McMullen 2013.
| Methods | Parallel‐group study with a wait list control group and equal randomisation (1:1) | |
| Participants | The trial was conducted in the Democratic Republic of the Congo, which is thought to have approximately 30,000 children fighting or living with armed group Inclusion criteria: male, younger than 18, either a former child soldier (abducted or recruited by an armed group) or a witness to a violent event involving a real or perceived direct threat to life. To keep the trial naturalistic, adolescents with suicidal ideation, substance abuse, or other mental health difficulties were not excluded |
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| Interventions | The intervention took place during May to July 2011 in Beni, a town in the North Kivu province. The city was affected by years of war, atrocities, and human rights violations against civilians Trauma‐focused cognitive‐behavioural therapy (TF‐CBT): 25 participants Wait list: 25 participants |
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| Outcomes | The UCLA‐PTSD‐RI was used to assess levels of post‐traumatic stress symptoms. The African Youth Psychosocial Assessment was used to measure levels of psychosocial distress | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "They were then randomly allocated, by the first author, to either TF‐CBT intervention group or wait‐list control group using a matched dyad sequence from a computer randomisation program (www.random.org) generated by the third author (off site)" |
| Allocation concealment (selection bias) | Low risk | Quote: "To prevent selection bias, the first author was not present during assessment and did not meet the participants prior to the group allocation" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No information was provided, but it's hard to believe that blinding of participants could have been respected in such a study design |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "None of the interviewers participated in the intervention to ensure blinding of treatment allocation" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 20% of patients abandoned the study prematurely Study endpoint: 1/25 missing from TF‐CBT group; 1/25 missing from WL group |
| Selective reporting (reporting bias) | Low risk | All outcomes are reported |
| Therapist qualification | Low risk | Interventon was delivered by 2 of the study authors (with PhD degree) and by 2 experienced Congolese counsellors through a local interpreter |
| Treatment fidelity | Unclear risk | Quote: "Daily training and evaluation sessions were held with these facilitators to ensure fidelity to the original intervention and to maximise cultural appropriateness" No further information provided |
| Therapist/investigator allegiance | Unclear risk | Study authors were involved in translation/cultural adaptation of the intervention; in training staff in administering pre‐intervention interviews |
| Other bias | Low risk | Quote: "No external funding was provided for this study. This project was made possible through generous support from Queens University, colleagues, family and friends" |