38 Clinical Trials for Various Conditions
This pilot will be used for academic research, in hopes of developing effective treatments for early childhood anxiety. The intervention is an adaptation of Parent-Child Interaction Therapy (PCIT). PCIT is an evidence-based intervention, rooted in attachment and social learning theory. In recent years, researchers have successfully adapted PCIT to address anxiety in a clinical setting (PCIT-CALM). In this pilot study, we will be applying the PCIT-CALM intervention in the school setting, emphasizing teachers as a therapeutic agent of change. PCIT is unique because the child's caregiver is trained on how to use therapeutic techniques, and then receives live coaching via a "bug in the ear" as they learn to implement the new skills. In this pilot study, both parents and teachers will be taught skills to create a therapeutic relationship and address anxiety. After these teaching sessions, the child's teacher will receive coaching in the classroom to implement the skills. The intervention will last approximately 12 weeks.
Treatment of every child with anxiety disorder begins with the question of which treatment to start first. Both fluoxetine and CBT have strong empirical support, but few studies have compared their initial effectiveness head-to-head, and none has investigated what to do if the treatment tried first isn't working well-whether to optimize the treatment already begun or to add the other treatment. Aims of the study: 1. The study will assess whether beginning with Cognitive Behavioral Therapy (CBT) or fluoxetine medication is more effective in improving youth-rated anxiety symptoms over the 24-week intervention 2. If the initial intervention fails to induce clinical remission by week 12, the study will assess whether optimizing the initial treatment modality alone, or adding the other modality to the first, yields better symptom improvement by week 24 3. The study will assess whether one sequence of treatment modalities - i.e., CBT followed by optimized CBT; CBT followed by optimized CBT+ medication; medication followed by optimized medication; medication followed by optimized medication + CBT -- is significantly better or worse than predicted from the two main effects 4. The study will assess the stability of treatment response for ≥12 months following completion of the 24-week trial
This study aims to investigate whether a parent-based treatment for childhood anxiety disorders engages child brain circuitry implicated in children's reliance on parents to reduce anxiety (R61), and whether change in child brain circuitry is associated with reduction in child anxiety (R33).
Anxiety disorders are among the most common psychological disorders, with prevalent onset in childhood and adolescence. While cognitive behavioral therapy (CBT) is considered the first-line treatment for pediatric anxiety, significant barriers remain in accessing CBT and other evidence-based treatments (EBTs), and credible self-help resources based in EBT concepts. This study evaluates a family-guided CBT game application (Anchors App), targeted to children ages 6-11 and their families, which focuses on delivering adaptive CBT-based coping skills to those who have sub-clinical to mild anxiety and related symptoms in a convenient and portable platform. Anchors App will be evaluated in two forms (standard and "parent-enhanced") in comparison to use of a self-help book or waitlist control. The rapid advancements in technology allows richer interactive capacity, content scalability, customizability, and subscription to a broader range of content, which this app capitalizes on in order to increase access to CBT skill concepts directly to pediatric stakeholder populations. If found to be effective, Anchors App has the opportunity to promote engagement of EBT concepts in every-day use through smartphone technology, and will change the landscape of mental health prevention and early intervention for children and families.
Clinically significant anxiety affects up to 20% of preschool-aged children and often fails to respond to currently available treatments. Emerging science suggests that increasing brain capacity for "effortful control" (EC) may help anxious children to regulate emotion and behavior to improve outcomes. Thus, in the proposed study, children will be trained on EC tasks (including selective attention, response inhibition, etc.) to increase capacity for effortful control (EC) over fear behaviors. To determine whether EC training improves brain capacity to regulate fear, investigators will assess neurophysiological and behavioral indices of effortful control and fear reactivity before and after this training.
This trial examines the effectiveness of training pediatric primary care providers (nurse practitioners, doctors) to use of strategies that enhance family/youth empowerment and engagement during office visits for children with mild to moderate problems with anxiety. Children coming for routine care at one clinic are screened for anxiety symptoms and seen by either a specially trained provider or one of the clinic's other regular staff members.
Childhood anxiety disorders are very common, carry tremendous personal and societal costs, frequently do not respond adequately to treatment, and involving parents in treatment has so far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific mechanisms of change that are not targeted in direct child treatment, and to identify markers of who is most likely to benefit from parent intervention. This study is an explanatory clinical trial of a parent based intervention and of cognitive behavioral therapy, and an investigation of biological and behavioral moderators of treatment response.
The primary goal of this research study is to develop an interactive smartphone app that could be used to increase the effectiveness of talk therapy such as cognitive behavioral therapy (CBT) for child anxiety.
This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT) program for children with anxiety disorders in community health centers. The first phase of the study will offer insight into the feasibility of providing this intervention in community health centers, while the second phase will compare CCBT to treatment as usual.
This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.
Anxiety is a common and impairing problem for children. The principle treatment for pediatric anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise called exposures. While exposures are effective, some feared situations cannot be confronted in a clinician's office (e.g., heights, public speaking, storms). This poses a logistical challenge in treatment that: (1) takes time away from patient care, (2) leads clinicians to rely on imagined exposures, and/or (3) requires families to complete exposures outside of the therapy visits. This creates a burden for clinicians and families, and impedes treatment success. Immersive virtual reality (VR) presents an innovative solution that allows children to face fears without leaving the clinician's office. While VR has been used to distract children during painful medical procedures, it has not been well examined as a primary treatment for pediatric anxiety. This study proposes to examine the effectiveness and acceptability of using immersive VR exposures to treat children and adolescents with specific phobias.
The proposed study is a one group pilot to assess the feasibility and acceptability of an 8-session intervention (STRONGer Together) for children between 8 - 12 years of age with asthma and anxiety/depressive symptoms.
Children with a chronic condition are at a significantly higher risk for anxiety and depression than those without a chronic condition. Asthma is the most common childhood chronic condition. Children with asthma and co-morbid anxiety and/or depression are at risk of poor health outcomes. The purpose of this study is to evaluate the effects of a manualized cognitive behavior skills-building intervention on key physical and mental health outcomes in 8 to 12-year old children with persistent asthma and co-morbid anxiety and/or depression. The results of this study will inform a large scale randomized controlled trial to fully test this needed intervention. COPE (Creating Opportunities for Personal Empowerment), developed by Dr. Melnyk, is a manualized intervention that has been implemented with children, adolescents, and young adults. COPE is a cognitive behavior skills-building program based on cognitive behavior theory. Results from previous studies using COPE have shown consistent decreases in anxiety and depression as well as an increase in healthy lifestyle behaviors in youth with elevated anxiety and depressive symptoms in inner city and rural settings, youth with obesity, and teens experiencing chronic recurrent headaches. However, the COPE program has never been adapted and tested with children who have persistent asthma. This study proposes to test an adaptation of this evidence-based program, "COPE for Asthma," with 8 to 12-year-old children with persistent asthma and elevated anxiety and/or depressive symptoms. COPE for Asthma combines components of asthma education with cognitive behavioral skills. This novel adaptation could fill a gap in research by providing a scalable intervention for this highly vulnerable population.
The purpose of this study is to examine whether an integrative group-based intervention will help children experiencing psychological and physical distress. Children, ages 10 to 12, will be recruited for participation in this therapeutic group. Eligible and consenting participants will be randomized to a wait-list control group or the group intervention. The group intervention will take place over a 12-week period, during which participants will attend a weekly coping skills group that integrates yoga-based practices (such as yoga poses, mindfulness, self-acceptance, breath work) with cognitive-behavioral principles (such as increasing awareness of thoughts and emotions).
Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child Anxiety Related Disorders (SCARED) during a routine medical visit in the pediatric gastroenterology clinic. Individuals who screen positive for depression or anxiety will be assessed to confirm diagnoses using the anxiety and M.I.N.I. 6.0. Participants will also complete a psychosocial risk assessment as well as medical and socio-demographic inventories. The investigators will include youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness. Patients will be excluded if they have active suicidal ideation with plan requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders, or significant intellectual disability/developmental delay. Participants meeting inclusion criteria will be randomly assigned to four sessions of IBBT administered on-site by a Fink social worker or treatment as usual (TAU), which is a facilitated community referral for mental health treatment.
The DECADES trial seeks to determine the comparative effectiveness of specialist-centered management of anxiety and depression vs. an imbedded and automated psychology referral for all subjects who screen positive for anxiety or depression.
This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.
The purpose of this research protocol is to adapt the Equine Assisted Therapy (EAT) protocol, which the investigators had developed to help treat PTSD (EAT-PTSD; the Man O' War (MOW) protocol), for use with adolescents who have an anxiety disorder. The MOW protocol is an eight session, group therapy EAT protocol, which the investigators developed, piloted, revised, and tested. EAT is an alternative treatment practiced across the United States and around the world for mental health disorders, in which the horse(s) play an essential role in an experientially oriented therapeutic approach. The MOW protocol is for group EAT, with groups led by a licensed mental health provider and an "equine specialist," working with two horses and assisted by a wrangler (horse handler) to assure safety. In the open trial, the MOW protocol showed promising results in reducing the level of PTSD and Depressive symptoms in veterans with moderate to severe PTSD, was found to be safe (no adverse events), and well accepted (very few dropouts (Fisher et al., 2021)) and found evidence of neural changes (Zhu et al, 2021). As part of the MOW project, the investigators prepared a well specified treatment manual (Fisher et al, 2021) - the first of its kind in the field of EAT - and have trained others in its use.
Excessive anxiety among elementary students is highly prevalent and associated with impairment in academic, social, and behavioral functioning. The primary aim of this project is to evaluate the initial efficacy of a brief nurse-delivered intervention (CALM: Child Anxiety Learning Modules), relative to a credible comparison (CALM-R, relaxation skills only) and a waitlist control for reducing anxiety symptoms and improving education outcomes at post intervention and at a 1-year follow-up. In addition, the research team will assess the cost effectiveness of CALM versus CALM-R and the waitlist control and examine potential predictors, moderators, and mediators of CALM's impact on child outcomes based on the proposed theory of change.
The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy (CBT) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. Before the COVID-19 pandemic, study visits and treatment sessions were conducted in office. Now all visits and treatment sessions are conducted remotely.
This two-site study is a test of Attention Bias Modification Treatment (ABMT) among 260 youths ages 10 to 14 years with social anxiety disorder. One-half of participants will receive 8 sessions of computer administered ABMT and the other half of participants will receive 8 sessions of computer administered Neutral Control Task (NCT). The investigators hypothesize that a biomarker of attention to social threat measured using electroencephalography (EEG) and ratings of social anxiety severity will be lower in participants who receive ABMT compared to participants who receive NCT.
Anxiety is very common in autistic youth. Recently, an intervention has been created by the investigators to target these symptoms in autistic youth in a community setting. The purpose of this study is to determine the feasibility of implementing this treatment in community care centers.
Anxiety and obsessive-compulsive disorders are among the most common in children. Although cognitive behavioral therapy (CBT) is an effective and evidence-based treatment for such disorders, access to CBT is often limited. Family-based and internet-delivered therapy is one method to increase access to care. The purpose of this project is to evaluate the comparative efficacy and treatment mechanisms of two lower-intensity but effective treatments for families of children with anxiety or obsessive compulsive disorder (OCD) via telehealth compared to an adapted Relaxation and Mentorship Training (RMT) intervention involving breathing exercises with a therapist.
Anxiety and obsessive-compulsive disorders are the most common mental health disorders in childhood and adolescence. A parenting intervention for youth with anxiety, called Supportive Parenting of Anxious Childhood Emotions ("SPACE"), has been recently developed to help target anxiety in children. In this intervention, therapists meet individually with parents to help them reduce anxiety behaviors in their children and support adaptive behaviors in their children. The purpose for the proposed study is to demonstrate the treatment efficacy of SPACE compared to a low-contact, therapist-supported bibliotherapy version of this intervention.
Adolescence and young adulthood is a critical period for the development of social anxiety, which is often linked to other mental health challenges such as depression, mood disorders, and substance abuse. Initial evidence suggests that interacting with animals can reduce stress and anxiety, but no research has tested whether this benefit extends to adolescents at risk for social anxiety disorder. Additionally, researchers and clinicians do not understand what mechanism is responsible for anxiety reduction in animal-assisted interventions (AAIs). Therefore, the objectives of this study are to explore the specific mechanisms by which interacting with a therapy dog reduces anxiety, and to test whether such an interaction reduces anxiety in adolescents with varying levels of social anxiety.
Anxiety disorders are the most common mental health diagnosis in the US and are associated with avoidance that causes functional impairments and decreases quality of life. Social anxiety disorder is among the most prevalent anxiety disorders, with most common age of onset being in adolescence. The frontline treatment for social anxiety disorder is cognitive behavioral therapy with exposure. However, a significant number of adolescent patients do not get better after completing cognitive behavioral therapy or experience relapse. This could be explained by findings in both mice and humans suggesting that cue-based extinction learning occurs less readily in adolescents than in children and adults. Studies using mouse-models have overcome this age disparity by enhancing contextual cues when fear extinction learning takes place. Providing realistic learning contexts for exposure could be the key to enhancing treatment effects in adolescents. This is often challenging for a variety of reasons, including difficulty realistically mimicking anxiety-provoking social situations due to limited resources, clinician training, time, or motivation. Virtual reality environments could provide contextual exposures for social anxiety. This pilot study will test the feasibility of integrating virtual reality technology in exposure-based treatment in youth ages 13-23 diagnosed with social anxiety disorder with the goal of approximating equivalent efficacy with traditional cognitive behavioral therapy, and assessing feasibility of virtual reality technology with this population. We will also pilot a fear conditioning and extinction learning paradigm to explore the relationship between extinction learning and efficacy of virtual reality exposure therapy, using physiological assessment indicators to mark changes in fear response. These markers will also be used prior to the initiation of the therapy to assess the degree to which virtual reality environments invoke a true fear response, comparing the 12 participants with social phobia to 12 age matched, non-anxious control participants. The aims of this study are threefold: to assess feasibility of using virtual reality in treatment of social anxiety in youth, to examine whether virtual reality invokes arousal similar to anxiety and test the physiological assessment protocol, and to evaluate whether exposure using virtual reality environments reduces symptoms of social anxiety and related functional impairment.
This clinical trial studies how well attention bias modification (ABM) improves anxiety in adolescent and young adult (AYA) cancer survivors. Cancer-related anxiety is the most prevalent mental health problem affecting AYA cancer survivors. Cancer-related anxiety is associated with long-term negative outcomes such as poor quality of life, depression, distress, substance use, sleep problems, fatigue, and pain. ABM uses techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. ABM uses brief self-guided smartphone applications. Patients complete repetitive association reaction-time tasks targeting automatic and unconscious negative attention biases to retrain attention away from perceived threat and towards a neutral or positive stimuli. Gratitude-finding and savoring activities are also provided to maintain and increase positive emotions. Using ABM plus gratitude-finding and savoring activities may improve anxiety in AYA cancer survivors.
This is a research study to find out if childhood trauma and stress are associated with depression or suicidal risk. The study will assess the effects of both short-term and long-term stress on biomarker (e.g. miRNA \[MiRNA\]) levels. miRNAs are a type of RNA (genetic material that is translated into protein) that are found in throughout the body and blood. They are called microRNA because their size is much smaller than typical RNA molecules. miRNAs are highly responsive to environment. This responsiveness is reflected in their expression in individuals who are affected by environment such as stress. The investigators are gathering genetic material, including DNA and RNA, from each participant. The RNA will be taken from the small vesicles and cells in the participant's blood and analyzed. The vesicles are small objects that occur normally in the blood and that contain RNA. This information may help us to understand the cause of mental illness and to improve medical and psychiatric care in the future. There will be 450 participants enrolled in this study.
Youth depression and anxiety represent a serious public health concern, with affected youth often experiencing social, familial, and academic impairment. Research evidence supports a growing array of effective treatments for youth depression and anxiety, yet as the collection of evidence-based treatments expands, so do the challenges of utilizing the evidence: clinicians must be able to (1) access, integrate, and apply the available evidence, and (2) engage in a collaborative process with each family to develop a plan that is responsive to each family's unique characteristics, preferences, and goals. Engaging caregivers and youths as active collaborators in the treatment planning process is a patient-centered approach with the potential to improve the process and outcome of youth mental health care by facilitating the personalization of established evidence-based treatment approaches. Such collaboration, frequently referred to as shared decision-making (SDM), is a hallmark of evidence-based practice and a key feature of federal guidelines for health care delivery. However, despite growing rhetorical support for SDM, empirical support is lacking, particularly in the area of youth mental health treatment. The absence of such research is unfortunate, given the potential for SDM to facilitate the dissemination and implementation of evidence-based treatments, and to personalize the use of established treatments to increase acceptability, retention, satisfaction, and overall effectiveness. The present project tests the feasibility and acceptability of SDM through a pilot randomized controlled trial of 40 youths (ages 7-15) meeting diagnostic criteria for an anxiety or depressive disorder. The trial will compare an evidence-based treatment that is planned collaboratively with youths and caregivers using the SDM protocol, to an evidence-based treatment that is planned by the clinician and supervisor using pretreatment assessment data. Eligible youths will received up to 26 treatment sessions at no cost and complete assessments prior to the start of treatment, at the end of treatment, and six months following the end of treatment.
Background: Despite advances in symptom management, children undergoing cancer treatment or receiving a chemotherapy-based Hematopoietic Stem Cell Transplant (HSCT) often suffer from moderate to severe symptoms of nausea/vomiting, pain, and fatigue along with psychological distress. Pharmacologic treatments of symptoms can cause side-effects. Patients, parents, and clinicians have expressed interest in including non-pharmacologic approaches to improve symptom management. Acupuncture/acupressure is a promising adjunctive therapy to usual care. More evidence is needed from well-designed trials with larger samples and rigorous designs in order to make definitive recommendations about the routine inclusion of acupressure among pediatric patients being treated for childhood cancer or receiving a HSCT. Design and Methods 100 dyads (one child with one parent/caregiver) will be randomized 1:1 into 2 study arms (50 children in each arm). Arm A participants will be offered usual care and professional acupressure five times weekly (15-20 minute sessions) and a parent/caregiver will be instructed in acupressure delivery for the child as symptoms arise. Arm B participants will receive usual care alone. (At the study end, Arm B parents will be offered acupressure instructions.) Children will be enrolled for \~30 days which can occur with one month of continuous hospital-based treatment or two months of intermittent hospital-based treatment (inpatient or regular outpatient treatment). Parent and child participants will receive a follow-up interview one month after completion of the intervention (Arm A) or the final symptom assessment (Arm B). Significance This is the first study to evaluate the effectiveness and safety of an acupressure intervention to decrease treatment-related symptoms in 100 patients in treatment for a childhood cancer or receiving a chemo-therapy based HSCT.