NCT02122887

Brief 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 the other, increase empathy, and reduce hostility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable healthy

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, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

August 5, 2019

Completed
Last Updated

April 3, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

April 23, 2014

Results QC Date

August 10, 2018

Last Update Submit

March 21, 2020

Conditions

Keywords

jewish, arab, israel, teenagers

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    trail 1-baseline

Secondary Outcomes (5)

  • Behavioral Assessment of Dialogue

    trail 2- 3 months after trail 1

  • Hormonal Assays-Oxytocin

    trail 2- 3 months after trail1

  • Changes in PT (Perspective-taking) After Intervention

    trail 2- 3 months after trail 1

  • Changes in Tension as a Function of Perspective-taking and Group

    trail 2- 3 months after trail1

  • Changes in Empathy as a Function of Perspective Taking

    trail 2- 3 months after trail 1

Study Arms (2)

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.

Behavioral: Peace-Building Intervention Process

Interventions

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.

experimental group

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • jewish israeli
  • arab israeli
  • lives in the center of israel
  • both parents agree to participation

You may not qualify if:

  • no mental disorder
  • no neurological-developmental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bar Ilan University

Ramat Gan, 5290002, Israel

Location

Related Publications (1)

  • 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.

Limitations and Caveats

Larger numbers are required before generalizations can be made. Participants had inters on resolving the conflict, enrolled from their own free will. The intervention group got no other intervention. We measured peripheral, not central Oxytocin.

Results Point of Contact

Title
Moran Influs
Organization
Bar Ilan University

Study Officials

  • Moran Influs, MA

    Bar Ilan University, Ramat Gan, Israel

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research manager

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 25, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 3, 2020

Results First Posted

August 5, 2019

Record last verified: 2020-03

Locations