A Psychosocial Program Impact Evaluation in Jordan

January 13, 2021 updated by: Yale University

Measuring the Health and Wellbeing Impacts of a Scalable Program of Psychosocial Intervention for Refugee Youth

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This study will provide a robust evaluation of the Mercy Corps 'Advancing Adolescents, No Lost Generation' program that targets stress alleviation in refugee youth (12-18 years) with specific measures of psychosocial stress, biological stress, and cognitive function.

Study Type

Interventional

Enrollment (Actual)

817

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 05611
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Advancing Adolescents
Received structured eight-week psychosocial sessions
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.
No Intervention: Control
Controls wait-listed for the intervention, matched for age and urban residence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosocial Stress: Insecurity (Regional Measure)
Time Frame: 11 weeks
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)
Time Frame: 11 weeks
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)
Time Frame: 11 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Health Difficulties: Regional Measure
Time Frame: 11 weeks
Mental health was assessed using the 21-item Arab Youth Mental Health questionnaire (Mahfoud et al., 2011; Mahkoul et al., 2011). This measure includes questions such as, "During the last week I was upset", "During the last week I was bored and hated my life", and "During the last week, I was having a lot of headaches, stomach-aches, and nausea" (1 = Rarely, 3 = Always). Higher scores indicate more symptoms of anxiety and depression.
11 weeks
Mental Health Difficulties: International Measure
Time Frame: 11 weeks
The Arabic version of the Strengths and Difficulties Questionnaire (SDQ), a brief screening tool for psychiatric difficulties (Alyahri & Goodman, 2006) was used. The 20 items include emotional, conduct, and hyperactivity symptom scores (range 0-40). We summed score of the Arabic version of the SDQ subscales relating to hyperactivity, emotional symptoms, conduct problems, and peer problems (Alyahri & Goodman, 2006).
11 weeks
Prosocial Behavior: International Measure
Time Frame: 11 weeks
The Strengths and Difficulties Questionnaire (SDQ) Prosocial Score, which featured 5 items to assess prosociality was used. Items include "I try to be nice to other people. I care about their feelings" and "I am helpful if someone is hurt, upset, or feeling sick" (0 = Not true, 2 = Certainly true). Higher scores indicate greater prosociality.
11 weeks
Resilience: Cross-cultural Measure
Time Frame: 11 weeks
Resilience was measured using the CYRM-28 (Liebenberg et al., 2012; Ungar & Liebenberg, 2011), which had been translated and culturally grounded for use into Arabic. Responses ranged from 1 ("Not at all") to 5 ("A lot"), with higher scores indicating greater resilience.
11 weeks
Biological Stress: Cortisol
Time Frame: 11 weeks
Cortisol was obtained from immunoassays of scalp hair cortisol that provide useful measures of the altered activity of the hypothalamic-pituitary-adrenal axis. Scalp hair is collected non-invasively (~100 strands, 0.5 cm area). This measure indicates chronic stress over the last month, and examined per individual for pre/post intervention levels. These analyses are being undertaken by Professor van Uum at Western Ontario University.
11 weeks
Biological Stress: Cell-mediated Immune Function
Time Frame: 11 weeks
Cell-mediated immune function was measured in field settings, using systemic suppression of immune function in response to chronic stress is measured via immunoassays for Epstein Barr Virus antibodies, in conjunction with C-Reactive Protein, from dried blood spots collected from pricking the finger with a sterile disposable lancet. Three drops of blood on filter paper are dried at room temperature, then frozen until lab assay. This measure reflects compromised immune response due to psychosocial stress over the past week, and examined per individual for pre/post intervention levels.
11 weeks
Cognitive function
Time Frame: 11 weeks
Cognitive function was assessed using tablet-based cognitive skill tasks, testing hippocampal function (long term memory) and prefrontal executive function. Children play short games (1-4 min each) during which they press the tablet in response to geometric shapes. Responses during game play are recorded and used to measure cognitive function.
11 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttraumatic stress symptoms
Time Frame: 11 weeks
The Arabic version of the Child Revised Impact of Events Scale (CRIES-8, 4-point scale) was implemented to assess posttraumatic stress symptoms. Analysis will be on dimensional scores, noting that CRIES >17 points is predictive of symptoms of posttraumatic stress disorder (http://www.childrenandwar.org).
11 weeks
Genetic markers of trauma and/or stress
Time Frame: 11 weeks
Genetic and epigenetic analyses in DNA will be undertaken from cheek swab samples to investigate the biological signatures of altered expressions of trauma and/or psychosocial stress. Whole-genome amplification of the extracted DNA will be used to generate maximum genetic data from the samples.
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: catherine panter-brick, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1502015359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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