Clinical trial NCT02301715: Effects of Intranasal Oxytocin on Emotion Regulation in Adolescents
Official title: Effects of Intranasal Oxytocin on Emotion Regulation to Stressful Interaction in Insecure Adolescents: a Study Protocol for a Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Emotion
Parent-Child Relations
Keywords: Intranasal oxytocin
Emotion regulation
Attachment
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 29
Sex: MALE
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect of intranasal administration of OT on behavior and discourse of insecure adolescents during a disagreement (stressful situation) with parents.

Detailed description: Emotional dysregulation and impaired attachment in adolescence are seen by clinical researchers as potential contributors to development of psychopathology. Recent evidence suggests that administration of intranasal OT may facilitate social interaction by attenuating the stress response to interpersonal conflict. However, to date there have been no studies investigating the effects of intranasal OT on parent-adolescent interaction and on neurophysiological emotional strategies in adolescence. To understand these mechanisms, this study examines the effects of OT on interpersonal emotional regulation in adolescent-parent stressful interaction, and on individual visual and physiological strategies in the visualizing attachment-related emotions pictures.

The main objective will be to evaluate the effect of intranasal administration of OT on behavior and discourse of insecure adolescents during a disagreement (stressful situation) with one of his parents.

Secondary is determine the effect of OT on visual exploration strategies and on the physiological responses (heart rate, galvanic skin response) on images elicited attachment-related emotions in insecure adolescents.

In this randomized, double-blind, placebo-controlled, parallel designs, 60 healthy male adolescents classified with an insecure attachment will receive 24 IU of intranasal OT or placebo, 45 min before the experimental tasks. Adolescent will be invited with his/her parent to an experimental conflict discussion. The conflict session will be videotaped and coded for verbal and nonverbal interaction behavior (e.g., eye contact, nonverbal positive/negative behavior, and self-disclosure) with GPACS. Eye tracking and physiological responses will be recorded simultaneously and continuously during pictures viewing.

Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of insecure attachment according to the Attachment Scale Interview
* Male adolescents (and parents) enrolled in high school or college
* Not hospitalized
* Without current or past history of neurological or psychiatric illness, including substance abuse or dependence
* Aged from 13 to 20 years
* Speaking French
* Have signed informed consent
* Affiliation to a French social security

Exclusion Criteria:

* Females
* Intellectual deficit
* Severe neurological symptoms
* Known allergies to oxytocin or to preservatives in the nasal spray
* Not speaking French
* Visual disturbances
* Chronic disease (liver failure, kidney failure, cardiovascular disease)
* Antihypertensive therapy

Primary outcomes:
measure: Conflict discussion
timeFrame: 3 years
Secondary outcomes:
measure: Visual patterns
timeFrame: 3 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Regional Hospital
state: Franche-Comté
Study officials:
affiliation: CHU Besançon
name: Lauriane Vulliez-Coady, PhD
role: PRINCIPAL_INVESTIGATOR
References: