Scheeringa 2014.
Methods | Design: Randomised, placebo controlled, double‐blind study Study duration: 12 weeks (4 weeks CBT only) Follow‐up: 3 months Country: USA |
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Participants | Sample size: 57 children and adolescents were randomised Recruitment: Investigators attempted to contact a total of 644 potential participants: 30% were referred by other professionals, 14% referred themselves from radio and television advertisements, and 56% were contacted from the local level I trauma centre registry Inclusion criteria ‐ diagnostic classification criteria: 5 or more PTSD symptoms plus functional impairment, specific diagnostic criteria not reported Inclusion criteria ‐ rating scales: National Institute of Mental Health Diagnostic Interview Schedule for Children‐IN (DISC‐IV) Included disorders: PTSD Co‐morbidities: Not reported Gender: DCS group 66% female; placebo group 46% female Mean age: DCS group mean age 12.4 (SD 3.3); placebo group mean age 12.6 (SD 3.4) Ethnicity: DCS group 41% Black, 41% White, 14% mixed, 3% other; placebo group 43% Black, 39% White, 14% mixed, 4% other Pharmacotherapy during the study: Naturalistic prescribing allowed. Subjects must have been stable on medication for at least 4 weeks prior to treatment |
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Interventions |
Therapists: Therapy was delivered by 2 masters‐level therapists trained in CBT and supervised by the authors |
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Outcomes | Response; withdrawals; anxiety: CPSS; co‐morbid depression: CDI; co‐morbid anxiety: SCARED | |
Notes | Funding from industry: No. Financial support for this study was provided by National Institute of Mental Health grant 5RC1MH088969‐02 and a 2009 National Alliance for Research on Schizophrenia and Depression (NARSAD) Independent Investigator Award (principal investigator: M.S.S.) Medication supplied by industry: Not reported Any author work for industry: Unclear, "No competing financial interests exist." Study ID: NCT01157416 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "For each age group, we created a list of randomised numbers using the Microsoft Excel 2007 random number generator. Block randomisation in sets of four was used. Within the first set of four numbers, two were randomly assigned to CBT and DCS and two to CBT and placebo." |
Allocation concealment (selection bias) | Unclear risk | Details on allocation concealment were not provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "All research personnel were blinded except the pharmacist, who had no contact with subjects." "The study was triple‐blind as the Board, the participants, and the investigators were blind to allocation status." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "All research personnel were blinded except the pharmacist, who had no contact with subjects." It is not specifically stated that outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | A total of 72% of DCS group completed treatment and follow‐up; 64% of placebo group completed treatment and follow‐up. Reasons were not reported |
Selective reporting (reporting bias) | Low risk | All outcomes stated in the protocol were reported |
Other bias | Low risk | The study appears to be free of other sources of bias |