Incidence and relative risk of negative outcomes of psychological interventions for pediatric posttraumatic stress disorder: a systematic review and meta-analysis of randomized controlled trials.
Abstract
Background
Negative outcomes of psychological treatments for pediatric posttraumatic stress disorder (PTSD) have been underresearched. Although reporting has increased over the years, a comprehensive systematic review and meta-analysis is lacking.
Methods
We conducted a preregistered systematic review and meta-analysis (PROSPERO ID: CRD42020206290) and followed PRISMA guidelines. MEDLINE, PsycInfo, Web of Science, and PTSDpubs were systematically searched from inception to May 13, 2025. Eligible studies were randomized controlled trials (RCTs) of psychotherapies for pediatric PTSD with ≥10 participants per arm. Two independent coders extracted data and assessed risk of bias.
Results
Seventy-two RCTs (N = 5,677) met inclusion criteria. Of these, 69, 6, and 19 reported the incidence of all-cause dropout, deterioration of PTSD, and adverse events, respectively. Most trials (74%) investigated trauma-focused cognitive behavioral therapy (TF-CBT). Random effects meta-analysis showed that 7.87% of patients (95% CI, 4.07-12.55; I2 = 82%) dropped out, with no significant difference relative to passive controls (RR = 1.04, 95% CI, 0.64-1.69; I2 = 53%). Less than 0.01% (95% CI, 0.00-2.39; I2 = 0%) of patients reported deterioration after TF-CBT, compared to 1.26% (95% CI, 0.00-8.13; I2 = 40%) of passive controls. Limited data prohibited isolated review of other treatments. The incidence of adverse events during psychological treatments was also uncommon (0.29%, 95% CI, 0.00-2.67; I2 = 34%) and similar to passive controls (1.14%, 95% CI, 0.00-8.02; I2 = 84%).
Conclusions
Psychological treatments for pediatric PTSD-with most accumulated evidence for TF-CBT-appear safe and acceptable for the vast majority of children and adolescents with PTSD, which is encouraging for clinical practice. Reporting on deterioration and adverse events was scarce, limiting statistical power. Negative outcomes should be routinely assessed in clinical practice and future research, using validated measures and clearly defined constructs. Future work should distinguish serious adverse events and adverse events.