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Trial · Interventional

WithdrawnPhase 1Registry data

Triadic Interactions of Families With Autism and Oxytocin

Short name TAO

NCTNCT01912378 (opens ClinicalTrials.gov in a new tab)Other idTAO
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 1
Enrollment
0 participants (actual)
Sponsor
University of California, San Francisco · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Aug 2013
Primary completion
May 2015
Completion
May 2015
First posted
31 Jul 2013 (estimated)
Last update posted
16 Jan 2019
Conditions
Autism Disorder

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 1

    TAO

    NCT01912378

    Aug 2013 to May 2015

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • Placebo nasal sprayDrug

Arms2

  • Experimental

    Oxytocin Nasal Spray

    40 IUs of Oxytocin nasal spray will be administered to both parents at one time during the lab visit.

  • Placebo comparator

    Placebo nasal spray

    40 IUs of Placebo nasal spray will be administered to both parents at one time during the lab visit.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Parental social behavior

    Time frame · 37 minutes into lab visit

    Registry description

    Social engagement behaviors, including postural orientation, high gaze, quality and quantity of language directed toward child, facial expressions of affect.

Secondary outcomes(2)

  1. Child and Parent Physiological Synchrony

    Time frame · 32 minutes into lab visit

    Registry description

    Sympathetic, parasympathetic, and neuroendocrine responses of both parents and child.

  2. Child social behavior

    Time frame · 37 minutes into lab visit

    Registry description

    Social engagement behaviors, including postural orientation, high gaze, quality and quantity of language directed toward parent, facial expressions of affect.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies12

Studies that cite this trial.

Studies with results

6 studies on this page

Indexing hint: Systematic review · 2011

3 results

A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research.

MacDonald et al. 2011Psychoneuroendocrinologycited by 276

PMID 21429671DOI 10.1016/j.psyneuen.2011.02.015PUB-21429671

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Clinical trial · 2010

2 results

Intranasal oxytocin increases fathers' observed responsiveness during play with their children: a double-blind within-subject experiment.

Naber et al. 2010Psychoneuroendocrinologycited by 146

PMID 20457491DOI 10.1016/j.psyneuen.2010.04.007PUB-20457491

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Clinical trial · 2010

4 results

The cross-generation transmission of oxytocin in humans.

Feldman et al. 2010Hormones and behaviorcited by 170

PMID 20558167DOI 10.1016/j.yhbeh.2010.06.005PUB-20558167

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Clinical trial · 2009

2 results

Intranasal oxytocin increases positive communication and reduces cortisol levels during couple conflict.

Ditzen et al. 2009Biological psychiatrycited by 478

PMID 19027101DOI 10.1016/j.biopsych.2008.10.011PUB-19027101

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2009

2 results

Oxytocin enhances the experience of attachment security.

Buchheim et al. 2009Psychoneuroendocrinologycited by 161

PMID 19457618PMC3138620DOI 10.1016/j.psyneuen.2009.04.002PUB-19457618

Rights unknown2 results
Source linkSee results (2)

Indexing hint: Randomized controlled trial · 2003

4 results

Social support and oxytocin interact to suppress cortisol and subjective responses to psychosocial stress.

Heinrichs et al. 2003Biological psychiatrycited by 1,264

PMID 14675803DOI 10.1016/s0006-3223(03)00465-7PUB-14675803

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

6 studies on this page

PubMed tag: none · 2010

Marital behavior, oxytocin, vasopressin, and wound healing.

Gouin et al. 2010Psychoneuroendocrinologycited by 128

PMID 20144509PMC2888874DOI 10.1016/j.psyneuen.2010.01.009PUB-20144509

Rights unknown
Source link

Indexing hint: Observational study · 2010

Oxytocin and the development of parenting in humans.

Gordon et al. 2010Biological psychiatrycited by 267

PMID 20359699PMC3943240DOI 10.1016/j.biopsych.2010.02.005PUB-20359699

Rights unknown
Source link

PubMed tag: none · 2009

Oxytocin and social perception: oxytocin increases perceived facial trustworthiness and attractiveness.

Theodoridou et al. 2009Hormones and behaviorcited by 213

PMID 19344725DOI 10.1016/j.yhbeh.2009.03.019PUB-19344725

Full text at the publisher
Publisher page

PubMed tag: none · 2008

Oxytocin and cortisol in romantically unattached young adults: associations with bonding and psychological distress.

Gordon et al. 2008Psychophysiologycited by 139

PMID 18266803DOI 10.1111/j.1469-8986.2008.00649.xPUB-18266803

Full text at the publisher
Publisher page

PubMed tag: none · 2005

More frequent partner hugs and higher oxytocin levels are linked to lower blood pressure and heart rate in premenopausal women.

Light et al. 2005Biological psychologycited by 217

PMID 15740822DOI 10.1016/j.biopsycho.2004.11.002PUB-15740822

Full text at the publisher
Publisher page

PubMed tag: none · 2005

Effects of partner support on resting oxytocin, cortisol, norepinephrine, and blood pressure before and after warm partner contact.

Grewen et al. 2005Psychosomatic medicinecited by 245

PMID 16046364DOI 10.1097/01.psy.0000170341.88395.47PUB-16046364

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 7 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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