Triadic Interactions of Families With Autism and Oxytocin (TAO)

January 14, 2019 updated by: University of California, San Francisco

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94118
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 58 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin Nasal Spray
40 IUs of Oxytocin nasal spray will be administered to both parents at one time during the lab visit.
Drug: Oxytocin
Other Names:
  • Novartis
Placebo Comparator: Placebo nasal spray
40 IUs of Placebo nasal spray will be administered to both parents at one time during the lab visit.
Drug: Placebo nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental social behavior
Time Frame: 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.
37 minutes into lab visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child and Parent Physiological Synchrony
Time Frame: 32 minutes into lab visit
Sympathetic, parasympathetic, and neuroendocrine responses of both parents and child.
32 minutes into lab visit
Child social behavior
Time Frame: 37 minutes into lab visit
Social engagement behaviors, including postural orientation, high gaze, quality and quantity of language directed toward parent, facial expressions of affect.
37 minutes into lab visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Wendy Mendes, Ph.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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