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Completed

NCT Number: NCT02737254

Oxytocin and Attachment-related Interpretation Bias

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.

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Key information

Conditions

Trust

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

KU Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Oxytocin

Drug

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

Placebo

Drug

NaCl 0,9 % nasal spray.

Secure CBM training

Other

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

Neutral CBM training

Other

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

Primary outcomes

  1. 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

  1. Change in attachment-related behavior towards mother

    Time frame: Immediately before and immediately after intervention

    Observation of the quality of the approach of child towards mother during a puzzle task.

  2. Change in secure interpretation of ambiguous maternal behavior

    Time frame: Immediately before and immediately after intervention

    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.

  3. Change in insecure interpretation of ambiguous maternal behavior

    Time frame: Immediately before and immediately after intervention

    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.

  4. Interpretation speed of positive maternal behavior

    Time frame: Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure

    Reaction times to scenarios describing secure maternal behavior.

  5. Interpretation speed of negative maternal behavior

    Time frame: Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure

    Reaction times to scenarios describing insecure maternal behavior.

Other outcomes

  1. Oxytocin side-effects

    Time frame: Immediately after intervention and 24 hours after intervention

    Questionnaire on possible oxytocin side-effects.

  2. Change in mood

    Time frame: Immediately before nasal spray, immediately before CBM training and immediately after CBM training

    Children rate on two visual analogous scales how happy and how sad they feel.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 13, 2016
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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