Clinical trial NCT01912378: Triadic Interactions of Families With Autism and Oxytocin
Official title: Phase 1 Study of Intranasal Oxytocin on Parents' Behavioral and Physiological Responses to Children With Autism
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Autism Disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Parental social behavior
timeFrame: 37 minutes into lab visit
Secondary outcomes:
measure: Child and Parent Physiological Synchrony
timeFrame: 32 minutes into lab visit
measure: Child social behavior
timeFrame: 37 minutes into lab visit
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Wendy Mendes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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