Autism Disorder Clinical Trial
Official title:
Phase 1 Study of Intranasal Oxytocin on Parents' Behavioral and Physiological Responses to Children With Autism
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.
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