NCT03012451

Brief Summary

The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living in urban settlements in Jordan. The study was conducted using two waves of data collection: the first featured an intervention and a matched control group, the second featured a full randomized control trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
817

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

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

April 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

December 21, 2016

Last Update Submit

January 13, 2021

Conditions

Keywords

StressInsecurityMental Health

Outcome Measures

Primary Outcomes (3)

  • Psychosocial Stress: Insecurity (Regional Measure)

    Insecurity was measured with The Human Insecurity (HI). This tool was developed for use in the West Bank (Ziadni, Hammoudeh et al. 2011, Hamayel, Ghandour et al. 2014). The 10-item scale is a 5-point Likert scale with scores expressed as percentages on a scale of 0-100. The HI covers issues such as worries regarding inability to obtain daily life necessities, losing a source of income, fears about the future, and family safety.

    11 weeks

  • Psychosocial stress: Distress (Regional Measure)

    Distress was measured with the Human Distress scale (Hamayel \& Ghandour, 2014), developed for use with conflict-affected adolescents in the West Bank. The 12-item scale is a 5-point Likert scale with scores expressed as percentages on a scale of 0-100. Sample items include, "To what extent have you felt worried," "To what extent did you feel humiliated," and "To what extent did you feel angry." Scores are presented as percentages (0-100%), with higher scores indicating greater distress.

    11 weeks

  • Psychosocial Stress (International Measure)

    Stress was measured using the Arabic version of the Perceived Stress Scale (Cohen, Karmarck, \& Mermelstein, 1983), validated with a Jordanian sample (Almadi, Cathers, Hamdan Mansour, \& Chow, 2012). This 14-item, 5-point Likert scale measures perceived stress over the last month, with higher scores indicating greater stress. Items include, "How often have you been upset because of something that happened unexpectedly?" and "How often have you been able to control irritations in your life?" (reverse-scored) (1 = Never, 5 = Very often).

    11 weeks

Secondary Outcomes (7)

  • Mental Health Difficulties: Regional Measure

    11 weeks

  • Mental Health Difficulties: International Measure

    11 weeks

  • Prosocial Behavior: International Measure

    11 weeks

  • Resilience: Cross-cultural Measure

    11 weeks

  • Biological Stress: Cortisol

    11 weeks

  • +2 more secondary outcomes

Other Outcomes (2)

  • Posttraumatic stress symptoms

    11 weeks

  • Genetic markers of trauma and/or stress

    11 weeks

Study Arms (2)

Advancing Adolescents

EXPERIMENTAL

Received structured eight-week psychosocial sessions

Behavioral: Advancing Adolescents

Control

NO INTERVENTION

Controls wait-listed for the intervention, matched for age and urban residence

Interventions

The "Advancing Adolescents" programme is a structured 8-week psychosocial intervention for adolescents in humanitarian crises, based on profound stress attunement processes. It features three elements that are widely viewed as important to support youth adjustment in contexts of complex emergencies: (i) safety: establishment of a 'safe space' within the community as a base for activities and site of protection; (ii) support: facilitation of social support and self-expression; and (iii) structured activities: access to scheduled group activities.

Advancing Adolescents

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Eligible and enrolled in Mercy Corps Advancing Adolescents program
  • Syrian refugee and Jordanian host-community youth residing in 4 urban centers in northern Jordan

You may not qualify if:

  • Not available for study recruitment (started sessions or deferred sessions before study start date).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 05611, United States

Location

Related Publications (1)

  • Panter-Brick C, Dajani R, Eggerman M, Hermosilla S, Sancilio A, Ager A. Insecurity, distress and mental health: experimental and randomized controlled trials of a psychosocial intervention for youth affected by the Syrian crisis. J Child Psychol Psychiatry. 2018 May;59(5):523-541. doi: 10.1111/jcpp.12832. Epub 2017 Oct 2.

Related Links

MeSH Terms

Conditions

Stress, PsychologicalPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • catherine panter-brick, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 6, 2017

Study Start

April 1, 2015

Primary Completion

September 1, 2016

Study Completion

April 1, 2017

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

We are sharing the anonymized dataset with project collaborators, but only with other researchers upon explicit request.

Locations