A Phase 1 interventional study of Oxytocin and Placebo nasal spray in Autism Disorder, sponsored by University of California, San Francisco. Withdrawn at 1 site in United States. Open to participants aged 7 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by University of California, San Francisco · Phase 1, Interventional, and Basic science
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.
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.
1,360 studies on the registry are indexed under Autistic Disorder; 332 are open to participants now.
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For parents of patients with ASD and TD controls:
For patient with ASD:
For TD controls:
Exclusion Criteria:
For parents of patients with ASD and TD controls:
For patients with ASD:
For TD controls:
40 IUs of Oxytocin nasal spray will be administered to both parents at one time during the lab visit.
Drug: Oxytocin
40 IUs of Placebo nasal spray will be administered to both parents at one time during the lab visit.
Drug: Placebo nasal spray
Also known as: Novartis
Parental social behavior
Social engagement behaviors, including postural orientation, high gaze, quality and quantity of language directed toward child, facial expressions of affect.
Time frame: 37 minutes into lab visit
Child and Parent Physiological Synchrony
Sympathetic, parasympathetic, and neuroendocrine responses of both parents and child.
Time frame: 32 minutes into lab visit
Child social behavior
Social engagement behaviors, including postural orientation, high gaze, quality and quantity of language directed toward parent, facial expressions of affect.
Time frame: 37 minutes into lab visit
This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxytocin
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