Effects of Intranasal Oxytocin on Emotion Regulation in Adolescents (ELOREA)
Effects of Intranasal Oxytocin on Emotion Regulation to Stressful Interaction in Insecure Adolescents: a Study Protocol for a Double Blind Randomized Controlled Trial
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Franche-Comté
-
Besançon、Franche-Comté、フランス、25000
- University Regional Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Oxytocin
24 IU Oxytocin, 3 puffs per nostril, each with 4 IU OXT, intranasal application 45 min prior to the experiment
|
OT spray will be performed by the research pharmacy at the University Regional Hospital Pharmacy of Besançon.
The placebo contained all inactive ingredients except for the neuropeptide.
Placebo and OT spray containers will be prepared to look identical and will be counterbalance to be randomly assigned by the pharmacy as well.
Double blinding and randomization of patients in the two groups will also be carried out by the pharmacy service.
Researchers, as well as participants, will be blinded to the content of the spray.
Participants will be instructed to sit and take one puff every 30 seconds, alternating nostrils.
Participant will take each dose in front of the clinician to assure correct administration and tolerability.
他の名前：
|
|
プラセボコンパレーター：Placebo
intranasal application, sodium chloride solution, 3 puffs per nostril, 45 min prior to the experiment
|
The placebo contained all inactive ingredients except for the neuropeptide.
Participants will be instructed to sit and take one puff every 30 seconds, alternating nostrils.
Participant will take each dose in front of the clinician to assure correct administration and tolerability.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Conflict discussion
時間枠：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.
|
3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Visual patterns
時間枠：3 years
|
Adolescent's eye tracking (i.e., time (ms) and frequency of fixations in an AOI) and physiological (Amplitude of SCL (microsiemens), Amplitude of SCRs (microsiemens), Time of latency (s)) responses will be recorded simultaneously and continuously during pictures viewing.
|
3 years
|
協力者と研究者
捜査官
- 主任研究者：Lauriane Vulliez-Coady, PhD、CHU Besançon
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。