Methods: A total of 53 young children (ages 3-7 years; M=5.04, SD=1.49) and their parent/guardian (ages 22-57 years; M=32.81, SD=8.42) were randomized (2:1) to SC-TF-CBT or TF-CBT. There were four assessment periods, all conducted by the blinded evaluator: screening/baseline, after Step One, post-treatment, and 3-month follow-up. Caregivers were provided compensation for their participation in the assessments ($25 for baseline, $50 for each remaining assessment). Standardized measures of posttraumatic stress symptoms (PTSS), severity, internalizing and externalizing behaviors, parent treatment credibility and satisfaction were collected. Therapist and patient time as well as cost characteristics were also collected. We conducted two analyses, “difference tests” (linear mixed-effects model for continuous outcomes or generalized linear mixed-effects model for non-continuous outcomes) and non-inferiority tests. Included in the model were treatment status, time, and treatment by time interaction. The presence of a non-significant interaction would suggest that the outcomes of the two conditions changed at comparable rates. Since the intent-to-treat (ITT) analysis and completers results were comparable, we reported the ITT results.
Results: Of those who participated in Step One, the response rate was 71% (22/31; ITT 22/35, 63%) and these treatment gains were maintained at the 3-month follow-up. There were comparable improvements over time in PTSS and secondary outcomes in both conditions. SC-TF-CBT was not inferior to TF-CBT on the primary outcome of PTSS, and the secondary outcome of severity and internalizing symptoms, but non-inferiority for externalizing symptoms was not supported. There were no statistical differences in comparisons of changes over time from pre- to post-treatment and pre- to 3 month follow-up for PTSD diagnostic status, treatment response or remission. Parent satisfaction was high for both conditions. Costs were 51.3% lower for children in SC-TF-CBT compared to TF-CBT.
Conclusions and Implications: Although future research is needed, preliminary evidence suggests that SC-TF-CBT is comparable to TF-CBT, and delivery costs are significantly less than standard care. SC-TF-CBT may be a viable service delivery system to address treatment barriers.