Oxytocin and Attachment-related Interpretation Bias

Study Overview
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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.

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

Conditions
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Trust

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo
* Other: Secure CBM training
* Other: Neutral CBM training


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin and Secure CBM training<br> | Drug: Oxytocin<br>* 40 IU/ML nasal spray. One administration: children <40kg administer 12IU, children >40kg administer 24IU.<br>Other: Secure CBM training<br>* Children are trained to interpret ambiguous maternal behavior in a secure way.<br>|
| Active Comparator: Placebo and Secure CBM training<br> | Drug: Placebo<br>* NaCl 0,9 % nasal spray.<br>Other: Secure CBM training<br>* Children are trained to interpret ambiguous maternal behavior in a secure way.<br>|
| Active Comparator: Oxytocin and Neutral CBM training<br> | Drug: Oxytocin<br>* 40 IU/ML nasal spray. One administration: children <40kg administer 12IU, children >40kg administer 24IU.<br>Other: Neutral CBM training<br>* Children receive a training unrelated to the interpretation of maternal behavior.<br>|
| Placebo Comparator: Placebo and Neutral CBM training<br> | Drug: Placebo<br>* NaCl 0,9 % nasal spray.<br>Other: Neutral CBM training<br>* Children receive a training unrelated to the interpretation of maternal behavior.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in trust in mother | Trust in mother as measured by People in My Life Trust subscale. | Immediately before and immediately after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in attachment-related behavior towards mother | Observation of the quality of the approach of child towards mother during a puzzle task. | Immediately before and immediately after intervention | 
| Change in secure interpretation of ambiguous maternal behavior | 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. | Immediately before and immediately after intervention | 
| Change in insecure interpretation of ambiguous maternal behavior | 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. | Immediately before and immediately after intervention | 
| Interpretation speed of positive maternal behavior | Reaction times to scenarios describing secure 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 | Reaction times to scenarios describing insecure maternal behavior. | Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attachment, Oxytocin, Cognitive bias modification, Middle childhood