Safety and Efficacy of Exposure-Based Risk Reduction Through Family Therapy for Co-occurring Substance Use Problems and Posttraumatic Stress Disorder Symptoms Among Adolescents: A Randomized Clinical Trial.

Importance: No empirically supported treatments have been evaluated to address co-occurring substance use problems (SUP) and posttraumatic stress disorder (PTSD) symptoms among adolescents in an integrative fashion. This lack is partially owing to untested clinical lore suggesting that delivery of exposure-based PTSD treatments to youth with SUP might be iatrogenic. Objective: To determine whether an exposure-based, integrative intervention for adolescents with SUP and PTSD symptoms-risk reduction through family therapy (RRFT)-resulted in improved outcomes relative to a treatment-as-usual (TAU) control condition consisting primarily of trauma-focused cognitive behavioral therapy. Design, Setting, and Participants: This randomized clinical trial enrolled 124 participants who were recruited from November 1, 2012, through January 30, 2017. Adolescents (aged 13-18 years) who engaged in nontobacco substance use at least once during the past 90 days, experienced at least 1 interpersonal traumatic event, and reported 5 or more PTSD symptoms were enrolled. Blinded assessments were collected at baseline and at 3, 6, 12, and 18 months after baseline. Recruitment and treatment took place in community-based child advocacy centers in the Southeastern United States. Data were analyzed from August 2 through October 4, 2018, and were based on intention to treat. Interventions: Participants were randomized to receive RRFT (n = 61) or TAU (n = 63). Main Outcomes and Measures: Primary outcomes focused on number of nontobacco substance-using days measured with the timeline follow-back method and PTSD symptom severity using the UCLA (University of California, Los Angeles) PTSD Reaction Index for DSM-IV completed by adolescents and caregivers. Secondary outcomes focused on marijuana, alcohol, and polysubstance use and PTSD criterion standard (re-experiencing, avoidance, and hyperarousal) symptom severity. Results: In all, 124 adolescents (mean [SD] age, 15.4 [1.3] years; 108 female [87.1%]) were randomized. For primary outcomes relative to TAU, RRFT yielded significantly greater reductions in substance-using days from baseline to month 12 (event rate [ER], 0.28; 95% CI, 0.12-0.65) and month 18 (ER, 0.10; 95% CI, 0.04-0.24). Significant reductions in PTSD symptoms were observed within groups for RRFT from baseline to months 3 (β = -9.25; 95% CI, -12.95 to -5.55), 6 (β = -16.63; 95% CI = -20.40 to -12.87), 12 (β = -17.51; 95% CI, -21.62 to -13.40), and 18 (β = -19.02; 95% CI, -23.07 to -14.96) and for TAU from baseline to months 3 (β = -9.62; 95% CI, -13.16 to -6.08), 6 (β = -13.73; 95% CI, -17.43 to -10.03), 12 (β = -15.53; 95% CI, -19.52 to -11.55), and 18 (β = -13.88; 95% CI, -17.69 to -10.09); however, between-group differences were not observed. Conclusions and Relevance: In this study, RRFT and TAU demonstrated within-group improvements in SUP and PTSD symptoms, with greater improvement for substance use and PTSD avoidance and hyperarousal symptoms among adolescents randomized to RRFT compared with TAU. No evidence of the worsening of SUP was observed in either condition. These results suggest that this exposure-based treatment is safe, feasibly delivered by community-based clinicians, and offers an effective approach to inform clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT01751035.