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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005352-25 | EudraCT Number |
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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin and Secure CBM training | Experimental |
| |
| Placebo and Secure CBM training | Active Comparator |
| |
| Oxytocin and Neutral CBM training | Active Comparator |
| |
| Placebo and Neutral CBM training | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 40 IU/ML nasal spray. One administration: children <40kg administer 12IU, children >40kg administer 24IU. |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Oxytocin side-effects | Questionnaire on possible oxytocin side-effects. | Immediately after intervention and 24 hours after intervention |
| Change in mood | Children rate on two visual analogous scales how happy and how sad they feel. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G. Bosmans, Prof. dr. | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28709470 | Derived | 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. |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | NaCl 0,9 % nasal spray. |
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| Secure CBM training | Other | Children are trained to interpret ambiguous maternal behavior in a secure way. |
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| Neutral CBM training | Other | Children receive a training unrelated to the interpretation of 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 |
| Immediately before nasal spray, immediately before CBM training and immediately after CBM training |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |