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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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Franche-Comté
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Besançon, Franche-Comté, Francie, 25000
- University Regional Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Oxytocin
24 IU Oxytocin, 3 puffs per nostril, each with 4 IU OXT, intranasal application 45 min prior to the experiment
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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.
Ostatní jména:
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Komparátor placeba: Placebo
intranasal application, sodium chloride solution, 3 puffs per nostril, 45 min prior to the experiment
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Conflict discussion
Časové okno: 3 years
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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.
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3 years
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Visual patterns
Časové okno: 3 years
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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.
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3 years
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Lauriane Vulliez-Coady, PhD, CHU Besançon
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P/2013/160
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