A Psychosocial Program Impact Evaluation in Jordan
Primary Purpose
Stress, Psychological, Mental Health Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advancing Adolescents
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological focused on measuring Stress, Insecurity, Mental Health
Eligibility Criteria
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).
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Advancing Adolescents
Control
Arm Description
Received structured eight-week psychosocial sessions
Controls wait-listed for the intervention, matched for age and urban residence
Outcomes
Primary Outcome Measures
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.
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.
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).
Secondary Outcome Measures
Mental Health Difficulties: Regional Measure
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.
Mental Health Difficulties: International Measure
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).
Prosocial Behavior: International Measure
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.
Resilience: Cross-cultural Measure
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.
Biological Stress: Cortisol
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.
Biological Stress: Cell-mediated Immune Function
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.
Cognitive function
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.
Full Information
NCT ID
NCT03012451
First Posted
December 21, 2016
Last Updated
January 13, 2021
Sponsor
Yale University
Collaborators
Queen Margaret University, University of Western Ontario, Canada, Harvard University, University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT03012451
Brief Title
A Psychosocial Program Impact Evaluation in Jordan
Official Title
Measuring the Health and Wellbeing Impacts of a Scalable Program of Psychosocial Intervention for Refugee Youth
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Queen Margaret University, University of Western Ontario, Canada, Harvard University, University of Florida
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Mental Health Impairment
Keywords
Stress, Insecurity, Mental Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
817 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advancing Adolescents
Arm Type
Experimental
Arm Description
Received structured eight-week psychosocial sessions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Controls wait-listed for the intervention, matched for age and urban residence
Intervention Type
Behavioral
Intervention Name(s)
Advancing Adolescents
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psychosocial Stress: Insecurity (Regional Measure)
Description
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.
Time Frame
11 weeks
Title
Psychosocial stress: Distress (Regional Measure)
Description
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.
Time Frame
11 weeks
Title
Psychosocial Stress (International Measure)
Description
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).
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Mental Health Difficulties: Regional Measure
Description
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.
Time Frame
11 weeks
Title
Mental Health Difficulties: International Measure
Description
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).
Time Frame
11 weeks
Title
Prosocial Behavior: International Measure
Description
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.
Time Frame
11 weeks
Title
Resilience: Cross-cultural Measure
Description
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.
Time Frame
11 weeks
Title
Biological Stress: Cortisol
Description
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.
Time Frame
11 weeks
Title
Biological Stress: Cell-mediated Immune Function
Description
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.
Time Frame
11 weeks
Title
Cognitive function
Description
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.
Time Frame
11 weeks
Other Pre-specified Outcome Measures:
Title
Posttraumatic stress symptoms
Description
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).
Time Frame
11 weeks
Title
Genetic markers of trauma and/or stress
Description
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.
Time Frame
11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
catherine panter-brick, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
05611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We are sharing the anonymized dataset with project collaborators, but only with other researchers upon explicit request.
Citations:
PubMed Identifier
28967980
Citation
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.
Results Reference
derived
Links:
URL
http://www.elrha.org/map-location/yale-psychosocial-call2/
Description
Save the Children Fund Enhancing Learning and Research for Humanitarian Assistance
Learn more about this trial
A Psychosocial Program Impact Evaluation in Jordan
We'll reach out to this number within 24 hrs