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Oxytocin and Attachment-related Interpretation Bias

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02737254
First Posted: April 13, 2016
Last Update Posted: November 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
  Purpose
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 Intervention Phase
Trust Drug: Oxytocin Drug: Placebo Other: Secure CBM training Other: Neutral CBM training Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcome Measures:
  • Oxytocin side-effects [ Time Frame: Immediately after intervention and 24 hours after intervention ]
    Questionnaire on possible oxytocin side-effects.

  • 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.


Enrollment: 100
Study Start Date: March 2016
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737254


Locations
Belgium
KU Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Katholieke Universiteit Leuven
Investigators
Principal Investigator: G. Bosmans, Prof. dr. KU Leuven
  More Information

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02737254     History of Changes
Other Study ID Numbers: S57012
2014-005352-25 ( EudraCT Number )
First Submitted: March 23, 2016
First Posted: April 13, 2016
Last Update Posted: November 8, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Universitaire Ziekenhuizen Leuven:
Attachment
Oxytocin
Cognitive bias modification
Middle childhood

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs