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Clinical Trials/NCT02737254
NCT02737254
Completed
Phase 4

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

Universitaire Ziekenhuizen KU Leuven1 site in 1 country100 target enrollmentMarch 2016

Overview

Phase
Phase 4
Intervention
Oxytocin
Conditions
Trust
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
100
Locations
1
Primary Endpoint
Change in trust in mother
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
October 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Oxytocin and Secure CBM training

Intervention: Oxytocin

Oxytocin and Secure CBM training

Intervention: Secure CBM training

Placebo and Secure CBM training

Intervention: Placebo

Placebo and Secure CBM training

Intervention: Secure CBM training

Oxytocin and Neutral CBM training

Intervention: Oxytocin

Oxytocin and Neutral CBM training

Intervention: Neutral CBM training

Placebo and Neutral CBM training

Intervention: Placebo

Placebo and Neutral CBM training

Intervention: Neutral CBM training

Outcomes

Primary Outcomes

Change in trust in mother

Time Frame: Immediately before and immediately after intervention

Trust in mother as measured by People in My Life Trust subscale.

Secondary Outcomes

  • Change in attachment-related behavior towards mother(Immediately before and immediately after intervention)
  • Change in secure interpretation of ambiguous maternal behavior(Immediately before and immediately after intervention)
  • Change in insecure interpretation of ambiguous maternal behavior(Immediately before and immediately after intervention)
  • Interpretation speed of positive maternal behavior(Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure)
  • Interpretation speed of negative maternal behavior(Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure)

Study Sites (1)

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