Autism Disorder Clinical Trial
— TAOOfficial title:
Phase 1 Study of Intranasal Oxytocin on Parents' Behavioral and Physiological Responses to Children With Autism
NCT number | NCT01912378 |
Other study ID # | TAO |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | August 2013 |
Est. completion date | May 2015 |
Verified date | January 2019 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Parental social behavior | 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 | Child and Parent Physiological Synchrony | Sympathetic, parasympathetic, and neuroendocrine responses of both parents and child. | 32 minutes into lab visit | |
Secondary | Child social behavior | 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 |
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