Effects of Intranasal Oxytocin on Emotion Regulation to Stressful Interaction in Insecure Adolescents: a Study Protocol for a Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Conflict discussion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oxytocin
24 IU Oxytocin, 3 puffs per nostril, each with 4 IU OXT, intranasal application 45 min prior to the experiment
干预措施: Oxytocin (Drug)
Placebo
intranasal application, sodium chloride solution, 3 puffs per nostril, 45 min prior to the experiment
干预措施: Placebo (Drug)
结局指标
主要结局
Conflict discussion
时间窗: 3 years
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.Behavioral data will be collected during each of the study visits. Drug effect will be determined by comparing data obtained during placebo and oxytocin visits.
次要结局
- Visual patterns(3 years)