Oxytocin and Attachment-related Interpretation Bias

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

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.

Study Overview

• Status: Completed
• Conditions: Trust
• Intervention / Treatment: Drug: Oxytocin; Other: Secure CBM training; Drug: Placebo; Other: Neutral CBM training

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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	Other: Secure CBM training; Children are trained to interpret ambiguous maternal behavior in a secure way.; Drug: Placebo; NaCl 0,9 % nasal spray.
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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	Immediately before nasal spray, immediately before CBM training and immediately after CBM training

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven
• Investigators: Principal Investigator: G. Bosmans, Prof. dr., KU Leuven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (ESTIMATE): April 13, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 7, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Oxytocin; Cognitive bias modification; Attachment; Middle childhood
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: S57012; 2014-005352-25 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO