Randomized Effectiveness Trial Research Articles

Comparative randomized trial addressing childhood emotional problems: Computerized vs. traditional transdiagnostic Super Skills program

BackgroundSuper Skills for Life is a structured intervention rooted in cognitive-behavioral therapy and a transdiagnostic approach, aimed at preventing childhood emotional problems. Over the past decade, it has demonstrated positive outcomes in various formats and countries. This study evaluated the comparative effectiveness of two individual modalities: the computerized and the traditional version enriched with multimedia content, through a comparative randomized effectiveness trial. Method109 children (55.24 % female) aged 8–12 years participated, randomly assigned to either the traditional (n = 54) or computerized (n = 51) groups. Pre- and post-intervention assessments involved emotional problem measures completed by children and parents. ResultsBoth groups exhibited significant reductions in all outcomes according to parent reports, including depression, anxiety, and anxiety-related life interference. Children's self-reports indicated improvements across all general measures. Generalized Estimating Equations indicated marginally better improvements in the traditional group. LimitationsLimitations included the absence of follow-up assessment, variability in participant regions across Spain, and input from other informants like teachers. ConclusionsThis study pioneers the examination of short-term effects of the program in both a fully computerized format supervised by a specialized therapist and an enriched traditional individual format, and the promising results suggest their potential for indicated prevention of childhood emotional problems.

Effects of the Pathways for African American Success Program: Reductions in Adolescent Depression Through the Promotion of Racial Equity-Informed Parenting and Racial Pride

African American adolescents face persistent disparities in depression and related behavioral health outcomes, which have been attributed to experiences with discrimination. The integrative model for the study of stress in Black American families provides a comprehensive perspective on how historical and current discrimination has direct and indirect effects on child behavioral health. Culturally based protective mechanisms (e.g., racial socialization) have been demonstrated to buffer adolescents from the negative effects of discrimination. The Pathways for African American Success (PAAS) program was developed as a scalable eHealth preventive intervention to facilitate parents’ use of strategies to protect their children from exposure to racism and the disproportionate consequences of risk behaviors, which we label as racial equity-informed parenting. Using data from a randomized effectiveness trial of PAAS and following stress and resilience approaches, we tested multiple hypotheses about the nature of discrimination as a source of risk, as well as program-driven improvements in adolescent racial pride as a source of protection. Our risk model indicated adolescent depression was associated with their own (direct) and their parents’ (indirect) experience of discrimination. Mediation analyses showed that program-driven improvements in adolescent racial pride served as a risk reducer/compensatory factor. Findings of moderation analyses, however, showed the negative effects of discrimination, even when racial pride was high. Implications for theory and cultural tailoring of evidence-based preventive interventions are presented.

Virtual multimodal hub for patients undergoing major gastrointestinal cancer surgery (PRIORITY-CONNECT 2 Pilot) - A pilot randomised type I hybrid effectiveness-implementation trial

BackgroundThe PRIORITY-CONNECT 2 pilot trial will establish the feasibility and acceptability of a virtual multimodal programme following gastrointestinal cancer surgery. The secondary aims are to obtain pilot data on the likely difference in key outcomes, data elements that will guide future implementation studies, and to identify barriers and facilitators that inform the development and execution of a substantive randomised clinical effectiveness trial of teleprehabilitation/rehabilitation. MethodsThis is a multicentre, assessor-blinded, pilot, randomised controlled trial utilising a Hybrid Type I effectiveness-implementation design. 20 participants undergoing major gastrointestinal cancer surgery will be randomised (1:1 allocation) to attend a virtual multimodal prehabilitation-rehabilitation hub (intervention group), delivered before (1–6 weeks) and after (up to 3 months) surgery plus usual care, or to usual care alone (control group). An individualised intervention will be delivered by an experienced multidisciplinary team including a physiotherapist, psychologist, dietitian, nurse, social worker, and a geriatrician. Outcomes will be collected at baseline, 1–2 days before surgery, during the hospital stay, day of discharge from hospital, and 3 months postoperatively. The primary outcomes will be feasibility and acceptability of the virtual multimodal hub. Secondary outcomes assess the rate of postoperative complications within 30 days after surgery, quality of life, the number of days at home within 30 and 90 days after surgery, healthcare use, and implementation outcomes. DiscussionThe PRIORITY-CONNECT 2 pilot trial will generate findings about the feasibility and acceptability of delivering an evidence-based virtual multimodal preoperative (prehabilitation) and postoperative (rehabilitation) intervention targeting patients having major gastrointestinal cancer surgery. Trial registrationThis trial was registered prospectively with the National Library of Medicine ClinicalTrials.gov Registry (NCT06212700) on 8th January 2024.

Reducing posttraumatic stress disorder symptom severity among depressed women with childhood sexual abuse histories in interpersonal psychotherapy-trauma: The role of improved social functioning.

Childhood sexual abuse (CSA) increases risk for posttraumatic stress disorder (PTSD), and both CSA and PTSD are strongly associated with impaired social functioning. Interpersonal psychotherapy (IPT) has demonstrated promise for adults with PTSD and has been shown to be effective for women with PTSD and histories of CSA, but the mechanisms by which IPT might improve PTSD are unknown. The current secondary analysis tested whether the ameliorative effect of IPT-trauma (IPT-T) on PTSD, demonstrated in a randomized effectiveness trial, was mediated by improved social function. The randomized effectiveness trial compared IPT-T to clinic psychotherapy in a publicly funded community mental health center. Women with CSA histories and major depression (n = 162; Mage = 36.3; 54% White, 38% Black, 8% other race) were randomly assigned to IPT-T or CP, and 16 free sessions of IPT-T or CP were offered within a 32-week treatment period. Eighty-eight percent of the sample met diagnostic criteria for PTSD. Mediation models confirmed hypotheses, showing that the effect of IPT-T on improved PTSD symptoms at Week 32 (end of treatment) was partially mediated by better social functioning at Week 16 (middle of treatment period; path c¹: B = 12.25, p = .04, 95% confidence interval [.44, 24.05]). Findings support that a non-exposure-based therapy can reduce PTSD symptoms via improved social functioning. Given extensive literature showing the importance of social functioning in mental health generally and PTSD specifically, integrating a focus on social functioning (e.g., building social skills, expanding support networks) into treatments, including exposure-based treatments, may enhance outcomes. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Police-mental health co-response versus police-as-usual response to behavioral health emergencies: A pragmatic randomized effectiveness trial

BackgroundPeople with mental illness are overrepresented in United States (US) criminal legal systems. In response, alternatives to traditional police response to behavioral health emergencies have become more common, despite limited evidence for their effectiveness. We conducted the first randomized controlled trial of a police-mental health co-response team to determine program effectiveness relative to a police-as-usual response on key outcomes identified by community stakeholders. MethodsBetween January 2020 and March 2021, we randomized behavioral health emergency calls for service in one of six police districts in Indianapolis, Indiana to receive a co-response or police-as-usual response during operational hours between 10 a.m. and 5 p.m. Mondays – Fridays. Eligible calls for service were determined via pre-specified phrases indicating a behavioral health incident over the police dispatch radio. Researchers then communicated random assignment with the co-response team to indicate whether they should respond or withhold. Logistic and negative binomial regression were used to assess group differences in emergency medical services (EMS) events within 12 months of the randomized incident along with jail booking, outpatient encounters, and emergency department visits. FindingsWe randomized 686 calls for service with co-response completed in 264 cases and police-as-usual response in 267 cases. The overall rate of attrition was similar across conditions and the final sample included 211 co-responses and 224 police-as-usual responses. We found no significant differences in any EMS event (odds ratio [OR]: 1.26; 95% confidence interval [CI]: 0.85–1.88, p = .246) or event counts (incidence rate ratio [IRR]: 0.85; 95% CI: 0.52–1.37, p = .504). We also found no differences in secondary outcomes (jail booking, outpatient encounters, and emergency department visits). DiscussionA police-mental health co-response team model was not more effective than traditional police response on key outcomes. Co-response team models, such as the one reported here, may unintentionally foster emergency services utilization among persons with behavioral health needs. Without a functioning national mental health system, communities in the US will continue to struggle to identify solutions to meet the needs of community members with complex behavioral health issues.

Design of a pragmatic randomized implementation effectiveness trial testing a health system wide hypertension program for older adults

Hypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension guidelines and effective lowering of BP. Some strategies such as self-measured blood pressure (SMBP) and remote management by pharmacists are safe and effectively lower BP but have not been effectively implemented. In this study, we combine such evidence-based strategies to build a remote hypertension program and test its effectiveness and implementation in large health systems. This randomized, controlled, pragmatic type I hybrid implementation effectiveness trial will examine the virtual collaborative care clinic (vCCC), a hypertension program that integrates automated patient identification, SMBP, remote BP monitoring by trained health system pharmacists, and frequent patient-provider communication. We will randomize 1000 patients with uncontrolled hypertension from two large health systems in a 1:1 ratio to either vCCC or control (usual care with education) groups for a 2-year intervention. Outcome measures including BP measurements, cognitive function, and a symptom checklist will be completed during study visits. Other outcome measures of cardiovascular events, mortality, and health care utilization will be assessed using Medicare data. For the primary outcome of proportion achieving BP control (defined as systolic BP < 130 mmHg) in the two groups, we will use a generalized linear mixed model analysis. Implementation outcomes include acceptability and feasibility of the program. This study will guide implementation of a hypertension program within large health systems to effectively lower BP.

External and Internal Validity Considerations in Youth Effectiveness Trials: Lessons Learned from the COMET Study

ABSTRACT Objective Effectiveness trials aim to increase the generalizability and public health impact of interventions. However, challenges associated with this design present threats to external and internal validity. This paper illustrates these challenges using data from a two-site randomized effectiveness trial, the Community Study of Outcome Monitoring for Emotional Disorders in Teens (COMET) and presents recommendations for future research. Method COMET was a randomized effectiveness trial conducted in 19 community mental health clinics in two states comparing three interventions: treatment as usual (TAU), TAU with measurement-based care (TAU+), and the Unified Protocol forTransdiagnostic Treatment of Emotional Disorders in Adolescents with MBC (UPA). Participants included 176 clinicians (mean age = 35.5; 85.8% cisgender female; 53.0% racially and/or ethnically minorized) and 196 adolescents (mean age = 14.7; 65.3% cisgender female; 69.4% racially and/or ethnically minorized). Analyses outlined participant flow from recruitment to study completion, described participant characteristics, and examined site differences. Results Analysis of participant flow suggested that recruitment and retention of clinicians and adolescents was challenging, raising questions about whether participants were representative of participating clinics. Both the clinician and adolescent samples were racially and ethnically diverse and adolescents were low income and clinically complex. Significant site differences were observed in clinician and adolescent characteristics. Conclusions While this study was successful in recruiting a diverse and historically under-represented sample, difficulties in recruitment and retention raise questions about external validity and site differences present challenges to internal validity of study findings. Suggestions for future effectiveness studies, drawing from implementation science approaches, are discussed.

Development of the HT&Me intervention to support women with breast cancer to adhere to adjuvant endocrine therapy and improve quality of life.

Breast cancer is the most common cancer in women worldwide. Approximately 80% of breast cancers are oestrogen receptor positive (ER+). Patients treated surgically are usually recommended adjuvant endocrine therapy (AET) for 5-10 years. AET significantly reduces recurrence, but up to 50% of women do not take it as prescribed. To co-design and develop an intervention to support AET adherence and improve health-related quality-of-life (QoL) in women with breast cancer. Design and development of the HT&Me intervention took a person-based approach and was guided by the Medical Research Council framework for complex interventions, based on evidence and underpinned by theory. Literature reviews, behavioural analysis, and extensive key stakeholder involvement informed 'guiding principles' and the intervention logic model. Using co-design principles, a prototype intervention was developed and refined. The blended tailored HT&Me intervention supports women to self-manage their AET. It comprises initial and follow-up consultations with a trained nurse, supported with an animation video, a web-app and ongoing motivational 'nudge' messages. It addresses perceptual (e.g. doubts about necessity, treatment concerns) and practical (e.g. forgetting) barriers to adherence and provides information, support and behaviour change techniques to improve QoL. Iterative patient feedback maximised feasibility, acceptability, and likelihood of maintaining adherence; health professional feedback maximised likelihood of scalability. HT&Me has been systematically and rigorously developed to promote AET adherence and improve QoL, and is complemented with a logic model documenting hypothesized mechanisms of action. An ongoing feasibility trial will inform a future randomised control trial of effectiveness and cost-effectiveness.

Change in glycaemic control with structured diabetes self-management education in urban low-resource settings: multicentre randomised trial of effectiveness

BackgroundIn high-resource settings, structured diabetes self-management education is associated with improved outcomes but the evidence from low-resource settings is limited and inconclusive.AimTo compare, structured diabetes self-management education to usual care, in adults with type 2 diabetes, in low-resource settings.Research design and methods.DesignSingle-blind randomised parallel comparator controlled multi-centre trial.Adults (> 18 years) with type 2 diabetes from two hospitals in urban Ghana were randomised 1:1 to usual care only, or usual care plus a structured diabetes self-management education program. Randomisation codes were computer-generated, and allotment concealed in opaque numbered envelopes. The intervention effect was assessed with linear mixed models.Main outcome: Change in HbA1c after 3-month follow-up.Primary analysis involved all participants.Clinicaltrial.gov identifier:NCT04780425, retrospectively registered on 03/03/2021.ResultsRecruitment: 22nd until 29th January 2021.We randomised 206 participants (69% female, median age 58 years [IQR: 49–64], baseline HbA1c median 64 mmol/mol [IQR: 45–88 mmol/mol],7.9%[IQR: 6.4–10.2]). Primary outcome data was available for 79 and 80 participants in the intervention and control groups, respectively. Reasons for loss to follow-up were death (n = 1), stroke(n = 1) and unreachable or unavailable (n = 47). A reduction in HbA1c was found in both groups; -9 mmol/mol [95% CI: -13 to -5 mmol/mol], -0·9% [95% CI: -1·2% to -0·51%] in the intervention group and -3 mmol/mol [95% CI -6 to 1 mmol/mol], -0·3% [95% CI: -0·6% to 0.0%] in the control group. The intervention effect was 1 mmol/mol [95%CI:-5 TO 8 p = 0.726]; 0.1% [95% CI: -0.5, 0.7], p = 0·724], adjusted for site, age, and duration of diabetes.No significant harms were observed.ConclusionIn low-resource settings, diabetes self-management education might not be associated with glycaemic control. Clinician’s expectations from diabetes self-management education must therefore be guarded.

An analysis of differential improvement by diagnosis in group transdiagnostic cognitive behaviour therapy for anxiety disorders

Introduction Anxiety disorders are the most prevalent among the mental health disorders and have a negative impact on an individual’s life. Cognitive behaviour therapy (CBT) is documented as the most effective treatment for anxiety disorders. However, challenges associated with implementing diagnosis-specific CBT have led to transdiagnostic approaches of CBT (tCBT). tCBT uses a single protocol with core elements of CBT for treatment of anxiety disorders broadly. The aim of the current study is to examine whether participants with different principal anxiety diagnoses demonstrate similar anxiety reduction. Methods The current study involved a secondary analysis of 117 participants randomly allocated to receive tCBT for anxiety disorders in a pragmatic randomised effectiveness trial. Beck Anxiety Inventory (BAI) and Clinician Severity Ratings (CSR) scales were administered at pre- and post-treatment and one-year follow-up, while the Anxiety Disorder Diagnostic Questionnaire – Weekly (ADDQ-W) was administered each session. Results Mixed-factorial analyses of variance (ANOVAs) indicated that participants with GAD, SAD and PD/A improved to post-treatment and maintained to follow-up, with no differential improvement across principal diagnoses. Mixed effect regression modelling of session by session measures indicated non-differential negative slopes across principal diagnoses of GAD, SAD and PD/A. Conclusion Overall, results indicate that group tCBT for anxiety disorders shows equal effectiveness for GAD, PD/A, and SAD in real-world conditions.

Effectiveness and cost-effectiveness of a personalised self-management intervention for living with long COVID: protocol for the LISTEN randomised controlled trial

BackgroundIndividuals living with long COVID experience multiple, interacting and fluctuating symptoms which can have a dramatic impact on daily living. The aim of the Long Covid Personalised Self-managemenT support EvaluatioN (LISTEN) trial is to evaluate effects of the LISTEN co-designed self-management support intervention for non-hospitalised people living with long COVID on participation in routine activities, social participation, emotional well-being, quality of life, fatigue, and self-efficacy. Cost-effectiveness will also be evaluated, and a detailed process evaluation carried out to understand how LISTEN is implemented.MethodsThe study is a pragmatic randomised effectiveness and cost-effectiveness trial in which a total of 558 non-hospitalised people with long COVID will be randomised to either the LISTEN intervention or usual care. Recruitment strategies have been developed with input from the LISTEN Patient and Public Involvement and Engagement (PPIE) advisory group and a social enterprise, Diversity and Ability, to ensure inclusivity. Eligible participants can self-refer into the trial via a website or be referred by long COVID services. All participants complete a range of self-reported outcome measures, online, at baseline, 6 weeks, and 3 months post randomisation (the trial primary end point). Those randomised to the LISTEN intervention are offered up to six one-to-one sessions with LISTEN-trained intervention practitioners and given a co-designed digital resource and paper-based book. A detailed process evaluation will be conducted alongside the trial to inform implementation approaches should the LISTEN intervention be found effective and cost-effective.DiscussionThe LISTEN trial is evaluating a co-designed, personalised self-management support intervention (the LISTEN intervention) for non-hospitalised people living with long COVID. The design has incorporated extensive strategies to minimise participant burden and maximise access. Whilst the duration of follow-up is limited, all participants are approached to consent for long-term follow-up (subject to additional funding being secured).Trial registrationLISTEN ISRCTN36407216. Registered on 27/01/2022.

Impact of Multi-site Clinical Trial Results on Clinical Practice: Use of Risperidone to Treat PTSD Nationally in the Veterans Health Administration

Multi-site randomized effectiveness trials evaluate treatments under real-world conditions. Whether results change practice is under-studied. A 6-month 26-site Veterans Health Administration (VHA) cooperative study published in 2011 compared an oral second-generation antipsychotic, risperidone, to placebo for refractory PTSD with null results. National VHA administrative data compared new starts on risperidone during the 5 years before and after the year of publication. Among the 450,000–841,000 Veterans diagnosed with PTSD annually from 2006 to 2016 the proportion with new starts on risperidone declined every year before and after publication. No evidence of an effect of null study results on VHA clinical practice was observed.

Are We on the Same Page? Therapist and Caregiver Agreement on Therapist Evidence-Based Strategy Use in Youth Mental Health

ABSTRACT This study examines therapist and caregiver report of evidence-based intervention (EBI) strategy use in the context of a community effectiveness trial of An Individualized Mental Health Intervention for Autism (AIM HI), a caregiver and child skill-building mental health intervention for school-aged children with autism. This study explores whether child, caregiver, or therapist characteristics or therapist training are associated with agreement between caregiver and therapist raters. Data were drawn from a cluster randomized effectiveness trial of AIM HI, in which therapists were trained and delivered AIM HI or treatment as usual. Therapists and caregivers completed assessments at baseline. At 6 months post baseline, therapists and caregivers reported on perceptions of therapist EBI delivery across sessions. Caregiver-therapist agreement on therapist EBI strategy use was generally high, with both reporters indicating trained therapists used more extensive EBI strategies than usual care therapists. When there were significant differences between therapists and caregivers, caregivers tended to rate therapists higher on EBI strategy delivery. The presence of an internalizing co-occurring mental health diagnosis and higher levels of child behavior problems were associated with lower caregiver-therapist agreement. Therapists with more years of experience and those with self-identified autism expertise had higher levels of therapist-caregiver disagreement. Results suggest that therapist EBI training results in increased report of therapist EBI strategy delivery from multiple reporters. There was general agreement between therapists and caregiver reporters. Examination of strategy ratings provides critical information about how stakeholders experience the delivery of EBI strategies in routine mental health services.

The ADAPT Parenting Intervention Benefits Combat Exposed Fathers Genetically Susceptible to Problem Drinking.

Testing a vantage sensitivity model from differential susceptibility theory (DST), we examined a G × E × I hypothesis; that is, whether a military parenting intervention program (I) might buffer a G × E susceptibility for military deployed fathers exposed to deployment combat stress and trauma. We hypothesized that combat stress (E, referring to the natural environmental factor) would lead to increases in problem drinking, and that the effect of problem drinking would be amplified by genetic predisposition (G) for drinking reward systems, substance use, and addictive behaviors (i.e., differential vulnerability). Providing a preventive intervention designed to improve post-deployment family environments (I, vantage sensitivity) is hypothesized to buffer the negative impacts of combat exposure and genetic susceptibility. The sample included 185 post-deployed military fathers who consented to genotyping, from a larger sample of 294 fathers enrolled in a randomized effectiveness trial of the After Deployment Adaptive Parenting Tools (ADAPT) intervention. Trauma-exposed military fathers at genetic susceptibility for problem drinking assigned to the ADAPT intervention reported significantly more reductions in risky drinking compared with fathers at genetic susceptibility assigned to the control group, with a small effect size for the G × E × I interaction (d = .2).Trial Registration. The ADAPT trial is registered at the US National Institutes of Health ( ClinicalTrials.gov ) # NCT03522610.

Protocol for a collaborative randomised effectiveness trial of lay-delivered versus clinician-delivered behavioural activation in senior centres

IntroductionDepression is common among community-dwelling older adults who make use of senior centre services yet remains undertreated due to a lack of acceptable and available treatments. Emerging evidence suggests that...

Patient and Clinician Perspectives on Two Telemedicine Approaches for Treating Patients with Mental Health Disorders in Underserved Areas.

Primary care practices in underserved and/or rural areas have limited access to mental health specialty resources for their patients. Telemedicine can help address this issue, but little is known about how patients and clinicians experience telemental health care. This pragmatic randomized effectiveness trial compared telepsychiatry collaborative care, where telepsychiatrists provided consultation to primary care teams, to a referral approach, where telepsychiatrists and telepsychologists assumed responsibility for treatment. Twelve Federally Qualified Health Centers in rural and/or underserved areas in 3 states participated. Patients and clinicians reported that both interventions alleviated barriers to accessing mental health care, provided quality treatment, and offered improvements over usual care. Telepsychiatry collaborative care was identified as better for patients with difficulty developing trust with new providers. This approach also required more primary care involvement than referral care, creating more opportunities for clinician learning related to mental health diagnosis and treatment. The referral approach was identified as better suited for patients with higher complexity or desiring specific psychotherapies. Both approaches addressed patient needs and provided access to specialty mental health care. Each approach better aligned with different patients' needs, suggesting that having both approaches available to practices is optimal for supporting patient-centered care.

Testing the Impact of the Whole-Day Good Behavior Game on Aggressive Behavior: Results of a Classroom-Based Randomized Effectiveness Trial.

Three generations of developmental epidemiologically based randomized field trials of the Good Behavior Game (GBG) have been delivered to Baltimore elementary schools. With the collaboration of family and community partners, all three trials were directed at decreasing proximal targets of aggressive behavior and improving learning in first-grade classrooms with distal mental health and substance abuse outcomes. GBG is a group-contingent classroom behavior management strategy that promotes classmate/peer concern for each child's positive behavior by rewarding teams with below-criterion levels of aggressive, disruptive behavior. GBG targets early risk factors for the above distal outcomes: aggressive, disruptive behavior, family/school relationships, and school failure. Here, we report on the third-generation randomized prevention trial of the GBG (whole-day first grade program (WD)), including 12 elementary schools. WD enhanced the standard curriculum in the areas of classroom behavior management; academic instruction, particularly reading; and family-classroom partnerships. Using a within-school classroom randomized trial design, we: 1) evaluate the effectiveness of the WD program by sex and cohort and 2) measure variation in WD impact by the quality of teachers' behavior management practices. Data from 961 first graders were used in general growth mixture modeling that accounts for classroom randomization to identify distinct developmental trajectories of aggressive, disruptive behavior and GBG impact on these trajectories. In the chronic high aggression trajectory of males, ratings of aggression after WD implementation and to the end of third grade were significantly lower in the WD condition than in controls in classrooms with a higher WD dosage (Cohort 2) and especially in classrooms with higher quality of WD implementation. For females, we found a modest but significant benefit of GBG in the low trajectory class when cohorts were combined. Regarding policy implications, embedding GBG into the curricula in teacher's colleges could better support student learning and behavior. Clinical Trials Registration number: NCT00257088.

Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Protocol of a Randomized Effectiveness Trial of a Technology-Assisted Parenting Intervention.

BackgroundAdolescents in residential substance use treatment are at extremely high risk for relapse following discharge to the community. Parenting practices, including parental monitoring and parent-adolescent communication, have been established as key predictors of adolescent substance use outcomes and relapse. However, traditional office-based therapy may not be feasible for parents who face structural and systemic barriers. There is a clear need for effective, accessible, and scalable interventions for parents of adolescents receiving residential substance use treatment. In a prior pilot randomized controlled trial, we tested Parent SMART (Substance Misuse among Adolescents in Residential Treatment)—a technology-assisted parenting intervention informed by extensive formative research—as an adjunct to residential treatment as usual (TAU). Parent SMART demonstrated high feasibility and acceptability, as well as evidence of effectiveness in improving parental monitoring and communication.ObjectiveThis protocol paper describes a fully-powered randomized controlled pragmatic effectiveness trial of Parent SMART as an adjunct to residential TAU. We hypothesize that families who receive Parent SMART will demonstrate greater improvements in parenting skills, reductions in adolescent substance use, and reductions in adolescent problem behaviors relative to families that receive residential TAU. We will test the exploratory hypothesis that reductions in adolescent substance use will be partially mediated by improvements in parenting skills.MethodsAdolescent-parent dyads (n = 220 dyads; 440 total) will be randomized to either residential TAU only or Parent SMART+TAU. Parents randomized to Parent SMART will receive access to a networking forum, an off-the-shelf computer program called Parenting Wisely, and up to four telehealth coaching calls. Multimethod follow-up assessments consisting of self-reported parent and adolescent measures, a parent-adolescent in vivo interaction task, and 8-panel urine screens will be conducted 6, 12, and 24 weeks postdischarge from residential care. Measures will assess parenting skills, adolescent substance use, and adolescent problem behaviors. Analyses will be conducted using latent change score structural equation modeling.ResultsThe trial was funded in August 2021; ethics approval was obtained in August 2020, prior to funding. Due to concerns with the administrative interface in the pilot trial, the Parent SMART networking forum is currently being rebuilt by a different vendor. The programming is scheduled to be completed by December 2021, with recruitment beginning in February 2022.ConclusionsThe proposed research has the potential to advance the field by serving a high-need, underserved population during a vital treatment juncture; targeting parenting practices (putative mediators) that have been shown to predict adolescent substance use outcomes; addressing barriers to accessing continuing care; and testing a highly scalable intervention model.Trial RegistrationClinicalTrials.gov NCT05169385; https://clinicaltrials.gov/ct2/show/NCT05169385International Registered Report Identifier (IRRID)PRR1-10.2196/35934

Learning, doing and sticking with it: A qualitative study on achieving clinically significant reduction in cardiovascular disease risk in a healthy lifestyle intervention for people with serious mental illness.

People with serious mental illness (SMI; e.g. schizophrenia) have mortality rates two to three times higher than the general population, largely due to a higher prevalence of cardiovascular disease (CVD). Healthy lifestyle interventions can improve the health of people with SMI, but information about why these interventions work for some and not others is scarce. Our study aims to qualitatively explore differences in these two groups' overall experiences and application of the intervention. Data were drawn from a randomised effectiveness trial of a peer-led healthy lifestyle intervention. Qualitative data from interviews and focus groups with 21 participants were linked to their 12-month outcome data. Grounded theory was used to compare the experiences of participants who achieved clinically significant CVD risk reduction (i.e. clinically significant weight loss or clinically significant improvements in cardiorespiratory fitness) versus those who did not. Three qualitative themes: learning, change, sticking with it - differentiated participants who achieved CVD risk reduction and those that did not. Participants achieving CVD risk reduction described learning and applying specific knowledge and skills related to a healthy lifestyle when making health decisions, made healthy concrete changes to diet and physical activity, and stuck with those changes. Participants not achieving clinically significant CVD risk reduction reported surface-level learning about healthy lifestyle practices, difficulty sticking with healthy changes, and were more likely to report ambiguous or no changes. Our findings suggest that healthy lifestyle interventions for people with SMI should provide experiential in-vivo learning experiences while periodically assessing participants' understanding and then tailoring the intervention to their needs. It is important to build self-efficacy for health behaviour changes by creating early perceptions of success, which was found to enhance motivation and sustain behaviour change. Helping people with SMI develop and strengthen their support systems will also be an important factor for building and sustaining health behaviour changes.

Assessing practical implementation of modular psychotherapy for youth in community-based settings using benchmarking.

Achieving high quality outcomes in a community context requires the strategic coordination of many activities in a service system, involving families, clinicians, supervisors, and administrators. In modern implementation trials, the therapy itself is guided by a treatment manual; however, structured supports for other parts of the service system may remain less well-articulated (e.g., supervision, administrative policies for planning and review, information/feedback flow, resource availability). This implementation trial investigated how a psychosocial intervention performed when those non-therapy supports were not structured by a research team, but were instead provided as part of a scalable industrial implementation, testing whether outcomes achieved would meet benchmarks from published research trials. In this single-arm observational benchmarking study, a total of 59 community clinicians were trained in the Modular Approach to Therapy for Children (MATCH) treatment program. These clinicians delivered MATCH treatment to 166 youth ages 6 to 17 naturally presenting for psychotherapy services. Clinicians received substantially fewer supports from the treatment developers or research team than in the original MATCH trials and instead relied on explicit process management tools to facilitate implementation. Prior RCTs of MATCH were used to benchmark the results of the current initiative. Client improvement was assessed using the Top Problems Assessment and Brief Problem Monitor. Analysis of client symptom change indicated that youth experienced improvement equal to or better than the experimental condition in published research trials. Similarly, caregiver-reported outcomes were generally comparable to those in published trials. Although results must be interpreted cautiously, they support the feasibility of using process management tools to facilitate the successful implementation of MATCH outside the context of a formal research or funded implementation trial. Further, these results illustrate the value of benchmarking as a method to evaluation industrial implementation efforts.Plain Language Summary: Randomized effectiveness trials are inclusive of clinicians and cases that are routinely encountered in community-based settings, while continuing to rely on the research team for both clinical and administrative guidance. As a result, the field still struggles to understand what might be needed to support sustainable implementation and how interventions will perform when brought to scale in community settings without those clinical trial supports. Alternative approaches are needed to delineate and provide the clinical and operational support needed for implementation and to efficiently evaluate how evidence-based treatments perform. Benchmarking findings in the community against findings of more rigorous clinical trials is one such approach. This paper offers two main contributions to the literature. First, it provides an example of how benchmarking is used to evaluate how the Modular Approach to Therapy for Children (MATCH) treatment program performed outside the context of a research trial. Second, this study demonstrates that MATCH produced comparable symptom improvements to those seen in the original research trials and describes the implementation strategies associated with this success. In particular, although clinicians in this study had less rigorous expert clinical supervision as compared with the original trials, clinicians were provided with process management tools to support implementation. This study highlights the importance of evaluating the performance of intervention programs when brought to scale in community-based settings. This study also provides support for the use of process management tools to assist providers in effective implementation.