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Clinical Trials/NCT02737254
NCT02737254CompletedPhase 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 enrollmentStarted: March 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Change in trust in mother

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
8 Years to 13 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Experimental

Intervention: Oxytocin (Drug)

Oxytocin and Secure CBM training

Experimental

Intervention: Secure CBM training (Other)

Placebo and Secure CBM training

Active Comparator

Intervention: Placebo (Drug)

Placebo and Secure CBM training

Active Comparator

Intervention: Secure CBM training (Other)

Oxytocin and Neutral CBM training

Active Comparator

Intervention: Oxytocin (Drug)

Oxytocin and Neutral CBM training

Active Comparator

Intervention: Neutral CBM training (Other)

Placebo and Neutral CBM training

Placebo Comparator

Intervention: Placebo (Drug)

Placebo and Neutral CBM training

Placebo Comparator

Intervention: Neutral CBM training (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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