NCT02737254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 8, 2016

Status Verified

February 1, 2016

Enrollment Period

7 months

First QC Date

March 23, 2016

Last Update Submit

November 7, 2016

Conditions

Trust

Keywords

AttachmentOxytocinCognitive bias modificationMiddle childhood

Outcome Measures

Primary Outcomes (1)

  • Change in trust in mother

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

    Immediately before and immediately after intervention

Secondary Outcomes (5)

  • Change in attachment-related behavior towards mother

    Immediately before and immediately after intervention

  • Change in secure interpretation of ambiguous maternal behavior

    Immediately before and immediately after intervention

  • Change in insecure interpretation of ambiguous maternal behavior

    Immediately before and immediately after intervention

  • Interpretation speed of positive 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

    Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure

Other Outcomes (2)

  • Oxytocin side-effects

    Immediately after intervention and 24 hours after intervention

  • Change in mood

    Immediately before nasal spray, immediately before CBM training and immediately after CBM training

Study Arms (4)

Oxytocin and Secure CBM training

EXPERIMENTAL
Drug: OxytocinOther: Secure CBM training

Placebo and Secure CBM training

ACTIVE COMPARATOR
Drug: PlaceboOther: Secure CBM training

Oxytocin and Neutral CBM training

ACTIVE COMPARATOR
Drug: OxytocinOther: Neutral CBM training

Placebo and Neutral CBM training

PLACEBO COMPARATOR
Drug: PlaceboOther: Neutral CBM training

Interventions

OxytocinDRUG

40 IU/ML nasal spray. One administration: children \<40kg administer 12IU, children \>40kg administer 24IU.

Oxytocin and Neutral CBM trainingOxytocin and Secure CBM training
PlaceboDRUG

NaCl 0,9 % nasal spray.

Placebo and Neutral CBM trainingPlacebo and Secure CBM training
Secure CBM trainingOTHER

Children are trained to interpret ambiguous maternal behavior in a secure way.

Oxytocin and Secure CBM trainingPlacebo and Secure CBM training
Neutral CBM trainingOTHER

Children receive a training unrelated to the interpretation of maternal behavior.

Oxytocin and Neutral CBM trainingPlacebo and Neutral CBM training

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 28709470DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • G. Bosmans, Prof. dr.

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 13, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 8, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)