The influence of pretreatment respiratory sinus arrhythmia dimensions on trauma-focused cognitive behavioral therapy outcomes: Findings from a randomized controlled feasibility trial.

Child maltreatment is associated with respiratory sinus arrhythmia (RSA) dysregulation, a physiological indicator of emotion regulation that predicts elevated posttraumatic stress disorder (PTSD) symptoms and may be a mechanism of action for exposure-based therapies, such as trauma-focused cognitive behavioral therapy (TF-CBT). Animal-assisted therapy (AAT) has been proposed as an adjunct to TF-CBT for improving emotion regulation following maltreatment. The current study reports findings from a randomized controlled feasibility trial (N = 33; Mage = 11.79 years, SD = 3.08; 63.6% White; 66.7% female) that measured youths' resting RSA, RSA reactivity, and RSA recovery in response to a pretreatment laboratory challenge. We tested whether (a) lower pretreatment resting RSA was associated with blunted RSA during the challenge; (b) either of the pretreatment RSA dimensions predicted more severe pretreatment PTSD symptoms; and (c) either of the pretreatment RSA dimensions predicted less severe posttreatment PTSD symptoms and, as an exploratory aim, whether this was moderated by treatment group (i.e., TF-CBT vs. TF-CBT + AAT). Results from multiple linear regression indicated that, after controlling for pretreatment symptom severity, there was a large effect size for higher resting RSA predicting less severe caregiver-reported posttreatment PTSD symptoms, ß = -.52, p = .058, and higher RSA during recovery predicting less severe child-reported posttreatment PTSD symptoms, ß = -.70, p = .056, although these findings were not significant. These preliminary results offer important insights for future studies to investigate how the ability to regulate RSA informs which children need additional support to benefit from psychotherapeutic treatment.

A Cluster Randomized Trial to Reduce Missed Abusive Head Trauma in Pediatric Intensive Care Settings.

OBJECTIVE: To estimate the impact of the PediBIRN (Pediatric Brain Injury Research Network) 4-variable clinical decision rule (CDR) on abuse evaluations and missed abusive head trauma in pediatric intensive care settings. STUDY DESIGN: This was a cluster randomized trial. Participants included 8 pediatric intensive care units (PICUs) in US academic medical centers; PICU and child abuse physicians; and consecutive patients with acute head injures <3 years (n = 183 and n = 237, intervention vs control). PICUs were stratified by patient volumes, pair-matched, and randomized equally to intervention or control conditions. Randomization was concealed from the biostatistician. Physician-directed, cluster-level interventions included initial and booster training, access to an abusive head trauma probability calculator, and information sessions. Outcomes included "higher risk" patients evaluated thoroughly for abuse (with skeletal survey and retinal examination), potential cases of missed abusive head trauma (patients lacking either evaluation), and estimates of missed abusive head trauma (among potential cases). Group comparisons were performed using generalized linear mixed-effects models. RESULTS: Intervention physicians evaluated a greater proportion of higher risk patients thoroughly (81% vs 73%, P = .11) and had fewer potential cases of missed abusive head trauma (21% vs 32%, P = .05), although estimated cases of missed abusive head trauma did not differ (7% vs 13%, P = .22). From baseline (in previous studies) to trial, the change in higher risk patients evaluated thoroughly (67%→81% vs 78%→73%, P = .01), and potential cases of missed abusive head trauma (40%→21% vs 29%→32%, P = .003), diverged significantly. We did not identify a significant divergence in the number of estimated cases of missed abusive head trauma (15%→7% vs 11%→13%, P = .22). CONCLUSIONS: PediBIRN-4 CDR application facilitated changes in abuse evaluations that reduced potential cases of missed abusive head trauma in PICU settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03162354.

Integrating Animal-Assisted Therapy Into TF-CBT for Abused Youth With PTSD: A Randomized Controlled Feasibility Trial.

This clinical trial examined animal-assisted therapy (AAT) as an adjunct to Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for abused youth with posttraumatic stress disorder (PTSD). Youth between the ages of 6 and 17 (M = 11.79, SD = 3.08) were randomized to receive standard TF-CBT or TF-CBT with adjunctive AAT (TF-CBT+AAT) employing retired service dogs. Feasibility metrics evaluating the addition of AAT were collected in addition to common clinical outcomes evaluated in TF-CBT trials. The inclusion of AAT increased the number of potential participants who declined participation and there were no noted benefits for treatment retention or satisfaction with services. Analyses showed that the inclusion of AAT did not enhance improvement of PTSD symptom severity (ß = .90, t = .94, p = .351) or a number of other outcomes. On the contrary, there were indications from analyses and clinician feedback that AAT may have attenuated improvement in many cases. This study identified a number of important feasibility considerations in the design of studies testing AAT. However, the results examining clinical outcomes suggest that the inclusion of AAT with TF-CBT in the treatment of maltreated youth with PTSD is not warranted at this time.

Respiratory Sinus Arrhythmia Change during Trauma-Focused Cognitive-Behavioral Therapy: Results from a Randomized Controlled Feasibility Trial.

Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) is a well-established treatment for pediatric posttraumatic stress disorder (PTSD). Animal-assisted therapy (AAT) has been proposed as an adjunct to TF-CBT that may improve treatment effects through enhanced targeting of affect regulation, as indexed by specific changes in the respiratory sinus arrhythmia (RSA). The current study reports results from a randomized controlled feasibility trial (N = 33; Mage = 11.79 [SD = 3.08]; 64% White; 67% female) that measured RSA during Sessions 1, 4, 8, and 12 of a twelve-session TF-CBT protocol and tested whether: 1) TF-CBT + AAT achieved higher average RSA amplitudes relative to TF-CBT alone, and 2) RSA regulation, defined as less variability around person-specific RSA slopes during treatment, explained variation in post-treatment PTSD symptoms. Multilevel modeling failed to support an effect for TF-CBT + AAT on RSA amplitudes (δ001 = 0.08, p = 0.844). However, regardless of treatment condition, greater RSA withdrawal was observed within Sessions 4 (γ11 = -.01, p < .001) and 12 (γ13 = -.01, p = .015) relative to the Session 1 baseline. The average level of RSA amplitude in Session 8 was also significantly lower compared to Session 1 (γ02 = -0.70, p = .046). Intraindividual regression models demonstrated that greater RSA regulation predicted improved PTSD symptoms at post-treatment after adjusting for pre-treatment levels (b3 = 20.00, p = .012). These preliminary results offer support for future confirmatory trials testing whether affect regulation, as indexed by changes in RSA, is a mechanism of action for TF-CBT in the treatment of pediatric PTSD.

A Randomized Controlled Trial of Strategies to Improve Family Members' Preparedness for Surrogate Decision-Making.

OBJECTIVE: To evaluate 2 strategies for preparing family members for surrogate decision-making. DESIGN: A 2 × 2 factorial, randomized controlled trial testing whether: (1) comprehensive online advance care planning (ACP) is superior to basic ACP, and (2) having patients engage in ACP together with family members is superior to ACP done by patients alone. SETTING: Tertiary care centers in Hershey, Pennsylvania, and Boston, Massachusetts. PARTICIPANTS: Dyads of patients with advanced, severe illness (mean age 64; 46% female; 72% white) and family members who would be their surrogate decision-makers (mean age 56; 75% female; 75% white). INTERVENTIONS: Basic ACP: state-approved online advance directive plus brochure. Making Your Wishes Known (MYWK): Comprehensive ACP decision aid including education and values clarification. MEASUREMENTS: Pre-post changes in family member self-efficacy (100-point scale) and postintervention concordance between patients and family members using clinical vignettes. RESULTS: A total 285 dyads enrolled; 267 patients and 267 family members completed measures. Baseline self-efficacy in both MYWK and basic ACP groups was high (90.2 and 90.1, respectively), and increased postintervention to 92.1 for MYWK ( P = .13) and 93.3 for basic ACP ( P = .004), with no between-group difference. Baseline self-efficacy in alone and together groups was also high (90.2 and 90.1, respectively), and increased to 92.6 for alone ( P = .03) and 92.8 for together ( P = .03), with no between-group difference. Overall adjusted concordance was higher in MYWK compared to basic ACP (85.2% vs 79.7%; P = .032), with no between-group difference. CONCLUSION: The disconnect between confidence and performance raises questions about how to prepare family members to be surrogate decision-makers.