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. 2024 May 21;2024(5):CD014300. doi: 10.1002/14651858.CD014300.pub2

O'Callaghan 2014.

Study characteristics
Methods Study design: RCT
Study grouping: parallel group
Study duration: 12 weeks
Participants Inclusion criteria: children aged 7–18 years and their caregivers living in a war‐affected community facing current risks of attack/abduction by armed groups
Exclusion criteria: not reported
Age range: 7–18 years
Gender: 55% boys, 45% girls
Intervention sample: 79
Control sample: 80
Main type of traumatic event: bereavement
Phase of humanitarian crisis: during the acute crisis (mortality was still higher than it was before the crisis)
Type of humanitarian crisis: war/armed conflict
Interventions Intervention name: no specific name. The intervention is generically described as a "psychosocial intervention."
Delivered by: para‐professional
Format of therapy: face to face
Number of sessions (total): 8
Type of control: waiting list
Type of intervention context: intervention took place in Li‐May and Kiliwa, 2 small villages in Dungu territory, in Haut Uele Province, with an estimated combined population of < 1000 inhabitants.
Type of promotion intervention: group level
Description of the intervention: the author‐compiled intervention manual was based on 3 components: 13 'Chuo Cha Maisha', a youth life skills leadership programme developed and piloted in Tanzania; 2. Mobile Cinema clips: narrative, fictional films, produced and created in Dungu in the local language to address stigma and discrimination and model how young people, parents and the village community could welcome formerly abducted children back into their communities; and 3. relaxation technique scripts used in trauma‐focused CBT and used in 3 studies with young people in the Democratic Republic of the Congo.
Outcomes Prosocial behaviour
  • Outcome type: continuous outcome

  • Reporting: fully reported

  • Scale: AYPA‐Prosocial

  • Direction: lower is better

  • Data value: endpoint


Acceptability (dropout from trial)
  • Outcome type: dichotomous

  • Reporting: fully reported

  • Data value: endpoint

Notes Sponsorship source: funded by a donor who wished to remain anonymous.
Country: Democratic Republic of Congo
Setting: rural communities in the Haut‐Uele Province of northern Democratic Republic of Congo
Author's name: Paul O'Callaghan
Institution: School of Psychology, Queen's University
Email: pocallaghan02@qub.ac.uk
Address: Belfast, Northern Ireland, UK
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "each member (…) was randomly assigned to either the treatment or the control group using a computer generated random sequence (www.random.org). This sequence was supplied by one of the authors off site. The lead author then allocated participants using the randomized sequence."
Allocation concealment (selection bias) Low risk Quote: "Selection bias was reduced by ensuring treatment allocation was concealed from those responsible for participant enrolment and by ensuring the person responsible for assigning participants met none of the participants prior to the group allocation."
Blinding of participants and personnel (performance bias)
All outcomes High risk Judgement comment: blinding procedures were not reported. It is likely that participants were not blinded to intervention allocation because the trial was open label.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "data were collected by the same blinded outcome assessors (…). Blinding involved with holding the randomization sequence from the assessors, having no overlap between the assessors and the intervention facilitation team, having no contact between assessors and participants during the intervention and requesting that the assessors do not ask participants which group they were in during the post‐intervention and follow‐up assessment."
Incomplete outcome data (attrition bias)
All outcomes Low risk Low attrition rate according to figure 1 of the publication. Dropouts were reported together with reasons (3/79 dropouts in the intervention group and 3/80 dropouts in the wait‐list group).
Selective reporting (reporting bias) High risk Data for the control group were missing at follow‐up. No protocol available but trial registered at ClinicalTrials.gov (NCT01542398).
Therapist qualification Unclear risk Quote: "Three male and three female local lay facilitators living in Dungu and working for SAIPED, a Dungu‐based humanitarian NGO, delivered the intervention in the church in Kiliwa in the morning and in the church in Li‐May in the afternoon every second day."
Therapist/investigator allegiance Unclear risk No information provided.
Intervention fidelity Low risk Quote: "To enhance intervention fidelity, facilitators were given a copy of the manualised intervention in French and met for three hours with the lead researcher the day before delivering each module in order to review the previous module taught, prepare for the subsequent module and discuss any suggested cultural changes to the module (e.g., using culturally familiar songs and games as warm‐up activities etc.)."
Other bias Low risk No other sources of bias detected.