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A Psychosocial Program Impact Evaluation in Jordan

13 januari 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

817

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 05611
        • Yale University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Advancing Adolescents
Received structured eight-week psychosocial sessions
Gedragsmatig: 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.
Geen tussenkomst: Control
Controls wait-listed for the intervention, matched for age and urban residence

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Psychosocial Stress: Insecurity (Regional Measure)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mental Health Difficulties: Regional Measure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Posttraumatic stress symptoms
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Yale University

Medewerkers

University of Florida
University of Western Ontario, Canada
Harvard University
Queen Margaret University

Onderzoekers

  • Hoofdonderzoeker: catherine panter-brick, PhD, Yale University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2015

Primaire voltooiing (Werkelijk)

1 september 2016

Studie voltooiing (Werkelijk)

1 april 2017

Studieregistratiedata

Eerst ingediend

21 december 2016

Eerst ingediend dat voldeed aan de QC-criteria

4 januari 2017

Eerst geplaatst (Schatting)

6 januari 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 januari 2021

Laatste update ingediend die voldeed aan QC-criteria

13 januari 2021

Laatst geverifieerd

1 januari 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1502015359

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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