Afifi 2010.
Study characteristics | ||
Methods | Study design: cluster‐RCT Study grouping: parallel group Cluster size: 60 children (mean) Study duration: 26 weeks |
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Participants | Inclusion criteria: 6 UNRWA (United Nations Refugee and Works Agency) schools in the camp having 5th and 6th grade (academic year 2008–2009); all students attending grades 5 and 6 (aged 11–14 years) Exclusion criteria: not reported Age range: 11–14 years Gender: boys and girls (unspecified percentage) Intervention sample: 299 Control sample: 247 Main type of traumatic event: displacement Phase of humanitarian crisis: during the acute crisis (mortality is still higher than it was before the crisis) Type of humanitarian crisis: war/armed conflict |
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Interventions | Intervention name: Qaderoon intervention Delivered by: para‐professionals: 6 facilitators and 23 youth mentors (and 1 master trainer for pilot session) Format of therapy: face to face Number of sessions (total): 45 sessions with children (35 manualised and 10 developed across intervention); plus 15 sessions with parents and 6 workshops with teachers Type of control: WLC Type of intervention context: primary school in a refugee camp Type of promotion intervention: group level Description of the intervention: Qaderoon (We are Capable) intervention: a year‐long social skill building intervention for children (aged 11–14 years), and their parents and teachers. It is based on stress inoculation training, improving social awareness and social problem‐solving, and positive youth development program. Main themes throughout sessions: communication, self‐esteem, self‐responsibility, social problem‐solving, social action project and, for extra sessions, creativity, stereotypes, peer pressure, smoking, self‐expression, proper nutrition/fitness/hygiene, controlling use of sharp weapons/violence, art therapy |
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Outcomes | Results are adjusted according to intraclass correlation coefficient of 0.02, as reported in the study publication. Mental well‐being
Acceptability (dropout from trial)
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Notes | Sponsorship source: Wellcome Trust (081915/Z/07/Z) Country: Lebanon Setting: Burj El Barajneh Palestinian refugee camp in Beirut, Lebanon Author's name: Rema A Afifi Institution: Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut Email: ra15@aub.edu.lb Address: Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, Box 11‐0236, Riad El Solh, Beirut 1107 2020, Lebanon |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The six elementary schools in the camp were randomly assigned by computer‐generated sequence, three to the intervention group and three to the control group." No further information reported on the method of random sequence generation, but the balance of participant level characteristics suggests that the randomisation procedures were successful. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | < 10% of participants in both groups lost to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | It was not possible to check this item as the information came from an abstract. No trial protocol/registration number available. |
Therapist qualification | Unclear risk | No information provided. |
Therapist/investigator allegiance | Unclear risk | No information provided. |
Intervention fidelity | Low risk | Quote: "high degree of fidelity." |
Other bias | Low risk | This was a Wellcome Trust funded investigation. Cluster‐RCT risk of bias extension 1. Recruitment bias; the recruited population belonged to the same catchment area (low risk of bias) 2. Baseline imbalance; no information provided (unclear risk of bias) 3. Loss of clusters; no information provided (unclear risk of bias) 4. Incorrect analysis; quote: "Changes in mental health scores were assessed with a modified t test that accounted for effects of clustering" (low risk of bias). |