Triadic Interactions of Families With Autism and Oxytocin

NCT01912378 | Withdrawn Phase 1

• 1 other identifier: TAO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Child and Parent Physiological Synchrony

  32 minutes into lab visit

• Child social behavior

  37 minutes into lab visit

Study Arms (2)

Oxytocin Nasal Spray

EXPERIMENTAL

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

Drug: Oxytocin

Placebo nasal spray

PLACEBO COMPARATOR

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

Drug: Placebo nasal spray

Interventions

Oxytocin DRUG

Also known as: Novartis

Oxytocin Nasal Spray

Placebo nasal spray DRUG

Placebo nasal spray

Eligibility Criteria

• Age: 7 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (21)

• Abidin, R. R. (1995). Parenting Stress Index, Third Edition. Professional Manual. Odessa, FL.: Psychological Assessment Resources, Inc.

  BACKGROUND

• Achenbach, T. (2001). Manual for the Child Behavior Checklist/4-18. Burlington, VT: University of Vermont.

  BACKGROUND

• Aron, A., Aron, E. N., & Smollan, D. (1992). Inclusion of other in the self scale and the structure of interpersonal closeness. Journal of Personality and Social Psychology, 63, 596-612.

  BACKGROUND

• Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.

  PMID: 7962581 BACKGROUND

• Buchheim A, Heinrichs M, George C, Pokorny D, Koops E, Henningsen P, O'Connor MF, Gundel H. Oxytocin enhances the experience of attachment security. Psychoneuroendocrinology. 2009 Oct;34(9):1417-22. doi: 10.1016/j.psyneuen.2009.04.002. Epub 2009 May 19.

  PMID: 19457618 BACKGROUND

• Busby, D. M., Christensen, C., Crane, D. R., & Larson, J. H. (1995). A revision of the Dyadic Adjustment Scale for use with distressed and nondistressed couples: Construct hierarchy and multidimensional scales. Journal of Marital and Family Therapy, 21, 289-308.

  BACKGROUND

• Ditzen B, Schaer M, Gabriel B, Bodenmann G, Ehlert U, Heinrichs M. Intranasal oxytocin increases positive communication and reduces cortisol levels during couple conflict. Biol Psychiatry. 2009 May 1;65(9):728-31. doi: 10.1016/j.biopsych.2008.10.011. Epub 2008 Nov 22.

  PMID: 19027101 BACKGROUND

• Feldman R, Gordon I, Zagoory-Sharon O. The cross-generation transmission of oxytocin in humans. Horm Behav. 2010 Sep;58(4):669-76. doi: 10.1016/j.yhbeh.2010.06.005. Epub 2010 Jun 15.

  PMID: 20558167 BACKGROUND

• Gordon I, Zagoory-Sharon O, Schneiderman I, Leckman JF, Weller A, Feldman R. Oxytocin and cortisol in romantically unattached young adults: associations with bonding and psychological distress. Psychophysiology. 2008 May;45(3):349-52. doi: 10.1111/j.1469-8986.2008.00649.x. Epub 2008 Feb 4.

  PMID: 18266803 BACKGROUND

• Gordon I, Zagoory-Sharon O, Leckman JF, Feldman R. Oxytocin and the development of parenting in humans. Biol Psychiatry. 2010 Aug 15;68(4):377-82. doi: 10.1016/j.biopsych.2010.02.005. Epub 2010 Mar 31.

  PMID: 20359699 BACKGROUND

• Gouin JP, Carter CS, Pournajafi-Nazarloo H, Glaser R, Malarkey WB, Loving TJ, Stowell J, Kiecolt-Glaser JK. Marital behavior, oxytocin, vasopressin, and wound healing. Psychoneuroendocrinology. 2010 Aug;35(7):1082-90. doi: 10.1016/j.psyneuen.2010.01.009. Epub 2010 Feb 9.

  PMID: 20144509 BACKGROUND

• Grewen KM, Girdler SS, Amico J, Light KC. Effects of partner support on resting oxytocin, cortisol, norepinephrine, and blood pressure before and after warm partner contact. Psychosom Med. 2005 Jul-Aug;67(4):531-8. doi: 10.1097/01.psy.0000170341.88395.47.

  PMID: 16046364 BACKGROUND

• Heinrichs M, Baumgartner T, Kirschbaum C, Ehlert U. Social support and oxytocin interact to suppress cortisol and subjective responses to psychosocial stress. Biol Psychiatry. 2003 Dec 15;54(12):1389-98. doi: 10.1016/s0006-3223(03)00465-7.

  PMID: 14675803 BACKGROUND

• Kerns KA, Aspelmeier JE, Gentzler AL, Grabill CM. Parent-child attachment and monitoring in middle childhood. J Fam Psychol. 2001 Mar;15(1):69-81. doi: 10.1037//0893-3200.15.1.69.

  PMID: 11322086 BACKGROUND

• Light KC, Grewen KM, Amico JA. More frequent partner hugs and higher oxytocin levels are linked to lower blood pressure and heart rate in premenopausal women. Biol Psychol. 2005 Apr;69(1):5-21. doi: 10.1016/j.biopsycho.2004.11.002. Epub 2004 Dec 29.

  PMID: 15740822 BACKGROUND

• MacDonald E, Dadds MR, Brennan JL, Williams K, Levy F, Cauchi AJ. A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research. Psychoneuroendocrinology. 2011 Sep;36(8):1114-26. doi: 10.1016/j.psyneuen.2011.02.015. Epub 2011 Mar 23.

  PMID: 21429671 BACKGROUND

• Naber F, van Ijzendoorn MH, Deschamps P, van Engeland H, Bakermans-Kranenburg MJ. Intranasal oxytocin increases fathers' observed responsiveness during play with their children: a double-blind within-subject experiment. Psychoneuroendocrinology. 2010 Nov;35(10):1583-6. doi: 10.1016/j.psyneuen.2010.04.007. Epub 2010 May 8.

  PMID: 20457491 BACKGROUND

• Radloff, L. S. (1977). The CES-D Scale. A self-report depression scale for research in the general population. Applied Psychological Measurement, 1, 385-401.

  BACKGROUND

• Theodoridou A, Rowe AC, Penton-Voak IS, Rogers PJ. Oxytocin and social perception: oxytocin increases perceived facial trustworthiness and attractiveness. Horm Behav. 2009 Jun;56(1):128-32. doi: 10.1016/j.yhbeh.2009.03.019. Epub 2009 Apr 1.

  PMID: 19344725 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Wei M, Russell DW, Mallinckrodt B, Vogel DL. The Experiences in Close Relationship Scale (ECR)-short form: reliability, validity, and factor structure. J Pers Assess. 2007 Apr;88(2):187-204. doi: 10.1080/00223890701268041.

  PMID: 17437384 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Interventions

Oxytocin; lactitol

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Wendy Mendes, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 31, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

US (1)