scholarly journals Preventing opioid use among justice-involved youth as they transition to adulthood: leveraging safe adults (LeSA)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Danica Kalling Knight ◽  
Yang Yang ◽  
Elizabeth D. Joseph ◽  
Elaine Tinius ◽  
Shatoya Young ◽  
...  

Abstract Background Juvenile justice (JJ) youth are at high risk of opioid and other substance use (SU), dysfunctional family/social relationships, and complex trauma. The purpose of the Leveraging Safe Adults (LeSA) Project is to examine the effectiveness of Trust-Based Relational Intervention® (TBRI®; leveraging family systems by providing emotional and instrumental guidance, support, and role modeling) in preventing opioid and other SU among youth after release from secure residential facilities. Methods An effectiveness-implementation Hybrid Type 1 design is used to test the effectiveness of TBRI for preventing non-medical use of opioids among JJ-youth (delayed-start at the site level; a randomized controlled trial at participant level) and to gain insight into facility-level barriers to TBRI implementation as part of JJ re-entry protocols. Recruitment includes two samples (effectiveness: 360 youth/caregiver dyads; implementation: 203 JJ staff) from nine sites in two states over 3 years. Participant eligibility includes 15 to 18-year-olds disposed to community supervision and receiving care in a secure JJ facility, without active suicide risk, and with one caregiver willing to participate. Effectiveness data come from (1) youth and caregiver self-report on background, SU, psychosocial functioning, and youth-caregiver relationships (Months 0, 3, 6, 12, and 18), youth monthly post-release check-ins, and caregiver report on youth psychological/behavioral symptoms, and (2) JJ facility records (e.g., recidivism, treatment utilization). Fidelity assessment includes post-session checklists and measures of TBRI strategy use. Collected four times over four years, implementation data include (1) JJ staff self-report on facility and staff characteristics, use of trauma-informed care and TBRI strategies, and (2) focus groups (line staff, leadership separately) on use of trauma-informed strategies, uptake of new interventions, and penetration, sustainment, and expansion of TBRI practices. Discussion The LeSA study is testing TBRI as a means to empower caregivers to help prevent opioid use and other SU among JJ-youth. TBRI’s multiple components offer an opportunity for caregivers to supplement and extend gains during residential care. If effective and implemented successfully, the LeSA protocol will help expand the application of TBRI with a wider audience and provide guidance for implementing multi-component interventions in complex systems spanning multiple contexts. Trial registration ClinicalTrials.govNCT04678960; registered November 11, 2020; https://clinicaltrials.gov/ct2/show/NCT04678960.

Author(s):  
Adam Marcus ◽  
Amerigo Rossi ◽  
Andrew Cornwell ◽  
Steven A. Hawkins ◽  
Nazareth Khodiguian

Abstract Background Previous studies have shown that sodium bicarbonate ingestion may enhance intense exercise performance, but may also cause severe gastrointestinal distress. The purpose of this study was to determine whether a modified sodium bicarbonate (SB) ingestion protocol would elevate serum bicarbonate concentration more than previous methods without causing gastrointestinal distress. Methods In randomized order, seven (5 men, 2 women) elite middle-distance runners ingested either placebo, Modified SB (600 mg·kg− 1 over 19.5 h), or Acute SB (300 mg·kg− 1) in opaque gelatin capsules. Baseline and post-ingestion blood samples were analyzed for bicarbonate, pH, sodium, hematocrit, and lactate. Repeated measures ANOVA (2 time points × 3 conditions) were analyzed to determine differences in serum bicarbonate, lactate, sodium, blood pH, and hematocrit. Gastrointestinal distress was assessed via self-report on a Likert scale of 1–10. Simple (condition) and repeated (time) within-participant contrasts were used to determine the location of any statistically significant main and interaction effects (p ≤ 0.05). Results Both Modified SB (7.6 mmol·L− 1, p < 0.01) and Acute SB (5.8 mmol·L− 1, p < 0.01) increased serum bicarbonate concentration compared to the placebo (p ≤ 0.05). Post-ingestion serum bicarbonate concentration was significantly higher for the Modified SB (34.7 ± 2.2 mmol·L− 1, 28.0% increase) trials than the Acute SB (33.5 ± 2.0 mmol·L− 1, 20.9% increase) trials (p = 0.05). There was no reported severe GI distress in the Modified SB trials, but two cases in the Acute SB trials. Conclusions Modified SB elevated serum bicarbonate concentration more than Acute SB, without any severe gastrointestinal side effects. Consequently, it is recommended that future experimentation involving SB by researchers and athletes use the novel ingestion protocol described in this study due to its potential for improved effectiveness and reduced gastrointestinal impact. Trial registration ClinicalTrials.gov ,NCT03813329. Registered 23 January 2019 - Retrospectively registered,


BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e020723 ◽  
Author(s):  
Nadine Ezard ◽  
Adrian Dunlop ◽  
Michelle Hall ◽  
Robert Ali ◽  
Rebecca McKetin ◽  
...  

IntroductionMethamphetamine dependence is a growing public health concern. There is currently no pharmacotherapy approved for methamphetamine dependence. Lisdexamfetamine (LDX) dimesylate, used in the treatment of attention-deficit hyperactivity disorder and binge eating disorder, has potential as an agonist therapy for methamphetamine dependence, and possible benefits of reduced risk of aberrant use due to its novel formulation.Methods and analysisA double-blind randomised controlled trial will be used to evaluate the efficacy of LDX in reducing methamphetamine use. The target sample is 180 participants with methamphetamine dependence of ≥2 years, using ≥14 days out of the previous 28, who have previously attempted but not responded to treatment for methamphetamine use. Participants will be randomly assigned to receive either a 15-week intervention consisting of induction (1 week of 150 mg LDX or placebo), maintenance (12 weeks of 250 mg LDX or placebo) and reduction (1 week of 150 mg LDX or placebo and 1 week of 50 mg LDX or placebo). All participants will be given access to four sessions of cognitive–behavioural therapy as treatment as usual and receive a 4-week follow-up appointment. The primary outcomes are efficacy (change from baseline in days of methamphetamine use by self-report for the last 28 days at week 13 and urinalyses confirmation of methamphetamine use) and safety (treatment-related adverse events). Secondary outcomes are total number of days of self-report methamphetamine use over the 12-week active treatment, longest period of abstinence during treatment period, percentage of achieving ≥21 days abstinence, craving, withdrawal, dependence, retention, bloodborne virus transmission risk behaviour, criminal behaviour, as well measures of abuse liability, physical and mental health, other substance use, cognitive performance, psychosocial functioning, treatment retention and satisfaction. Additionally, the study will assess the cost-effectiveness of LDX relative to the placebo control.Ethics and disseminationThe study has been approved by the Human Research Ethics Committee of St. Vincent’s Hospital, Sydney, Australia (HREC/16/SVH/222). Contact the corresponding author for the full trial protocol.Trial registration numberACTRN12617000657325; Pre-results.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Laura L. Oakley ◽  
Deepa R ◽  
Arthur Namara ◽  
Biswamitra Sahu ◽  
Iliatha Papachristou Nadal ◽  
...  

Abstract Background The prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs). Most women with GDM in LMICs are undiagnosed and/or inadequately managed due to a lack of knowledge and skills about GDM on the part of both providers and patients. Following contextual analysis, we developed an educational/behavioural intervention for GDM delivered through a package of culturally tailored films. This trial aims to evaluate whether the intervention can improve the timely detection and management of GDM in two LMIC settings. Methods Two independent cluster randomised controlled trials, one each to be conducted in Uganda and India. Thirty maternity facilities in each country have been recruited to the study and randomised in a 1:1 ratio to the intervention and control arms. The intervention comprises of three interconnected sets of films with the following aims: to improve knowledge of GDM guidelines and skills of health providers, to raise awareness of GDM screening among pregnant women and their families, and to improve confidence and skills in self-management among those diagnosed with GDM. In facilities randomised to the intervention arm, a GDM awareness-raising film will be shown in antenatal care waiting rooms, and four films for pregnant women with GDM will be shown in group settings and made available for viewing on mobile devices. Short films for doctors and nurses will be presented at professional development meetings. Data will be collected on approximately 10,000 pregnant women receiving care at participating facilities, with follow-up at 32 weeks gestational age and 6 weeks postnatally. Women who self-report a GDM diagnosis will be invited for a clinic visit at 34 weeks. Primary outcomes are (a) the proportion of women who report a GDM diagnosis by 32 weeks of pregnancy and (b) glycaemic control (fasting glucose and HbA1C) in women with GDM at ~34 weeks of pregnancy. The secondary outcome is a composite measure of GDM-related adverse perinatal-neonatal outcome. Discussion Screening and management of GDM are suboptimal in most LMICs. We hypothesise that a scalable film-based intervention has the potential to improve the timely detection and management of GDM in varied LMIC settings. Trial registration ClinicalTrials.gov NCT03937050, registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605, registered on 26 February 2020.


SLEEP ◽  
2020 ◽  
Author(s):  
Shira Maguen ◽  
Rebecca Gloria ◽  
Joy Huggins ◽  
Lizabeth A Goldstein ◽  
Jennifer C Kanady ◽  
...  

Abstract Study Objectives Our goal was to compare brief behavioral treatment for insomnia (BBTI) to a progressive muscle relaxation training (PMRT) control condition among veterans with insomnia, examining psychosocial functioning as a primary outcome and sleep-related outcomes, mood, cognition, and pain as secondary outcomes. Methods Veterans were randomly assigned to either BBTI or PMRT (N = 91; 24–74 years; M = 49 years). BBTI consisted of two in-person (60-min and 30-min sessions) and two telephone sessions (20-min each), and the PMRT control condition was matched to BBTI for session duration and type. Veterans were assessed through clinical interview at baseline and self-report measures at pre-, mid-, and posttreatment, as well as 6-month follow-up for the BBTI condition to assess sustained response. Measures also included continuous sleep monitoring with sleep diary. Results Intent-to-treat analyses demonstrated that individuals who completed BBTI versus PMRT reported greater improvements in work, home, social and cognitive functioning, insomnia symptom severity, mood, and energy. Improvements in psychosocial functioning, insomnia symptoms, and mood were maintained 6-months following BBTI treatment completion. Conclusions Veterans who received BBTI improved and maintained gains in psychosocial functioning, insomnia, and mood. BBTI is a treatment that can be implemented in primary care, mental health, or integrated care settings and provide symptom relief and improved functioning among those with insomnia, one of the most commonly reported mental health problems among veterans. Clinical trial registration NCT02571452.


2022 ◽  
Vol 22 (1) ◽  
Author(s):  
C. Acarturk ◽  
E. Uygun ◽  
Z. Ilkkursun ◽  
T. Yurtbakan ◽  
G. Kurt ◽  
...  

Abstract Background Syrian refugees resettled in Turkey show a high prevalence of symptoms of mental disorders. Problem Management Plus (PM+) is an effective psychological intervention delivered by non-specialist health care providers which has shown to decrease psychological distress among people exposed to adversity. In this single-blind pilot randomised controlled trial, we examined the methodological trial procedures of Group PM+ (gPM+) among Syrian refugees with psychological distress in Istanbul, Turkey, and assessed feasibility, acceptability, perceived impact and the potential cost-effectiveness of the intervention. Methods Refugees with psychological distress (Kessler Psychological Distress Scale, K10 > 15) and impaired psychosocial functioning (World Health Organization Disability Assessment Schedule, WHODAS 2.0 > 16) were recruited from the community and randomised to either gPM+ and enhanced care as usual (E-CAU) (n = 24) or E-CAU only (n = 22). gPM+ comprised of five weekly group sessions with eight to ten participants per group. Acceptability and feasibility of the intervention were assessed through semi-structured interviews. The primary outcome at 3-month follow-up was symptoms of depression and anxiety (Hopkins Symptoms Checklist-25). Psychosocial functioning (WHODAS 2.0), symptoms of posttraumatic stress disorder and self-identified problems (Psychological Outcomes Profiles, PSYCHLOPS) were included as secondary outcomes. A modified version of the Client Service Receipt Inventory was used to document changes in the costs of health service utilisation as well as productivity losses. Results There were no barriers experienced in recruiting study participants and in randomising them into the respective study arms. Retention in gPM+ was high (75%). Qualitative analyses of the interviews with the participants showed that Syrian refugees had a positive view on the content, implementation and format of gPM+. No adverse events were reported during the implementation. The study was not powered to detect an effect. No significant difference between gPM+ and E-CAU group on primary and secondary outcome measures, or in economic impacts were found. Conclusions gPM+ delivered by non-specialist peer providers seemed to be an acceptable, feasible and safe intervention for Syrian refugees in Turkey with elevated levels of psychological distress. This pilot RCT sets the stage for a fully powered RCT. Trial registration ClinicalTrials.gov Identifier NCT03567083; date: 25/06/2018.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sigal Zilcha-Mano ◽  
Ben Shahar ◽  
Hadar Fisher ◽  
Tohar Dolev-Amit ◽  
Leslie S. Greenberg ◽  
...  

Abstract Background Major depressive disorder (MDD) is the leading cause of disability worldwide and one of the most heterogeneous mental health disorders. Although there are effective treatments for MDD, about 50% of patients do not respond to treatment. One of the greatest challenges in improving current treatments is identifying the mechanisms responsible for therapeutic change in MDD. The proposed study aims to identify patient-specific mechanisms of change in two treatments for MDD by investigating whether subpopulations of patients differ in the mechanisms of change that operate when receiving a given treatment. Based on theories of targeting weakness and building on strength, we will examine whether the mechanism of change operating when a treatment is provided depends on whether the treatment targets the patient’s strength or weakness. Method To test our hypothesis that two treatments, supportive-expressive treatment (SET) and emotion-focused treatment (EFT), differ in their mechanisms of change and to explore whether focusing on the patient’s strength or weakness will result in better treatment outcome, we conduct a mechanistic randomized controlled trial. One hundred and twenty-four individuals diagnosed with MDD are randomized to 16 sessions of either SET or EFT. The two treatments are theorized to differ in their main mechanism of change: SET places emphasis on insight as its main mechanism of change, and EFT places emphasis on emotional processing. Both can serve as strength- or weakness-focused treatments, based on the patient’s baseline levels of insight and emotional processing. The primary outcome is the Hamilton Rating Scale for Depression. Additional measures include self-report measures and clinical interviews, hormonal, motion, acoustic, physiological, and neuroimaging assessments, performance on cognitive tasks, and narrative material (collected from the sessions and interviews). Discussion The RCT will expand our understanding of mechanisms of change in psychotherapy, from one-size-fits-all to patient-specific mechanisms of change. By informing therapists about which of the two approaches is most effective with patients based on their baseline characteristics, the RCT will contribute to progress toward personalized treatment. Trial registration clinicaltrials.gov Identifier: NCT04576182 submitted on October 1st 2020. Funding: The Israel Science Foundation. Trial status: Recruitment is ongoing.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David C. Schwebel ◽  
D. Leann Long ◽  
Marissa Gowey ◽  
Joan Severson ◽  
Yefei He ◽  
...  

Abstract Background Firearms injuries present a major pediatric public health challenge in the United States. This study protocol describes research to develop and then conduct a randomized clinical trial to evaluate ShootSafe, an interactive, engaging, educational website to teach children firearms safety. ShootSafe has three primary goals: (a) teach children basic knowledge and skills needed to hunt, shoot, and use firearms safely; (b) help children learn and hone critical cognitive skills of impulse control and hypothetical thinking needed to use firearms safely; and (c) alter children’s perceptions about their own vulnerability and susceptibility to firearms-related injuries, the severity of those injuries, and their perceived norms about peer behavior surrounding firearms use. ShootSafe will accomplish these goals through a combination of interactive games plus short, impactful testimonial videos and short expert-led educational videos. Methods Following website development, ShootSafe will be evaluated through a randomized controlled trial with 162 children ages 10–12, randomly assigning children to engage in ShootSafe or an active control website. Multiple self-report, computer-based, and behavioral measures will assess functioning at baseline, immediately following training, and at 4-month follow-up. Four sets of outcomes will be considered: firearms safety knowledge; cognitive skills in impulse control and hypothetical thinking; perceptions about firearms safety; and simulated behavior when handling, storing and transporting firearms. Training in both conditions will comprise two 45-min sessions. Discussion If results are as hypothesized, ShootSafe offers potential as a theory-based program to teach children firearms safety in an accessible, engaging and educational manner. Translation into practice is highly feasible. Trial registration The study protocol was registered on 11/10/20 at clinicaltrials.gov (NCT04622943).


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kirsty Sprange ◽  
Jules Beresford-Dent ◽  
Gail Mountain ◽  
Claire Craig ◽  
Clare Mason ◽  
...  

Abstract Background Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part of a trial of a complex community-based psychosocial intervention, Journeying through Dementia (JtD). The intervention was designed to equip individuals with the knowledge and skills to successfully self-manage, maintain independence, and live well with dementia and involves both group and individual sessions. The methodological challenges of developing a conceptual framework for fidelity assessment and creating and applying purposely designed measures derived from this framework are discussed to inform future studies. Methods A conceptual fidelity framework was created out of core components of the intervention (including the intervention manual and training for delivery), associated trial protocols and pre-defined fidelity standards and criteria against which intervention delivery and receipt could be measured. Fidelity data collection tools were designed and piloted for reliability and usability. Data collection in four selected sites (fidelity sites) was via non-participatory observations of the group aspect of the intervention, attendance registers and interventionist (facilitator and supervisor) self-report. Results Interventionists from all four fidelity sites attended intervention training. The majority of group participants at the four sites (71%) received the therapeutic dose of 10 out of 16 sessions. Weekly group meeting attendance (including at ‘out of venue’ sessions) was excellent at 80%. Additionally, all but one individual session was attended by the participants who completed the intervention. It proved feasible to create tools derived from the fidelity framework to assess in-venue group aspects of this complex intervention. Results of fidelity assessment of the observed groups were good with substantial inter-rater reliability between researchers KAPPA 0.68 95% CI (0.58–0.78). Self-report by interventionists concurred with researcher assessments. Conclusions There was good fidelity to training and delivery of the group aspect of the intervention at four sites. However, the methodological challenges of assessing all aspects of this complex intervention could not be overcome due to practicalities, assessment methods and ethical considerations. Questions remain regarding how we can assess fidelity in community-based complex interventions without impacting upon intervention or trial delivery. Trial registration ISRCTN17993825.


2020 ◽  
Author(s):  
Kartik K Iyer ◽  
Andrew Zalesky ◽  
Luca Cocchi ◽  
Karen M Barlow

Evidence-based treatments for children with persistent post-concussion symptoms (PPCS) are few and limited. Common PPCS complaints such as sleep disturbance and fatigue could be ameliorated via the supplementation of melatonin, which has significant neuroprotective and anti-inflammatory properties. This study aims to identify neural correlates of melatonin treatment with changes in sleep disturbances and clinical recovery in a pediatric cohort with PPCS. We examined structural and functional neuroimaging (MRI) in 62 children with PPCS in a randomized, double-blind, placebo-controlled trial of 3mg or 10mg of melatonin (NCT01874847). The primary outcome was the total youth self-report Post-Concussion Symptom Inventory (PCSI) score after 28 days of treatment. Secondary outcomes included the change in the sleep domain PCSI score and sleep-wake behavior (assessed using wrist-worn actigraphy). Whole-brain analyses of (i) functional connectivity (FC) of resting-state fMRI, and (ii) structural grey matter (GM) volumes via voxel-based morphometry were assessed immediately before and after melatonin treatment and compared to placebo in order to identify neural effects of melatonin treatment. Increased FC of posterior default mode network (DMN) regions with visual, somatosensory and dorsal networks was detected in the melatonin groups over time. FC increases also corresponded with reduced wake periods (r=-0.27, p=0.01). Children who did not recover (n=39) demonstrated significant FC increases within anterior DMN and limbic regions compared to those that did recover (i.e. PCSI scores returned to pre-injury level n=23) over time, (p=0.026). Increases in GM volume within the posterior cingulate cortex were found to correlate with reduced wakefulness after sleep onset (r=-0.32, p=0.001) and sleep symptom improvement (r=0.29, p=0.02). Although the melatonin treatment trial was negative and did not result in PPCS recovery (with or without sleep problems), the relationship between melatonin and improvement in sleep parameters were linked to changes in function-structure within and between brain regions interacting with the DMN. Clinical Trial Registration ID#NCT01874847.


Crisis ◽  
2020 ◽  
pp. 1-7
Author(s):  
Karien Hill ◽  
Shawn Somerset ◽  
Ralf Schwarzer ◽  
Carina Chan

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.


Sign in / Sign up

Export Citation Format

Share Document