the affected child.

Oxytocin (OT) is a neuropeptide associated with parenting and social perception in mammals. Exogenous OT can be safely administered intranasally in humans, enters the brain in high concentrations, increases positive interpersonal and parenting interactions, promotes cooperation and trust, and reduces stress-induced physiological responses. Due to OT's involvement in processes associated with parent-child interactions (e.g. bonding), we hypothesize that the OT system represents a highly promising focus of research into the biological underpinnings of family functioning, as well as a promising target for biological interventions aimed at improving communication between parents and their children with ASD and reducing unhealthy interactions. We will test these hypotheses by exploring the effects of exogenously administered OT to caregivers on parent-child interactions and physiology during a laboratory-based parent-child interaction task. If successful, this would represent the first demonstration of a neurobiological factor in the family functioning of persons with ASD, and would represent the first biological intervention applied to family members of persons with ASD, rather than to the individual with ASD.

The purpose of the current study is twofold: 2) To determine whether administration of the affiliative neuropeptide oxytocin to the parent positively influences parent-child interactions of patients with autism spectrum disorders, and 2) to explore the mechanisms by which parental behavior affects children's behavior, feelings, and physiology.

Participants will be 40 triads consisting of mother, father, and child with ASD and 40 triads of mother, father, and typically developing (TD) children. Families will come to our lab at UCSF's Parnassus campus for one 2-hour visit. Parent dyads will be randomly assigned to receive either OT or placebo immediately before the triad engages in triadic discussion and play tasks. We will monitor mothers', fathers', and children's physiological and behavioral responses during these tasks. In summary, this is a randomized 2 (diagnosis) x 2 (spray) between-subjects study of triadic physiology and behavior in children with ASD or TD in which both mothers and fathers are given either OT or placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • For parents of patients with ASD and TD controls:
  • Age between 25 and 60 years old
  • Live with child
  • Read and communicate in English
  • For patient with ASD:
  • Age between 7 and 12 years old
  • Lives with parents
  • Has diagnosis of autism spectrum disorder, pervasive developmental disorder, or pervasive developmental disorder-not otherwise specified(PDD-NOS)
  • Communicates in English
  • Has IQ at or above 75
  • For TD controls:
  • Age between 7 and 12 years
  • Lives with parents

排除标准

  • For parents of patients with ASD and TD controls:
  • Female parents who state they are pregnant or have a positive pregnancy test
  • Severe psychiatric, neurologic or medical illness
  • Severe nasal pathology, atrophic rhinitis, recurrent nose bleeds, or history of cranial-surgical procedures (hypophysectomy)
  • History of severe psychiatric diagnosis including schizophrenia, bipolar, and autism
  • Divorce or separation
  • Hypertension, pacemaker, cardiovascular medications
  • For patients with ASD:
  • IQ lower than 75
  • For TD controls:
  • Current psychiatric illness or developmental disability
  • Current psychiatric medication

研究组 & 干预措施

Oxytocin Nasal Spray

Experimental

40 IUs of Oxytocin nasal spray will be administered to both parents at one time during the lab visit.

干预措施: Oxytocin (Drug)

Placebo nasal spray

Placebo Comparator

40 IUs of Placebo nasal spray will be administered to both parents at one time during the lab visit.

干预措施: Placebo nasal spray (Drug)

结局指标

主要结局

Parental social behavior

时间窗: 37 minutes into lab visit

Social engagement behaviors, including postural orientation, high gaze, quality and quantity of language directed toward child, facial expressions of affect.

次要结局

  • Child social behavior(37 minutes into lab visit)
  • Child and Parent Physiological Synchrony(32 minutes into lab visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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