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Oxytocin and Attachment-related Interpretation Bias

NCT ID: NCT02737254

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Trust

Keywords

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Attachment Oxytocin Cognitive bias modification Middle childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oxytocin and Secure CBM training

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

40 IU/ML nasal spray. One administration: children \<40kg administer 12IU, children \>40kg administer 24IU.

Secure CBM training

Intervention Type OTHER

Children are trained to interpret ambiguous maternal behavior in a secure way.

Placebo and Secure CBM training

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

NaCl 0,9 % nasal spray.

Secure CBM training

Intervention Type OTHER

Children are trained to interpret ambiguous maternal behavior in a secure way.

Oxytocin and Neutral CBM training

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

40 IU/ML nasal spray. One administration: children \<40kg administer 12IU, children \>40kg administer 24IU.

Neutral CBM training

Intervention Type OTHER

Children receive a training unrelated to the interpretation of maternal behavior.

Placebo and Neutral CBM training

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NaCl 0,9 % nasal spray.

Neutral CBM training

Intervention Type OTHER

Children receive a training unrelated to the interpretation of maternal behavior.

Interventions

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Oxytocin

40 IU/ML nasal spray. One administration: children \<40kg administer 12IU, children \>40kg administer 24IU.

Intervention Type DRUG

Placebo

NaCl 0,9 % nasal spray.

Intervention Type DRUG

Secure CBM training

Children are trained to interpret ambiguous maternal behavior in a secure way.

Intervention Type OTHER

Neutral CBM training

Children receive a training unrelated to the interpretation of maternal behavior.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Known oxytocin allergy
* Currently using medication
* Kidney or cardial condition
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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G. Bosmans, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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KU Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 28709470 (View on PubMed)

Other Identifiers

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2014-005352-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S57012

Identifier Type: -

Identifier Source: org_study_id