Clinical trial NCT02737254: Oxytocin and Attachment-related Interpretation Bias
Official title: The Effect of Oxytocin on the Training of Attachment-related Interpretation Bias in Middle Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trust
Keywords: Attachment
Oxytocin
Cognitive bias modification
Middle childhood
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2016-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Between 8 and 13 years old
* Mother can also participate

Exclusion Criteria:

* Known oxytocin allergy
* Currently using medication
* Kidney or cardial condition

Primary outcomes:
measure: Change in trust in mother
timeFrame: Immediately before and immediately after intervention
Secondary outcomes:
measure: Change in attachment-related behavior towards mother
timeFrame: Immediately before and immediately after intervention
measure: Change in secure interpretation of ambiguous maternal behavior
timeFrame: Immediately before and immediately after intervention
measure: Change in insecure interpretation of ambiguous maternal behavior
timeFrame: Immediately before and immediately after intervention
measure: Interpretation speed of positive maternal behavior
timeFrame: Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure
measure: Interpretation speed of negative maternal behavior
timeFrame: Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure
Other outcomes:
measure: Oxytocin side-effects
timeFrame: Immediately after intervention and 24 hours after intervention
measure: Change in mood
timeFrame: Immediately before nasal spray, immediately before CBM training and immediately after CBM training
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
affiliation: KU Leuven
name: G. Bosmans, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verhees MWFT, Ceulemans E, Bakermans-Kranenburg MJ, van IJzendoorn MH, de Winter S, Bosmans G. The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial. Trials. 2017 Jul 14;18(1):326. doi: 10.1186/s13063-017-2077-2.