Oxytocin and Attachment-related Interpretation Bias

Trust Clinical Trial

Official title:

The Effect of Oxytocin on the Training of Attachment-related Interpretation Bias in Middle Childhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737254
• Other study ID #: S57012
• Secondary ID: 2014-005352-25
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2016
• Last updated: November 7, 2016
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: February 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of oxytocin and a cognitive bias modification (CBM) procedure on children's trust in their mother.

Description:

Previous research has shown that children can be trained to interpret ambiguous interactions with mother in a more secure way by use of a CBM procedure. A secure attachment-related processing bias can causally increase children's trust in mother's availability. The present study tests whether intranasal administration of oxytocin can increase the effect of a secure cognitive bias training. Oxytocin is a neuropeptide that is involved in human attachment and bonding. Intranasal administration of oxytocin can increase trust among people. After oxytocin or placebo administration, children are either trained to interpret ambiguous interactions with mother in a secure way or receive a neutral training unrelated to interpretation of maternal behavior. Pre- and post-intervention children's trust in mother, support seeking behavior and interpretation of maternal behavior is assessed. Moreover, possible oxytocin side-effects will be monitored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

• Between 8 and 13 years old

• Mother can also participate

Exclusion Criteria:

• Known oxytocin allergy

• Currently using medication

• Kidney or cardial condition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trust

Intervention

Drug:
• Oxytocin
40 IU/ML nasal spray. One administration: children <40kg administer 12IU, children >40kg administer 24IU.
• Placebo
NaCl 0,9 % nasal spray.

Other:
• Secure CBM training
Children are trained to interpret ambiguous maternal behavior in a secure way.
• Neutral CBM training
Children receive a training unrelated to the interpretation of maternal behavior.

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxytocin side-effects	Questionnaire on possible oxytocin side-effects.	Immediately after intervention and 24 hours after intervention	No
Other	Change in mood	Children rate on two visual analogous scales how happy and how sad they feel.	Immediately before nasal spray, immediately before CBM training and immediately after CBM training	No
Primary	Change in trust in mother	Trust in mother as measured by People in My Life Trust subscale.	Immediately before and immediately after intervention	No
Secondary	Change in attachment-related behavior towards mother	Observation of the quality of the approach of child towards mother during a puzzle task.	Immediately before and immediately after intervention	No
Secondary	Change in secure interpretation of ambiguous maternal behavior	After reading scenarios describing ambiguous maternal behavior, children will be presented with sentences describing secure interpretations of this behavior and are asked to rate on a 4-point Likert scale to what extent this did or did not happen in the scenario. Thereby, children's spontaneous secure interpretation of ambiguous maternal behavior can be assessed.	Immediately before and immediately after intervention	No
Secondary	Change in insecure interpretation of ambiguous maternal behavior	After reading scenarios describing ambiguous maternal behavior, children will be presented with sentences describing insecure interpretations of this behavior and are asked to rate on a 4-point Likert scale to what extent this did or did not happen in the scenario, assessing children's spontaneous insecure interpretation of ambiguous maternal behavior.	Immediately before and immediately after intervention	No
Secondary	Interpretation speed of positive maternal behavior	Reaction times to scenarios describing secure maternal behavior.	Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure	No
Secondary	Interpretation speed of negative maternal behavior	Reaction times to scenarios describing insecure maternal behavior.	Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure	No