Oxytocin and Attachment-related Interpretation Bias

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT02737254
• Collaborator: KU Leuven (Other)
• Enrollment: 100
• Location: 1
• Arms: 4
• Duration (Months): 7
• Patients Per Site Per Month: 14.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trust	Drug: Oxytocin; Drug: Placebo; Other: Secure CBM training; Other: Neutral CBM training	Phase 4

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
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Oxytocin on the Training of Attachment-related Interpretation Bias in Middle Childhood
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in trust in mother [Immediately before and immediately after intervention]

   Trust in mother as measured by People in My Life Trust subscale.

Secondary Outcome Measures

1. Change in attachment-related behavior towards mother [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 [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 [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 [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 [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 Outcome Measures

1. Oxytocin side-effects [Immediately after intervention and 24 hours after intervention]

   Questionnaire on possible oxytocin side-effects.

2. Change in mood [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 13 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KU Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven
• KU Leuven

Investigators

• Principal Investigator: G. Bosmans, Prof. dr., KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT02737254
• Other Study ID Numbers: S57012; 2014-005352-25
• First Posted: Apr 13, 2016
• Last Update Posted: Nov 8, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Universitaire Ziekenhuizen Leuven: Attachment; Oxytocin; Cognitive bias modification; Middle childhood
• Additional relevant MeSH terms: Oxytocin

Study Results

No Results Posted as of Nov 8, 2016