Feasibility, Acceptability, and Potential Efficacy of a Self-Guided Internet-Delivered Dialectical Behavior Therapy Intervention for Substance Use Disorders: Randomized Controlled Trial.

BACKGROUND: People with alcohol and substance use disorders (SUDs) often have underlying difficulties in regulating emotions. Although dialectical behavioral therapy is effective for SUDs, it is often difficult to access. Self-guided, internet-delivered dialectical behavioral therapy (iDBT) allows for expanded availability, but few studies have rigorously evaluated it in individuals with SUDs. OBJECTIVE: This study examines the feasibility, acceptability, and potential efficacy of an iDBT intervention in treatment-seeking adults with SUDs. We hypothesized that iDBT would be feasible, credible, acceptable, and engaging to people with SUDs. We also hypothesized that the immediate versus delayed iDBT group would show comparatively greater improvements and that both groups would show significant improvements over time. METHODS: A 12-week, single-blinded, parallel-arm, randomized controlled trial was implemented, with assessments at baseline and at 4 (acute), 8, and 12 weeks (follow-up). A total of 72 community adults aged 18 to 64 years were randomized. The immediate group (n=38) received access to iDBT at baseline, and the delayed group (n=34) received access after 4 weeks. The intervention (Pocket Skills 2.0) was a self-guided iDBT via a website, with immediate access to all content, additional text and email reminders, and additional support meetings as requested. Our primary outcome was substance dependence, with secondary outcomes pertaining to feasibility, clinical outcomes, functional disability, and emotion dysregulation, among other measures. All outcomes were assessed using self-report questionnaires. RESULTS: iDBT was perceived as a credible and acceptable treatment. In terms of feasibility, 94% (68/72) of the participants started iDBT, 13% (9/68) were early dropouts, 35% (24/68) used it for the recommended 8 days in the first month, and 50% (34/68) were still active 4 weeks later. On average, the participants used iDBT for 2 hours and 24 minutes across 10 separate days. In the acute period, no greater benefit was found for the immediate group on substance dependence, although we did find lower depression (b=-2.46; P=.02) and anxiety (b=-2.22; P=.02). At follow-up, there were greater benefits in terms of reduced alcohol (b=-2.00; P=.02) and nonalcoholic substance (b=-3.74; P=.01) consumption in the immediate access group. Both groups demonstrated improvements in substance dependence in the acute (b=-1.73; P<.001) and follow-up period (b=-2.09; P<.001). At follow-up, both groups reported reduced depression, anxiety, suicidal behaviors, emotional dysregulation, and functional disability. CONCLUSIONS: iDBT is a feasible and acceptable intervention for patients with SUDs, although methods for improving engagement are warranted. Although results did not support efficacy for the primary outcome at 4 weeks, findings support reductions in substance dependence and other mental health concerns at 12 weeks. Notwithstanding the limitations of this study, the results suggest the potential value of iDBT in the treatment of SUDs and other mental health conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05094440; https://clinicaltrials.gov/show/NCT05094440.

Systematic review: emotion dysregulation and challenging behavior interventions for children and adolescents on the autism spectrum with graded key evidence-based strategy recommendations.

Challenging behavior, such as aggression, is highly prevalent in children and adolescents on the autism spectrum and can have a devastating impact. Previous reviews of challenging behavior interventions did not include interventions targeting emotion dysregulation, a common cause of challenging behavior. We reviewed emotion dysregulation and challenging behavior interventions for preschoolers to adolescents to determine which evidence-based strategies have the most empirical support for reducing/preventing emotion dysregulation/challenging behavior. We reviewed 95 studies, including 29 group and 66 single case designs. We excluded non-behavioral/psychosocial interventions and those targeting internalizing symptoms only. We applied a coding system to identify discrete strategies based on autism practice guidelines with the addition of strategies common in childhood mental health disorders, and an evidence grading system. Strategies with the highest quality evidence (multiple randomized controlled trials with low bias risk) were Parent-Implemented Intervention, Emotion Regulation Training, Reinforcement, Visual Supports, Cognitive Behavioral/Instructional Strategies and Antecedent-Based Interventions. Regarding outcomes, most studies included challenging behavior measures, while few included emotion dysregulation measures. This review highlights the importance of teaching emotion regulation skills explicitly, positively reinforcing replacement/alternative behaviors, using visuals and metacognition, addressing stressors proactively, and involving parents. It also calls for more rigorously designed studies and for including emotion dysregulation as an outcome/mediator in future trials.

A Digital Mental Health App Incorporating Wearable Biosensing for Teachers of Children on the Autism Spectrum to Support Emotion Regulation: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: As much as 80% of children on the autism spectrum exhibit challenging behaviors (ie, behaviors dangerous to the self or others, behaviors that interfere with learning and development, and behaviors that interfere with socialization) that can have a devastating impact on personal and family well-being, contribute to teacher burnout, and even require hospitalization. Evidence-based practices to reduce these behaviors emphasize identifying triggers (events or antecedents that lead to challenging behaviors); however, parents and teachers often report that challenging behaviors surface with little warning. Exciting recent advances in biometric sensing and mobile computing technology allow the measurement of momentary emotion dysregulation using physiological indexes. OBJECTIVE: We present the framework and protocol for a pilot trial that will test a mobile digital mental health app, the KeepCalm app. School-based approaches to managing challenging behaviors in children on the autism spectrum are limited by 3 key factors: children on the autism spectrum often have difficulties in communicating their emotions; it is challenging to implement evidence-based, personalized strategies for individual children in group settings; and it is difficult for teachers to track which strategies are successful for each child. KeepCalm aims to address those barriers by communicating children's stress to their teachers using physiological signaling (emotion dysregulation detection), supporting the implementation of emotion regulation strategies via smartphone pop-up notifications of top strategies for each child according to their behavior (emotion regulation strategy implementation), and easing the task of tracking outcomes by providing the child's educational team with a tool to track the most effective emotion regulation strategies for that child based on physiological stress reduction data (emotion regulation strategy evaluation). METHODS: We will test KeepCalm with 20 educational teams of students on the autism spectrum with challenging behaviors (no exclusion based on IQ or speaking ability) in a pilot randomized waitlist-controlled field trial over a 3-month period. We will examine the usability, acceptability, feasibility, and appropriateness of KeepCalm as primary outcomes. Secondary preliminary efficacy outcomes include clinical decision support success, false positives or false negatives of stress alerts, and the reduction of challenging behaviors and emotion dysregulation. We will also examine technical outcomes, including the number of artifacts and the proportion of time children are engaged in high physical movement based on accelerometry data; test the feasibility of our recruitment strategies; and test the response rate and sensitivity to change of our measures, in preparation for a future fully powered large-scale randomized controlled trial. RESULTS: The pilot trial will begin by September 2023. CONCLUSIONS: Results will provide key data about important aspects of implementing KeepCalm in preschools and elementary schools and will provide preliminary data about its efficacy to reduce challenging behaviors and support emotion regulation in children on the autism spectrum. TRIAL REGISTRATION: ClinicalTrials.gov NCT05277194; https://www.clinicaltrials.gov/ct2/show/NCT05277194. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45852.

Systematic Review: Emotion Dysregulation and Challenging Behavior Interventions for Children andAdolescents with Autism with Graded Key Evidence-Based Strategy Recommendations.

Challenging behavior, such as aggression, is highly prevalent in children and adolescents with autism and can have a devastating impact. Previous reviews of challenging behavior interventions did not include interventions targeting emotion dysregulation, a common cause of challenging behavior. We reviewed emotion dysregulation and challenging behavior interventions for preschoolers to adolescents to determine which evidence-based strategies have the most empirical support for reducing/preventing emotion dysregulation/challenging behavior. We reviewed 95 studies, including 29 group and 66 single-case designs. We excluded non-behavioral/psychosocial interventions and those targeting internalizing symptoms only. We applied a coding system to identify discrete strategies based on autism practice guidelines with the addition of strategies common in childhood mental health disorders, and an evidence grading system. Strategies with the highest quality evidence (multiple randomized controlled trials with low bias risk) were Parent-Implemented Intervention, Emotion Regulation Training, Reinforcement, Visual Supports, Cognitive Behavioral/Instructional Strategies and Antecedent-Based Interventions. Regarding outcomes, most studies included challenging behaviors measures while few included emotion dysregulation measures. This review highlights the importance of teaching emotion-regulation skills explicitly, positively reinforcing replacement/alternative behaviors, using visuals and metacognition, addressing stressors proactively, and involving parents. It also calls for more rigorously-designed studies and for including emotion dysregulation as an outcome/mediator in future trials.

Economic evaluation of an online single-session intervention for depression in Kenyan adolescents.

Objective: To evaluate the costs and cost-effectiveness of Shamiri-Digital, an online single-session intervention (SSI) for depression among Kenyan adolescents. Method: Data were drawn from a randomized clinical trial with n = 103 Kenyan high school students (64% female, Mage = 15.5). All students were eligible to participate, regardless of baseline depression symptomatology. We estimated delivery costs in 2020 U.S. dollars from multiple perspectives. To account for uncertainty, we performed sensitivity analyses with different cost assumptions and definitions of effectiveness. Using number needed to treat (NNT) estimates, we also evaluated the cost required to achieve a clinically meaningful reduction in depressive symptoms. Results: In the base-case (the most realistic cost estimate), it costs U.S. $3.57 per student to deliver Shamiri-Digital. Depending on the definition of clinically meaningful improvement, 7.1-9.7 students needed to receive the intervention for one student to experience a clinically meaningful improvement, which translated to a cost of U.S. $25.35 to U.S. $34.62 per student. Under a worst-case scenario (i.e., assuming the highest treatment cost and the strictest effectiveness definition), the cost to achieve clinically meaningful improvement was U.S. $92.05 per student. Conclusions: Shamiri-Digital is a low-cost intervention for reducing depression symptomatology. The public health benefit of empirically supported SSIs is especially important in low-income countries, where funding for mental health care is most limited. Future research can compare the cost-effectiveness of online SSIs to higher-cost treatments and estimate the robustness of Shamiri-Digital's effects over a longer time horizon. (PsycInfo Database Record (c) 2021 APA, all rights reserved).