A Psychosocial Program Impact Evaluation in Jordan
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|ClinicalTrials.gov Identifier: NCT03012451|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : January 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stress, Psychological Mental Health Impairment||Behavioral: Advancing Adolescents||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||817 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measuring the Health and Wellbeing Impacts of a Scalable Program of Psychosocial Intervention for Refugee Youth|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||April 2021|
Experimental: Advancing Adolescents
Received structured eight-week psychosocial sessions
Behavioral: Advancing Adolescents
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
- 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.
- 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.
- 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).
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012451
|United States, Connecticut|
|New Haven, Connecticut, United States, 05611|
|Principal Investigator:||catherine panter-brick, PhD||Yale University|