O' Callaghan 2013.
| Methods | Single‐centred, equal randomisation, single‐blind (outcome assessors), parallel‐group (active and wait list control) study | |
| Participants | The study was conducted in the Democratic Republic of the Congo, which was affected by the highest rate of gender‐based violence in the world. The consequences of war and sexual violence for girls include physical injury, sexually transmitted infection and pregnancy, psychological distress, stigmatisation, rejection by family, and poverty Fifty‐two war‐affected girls who had witnessed or had personal experience of rape or sexual abuse (described in the questionnaire as inappropriate sexual touch) Age range: 12‐17 years |
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| Interventions | Trauma‐focused cognitive‐behavioural therapy (TF‐CBT): 24 participants Wait list (WL): 28 participants |
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| Outcomes | The UCLA‐PTSD‐RI was used to assess the severity of post‐traumatic stress symptoms. AYPA (African Youth Psychosocial Assessment Instrument) was used to assess the psychosocial functioning | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomly assigned using a computer‐generated random sequence of numbers" |
| Allocation concealment (selection bias) | Low risk | Quote: "Selection bias was reduced by ensuring that treatment allocation was concealed from those responsible for participant enrolment and by ensuring that the person responsible for assigned participants had met none of the participants before the group allocation" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were aware of their treatment allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The interviewers (outcome assessors) were blinded to the intervention allocation" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Study endpoint: 4/24 missing from TF‐CBT group; 2/28 missing from WL control group |
| Selective reporting (reporting bias) | Low risk | All outcomes are reported |
| Therapist qualification | Unclear risk | Intervention was delivered by non‐clinical facilitators |
| Treatment fidelity | Low risk | Quote: "The lead researcher (...) monitored each session to ensure treatment integrity and to check that examples, activities, and teaching points discussed at the preintervention meeting were addressed" |
| Therapist/investigator allegiance | Unclear risk | No information provided |
| Other bias | Low risk | The study appears to be free of other sources of bias |