55 Clinical Trials for Various Conditions
This research is being done to: * identify any emotional, behavioral or other troubling psychological problems that some people have who are seeking and receiving treatment for heroin or other drug use problems, * learn if providing additional psychiatric treatment services in the ATS drug abuse treatment program is as beneficial for and acceptable to patients as referring them to the Bayview Community Psychiatry Program to get help for their emotional, behavioral and other psychological problems.
The purpose of the present study is to conduct a pilot randomized clinical trial (RCT) of a parent coaching intervention for parents of youth hospitalized for suicidal ideation, suicide attempt(s), or non-suicidal self-injury. Parents will receive either the parent coaching intervention (which includes safety planning and behavioral parenting skills training with a clinician and assistance with linkage to follow-up care by a case manager) or treatment as usual (TAU) for the inpatient unit. The long-term goal of the research is to determine if augmenting standard inpatient treatment with additional parenting intervention improves youth treatment response on suicide-related outcomes (i.e., suicidal ideation, non-suicidal self-injury, and suicide attempts). The goal of this pilot RCT is to collect preliminary data needed for a larger RCT, including feasibility, acceptability, safety, tolerability, engagement of the presumed mechanism of change (changes in parent emotions and behaviors), and signal detection of any changes in youth suicide-related outcomes.
The purpose of the present study is to conduct a pilot randomized clinical trial (RCT) of an 8-10 session DBT-based parenting intervention (DBT PI) plus standard Dialectical Behavior Therapy delivered in the context of an intensive outpatient program (DBT IOP) to DBT IOP alone. The long term goal of the research is to determine if augmenting standard DBT with additional parenting intervention improves youth treatment response on suicide-related outcomes (i.e., suicidal ideation, non-suicidal self-injury and suicide attempts). The goal of this pilot RCT is to collect preliminary data needed for a larger RCT, including feasibility, acceptability, safety, tolerability, engagement of the presumed mechanism of change (changes in parent emotions and behaviors) and signal detection of any changes in youth suicide-related outcomes.
The goal of this study is to determine whether a community-based website that is intended to provide support for adolescents experiencing psychological distress can improve members' mental health outcomes. The investigators want to understand if a digital platform can help young people who are suffering and may be unlikely to access more traditional forms of mental health services.
The primary goal of the proposed research is to assess the effectiveness of the Adolescent Depression Awareness Program (ADAP), a school-based depression education program, in increasing depression literacy and treatment seeking in high school students. The ADAP intervention will be carried out in approximately 60 schools with over 15,000 students. The following are ADAP Implementation Sites: Baltimore Archdiocese High Schools; New Castle County, Delaware; Washtenaw County, Michigan; and York County, Pennsylvania.
It has been shown in the adult literature that smoking is related to depression and visa versa. Not much is known about how this relationship is started or if one perhaps leads to the other. We are performing 1 hour long interviews with adolescents ages 12-19 who meet criteria for major depression and who smoke. They are interviewed along with their parent. Questions center around their view of depression and their history of depression as well as questions around their smoking as well as the interrelationships between the two. Transcripts are made of the interview and are being analyzed for themes.
This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood. By targeting Head Start racially/ethnically diverse preschoolers from low-income backgrounds in both urban and rural areas, this intervention is expected to contribute toward reducing health disparities and promoting health equity, a major priority of the NIH and Healthy People 2030. If effective, it can be scalable to Head Start programs across urban and rural settings nationally with long-term sustainability benefits.
The goal of this study is to test the efficacy of a brief video intervention emphasizing peer inclusion on depression-related stigma and stigma outcomes (e.g., help seeking attitudes, secrecy) among adolescents 14-18. Timely identification and treatment of depression in adolescents is a public health priority. However, most youth with depression do not seek treatment, and stigma has been identified as the primary barrier to help-seeking. Experiments have found brief video-based interventions (BVIs), 1-2 minute videos similar to those viewed by youth on social media platforms, based on the principle of "social contact" with individuals affected by a stigmatized condition, effective in reducing depression-related stigma and increasing help-seeking among adolescents. However, given the extreme time constraints of these videos, optimizing the messaging is paramount. Prior research has indicated that concerns about peer social inclusion are fundamental in shaping stigma among adolescents. In this 3-arm RCT, we will recruit adolescents aged 14-18 using an online crowdsourcing platform, to test the efficacy of a) standard BVI that addresses mental health treatment but does not address concerns about peer inclusion/exclusion, b) novel BVI focused on mental health treatment and peer inclusion, and c) control condition that provides information without social contact.
The goal of this placebo lead-in clinical trial was to test bright light therapy (BLT) in adolescents with depression. The main question\[s\] it aimed to answer were: 1. characterize and define facilitators/barriers to treatment with BLT in adolescents); 2. evaluate the acceptability and feasibility of outpatient BLT in a dose titration protocol; 3. establish an effective, safe and tolerable light dose.
This study will identify components for inclusion in a coping intervention package to reduce mental health problems among children exposed to high interparental conflict after parental separation/divorce. Reappraisal, distraction, and relaxation coping strategies are related to fewer mental health problems among children, making intervention components based on these strategies key candidates for inclusion in an optimized coping intervention. The primary aim is to experimentally assess the main and interactive effects of three digital intervention coping components (reappraisal, distraction, relaxation) on children's coping efficacy, emotional security, and internalizing and externalizing problems. Secondary aims are to assess indirect effects of the intervention components on children's coping efficacy, emotional security, and internalizing and externalizing problems through their cognitive, emotional, and behavioral reactions to post-separation/divorce interparental conflict events.
The goal of this randomized controlled trial is to determine the feasibility, acceptability, and preliminary effects of a web-based parent training (Parenting Wisely) augmented with facilitated parent groups (referred to as PWRT). PWRT is designed to prepare parents for the reintegration of their adolescents in the home after intensive psychiatric residential treatment. Researchers will compare PWRT to treatment as usual to determine whether PWRT effects target mechanisms (i.e., family function, social support, parental self-efficacy, parenting practices) and adolescent outcomes (i.e., internalizing and externalizing behaviors, placement restrictiveness).
The primary aim of this pilot study is to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for symptoms of depression among adolescents being treated in specialty medical care settings at Children's Hospital of Los Angeles (CHLA).
This is a naturalistic treatment and follow-up study of youth with bipolar spectrum disorders (BSDs) across four US sites of The Childhood Bipolar Network (CBN). CBN sites have expertise in diagnosing, assessing, and treating BSDs in youth. The primary aims of this study are to (1) identify and reliably diagnose youth (ages 9 to 19 yrs) with full bipolar disorder (BD) and BSDs, and (2) examine predictors (e.g., mood instability, inflammatory marker C-reactive protein) of clinical outcome over a 12 month period. Participating youth will initially complete a screening that includes a structured diagnostic interview and a baseline blood draw to measure inflammatory processes. Youth with BSD and parents (80 families) will be asked to participate in multiple follow up research visits with interviews, rating instruments, and questionnaires. Per established CBN guidelines, study psychiatrists will provide and track medication management and sites will also track psychosocial treatments. This study ultimately aims to further understanding of best practice pediatric BSD psychiatric and psychosocial treatments and development of a standardized and validated set of clinical tools for patient assessment, diagnosis, and tracking.
The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children's Health System of Texas (CHST).
The present study is a randomized control trial to evaluate the efficacy and effectiveness of a school-based group prevention program (Fuerte) in San Francisco Unified School District Public Schools. In addition, the present study will also inform effective procedures for adaptations of the Fuerte program for other newcomer immigrant youth from non-Latin American countries. Fuerte targets newcomer Latinx immigrant youth (five years or less post arrival in the U.S.) who are at risk of experiencing traumatic stress. In particular, the Fuerte program focuses on increasing youth's mental health literacy, improving their social functioning, and identifying and connecting at-risk youth to specialty mental health services. The program will be implemented by mental health providers from various county community-based organizations, as well as from the SFUSD Wellness Centers, who already offer mental health services in SFUSD schools.
Does Family Centered Treatment (FCT) result in better youth, family, and cost outcomes, as compared to a Level II or Level III out-of-home placement (OHP)? The investigators test the hypotheses that among children/youth authorized to a Level II or Level III out-of-home placement, relative to youth who receive such a placement, those who receive FCT will have: * Better: family functioning and mental/behavioral health outcomes (youth and caregiver). * Lower probability of: being subject of a child protective services report, entering (or re-entering) foster care, being arrested, being retained in grade, being chronically absent (missing \>15 days), dropping out of high school, or receiving an out-of-home placement. * Lower cost of care.
The purpose of this protocol is to employ single case analytic strategies, including a multiple baseline design and novel modeling techniques to identify changes in cross-cutting features of emotional disorders as well as emotional disorder symptoms during the implementation of The Unified Protocol for the Treatment of Emotional Disorders in Adolescents (UP-A). The first aim is to investigate relationships between the use of UP-A treatment components and changes in measures of cross-cutting features of emotional disorders. The second aim is to investigate when and how reductions in symptoms of emotional disorders and presenting problems (i.e., symptoms of anxiety and depression, severity of presenting problems) occur throughout treatment.
Offspring of mothers with Borderline Personality Disorder (BPD) are at serious risk for developing mental illness at every stage of their life, and yet little is known about how this risk is transmitted. This study will leverage Dialectical Behavior Therapy Skills as an experimental intervention to determine if preschool emotion regulation develops more rapidly as a result of improvements in mothers' ability to regulate her own emotions. The knowledge from this study will identify a modifiable pathway by which maternal BPD places offspring at risk for later mental disorders and will quantify how much improvement in children's ability to regulate their emotions can be achieved by treating mothers alone.
This study evaluates the efficacy of the RECAP Mental Health + Academic Program for special education students in behavioral classrooms. The program includes multiple service components: the RECAP classroom mental health curriculum, which develops students' behavioral and social skills; reading intervention; individualized skills training; and parent group. Schools are randomly assigned to the treatment or control group. This two-year multi-component mental health and academic intervention is hypothesized to improve students' mental health, social skills, and academic functioning.
The aim of the present project is to develop and evaluate a novel and brief method of generalizing habituation (i.e., calming down after being upset) from an original learning context in the laboratory to other contexts inside and outside the laboratory. Specifically, the primary aim of this project is to evaluate whether novel habituation reminders (HRs) introduced following personally-relevant emotional stressors reduce acute negative emotions and psychological distress outside of an original learning context. Using a team of basic and applied scientists, over 4 years the investigators expect to screen 420 adult outpatients to enroll 250 study participants who have extreme difficulties with emotion regulation. These 250 participants will be randomly assigned to one of eight experimental groups, with the experimental design leading them through 1 or 2 of 3 project experiments. Actual enrollment: 372 adult outpatients signed consent and enrolled into the study. 222 participants were eligible and began the study. Out of the 222, 210 completed the study (as opposed to the desired 250). Experiment 1 will evaluate whether novel auditory HRs following personally-relevant emotional stressors differentially reduce psychological distress and negative emotions (via self-report and psychophysiology), compared to no HRs, within the same and different lab contexts after a 1 week delay. Experiment 2 will evaluate whether HRs differentially reduce negative emotions, psychological distress, difficulties with emotion regulation, and psychiatric symptoms, compared to sham sounds outside the laboratory across a 1 week period, using 8x daily assessments of distress and emotions and automated HRs/shams when acute negative emotions are present. An automated server and cellular phone system will be used to assess distress and emotional states and to deliver HRs/shams. Experiment 3 will examine the feasibility, acceptability, and preliminary effect size estimates when participants self-initiate the use of HRs in their daily lives across a 2 week period when acute negative emotions are present. The specific randomization rules across the 8 groups are explained in detail in the full protocol . Risks in this study may arise from 1) the assessment interviews and questionnaires, and 2) discussing and hearing self-reported distressing events. Initial analyses will focus on the success of randomization to groups. The investigators will examine group differences on possible covariates (e.g., demographic variables) and those that are different across conditions will be used as covariates. Preliminary analyses will examine distributional properties of primary outcome measures and correlations among outcome measures and possible covariates. The investigators will set alpha at .05 for all analyses of primary hypotheses. To examine the influence of psychiatric symptoms (compared to the HR) on primary outcomes, the investigators will examine the relationship between baseline clinically relevant psychiatric variables (e.g., symptom severity) and changes in SUDS, emotional arousal, and clinical outcomes over time and if appropriate include these variables in primary analyses. Full data analytic plans are described in the full protocol.
The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training. Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.
I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60 children in the comparison condition). II: Finalize therapist training manuals and educational materials to guide selection, training, and supervision of treatment providers.
Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD.
The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. TPI participants will receive four weekly individual virtual sessions of motivational interviewing to promote self-efficacy and mental wellness skills to enhance self-awareness and self-regulation. TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities. * With the assistance of a trained facilitator, participants will be guided to identify a specific goal related to the behavior they want to change. * Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping, accountability, and self-care rewards. * Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire, motivation, and individual responses to stress. Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological (e.g., depression, anxiety, and perceived stress), and socio-emotional (e.g., mood, resilience, social support), and prenatal health behaviors.
Aim: To examine if parental emotion regulation (ER) moderates the response to parent training interventions. H1: Reduced parental ER capacity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD. H2: Increased parental emotional reactivity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.
The primary objective of this research is to examine two brief interventions for depression, Behavioral Activation (BA), and Problem Solving Therapy (PST), to investigate whether exposure to adverse childhood experiences influences change in the hypothesized target treatment mechanisms linked to each intervention. Research suggests that the treatment targets of BA (reward processing) may be well-matched for youths exposed to childhood adversity, due to disruptions in reward that are linked with adversity exposure. The investigators will examine the effects of youths' adverse life experiences on change in reward-related treatment targets in BA, and compare this to change in the treatment targets of PST, executive functioning processes. The first aim is to investigate the effects of childhood adversity on change in target treatment mechanisms in BA and PST. The second aim is to test whether changes in reward processes is specific to BA, and not PST, among youths exposed to adversity. The third aim is to test the match of BA for depression among youths exposed to adversity, by examining whether BA results in greater reductions in depression symptoms among youths with greater adversity exposure. The investigators will also test whether greater change in reward in associated with greater depression symptom reductions in BA, and not PST.
This study aims to better understand how to best help parents of young children with problem behavior. Problem behaviors vary between and within children, but can include inattention/hyperactivity, tantrums, and/or noncompliance.
This study will examine the efficacy of an emotion regulation intervention delivered online to individuals with traumatic brain injury (TBI) with deficits in emotion regulation. 104 subjects will be enrolled and will receive 24, 60-minute emotion regulation skills-training sessions twice a week for 12 weeks, delivered online in a group video-conference with 3-5 other participants. Participants will be asked to complete online surveys, lasting approximately 40-50 minutes, every four weeks during the intervention and the 12-week follow-up phase. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods.
This study fills a notable gap in the transdiagnostic literature by evaluating whether an evidence-based transdiagnostic treatment for emotional disorders such as the Unified Protocol for Children (UP-C) is effective for treating childhood behavior problems.
This study will examine the feasibility of online delivery of emotional regulation training to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online in group modality. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods. Treatment satisfaction and participant subjective experience will also be assessed.