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We call for clinical trials researchers to carefully consider questions about use of intention-to-treat (ITT) analysis and per protocol analysis. We discuss how questions about efficacy and mechanisms of efficacy are appropriately answered through the application of per protocol analysis. ITT analysis is well-suited and appropriate for addressing questions related to treatment effectiveness, typically adherence to the treatment with respect to an outcome. While guided by admirable intentions, ITT analysis is often not guided by the right questions, leading to ITT misapplication. We address additional misconceptions that often lead to ITT misapplication, including issues relating to treatment noncompletion and violation of random assignment. We further highlight future directions and implications, particularly that future clinical child and adolescent research trial designs will be increasingly characterized by hybrid trials that combine elements of efficacy, effectiveness, and implementation research, where ITT and per protocol analysis will be appropriately applied to answer the right questions.
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Among the many social determinants linked to adolescent alcohol use and depression, racial and ethnic discrimination is a prevalent determinant among Latinx adolescents and adults that is largely overlooked in preventive interventions. This study explored the influence of perceived racial and ethnic discrimination on depressive symptoms and alcohol use intentions among Latinx adolescents. Additionally, the study explored the cross-generational effects of how mothers' perceived discrimination impacts the depressive symptoms and alcohol use of the adolescent. The study used a sample of 800 inner-city Dominican and Puerto Rican adolescent-mother dyads (adolescent mean age = 12.42 years, SD = 0.81; mother mean age = 40.55 years, SD = 8.70). Employing a five-wave panel design that followed adolescents from 8th grade to 10th grade, the study found statistically significant mediation pathways which showed that adolescents' self-reported racial and ethnic discrimination experiences were associated with increases in their immediate and long-term depressive symptoms, which in turn were associated with stronger intentions to use alcohol in the future. Further, perceived racial and ethnic discrimination experienced by Latinx mothers was associated with increases in adolescents' intentions to drink alcohol in the future, mediated by the mothers' depressive symptoms and subsequently the adolescents' depressive symptoms. As discussed, these findings have wide-ranging implications for alcohol use prevention programs targeting inner-city Latinx adolescents.
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Depressão , Hispânico ou Latino , Racismo , Humanos , Adolescente , Hispânico ou Latino/psicologia , Feminino , Depressão/etnologia , Masculino , População Urbana , Consumo de Bebidas Alcoólicas/etnologia , Consumo de Bebidas Alcoólicas/psicologia , Adulto , Criança , IntençãoRESUMO
BACKGROUND: Depression continues to be an ongoing threat to adolescent well-being with Black adolescents being particularly vulnerable to greater burdens of depression as well as lower mental health service utilization. Black adolescents are likely to have untreated depression due to social network influences, varied perceptions of services and providers, or self-stigma associated with experiencing depressive symptoms. Furthermore, if or when treatment is initiated, low engagement and early termination are common. To address this gap, a trial is being conducted to preliminarily test the effectiveness of an engagement intervention targeting Black adolescents with depression in school mental health services in New York City. METHODS: A total of 60 Black middle and high school adolescents displaying depressive symptoms are equally randomized (based on school site) to the treatment arms. Both trial arms deliver Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), a time-limited, evidence-based treatment for depression. Additionally, one arm pairs IPT-A with a brief, multi-level engagement intervention, the Making Connections Intervention (MCI), involving adolescents, caregivers, and clinicians. Outcomes of interest are group differences in depression and suicide ideation, adolescent and caregiver engagement, and mental health service use. DISCUSSION: This trial will serve as an efficacy assessment of the MCI among a sample of Black adolescent students with depressive symptoms. Clinical and implementation results will be used to inform future research to further test the MCI intervention in a larger sample. TRIAL REGISTRATION: Registered by ClinicalTrials.gov on May 3, 2019, identifier: NCT03940508.
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Psicoterapia Interpessoal , Serviços de Saúde Mental , Serviços de Saúde Mental Escolar , Humanos , Adolescente , Depressão/diagnóstico , Depressão/prevenção & controle , Prevenção do Suicídio , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Using a stress process lens, this paper considers the interrelationship between individual and family-level stress exposures and military spouse resources, including problem-solving appraisals and problem-solving support (PSS), and their associations with posttraumatic stress symptoms (PTSS) among both partners in military marital dyads. The study employs data from the Millennium Cohort Family Study, a longitudinal survey of married military dyads, with an initial panel of 9,872 spouses enroled from 2011 to 2013. A structural equation model explored the associations between service member and spouse childhood maltreatment exposure, nonmilitary and military stressors, as well as interactions with spouse resources on self-reported PTSS among both service member (SM) and spouse (SP). Among our findings, spouse childhood maltreatment muted later self-reported problem-solving appraisal and support. Spouse resources, in turn, had both protective (problem-solving appraisal) and promotive (problem-solving support) effects on PTSS for both service members and spouses. These findings emphasise the central role of spouses in military families, as more psychological resources among spouses appeared to buffer against the deleterious effects of stress exposure on both their own and their partners mental health.
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Militares , Resolução de Problemas , Apoio Social , Cônjuges , Transtornos de Estresse Pós-Traumáticos , Humanos , Cônjuges/psicologia , Militares/psicologia , Feminino , Masculino , Transtornos de Estresse Pós-Traumáticos/psicologia , Adulto , Estudos Longitudinais , Estresse Psicológico/psicologia , Pessoa de Meia-IdadeRESUMO
PURPOSE: Young adults from minoritized racial and ethnic groups have lower rates of engagement in treatment for serious mental illnesses (SMI). Previous research suggests a relationship between ethnic identity development and engagement in mental health services, but it remains unclear how a sense of belonging and attachment to one's racial and ethnic group influences participation in treatment among young adults with SMI. METHODS: Bivariate analyses and structural equation modeling (SEM) were used to examine whether ethnic identity was associated with treatment engagement (attendance and investment in treatment) and how ethnic identity might influence engagement through theoretical proximal mediators. Eighty-three young adults with SMI (95% from minoritized racial and ethnic groups) were recruited from four outpatient psychiatric rehabilitation programs and assessed at least 3 months after initiating services. RESULTS: Stronger ethnic identity was associated with greater investment in treatment but not with treatment attendance. The SEM analysis indicated that stronger ethnic identity may improve investment in treatment by enhancing hope (0.53, p < .05) and beliefs that mental health providers are credible (0.32, p < .05), and by increasing self-efficacy (-0.09, p < .05). Proximal mediators of engagement were associated with investment in treatment (hope and credibility, p < .05, and self-efficacy p = 0.055). CONCLUSIONS: Findings provide preliminary evidence of an empirical and theoretical relationship between ethnic identity development and engagement in treatment among young adults with SMI. Assessment and strengthening of a young person's ethnic identity may be a promising approach for improving their engagement in services and reducing inequities in their care.
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Disparities in posttraumatic stress symptoms (PTSS) have been observed among military service members (SMs) and spouses (SPs) compared to their civilian peers, but exposure to military stressors does not adequately explain observed differences. Using a stress process framework, this study considered the associations between early and recent military and nonmilitary stressors and PTSS among SMs and SPs. We analyzed data from 3,314 SM-SP dyads in the Millennium Cohort and Millennium Cohort Family Studies. Accounting for covariates, multiple linear regression and dominance analyses were employed to consider the effects of SM and SP childhood maltreatment, recent nonmilitary stressors (e.g., financial difficulties), and recent military stressors (e.g., deployment) on their own and their partner's self-reported PTSS. For both SMs and SPs, childhood maltreatment was the strongest predictor of their own PTSS, followed by nonmilitary stressors. Couple crossover dynamics were evident as SP maltreatment and nonmilitary stressors significantly predicted SM PTSS, and SM maltreatment predicted SP PTSS. Maltreatment also multiplied the effects of SM, product term B = 0.92, p = .031, and SP, product term B = 0.75, p = .004, nonmilitary stressors. The findings emphasize the essential role of exposure to early adversity in understanding PTSS among SMs and SPs, as childhood maltreatment strongly predicted PTSS and exacerbated the effects of other stressors on PTSS. Providers should assess for early adversity among both SMs and SPs and consider the provision of services at the couple level given the potential for the transmission of stress within couples.
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BACKGROUND: Despite growing recognition of the importance of fathers in child abuse risk, the field of perinatal home visitation has only begun to consider fathers' roles in the implementation of such services. OBJECTIVES: This study examines the effectiveness of Dads Matter-HV ("DM-HV"), a father-inclusion enhancement to home visitation, and hypothesized mediators of impact. METHODS: A multisite cluster randomized controlled trial was conducted with 17 home visiting program teams serving 204 families across study conditions. Program supervisors and their teams were randomized to deliver home visiting services plus DM-HV enhanced services (intervention) or home visiting services alone (control). Data were collected at three time points: baseline, 4 months post-baseline immediately following the intervention, and 12 months post-baseline. We employed structural equation modeling to estimate the effect of the intervention on physical child abuse risk and to trace hypothesized mediators, including the quality of the father-worker relationship, parents' partner support and abuse, and the timing of service initiation. RESULTS: Results indicated that the DM-HV enhancement improved home visitor relationships with fathers, but only for families receiving services initiated postnatally. For these families, the improved quality of the father-worker relationship predicted improved parents' support of one another and reduced bidirectional mother-father partner abuse at 4-month follow-up, which in turn lowered maternal physical child abuse risk and paternal physical child abuse risk at 12-month follow-up. CONCLUSIONS: DM-HV can strengthen the impact of home visitation services on physical child abuse risk for families when services are initiated postnatally.
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Maus-Tratos Infantis , Maus-Tratos Conjugais , Masculino , Feminino , Gravidez , Criança , Humanos , Maus-Tratos Infantis/prevenção & controle , Mães , Relações Familiares , Pai , Visita Domiciliar , Poder FamiliarRESUMO
OBJECTIVE: This study tested how individuals anticipate they will respond to opportunities to engage in simultaneous alcohol and marijuana (SAM) use. METHODS: Two studies utilizing a within-subjects design were conducted. Study 1 was conducted in Spring 2021 and a replication (Study 2) was conducted in Fall 2021. Participants were presented with pairs of scenarios. One scenario pair compared how willing participants expected to be to get drunk if they were sober vs. high. Another pair compared how willing participants would be to take a hit of marijuana if they were sober vs. drunk. College attending young adults (Study 1: N = 173; female = 81%; Study 2: N = 212; female = 49.1%) with varying degrees of substance use experience were recruited. RESULTS: In Study 1 participants reported greater willingness to get drunk when sober than when high. This was qualified by a statistically significant interaction whereby differences were greater among those who had more experience with past 30-day heavy drinking. Similar findings emerged for willingness to use marijuana. Participants anticipated greater willingness to use marijuana when sober than when drunk. This was also qualified by a statistically significant interaction whereby differences were greater among experimental or established users of marijuana than among abstainers. Study 2 findings replicated those from Study 1. CONCLUSIONS: College attending young adults state greater willingness to remain under the influence of one substance than to engage in SAM use when opportunities arise. Simultaneous use of alcohol and marijuana among college students is likely an exception, not the rule. Implications for prevention are discussed.
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Intoxicação Alcoólica , Alcoolismo , Cannabis , Alucinógenos , Fumar Maconha , Uso da Maconha , Transtornos Relacionados ao Uso de Substâncias , Adulto Jovem , Humanos , Feminino , Consumo de Bebidas Alcoólicas , EtanolRESUMO
OBJECTIVE: Cognitive behavioral therapy (CBT) is efficacious for hoarding disorder (HD), though results are modest. HD patients show an increase in activity in the dorsal anterior cingulate cortex (dACC) when making decisions. The aim of this study is to determine whether CBT's benefits follow improvements in dACC dysfunction or abnormalities previously identified in other brain regions. METHOD: In this randomized clinical trial of 64 treatment-seeking HD patients, patients received group CBT, delivered weekly for 16 weeks, versus wait list. Functional magnetic resonance imaging was used to examine neural activity during simulated decisions about whether to acquire and discard objects. RESULTS: During acquiring decisions, activity decreased in several regions, including right dorsolateral prefrontal, right anterior intraparietal area, both right and left medial intraparietal areas, left and right amygdala, and left accumbens. During discarding decisions, activity decreased in right and left dorsolateral prefrontal, right and left rostral cingulate, left anterior ventral insular cortex, and right medial intraparietal areas. None of the a priori brain parcels of interest significantly mediated symptom reduction. Moderation effects were found for left rostral cingulate, right and left caudal cingulate, and left medial intraparietal parcels. CONCLUSIONS: Therapeutic benefits of CBT for HD do not appear to be mediated by changes in dACC activation. However, pretreatment dACC activation predicts outcome. Findings suggest the need to re-evaluate emerging neurobiological models of HD and our understanding of how CBT affects the brain in HD, and perhaps shift focuses to new neural target discovery and target engagement trials. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
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Terapia Cognitivo-Comportamental , Transtorno de Acumulação , Humanos , Transtorno de Acumulação/terapia , Transtorno de Acumulação/psicologia , Encéfalo/diagnóstico por imagem , Giro do Cíngulo/diagnóstico por imagem , Tomada de Decisões/fisiologiaRESUMO
Importance: Studies linking the quality of parent-adolescent relationships with young adult health outcomes could inform investments to support these complex relationships. Objective: To evaluate whether consistently measured, modifiable characteristics of parent-adolescent relationships are associated with young adult health across multiple domains. Design, Setting, and Participants: This cohort study used data from waves I (1994-1995; ages 12-17 years) and IV (2008-2009; ages 24-32 years) of the US National Longitudinal Study of Adolescent to Adult Health. Of 20â¯745 adolescents enrolled in wave I, 15â¯701 of 19â¯560 who were eligible completed wave IV (response rate, 80.3%). Data analyses were conducted from February 2019 to November 2020. Exposures: Parental warmth, parent-adolescent communication, time together, relationship and communication satisfaction, academic expectations, and maternal inductive discipline as reported at wave I by adolescent participants. Main Outcomes and Measures: Wave IV participant-reported self-rated health, depression, stress, optimism, nicotine dependence, substance abuse symptoms (alcohol, cannabis, or other drugs), unintended pregnancy, romantic relationship quality, physical violence, and alcohol-related injury. Separate regression models were run for mother-adolescent and father-adolescent relationships while controlling for age, biological sex, race and ethnicity, parental educational level, family structure, and child maltreatment experiences. Results: A total of 10â¯744 participants (mean [SD] age at wave IV, 28.2 [1.8] years; 52.0% female; 67.3% non-Hispanic White) and 8214 participants (mean [SD] age at wave IV, 28.2 [1.8] years; 50.8% female; 71.9% non-Hispanic White) had valid sampling weights and complete data for mother-adolescent and father-adolescent relationship characteristics, respectively. Adolescents who reported higher levels of mother-adolescent warmth (ß = 0.11 [95% CI, 0.06-0.15]), communication (ß = 0.02 [95% CI, 0.00-0.04]), time together (ß = 0.07 [95% CI, 0.05-0.09]), academic expectations (ß = 0.05 [95% CI, 0.02-0.08]), relationship or communication satisfaction (ß = 0.07 [95% CI, 0.04-0.10]), and inductive discipline (ß = 0.03 [95% CI, 0.01-0.05]) reported significantly higher levels of self-rated general health in young adulthood. Adolescents who reported higher levels of father-adolescent warmth (ß = 0.07 [95% CI, 0.03-0.11]), communication (ß = 0.03 [95% CI, 0.01-0.05]), time together (ß = 0.06 [95% CI, 0.03-0.08]), academic expectations (ß = 0.04 [95% CI, 0.01-0.06]), and relationship satisfaction (ß = 0.07 [95% CI, 0.04-0.10]) also reported significantly higher levels of self-rated general health in young adulthood. Adolescents reporting higher levels of all exposures also reported significantly higher levels of optimism and romantic relationship quality in young adulthood (ß coefficient range, 0.02 [95% CI, 0.00-0.04] to 0.24 [95% CI, 0.15-0.34]) and lower levels of stress and depressive symptoms (ß coefficient range, -0.07 [95% CI, -0.12 to -0.02] to -0.48 [95% CI, -0.61 to -0.35]). Higher levels of parental warmth, time together, and relationship or communication satisfaction were significantly associated with lower levels of nicotine dependence (odds ratio range, 0.78 [95% CI, 0.72-0.85] to 0.89 [95% CI, 0.81-0.98]) and substance abuse symptoms (incidence rate ratio range, 0.60 [95% CI, 0.50-0.73] to 0.94 [95% CI, 0.89-0.99]), as well as lower odds of unintended pregnancy (odds ratio range, 0.81 [95% CI, 0.74-0.88] to 0.93 [95% CI, 0.86-0.99]). Patterns were less consistent for physical violence and alcohol-related injury. Characteristics of mother-adolescent and father-adolescent relationships were similarly associated with young adult outcomes. Conclusions and Relevance: The findings of this cohort study suggest that adolescents' positive perceptions of their relationships with their mothers and fathers are associated with a wide range of favorable outcomes in young adulthood. Investments in improving parent-adolescent relationships may have substantial benefits for young adult population health.
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Mães , Pais , Gravidez , Criança , Humanos , Adolescente , Feminino , Adulto Jovem , Adulto , Lactente , Masculino , Estudos Longitudinais , Estudos de Coortes , PaiRESUMO
Transition-age youth with mental health conditions from low socio-economic backgrounds often drop out of mental health services and, as such, do not receive therapeutic doses of treatment. Cornerstone is an innovative team-based, multi-component intervention designed to address the clinical needs of this understudied population through coordination and extensive provision of services in vivo (in the community). The present study used a convergent parallel mixed-methods design. Researchers collected quantitative and qualitative data during a small developmental trial, analyzing the two data types independently and then exploring them side-by-side to evaluate feasibility, acceptability, and preliminary implementation. Semi-structured interviews and quantitative surveys were conducted with transition-age youth, clinic staff, and policy makers. Qualitative interview guides were developed using the Consolidated Framework for Implementation Research to build understanding on implementation determinants alongside feasibility and acceptability. A two-group preliminary randomized trial was conducted to assess feasibility outcomes, such as recruitment, randomization, measurement performance, and trends in pre- to post- outcomes. Using grounded theory coding techniques, transcripts were coded by multiple coders, and themes were identified on acceptability and implementation. The team recruited fifty-six transition-age youth. Randomization was used in the study and the intervention was provided without incident. Results suggest individual components with both the social worker and mentor were more acceptable to participants than group-based approaches. Thematic analyses revealed themes associated with the inner, outer, and policy contexts describing a range of critical implementation determinants. Findings suggest that Cornerstone is feasible, acceptable, and promising for transition-age youth. It represents an innovative multi-component intervention worth exploring for transition-age youth with mental health conditions in a larger efficacy trial.Trial registration: The trial was registered at ClinicalTrials.gov (NCT02696109) on 22 April 16, Protocol Record R34-MH102525-01A1, New York University, Cornerstone program for transition-age youth with serious mental illness: study protocol for a randomized controlled trial.
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Transtornos Mentais , Serviços de Saúde Mental , Adolescente , Humanos , Estudos de Viabilidade , Transtornos Mentais/terapia , Transtornos Mentais/psicologia , Saúde Mental , Inquéritos e QuestionáriosRESUMO
Although youth anxiety treatment research has focused largely on severe and impairing anxiety levels, even milder anxiety levels, including levels that do not meet full criteria for a diagnosis, can be impairing and cause for concern. There is a need to develop and test viable treatments for these concerning anxiety levels to improve functioning and reduce distress. We present findings from a randomized controlled efficacy trial of attention bias modification treatment (ABMT) and attention control training (ACT) for youths with concerning anxiety levels. Fifty-three clinic-referred youths (29 boys, M ageâ¯=â¯9.3 years, SD ageâ¯=â¯2.6) were randomized to either ABMT or ACT. ABMT and ACT consisted of attention-training trials in a dot-probe task presenting angry and neutral faces; probes appeared in the location of neutral faces in 100% of ABMT trials and 50% of ACT trials. Independent evaluators provided youth anxiety severity ratings; youths and parents provided youth anxiety severity and global impairment ratings; and youths completed measures of attention bias to threat and attention control at pretreatment, posttreatment, and 2-month follow-up. In both arms, anxiety severity and global impairment were significantly reduced at posttreatment and follow-up. At follow-up, anxiety severity and global impairment were significantly lower in ACT compared with ABMT. Attention control, but not attention bias to threat, was significantly improved at follow-up in both arms. Changes in attention control and attention focusing were significantly associated with changes in anxiety severity. Findings support the viability of attention training as a low-intensity treatment for youths with concerning anxiety levels, including levels that do not meet full criteria for a diagnosis. Superior anxiety reduction effects in ACT highlight the critical need for mechanistic research on attention training in this population.
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Viés de Atenção , Terapia Cognitivo-Comportamental , Masculino , Humanos , Adolescente , Criança , Pré-Escolar , Resultado do Tratamento , Transtornos de Ansiedade/terapia , Ansiedade/terapiaRESUMO
Engaging fathers early in child and family services has the potential to promote positive father contributions towards positive child development, improve family well-being, and enhance service outcomes over time. However, low father engagement in child and family services remains a persistent problem, and few interventions designed to improve father engagement in these services have been rigorously tested. The current study assesses the effect of a service enhancement intervention called Dads Matter-Home Visiting (Dads Matter-HV) on biological father engagement in home visiting services when compared to home visiting services delivered as usual. To assess the efficacy of the Dads Matter-HV intervention, the research team used a stratified cluster randomized clinical trial design with five agencies delivering early home visiting service programs. Seventeen teams across the five agencies were randomly assigned to either the control group condition (i.e., standard home visiting services as usual) or the intervention condition (i.e., Dads Matter-HV). Data were collected from a total of 204 families at baseline, 4 months postbaseline (92% retention rate), and 12 months postbaseline (84% retention rate). The results suggest that Dads Matter-HV increases biological father engagement for fathers who begin services in the postnatal period, but reduces engagement when services are initiated prenatally. Findings suggest some pathways through which the intervention effects engagement.
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Desenvolvimento Infantil , Pai , Criança , Masculino , Humanos , Visita Domiciliar , Grupos ControleRESUMO
OBJECTIVE: Serious mental illnesses (SMI) commonly emerge during young adulthood. Effective treatments for this population exist; however, engagement in treatment is a persistent challenge. This study examines the impact of Just Do You (JDY), an innovative intake-focused intervention designed to improve engagement in treatment and enhance personal recovery. METHODS: The study used a parallel group randomized trial to examine if and how JDY improved recovery among 121 young adults with SMI from low-resourced communities referred to personalized recovery-oriented services (PROS). Measures of engagement (buy-in and attendance) and personal recovery in this pilot study were assessed at baseline and 3-month follow-up. RESULTS: Participants in JDY reported more positive engagement outcomes; that is, relative to the control group they reported higher past two week attendance (b = 0.72, p < 0.05, Cohen's d = 0.56) and higher levels of buy-in to treatment (b = 2.42, p < 0.05, Cohen's d = 0.50). JDY also impacted young adults' personal recovery (b = 0.99, p < 0.05, Cohen's d = 1.15) and did so largely by increasing their level of buy-in to the treatment program. CONCLUSION: This study suggests that an engagement intervention for young adults that orients, prepares, and empowers them to be active and involved in the larger treatment program makes a difference by improving engagement and enhancing recovery. Data also support conceptualizing and examining engagement beyond treatment attendance; in this study what mattered most for recovery was the level of buy-in to treatment among young adults.
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Transtornos Mentais , Adulto , Humanos , Adulto Jovem , Transtornos Mentais/terapia , Projetos Piloto , Resultado do TratamentoRESUMO
BACKGROUND: Urologic chronic pelvic pain syndrome (UCPPS) encompasses several common, costly, diagnoses including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome that are poorly understood and inadequately treated with conventional medical therapies. Behavioral strategies, recommended as a first-line treatment for managing symptoms, are largely inaccessible, time and labor intensive, and technically complex. The Easing Pelvic Pain Interventions Clinical Research Program (EPPIC) is a clinical trial examining the efficacy of low-intensity cognitive behavioral therapy (Minimal Contact CBT or MC-CBT) for UCPPS and its durability 3 and 6 months post treatment. Additional aims include characterizing the operative processes (e.g., cognitive distancing, context sensitivity, coping flexibility, repetitive negative thought) that drive MC-CBT-induced symptom relief and pre-treatment patient variables that moderate differential response. METHODS: UCPPS patients (240) ages 18-70 years, any gender, ethnicity, and race, will be randomized to 4-session MC-CBT or a credible, non-specific education comparator (EDU) that controls for the generic effects from simply going to treatment. Efficacy assessments will be administered at pre-treatment, 2 weeks, and 3 and 6 months post treatment-week acute phase. A novel statistical approach applied to micro-analytic mediator assessment schedule will permit the specification of the most effective CBT component(s) that drive symptom relief. DISCUSSION: Empirical validation of a low-intensity self-management therapy transdiagnostic in scope has the potential to improve the health of chronic pelvic pain patients refractory to medical therapies, reduce social and economic costs, conserve health care resources, as well as inform evidence-based practice guidelines. Identification of change mechanisms and moderators of treatment effects can provide proactive patient-treatment matching fundamental to goals of personalized medicine. TRIAL REGISTRATION: Clinicaltrials.gov NCT05127616. Registered on 9/19/21.
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Dor Crônica , Terapia Cognitivo-Comportamental , Cistite Intersticial , Doenças dos Genitais Femininos , Prostatite , Doenças Vasculares , Adolescente , Adulto , Idoso , Dor Crônica/diagnóstico , Dor Crônica/psicologia , Dor Crônica/terapia , Cistite Intersticial/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor Pélvica/diagnóstico , Dor Pélvica/terapia , Prostatite/diagnóstico , Prostatite/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Síndrome , Adulto JovemRESUMO
We conducted a dismantling design treatment study comparing individual CBT, CBT targeting parents' reinforcement skills (CBT+Reinf), and CBT targeting parents' relationship skills (CBT+ Relat) in 341 youths with primary anxiety diagnoses. At posttreatment, youths in CBTs with parent involvement had lower anxiety than youths in CBT. At 12-month follow-up, youths in CBT+Relat maintained lower anxiety relative to CBT. At posttreatment, negative reinforcement was significantly lower in CBT+Reinf than CBT+Relat and CBT; negative reinforcement partially mediated youth anxiety reduction. Reducing parental negative reinforcement in CBT+Reinf was associated with lower parental psychological control which also partially mediated youth anxiety reduction. Some of these mediational dynamics continued through follow-up. Targeting concrete behavioral parenting skills, especially negative reinforcement, produced treatment specificity and partial mediation relative to less concrete targeting, and enhanced CBT. Findings highlight complexities in identifying mechanisms through which targeting of parenting skills produces youth anxiety reduction and suggest avenues for future research.
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BACKGROUND: Child maltreatment recidivism substantially increases the likelihood of adverse life outcomes, but there is little evidence that family preservation services are effective at reducing recidivism. Mothers in child welfare have very high rates of trauma exposure; maternal post-traumatic stress disorder (PTSD) is an intervention target that has the potential to reduce abuse and neglect. The Safe Mothers, Safe Children (SMSC) intervention program involves the delivery of an innovative combination of interventions, including Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT). The combined intervention, Parenting-STAIR (P-STAIR), targets maternal PTSD and comorbid depression symptoms to reduce the adverse effects of PTSD on parenting, improve positive parenting skills, and prevent maltreatment recidivism. METHODS: This study is a two-arm randomized controlled trial: P-STAIR (23 sessions) versus supportive counseling (23 sessions). Participants are mothers receiving child welfare family preservation services (FPS), with a child in the age range of 1-8 years old and meeting diagnostic criteria for PTSD (with/without depression). Clinical assessment occurs at pre-treatment (baseline), two in-treatment assessments (mid-assessment #1 after module 9 and mid-assessment #2 after module 15), post-treatment, and at a 6-month follow-up. Recidivism will be measured using the New York State Child Welfare Registry (NYSCWR). We will enroll a total of 220 participants over 4 years: half (N = 110) randomly assigned to the P-STAIR condition and half (N = 110) to the supportive counseling condition. DISCUSSION: This is the first RCT to investigate the efficacy of P-STAIR. The findings for the trial have the potential to contribute to the expansion of evidence-based practices for maternal PTSD, maltreatment, and child welfare.
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Maus-Tratos Infantis , Relações Mãe-Filho , Reincidência , Transtornos de Estresse Pós-Traumáticos , Criança , Maus-Tratos Infantis/prevenção & controle , Maus-Tratos Infantis/psicologia , Serviços de Proteção Infantil , Pré-Escolar , Feminino , Humanos , Lactente , Relações Mãe-Filho/psicologia , Mães/psicologia , New York , Poder Familiar/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Reincidência/prevenção & controle , Transtornos de Estresse Pós-Traumáticos/complicações , Transtornos de Estresse Pós-Traumáticos/diagnóstico , Transtornos de Estresse Pós-Traumáticos/prevenção & controle , Transtornos de Estresse Pós-Traumáticos/terapiaRESUMO
OBJECTIVE: Although implementation science has taken hold in many areas of psychiatric services research, a need remains for developing effective, low-cost interventions for specific subpopulations with mental health conditions. The experimental therapeutics approach has gained momentum as a framework for developing effective interventions. However, few studies have taken steps to rigorously apply experimental therapeutics. This article provides a blueprint for applying this approach. METHODS: A focused literature review was conducted to document the frequency of the application of experimental therapeutics among articles published between 2011 and 2021 in some of the American Psychiatric Association's journals. Independently of the review, the authors delineated a four-component approach for applying experimental therapeutics in research and present practical, innovative strategies to advance psychiatric services research. RESULTS: The four-component approach includes outlining prerequisites, identifying target mechanisms, proposing intervention strategies to address target mechanisms, and using advanced analytic methods. The strategies described for each component are not exhaustive; rather, they suggest promising avenues for research that can lead to more effective interventions and deeper understanding of how, and for whom, an intervention works. CONCLUSIONS: The application of experimental therapeutics in psychiatric services research can lead to increased development, refinement, and implementation of effective interventions for specific populations or conditions.
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Transtornos Mentais , Humanos , Transtornos Mentais/terapia , Estados UnidosRESUMO
BACKGROUND: Medical gender affirmation (i.e., hormone use) is one-way transgender (trans) people affirm their gender and has been associated with health benefits. However, trans people face stigmatization when accessing gender-affirming healthcare, which leads some to use non-prescribed hormones (NPHs) that increase their risk for poor health. PURPOSE: We examined whether healthcare policy stigma, as measured by state-level trans-specific policies, was associated with NPHs use and tested mediational paths that might explain these associations. Because stigmatizing healthcare policies prevent trans people from participation in healthcare systems and allow for discrimination by healthcare providers, we hypothesized that healthcare policy stigma would be associated with NPHs use by operating through three main pathways: skipping care due to anticipated stigma in healthcare settings, skipping care due to cost, and being uninsured. METHODS: We conducted analyses using data from the 2015 U.S. Transgender Survey. The analytic sample included trans adults using hormones (N = 11,994). We fit a multinomial structural equation model to examine associations. RESULTS: Among trans adults using hormones, we found that healthcare policy stigma was positively associated with NPHs use and operated through insurance coverage and anticipating stigma in healthcare settings. The effect sizes on key predictor variables varied significantly between those who use supplemental NPHs and those who only use NPHs suggesting the need to treat NPHs use as distinct from those who use supplemental NPHs. CONCLUSIONS: Our work highlights the importance of healthcare policy stigma in understanding health inequities among trans people in the USA, specifically NPHs use.