HealthyNCT02122887
Peace-Building Interventions for Israeli and Palestinian Youth
A study testing Peace-Building Intervention Process in people with Healthy, run by Bar-Ilan University, Israel at 1 site in Israel.
Trial summary
The investigators expect an intervention that focuses on actual dialogue and familiarity with members of the other culture, discussion of empathy, generosity, and kindness, and focus on adaptive and reciprocal modes of conflict resolution will alter both physiological, behavioral, and mental response to the pain of… Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Peace-Building Intervention Process
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- jewish israeli
- arab israeli
- lives in the center of israel
- both parents agree to participation
Who cannot join
- no mental disorder
- no neurological-developmental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peace-Building Interventions for Israeli and Palestinian Youth: Effects on Biological and Behavioral Markers of Empathy, Prejudice, and Dialogue
The investigators expect an intervention that focuses on actual dialogue and familiarity with members of the other culture, discussion of empathy, generosity, and kindness, and focus on adaptive and reciprocal modes of conflict resolution will alter both physiological, behavioral, and mental response to the pain of the other, increase empathy, and reduce hostility.
Read the detailed description
We hypothesized that the intervention will impact perspective taking (PT) on the national conflict, reducing the tendency to view justice only on one's side. Such increase in PT would initiate a chain leading to greater behavioral empathy.
Second, we hypothesize that change in oxytocin (OT) levels and empathic behavior (less withdrawal and tension and more synchrony) would be impacted by the intervention and the degree to which it altered youth PT on the conflict.
Finally, we suggest a 3-path model charting the multi-dimensional pathways leading to behavioral empathy toward outgroup member. First, individual differences in OT functionality will shape empathy so that youth with higher OT levels at pre-intervention and greater PT will show more empathic dialogue at post-intervention. Second, dispositional cognitive empathy, as tested by the Interpersonal Reactivity Index questioner (IRI), at pre-intervention will predict higher behavioral empathy at T2, both directly and as mediated by reduction in ethnocentric attitudes following the intervention. Finally, we hypothesize that the intervention will influence empathy by initiating a chain that begins with increasing PT, which, in turn, will lead to reduction in tension during interaction with outgroup, and culminating in greater empathy during face-to-face encounters
- Conditions
- Healthy
- Being tested
- Peace-Building Intervention Process
- Keywords
- jewish, arab, israel, teenagers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peace-Building Intervention ProcessBehavioural
The eight sessions include (1) presentation of the self to others members (2) getting familiar with the other culture (3) what is a conflict - how do conflicts come about, what are adaptive and non-adaptive modes of resolving conflict (4) getting to know the "Other" - preconceived notions about the other side (5) on dialogue- what is dialogue, can dialogue offer means for conflict resolution, what are the benefits of dialogue to inter-cultural and inter-racial conflicts, (6) empathy, generosity, and kindness (7) wrapping up - hopes for the future at the personal and community levels, practical suggestions (8) goodbye and summary - what have we learned ,"gift giving", summary of process by group leaders.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | no intervention for 3 months |
| experimental group | Experimental | Peace-Building Intervention Process- The intervention process consists of eight sessions and adheres to a manualized protocol that we developed. Each session lasts 120 minutes. Receives: Behavioral: Peace-Building Intervention Process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Assessment of Dialogue
Interactions were coded with the "Coding Interactive Behavior" (CIB) manual (Feldman, 1998), adolescent version. This version of the CIB is composed of 32 codes rated on a scale of 1 to 5, as higher score mean a better outcome. The Two following constructs were used: A personal measure of "Behavioral Empathy" - an average of the following CIB codes: expressing empathy, acknowledging other's communication, elaborating other's topics and ideas, maintaining positive affect, maintaining visual, and give-and-receive reciprocity and Dyadic Tension - averaged codes; displaying a tense, anxious, and uneasy behavior, fear, and constriction of communicative output and social behavior.
Measured: trail 1-baseline
Hormonal Assays- Oxytocin
Three saliva samples were collected using Salivettes® at baseline, following interaction, and ten minutes after end and averaged. All samples were then stored at -20°C. Salivette were treated as following: centrifuged twice, at 4°C at 1500 x g for 30 minutes, aliquoted and lyophilized over few days- to concentrate by 4 times. The dry samples were reconstructed in the assay buffer immediately before analysis using an oxytocin enzyme immunoassay commercial kit (ENZO, NY). The assay preformed according the kit's instruction. The concentration of oxytocin was calculated using MatLab-7
Measured: trail 1- baseline
PT (Perspective-taking)
Participants were interviewed individually on their attitudes towards the Israeli-Palestinian conflict. Perspective-taking (PT), addressed the degree to which adolescents thought justice was solely on their side and the other side is totally wrong, aggressive, and vicious compared to the ability to see some justice on both sides. Participants received binary score for PT, as 1 is some ability to see justice on the other side, and 0 is seeing justice only in own side.
Measured: trail 1-baseline
Secondary outcomes (5)
Behavioral Assessment of Dialogue
interactions were coded with the "Coding Interactive Behavior" (CIB) manual (Feldman, 1998), adolescent version. This version of the CIB is composed of 32 codes rated on a scale of 1 to 5, as higher score mean a better outcome. The Two following constructs were used: A personal measure of "Behavioral Empathy" - an average of the following CIB codes: expressing empathy, acknowledging other's communication, elaborating other's topics and ideas, maintaining positive affect, maintaining visual, and give-and-receive reciprocity and Dyadic Tension - averaged codes; displaying a tense, anxious, and uneasy behavior, fear, and constriction of communicative output and social behavior.
Measured: trail 2- 3 months after trail 1
Hormonal Assays-Oxytocin
Three saliva samples were collected using Salivettes® at baseline, following interaction, and ten minutes after end and averaged. All samples were then stored at -20°C. Salivette were treated as following: centrifuged twice, at 4°C at 1500 x g for 30 minutes, aliquoted and lyophilized over few days- to concentrate by 4 times. The dry samples were reconstructed in the assay buffer immediately before analysis using an oxytocin enzyme immunoassay commercial kit (ENZO, NY). The assay preformed according the kit's instruction. The concentration of oxytocin was calculated using MatLab-7
Measured: trail 2- 3 months after trail1
Changes in PT (Perspective-taking) After Intervention
Participants were interviewed individually on their attitudes towards the Israeli-Palestinian conflict. Perspective-taking (PT), addressed the degree to which adolescents thought justice was solely on their side and the other side is totally wrong, aggressive, and vicious compared to the ability to see some justice on both sides. Participants received binary score for PT.
Measured: trail 2- 3 months after trail 1
Changes in Tension as a Function of Perspective-taking and Group
Perspective-taking (PT), addressed the degree to which adolescents thought justice was solely on their side compared to the ability to see some justice on both sides. Participants received binary score for PT and were divided to high vs low PT groups accordingly.
We compared participants' tension levels, according to level of PT and group (intervention or control). Interactions were coded with the "Coding Interactive Behavior" (CIB) manual (Feldman, 1998), adolescent version. This version of the CIB is composed of 32 codes rated on a scale of 1 to 5, as higher score means a better outcome. Dyadic Tension is the averaged codes; displaying a tense, anxious, and uneasy behavior, fear, and constriction of communicative output and social behavior.
Measured: trail 2- 3 months after trail1
Changes in Empathy as a Function of Perspective Taking
Perspective-taking (PT), addressed the degree to which adolescents thought justice was solely on their side compared to the ability to see some justice on both sides. Participants received binary score for PT and were divided to high vs low PT groups accordingly.
We compared participants' behavioral empathy levels. Interactions were coded with the "Coding Interactive Behavior" (CIB) manual (Feldman, 1998), adolescent version. This version of the CIB is composed of 32 codes rated on a scale of 1 to 5, as higher score means a better outcome. "Behavioral Empathy" is the average of the following CIB codes: expressing empathy, acknowledging other's communication, elaborating other's topics and ideas, maintaining positive affect, maintaining visual, and give-and-receive reciprocity
Measured: trail 2- 3 months after trail 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moran Influs, Bar-Ilan University, Israel
- Investigators
- Moran Influs, MA, Principal investigator, Bar Ilan University, Ramat Gan, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122887
- Sponsor's protocol ID
- BIU901305
- Status last verified
- Mar 2020
- First submitted
- 23 Apr 2014
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Influs M, Masalha S, Zagoory-Shaon O, Feldman R. Dialogue intervention to youth amidst intractable conflict attenuates stress response to outgroup. Horm Behav. 2019 Apr;110:68-76. doi: 10.1016/j.yhbeh.2019.02.013. Epub 2019 Mar 9.
PubMed 30807738
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peace-Building Interventions for Israeli and Palestinian Youth: Effects on Biological and Behavioral Markers of Empathy, Prejudice, and Dialogue
- ClinicalTrials.gov ID
- NCT02122887
- Acronym / sponsor ID
- BIU901305
- Conditions
- Healthy
- Keywords
- jewish, arab, israel, teenagers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators expect an intervention that focuses on actual dialogue and familiarity with members of the other culture, discussion of empathy, generosity, and kindness, and focus on adaptive and reciprocal modes of conflict resolution will alter both physiological, behavioral, and mental response to the pain of the other, increase empathy, and reduce hostility.
Detailed description
We hypothesized that the intervention will impact perspective taking (PT) on the national conflict, reducing the tendency to view justice only on one's side. Such increase in PT would initiate a chain leading to greater behavioral empathy.
Second, we hypothesize that change in oxytocin (OT) levels and empathic behavior (less withdrawal and tension and more synchrony) would be impacted by the intervention and the degree to which it altered youth PT on the conflict.
Finally, we suggest a 3-path model charting the multi-dimensional pathways leading to behavioral empathy toward outgroup member. First, individual differences in OT functionality will shape empathy so that youth with higher OT levels at pre-intervention and greater PT will show more empathic dialogue at post-intervention. Second, dispositional cognitive empathy, as tested by the Interpersonal Reactivity Index questioner (IRI), at pre-intervention will predict higher behavioral empathy at T2, both directly and as mediated by reduction in ethnocentric attitudes following the intervention. Finally, we hypothesize that the intervention will influence empathy by initiating a chain that begins with increasing PT, which, in turn, will lead to reduction in tension during interaction with outgroup, and culminating in greater empathy during face-to-face encounters
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –no intervention for 3 months |
| experimental group | Experimental | Behavioral: Peace-Building Intervention ProcessPeace-Building Intervention Process- The intervention process consists of eight sessions and adheres to a manualized protocol that we developed. Each session lasts 120 minutes. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- jewish israeli
- arab israeli
- lives in the center of israel
- both parents agree to participation
Key exclusion criteria (2 listed)
- no mental disorder
- no neurological-developmental disorder
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 |
|---|---|---|
| Peace-Building Intervention ProcessThe eight sessions include (1) presentation of the self to others members (2) getting familiar with the other culture (3) what is a conflict - how do conflicts come about, what are adaptive and non-adaptive modes of resolving conflict (4) getting to know the "Other" - preconceived notions about the other side (5) on dialogue- what is dialogue, can dialogue offer means for conflict resolution, what are the benefits of dialogue to inter-cultural and inter-racial conflicts, (6) empathy, generosity, and kindness (7) wrapping up - hopes for the future at the personal and community levels, practical suggestions (8) goodbye and summary - what have we learned ,"gift giving", summary of process by group leaders. | Behavioural | experimental group |
Primary outcome
Behavioral Assessment of Dialogue
Time frame: trail 1-baseline
Interactions were coded with the "Coding Interactive Behavior" (CIB) manual (Feldman, 1998), adolescent version. This version of the CIB is composed of 32 codes rated on a scale of 1 to 5, as higher score mean a better outcome. The Two following constructs were used: A personal measure of "Behavioral Empathy" - an average of the following CIB codes: expressing empathy, acknowledging other's communication, elaborating other's topics and ideas, maintaining positive affect, maintaining visual, and give-and-receive reciprocity and Dyadic Tension - averaged codes; displaying a tense, anxious, and uneasy behavior, fear, and constriction of communicative output and social behavior.
Hormonal Assays- Oxytocin
Time frame: trail 1- baseline
Three saliva samples were collected using Salivettes® at baseline, following interaction, and ten minutes after end and averaged. All samples were then stored at -20°C. Salivette were treated as following: centrifuged twice, at 4°C at 1500 x g for 30 minutes, aliquoted and lyophilized over few days- to concentrate by 4 times. The dry samples were reconstructed in the assay buffer immediately before analysis using an oxytocin enzyme immunoassay commercial kit (ENZO, NY). The assay preformed according the kit's instruction. The concentration of oxytocin was calculated using MatLab-7
PT (Perspective-taking)
Time frame: trail 1-baseline
Participants were interviewed individually on their attitudes towards the Israeli-Palestinian conflict. Perspective-taking (PT), addressed the degree to which adolescents thought justice was solely on their side and the other side is totally wrong, aggressive, and vicious compared to the ability to see some justice on both sides. Participants received binary score for PT, as 1 is some ability to see justice on the other side, and 0 is seeing justice only in own side.
5 secondary outcomes
Behavioral Assessment of Dialogue
Time frame: trail 2- 3 months after trail 1
Hormonal Assays-Oxytocin
Time frame: trail 2- 3 months after trail1
Changes in PT (Perspective-taking) After Intervention
Time frame: trail 2- 3 months after trail 1
Changes in Tension as a Function of Perspective-taking and Group
Time frame: trail 2- 3 months after trail1
Changes in Empathy as a Function of Perspective Taking
Time frame: trail 2- 3 months after trail 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30807738Influs M, Masalha S, Zagoory-Shaon O, Feldman R. Dialogue intervention to youth amidst intractable conflict attenuates stress response to outgroup. Horm Behav. 2019 Apr;110:68-76. doi: 10.1016/j.yhbeh.2019.02.013. Epub 2019 Mar 9.
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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.
Moran Influs, MA principal investigator
Bar Ilan University, Ramat Gan, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peace-Building Intervention Process in people with Healthy, run by Bar-Ilan University, Israel at 1 site in Israel.
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 4 inclusion and 2 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 3 Apr 2020. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Behavioral Assessment of Dialogue (time frame: trail 1-baseline). The study lists 3 primary outcomes in all. 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 NCT02122887, 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 3 Apr 2020.