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Search Results Within Category "Mental Health"

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8 Study Matches

Regulating Together in Tuberous Sclerosis Complex (RT)

The purpose of this study is to use a program called Regulating Together (RT), a remote, non-pharmacologic intervention to treat symptoms of emotion dysregulation in children and adolescents with Tuberous Sclerosis Complex (TSC) and TSC-Associated Neuropsychiatric Disorder (TAND).

Molly Griffith - molly.griffith@cchmc.org

ALL
8 years to 17 years old
NA
This study is NOT accepting healthy volunteers
NCT06105736
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Inclusion Criteria:
* Children ages 8-17 years inclusive with a documented clinical and/or genetic diagnosis of TSC and exhibiting symptoms of behavioral dysregulation (identified on the TAND Checklist having temper tantrums, aggressive outbursts, self-injury, and/or impulsivity) are eligible for inclusion. Additional inclusion/eligibility criteria include: * Participants and their caregivers have access to a computer, phone, or tablet with video capability and stable internet connection. If lack of a device or internet service is the sole barrier to eligibility/participation, interested individuals will be connected to a TSC Clinic social worker to link them to existing government and charity programs specifically addressing this disparity in underserved communities and households in need (e.g., the Affordable Connectivity Program). * Participants must also be willing to participate in treatment sessions and have minimal levels of functional verbal communication (child and their caregiver must be fluent in English * Child must have a minimum IQ\>65 on the WASI-II at the screening/baseline visit).
Exclusion Criteria:
* Participants be on a stable medication regimen at least 4 weeks prior to enrollment * Do not have a plan to start a new psychosocial intervention (e.g., individual psychotherapy, family psychotherapy, group psychotherapy or social skills training) or behavior medication within 30 days prior to enrollment or at any point during the study. ----Participants with significant disruptive, aggressive, self-injurious or sexually inappropriate behaviors deemed potentially dangerous or overly disruptive to the group dynamic/session, having significant co-occurring neuropsychiatric illness warranting other treatment approaches as determined by study clinician (e.g., substance use disorders, psychotic disorders, schizophrenia), or having significant sensory impairment that would limit participation in intervention curriculum/materials (e.g., blindness or uncorrected hearing loss) also will be excluded.
BEHAVIORAL: Behavioral Intervention in a small group platform
TSC, Behavioral Symptoms
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Engaging Mental Health Services for Preschoolers at Risk (NTRI-MH)

Most mental health (MH) disorders develop in early childhood but are not clinically identified or treated until later-delaying treatment services that could prevent the enduring effects of long-term MH problems. Moreover, low income, ethno-racial minoritized children who exhibit higher rates of persistent MH disorders, are at greater risk for lags in identification and treatment. Head Start (HStart) has shown early school success for low-income children, aged 3-5 years, who are disproportionately Black or Latinx. HStart monitors early childhood MH symptoms, yet studies have found that when detected, only those most impaired are referred for treatment. In our research, the investigators learned that system and individual level barriers preclude early treatment among HStart preschoolers with developmental concern. The investigators showed that caregivers encountered system barriers of HStart teachers and primary care providers (PCPs) falling behind in referrals for intervention, and caregiver beliefs about stigma, their limited knowledge and distrust of healthcare hindered early engagement in services. Studies on MH treatment obstacles for low-income, ethno-racial minoritized people illustrate similar barriers to those found among HStart preschoolers with developmental concern. We developed and tested an ethno-racially matched, peer-based family navigator program for HStart preschoolers with developmental concern. Navigators used trust and empowerment to increase caregiver advocacy thereby leading to improved professional alliances and treatment. A navigator program for those with primary MH concerns has not been trialed. For Aim 1, the investigators aim to tailor and trial in a case series the Navigate-Train-Referral-Intervention Mental Health (NTRI-MH) intervention to promote access, engagement, coordination, and optimization of services for preschoolers with MH symptoms. The investigators have used focus group feedback from caregiver, navigator, HStart teacher, and PCP stakeholders to adapt NTRI-MH and created a web-based dashboard to monitor outcomes (Phase 1). Then, for phase 2, the investigators will conduct a feasibility study for caregivers of HStart preschoolers with MH symptoms, guided by ethno-racially matched family navigators and referrals by HStart teachers and PCPs (n=20). Further, for Aim 2, the investigators will pilot test NTRI-MH for caregivers of preschoolers with MH symptoms compared to an active control group of caregivers who receive child behavior training (n=86). The investigators will trial the effectiveness of the NTRI-MH mechanisms of caregiver beliefs on MH, empowerment, and professional alliances on family functioning and child emotion regulation. If the aims of the project are achieved, this study would have a large impact on early MH service use for ethno-racial minoritized young children with the potential to improve child MH outcomes.

Andrea Davila Bocaranda - andrea.davilabocaranda@cchmc.org

ALL
18 years and over
NA
This study is NOT accepting healthy volunteers
NCT07054554
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Inclusion Criteria:
* Family Navigators: Having experience working as family navigator and/or community health worker; Latinx, Black or White; \> 18 years old. * Caregivers: current caregiver of a HStart preschooler at-risk for MH disorders (ASQ-SE above threshold score) * Teachers: Current Head Start (HStart) teacher from one of the 2 HStart site;\> 18 years old; Any race/ethnicity. * PCPs: Currently providing primary care for HStart preschool age children at risk for MH disorders; \> 18 years old; Any race/ethnicity.
Exclusion Criteria:
* Unable to read/speak either English or Spanish.
OTHER: NTRI-MH
Mental Health Disorder, Family Navigation, Minoritized Population, Preschool Age Children
Family Navigation, mental health disorder, Preschool Age Children
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I-InTERACT Preterm Parenting (I2P-RCT)

Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.

Zyah Flagg - zyah.flagg@cchmc.org

ALL
3 years to 8 years old
NA
This study is also accepting healthy volunteers
NCT06767293
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Inclusion Criteria:
* Born at \< 32 weeks gestational age. * Total T score of \> 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR Total T score of \> 55 on the Eyberg Child Behavior Inventory total problem- or total intensity-scale. * English is the primary spoken language in the home.
Exclusion Criteria:
* Is not 18 years or older. * Participant will be excluded from the study if the child does not reside with the caregiver at least half-time; the caregiving situation is not stable (i.e., there must be no scheduled custody hearings). * English is not the primary language spoken in the home. * Caregivers with a psychiatric hospitalization in the past year.
BEHAVIORAL: I-InTERACT Parenting Intervention (I2P) and coaching sessions, BEHAVIORAL: I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions, OTHER: Internet Resources
Child Behavior Problem, Preterm, Parent-Child Relations, Parenting
telehealth, online learning, microlearning
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Chicago Parent Program for Foster and Kinship Caregivers

The primary objective of this study is to test the effects of an evidence-based prevention intervention (CPP) adapted for foster and kinship caregivers of young children (FC; foster care) on caregiver competence and child behavior problems for children in foster care compared with an active comparator group that receives standard supports through the child welfare and healthcare systems (i.e., usual care).

Laura Fossett - laura.fossett@cchmc.org

ALL
2 years and over
NA
This study is also accepting healthy volunteers
NCT06170047
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Inclusion Criteria:
* Must be a licensed foster caregiver or kinship caregiver to a foster child between the ages of 2 and less than 9 years of age * Must be a licensed foster caregiver or kinship caregiver to a foster child in Ohio and in the custody of Hamilton County Job and Family Services, Butler County Children Services, or Montgomery County Children Services * Must be in good standing with the foster care agency * Must be English-speaking
Exclusion Criteria:
* Not having a foster child between the ages of 2 and less than 9 years * The foster child not being in the custody of Ohio counties: Hamilton County Job and Family Services, Butler County Children Services, or Montgomery County Children Services * The foster child was placed in the home more than 45 days prior to enrollment * The foster child being moved out of the placement prior to the start of the intervention * The foster child having been previously enrolled with another caregiver * The caregiver having been previously enrolled with another child * The caregiver unable to commit to completing all study activities * The foster child is not enrolled in the study
BEHAVIORAL: Chicago Parent Program for Foster Care, OTHER: Usual Care
Behavior Problem, Parenting
Foster care, Child behavior, Parenting skills, Behavioral health, Prevention, Parenting confidence, Parenting stress
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Evaluating Additive Effects of Including Canines in Regulating Together

The primary objective is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD). Aim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard. Aim 2: Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard. Exploratory Aim: Explore association of physiological arousal (via heart rate tracking) with emotion dysregulation, treatment engagement, and learning.

Carrie Fassler - carrie.fassler@cchmc.org

ALL
8 years to 15 years old
NA
This study is NOT accepting healthy volunteers
NCT05803343
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Inclusion Criteria:
* Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R) * Diagnosis of autism spectrum disorder (ASD) * Diagnosis confirmed by an experienced ASD clinician and further supported by scoring in the range for ASD on the Autism Diagnostic Observation Schedule (ADOS-2) * A Full Scale Intelligence Quotient score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II) * English is the primary language * Family willing to keep prescribed medication stable over the course of the study period
Exclusion Criteria:
* Participant has a phobia toward or is allergic to canines * Participant has a history of aggression toward animals * Participant has had any physical aggression toward other children outside the home in the past 2 weeks that resulted in injury * Presence of comorbid major neuropsychiatric illness warranting other treatment approaches as determined by the study clinician(s) including substance use disorders, psychotic disorders/schizophrenia, and bipolar disorder, among others * Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss * A legal guardian is not available to provide informed consent
BEHAVIORAL: Regulating Together-Canine, BEHAVIORAL: Regulating Together-Standard
Autism Spectrum Disorder, Emotion Regulation
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Suicide Treatment Alternatives for Teens (START)

Quasi-Randomized trial to compare inpatient care versus outpatient crisis intervention clinic. This study plans to enroll up to 1,000 participants across 4 sites in a 5 years period.

Katelyn Armstrong - katelyn.armstrong@cchmc.org

ALL
12 years to 18 years old
NA
This study is also accepting healthy volunteers
NCT04089254
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Inclusion Criteria:

• Adolescents that are 12 through 17 years old (including 17 year olds who will turn 18 years old during the course of the study).
• Are brought to the Emergency Department (ED) due to suicidal thoughts or behaviors
• Require a higher level of care (OCIC or Inpatient) indicated by clinician determination and a CHRT-SR score of 15 to 52.
• The presence of a legal guardian
• Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:

• Adolescents with suicidal thoughts that place themselves at a serious imminent risk of suicide based on clinical judgment.
• Adolescents who require 24 hour/day supervision but no adult can provide 24 hour/day supervision outside of the hospital
• Adolescents without the ability to read and answer survey questions
• Adolescents that are non-English speaking due to the scales and surveys that are used for this study only being available in English.
BEHAVIORAL: Inpatient Psychiatry, BEHAVIORAL: Outpatient Crisis Intervention Clinic
Suicidal Ideation
Suicide, Suicidal, Adolescent
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HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis (HeartGPS)

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

- heartgps@cchmc.org

ALL
18 years and over
NA
This study is NOT accepting healthy volunteers
NCT06175104
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Inclusion Criteria
• Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
• Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
• Singleton pregnancy.
• Pregnant person is planning to continue with the pregnancy.
• Pregnant person is able to participate and complete study assessments in English. Exclusion Criteria
• Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
• Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
• Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
• Parent with a moderate to severe intellectual disability.
• Parent age \<18 years.
• Surrogate for pregnancy. Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
BEHAVIORAL: HeartGPS
Heart Defects, Congenital, Anxiety in Pregnancy, Depression, Postpartum, Trauma, Psychological, Neurodevelopmental Disorders
Congenital Heart Disease, Prenatal, Mental Health, Neurodevelopment, Neurobehavior, Fetal Cardiology, Psychological Intervention, Mother-Infant Attachment, Mother-Infant Bonding, Medical Traumatic Stress, Neuroimaging, Brain Development, Fetal Neuroimaging, Perinatal Mental Health, Medical Psychology
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A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study (PHN WBC)

The goal of this pragmatic clinical trial is to learn if the WE BEAT program, a 5-week group-based online wellbeing and skill-building program, can help teens with congenital heart disease (CHD) improve their ability to handle stress. The main question it aims to answer is if participants who receive the WE BEAT program become more resilient (the ability to bounce back from from tough times or recover from something difficult) and have better quality of life compared to participants who receive usual care. The study also aims to learn if there are connections between participant-reported psychosocial data (such as resilience, feelings about one's life and one's physical, mental, and social wellbeing) and clinical outcomes. Eligible participants who are 12-17-year-old will be in the study for about 6 months and be randomized to receive either the WE BEAT program or usual care. Following completion of the primary WE BEAT intervention at Week 5, intervention arm participants will be randomized to a single-session booster session (occurring at Week 18) vs no booster session. The booster session will be provided in a similar format to the WE BEAT program. A review of all modules/skills introduced in the program will be provided. All participants will complete 4 sets of online surveys and give 3 hair/saliva samples at different timepoints. Some participants may volunteer to give optional blood and urine samples.

Elise Pickering - Elise.Pickering@cchmc.org

ALL
12 years to 17 years old
NA
This study is NOT accepting healthy volunteers
NCT07525843
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Inclusion Criteria:
* Age 12-17 years old * CHD of moderate or severe complexity (Class II/III, 2018 AHA/ACC ACHD, Table 4) * English or Spanish language proficiency * Receives cardiology care at a PHN or PHN auxiliary site * Parent or guardian and participant willing to comply with protocol and provide written/electronic informed consent and assent
Exclusion Criteria:
* CHD of mild or simple complexity (Class I, 2018 AHA/ACC ACHD, Table 4) * Prior heart transplant to treat CHD * Heart disease that is not classified as structural CHD (e.g., connective tissue disease, genetic cardiomyopathy, or acquired heart disease) * Cognitive or developmental conditions that limit program participation and/or ability to complete self-reported measures as determined by a primary cardiology clinician * Suicidality, homicidality, or psychosis in the past 12 months as per medical chart review, clinician report, or eligibility screening * Medically unable to participate (e.g., intubated, unable to respond verbally, active delirium)
BEHAVIORAL: Telemedicine-based resiliency-building intervention
Patient-Reported Outcome Measures (PROMs), Pragmatic Trial, Adolescent Congenital Heart Disease, Resiliency-building Intervention, Resilience, Psychological, Telemedicine-Based Education
WE BEAT, Well-Being Education Program, Adolescent CHD, Pragmatic Clinical Trial, Telemedicine
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