TrustPhase 4NCT02737254
Oxytocin and Attachment-related Interpretation Bias
A Phase 4 study testing Oxytocin, Secure CBM training and Neutral CBM training in people with Trust, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Trust
- What is being tested?
- Oxytocin, Secure CBM training and Neutral CBM training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2016to Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 8 and 13 years old
- Mother can also participate
Who cannot join
- Known oxytocin allergy
- Currently using medication
- Kidney or cardial condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
40 IU/ML nasal spray. One administration: children <40kg administer 12IU, children >40kg administer 24IU.
PlaceboDrug
NaCl 0,9 % nasal spray.
Secure CBM trainingOther
Children are trained to interpret ambiguous maternal behavior in a secure way.
Neutral CBM trainingOther
Children receive a training unrelated to the interpretation of maternal behavior.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin and Secure CBM training | Experimental | Not described Receives: Drug: Oxytocin; Other: Secure CBM training |
| Placebo and Secure CBM training | Active comparator | Not described Receives: Drug: Placebo; Other: Secure CBM training |
| Oxytocin and Neutral CBM training | Active comparator | Not described Receives: Drug: Oxytocin; Other: Neutral CBM training |
| Placebo and Neutral CBM training | Placebo comparator | Not described Receives: Drug: Placebo; Other: Neutral CBM training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trust in mother
Trust in mother as measured by People in My Life Trust subscale.
Measured: Immediately before and immediately after intervention
Secondary outcomes (5)
Change in attachment-related behavior towards mother
Observation of the quality of the approach of child towards mother during a puzzle task.
Measured: 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.
Measured: 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.
Measured: Immediately before and immediately after intervention
Interpretation speed of positive maternal behavior
Reaction times to scenarios describing secure maternal behavior.
Measured: 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.
Measured: Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TrustStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- G. Bosmans, Prof. dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737254
- Sponsor's protocol ID
- S57012
- Other IDs
- 2014-005352-25, 2014
- Status last verified
- Feb 2016
- First submitted
- 23 Mar 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 28709470
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxytocin on the Training of Attachment-related Interpretation Bias in Middle Childhood
- ClinicalTrials.gov ID
- NCT02737254
- Acronym / sponsor ID
- S57012
- Conditions
- Trust
- Keywords
- Attachment, Oxytocin, Cognitive bias modification, Middle childhood
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxytocin and Secure CBM training | Experimental | Drug: Oxytocin, Other: Secure CBM training |
| Placebo and Secure CBM training | Active comparator | Drug: Placebo, Other: Secure CBM training |
| Oxytocin and Neutral CBM training | Active comparator | Drug: Oxytocin, Other: Neutral CBM training |
| Placebo and Neutral CBM training | Placebo comparator | Drug: Placebo, Other: Neutral CBM training |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Between 8 and 13 years old
- Mother can also participate
Key exclusion criteria (3 listed)
- Known oxytocin allergy
- Currently using medication
- Kidney or cardial condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin40 IU/ML nasal spray. One administration: children <40kg administer 12IU, children >40kg administer 24IU. | Drug | Oxytocin and Neutral CBM training, Oxytocin and Secure CBM training |
| PlaceboNaCl 0,9 % nasal spray. | Drug | Placebo and Neutral CBM training, Placebo and Secure CBM training |
| Secure CBM trainingChildren are trained to interpret ambiguous maternal behavior in a secure way. | Other | Oxytocin and Secure CBM training, Placebo and Secure CBM training |
| Neutral CBM trainingChildren receive a training unrelated to the interpretation of maternal behavior. | Other | Oxytocin and Neutral CBM training, Placebo and Neutral CBM training |
Primary outcome
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.
5 secondary outcomes
Change in attachment-related behavior towards mother
Time frame: Immediately before and immediately after intervention
Change in secure interpretation of ambiguous maternal behavior
Time frame: Immediately before and immediately after intervention
Change in insecure interpretation of ambiguous maternal behavior
Time frame: Immediately before and immediately after intervention
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Derived from this study: PubMed 28709470Verhees 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Bosmans, Prof. dr. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin, Secure CBM training and Neutral CBM training in people with Trust, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in trust in mother (time frame: Immediately before and immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02737254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.