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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Franche-Comté
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Besançon, Franche-Comté, Frankrijk, 25000
- University Regional Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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.
Andere namen:
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Placebo-vergelijker: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Conflict discussion
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Visual patterns
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Lauriane Vulliez-Coady, PhD, CHU Besançon
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P/2013/160
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