Clinical Research Directory

Intervention to Enhance Coping and Help-seeking Among Youth in Foster Care

This study will deploy a scalable secondary prevention program that leverages existing foster youth transition services to improve mental health functioning and service use before and after exiting foster care. Our short-term objective is to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing stress responses, including mental health help-seeking and service engagement, among foster youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to promote informal and formal help-seeking as an effective coping strategy. The proposed aims will establish whether the 10-module program engages the targeted proximal mechanisms with a signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to refine our SYNC curriculum and training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=26). Our second aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b) association between the mechanisms and targeted outcomes, including emotional regulation, coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and standardize the intervention and research protocol for an effectiveness trial, including confirming transferability with national stakeholders.

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.

Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples

Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers/partners playing a significant role in influencing maternal stress and mood symptoms. This goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control. Expecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health. Participants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.

Feasibility Testing a Meditation App for Professionals Working With Youth in the Legal System

This feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with officers in the juvenile legal system and other professionals working directly with legal-involved youth.

Sharing Tales That Teach: Shared Picturebook Reading for Early Childhood Emotional and Cognitive Development

Sharing Tales That Teach is a randomised study of a shared picturebook reading programme for 4- to 5-year-old children and their primary caregivers. The study will test whether a caregiver-delivered, emotion-focused shared reading programme leads to greater improvements in children's emotion regulation than a standard dialogic shared reading programme. Emotion regulation refers to children's developing ability to understand, express and manage emotions in ways that support learning, relationships and wellbeing. These skills are closely linked with executive function, including children's ability to remember instructions, control impulses and shift flexibly between activities. Shared picturebook reading may provide a natural, low-cost way for caregivers to support these skills through everyday interaction. Families in the randomised part of the study will be allocated to one of two 8-week shared reading programmes. In the emotion-focused group, caregivers will receive training in strategies such as naming emotions, discussing why characters feel as they do, talking about consequences of emotions and modelling ways to manage feelings. In the comparison group, caregivers will receive training in standard dialogic picturebook reading strategies, such as naming, describing, sequencing and asking open questions, without an explicit focus on emotions or emotion regulation. Both groups will use the same picturebooks and will be asked to complete three shared reading sessions per week at home. The main hypothesis is that children in the emotion-focused shared reading group will show greater improvement in emotion regulation from baseline to 12-month follow-up than children in the standard dialogic shared reading group. The study will also examine whether the programme affects children's executive function, caregiver wellbeing and caregiver emotion regulation. Additional exploratory analyses will examine caregiver-child interaction processes and whether caregiver or child characteristics are associated with different intervention effects. The study will recruit caregiver-child dyads through state primary schools in Greater London. Children will complete age-appropriate tasks and caregivers will complete questionnaires at baseline and follow-up. A laboratory subsample may also complete additional behavioural, observational and neurophysiological assessments. The study is low risk, non-invasive and does not involve medical treatment.

An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph II (iTRAC HERO)

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.

AI-Based Communication Simulation and Human Library Narratives.

This research plan aims to establish an effectiveness assessment system for promoting clinical communication, empathy, and emotion regulation in pediatric nursing students through a combination of AI communication simulation and human library narrative. This study sets five specific objectives: 1. To develop and implement a pediatric nursing teaching model that integrates AI communication simulation and human library narrative. 2. To evaluate the effectiveness of this teaching model in improving nursing students' clinical communication skills. 3. To examine the effectiveness of this teaching intervention in enhancing nursing students' empathy. 4. To explore the impact of this teaching intervention on nursing students' emotion regulation abilities. 5. To understand students' learning experiences, feelings, changes in emotion regulation, and suggestions for improvement regarding this integrated teaching intervention.

Manage Emotions to Reduce Aggression (MERA)

PTSD is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with posttraumatic stress disorder (PTSD) report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD.

Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads

The investigators are interested in learning more about how the role of mothers' emotions has on the transmission of suicide risk to children. Eligible participants will be invited to participate in a baseline assessment, and 4 follow-up assessments in the next year. This research study is a randomized control trial. Participants that choose to enroll are randomly assigned, that is by chance (like by flipping a coin) to receive DBT Skills Training or treatment as usual (TAU). Participants may also be selected for DBT skills training, it which would occur once a week for 6 months.

Music Program for Hong Kong Adolescents: Improving Emotion Regulation and Reducing Depression, Anxiety, and Loneliness

This study is a clinical trial that aims to test and validate a music-based program called "Tuned In" in helping adolescents in Hong Kong improve their mental well-being. The researchers want to find out if the program can help participants enhance their ability to regulate their emotions, reduce mood symptoms and feelings of loneliness. Participants in the study will be randomly assigned to either the group that receives the program right away (intervention group) or the group that waits for four weeks before receiving the program (wait list group). They will take part in a group-based weekly program for four weeks. Additionally, they will be asked to complete questionnaires before and after the program to see if there are any changes in their mental well-being. The program will be delivered by a facilitator with a psychology background, and a registered music therapist. By addressing the gaps in mental health interventions for young people in Hong Kong, this study aims to contribute to the development of effective strategies to support their emotional well-being.

SCREENS: Sleep, Circadian Rhythms, and Electronics in the EveNing Study

The proposed project aims to disentangle the impact of evening light exposure emitted from tablet devices from the impact of arousing media content on children's sleep regulation, circadian physiology and next-day emotion regulation and executive functioning.

Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease

Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability data) using pre-mailed Polar H10 chest bands, and health-related questionnaire reports. Distancing training is expected to result in longitudinal reductions in self-reported negative affect, longitudinal increases in positive affect, and longitudinal increases in HRV that are larger than those attributable to reinterpretation training and no-regulation control training.

Testing the Effects of the Caregiver Interaction Profile Training on the Interactive Skills of Daycare Providers

The goal of this clinical trial is to test the Caregiver Interaction Profile (CIP) training program (Helmerhorst et al., 2017) promoting the relational quality between professional caregivers and children in daycare. The main questions it aims to answer are: * Does the CIP training program, compared to no training, improve the relational quality between daycare providers and children in daycare? * Does the CIP training program, compared to no training, foster children's social, emotional, and language development? Daycare providers assigned to the "training group" will participate in the CIP training program, which uses video-recorded interactions between the daycare providers and children in daycare to give feedback on the relational quality as observed in the videos. Daycare providers assigned to the "waiting list control group" will initially not take part in the training program but will receive the training after the study is finished. All daycare providers' daily interactions with the children in daycare will be filmed before and after the training in order to see if there has been a change in relational quality for the daycare providers in the training group (compared to the control group). Daycare providers in the training and control groups will also fill out questionnaires about the social, emotional, and language development of the children in their care. Researchers will compare daycare providers (and the children in their care) in the "training group" to daycare providers (and the children in their care) in the "control group" to see if the relational quality in the training group improves more than that in the control group as a result of the CIP training, and how that impacts the social, emotional, and language development of children.

MICBT for Non-underweight Adults With Eating Disorders

Eating disorders (ED) are severe but treatable conditions, but there are large margin for improvements in terms of efficacy and adherence. There is room to explore new treatment options who are either more capable to retain patients in therapy, more effective. Alternative their efficacy may match the ones of current available treatments but offer new options to ones that did not respond to available therapies. Here the investigators explored if a combination of CBT-focused plus Metacognitive Interpersonal Therapy (MIT) is an empirically supported therapy for personality disorders and could be a new viable treatment option for non-underweight ED. MIT targets some aspects of ED such as poor awareness of mental states and maladaptive interpersonal schemas that are not included in the transdiagnostic model underlying the most investigated empirically supported treatment for ED that is CBT-E. It is reasonable therefore that targeting these aspects of psychopathology can be a path to treatment adherence and effectiveness

Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

The goal of this clinical trial is to assess if Metacognitive Interpersonal Therapy for Eating Disorders (MIT-ED) is effective for treating various forms of Eating Disorders (ED) and reducing dropout rates. The trial will also evaluate its feasibility and outcomes in a patient group including also underweight participants. The main questions it aims to answer are: * Does MIT-ED improve eating disorder symptoms and reduce overall maintenance factors, as alexithymia, emotional dysregulation, maladaptive perfectionism, and self-esteem? * Is MIT-ED effective in reducing the severity of personality disorders and associated global psychiatric symptoms? * What are the dropout rates and adherence levels for patients receiving MIT-ED? Participants will: * Undergo an initial screening to confirm eligibility, including a comprehensive clinical interview and assessments based on inclusion and exclusion criteria for the study. * Receive up to 40 individual sessions of MIT-ED, each lasting 50-60 minutes, over a period of approximately 10-12 months. * Attend regular assessment focusing on eating disorder symptoms (Eating Disorder Examination Questionnaire, EDE-Q 6.0, and ED Interview, EDE), emotional dysregulation (Difficulties in Emotion Regulation Scale, DERS), alexithymia (Toronto Alexithymia Scale-20, TAS-20), and self-esteem (Rosenberg Self-Esteem Scale, RSES). Assessment will be conducted at baseline (before starting MIT-ED sessions), after 20 MIT-ED sessions (approximately after 5 months), post-treatment (approximately after 10 months), and at 3 months follow-up. A longer 12-months follow-up is planned. Researchers will evaluate the effectiveness of MIT-ED based on treatment adherence, symptom improvement, and the reduction of maintenance mechanisms associated with Eating Disorders. Positive results could support the design of a larger, controlled Randomized Clinical Trial (RCT).

Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors (SITBs) in Children

The goal of this study is to develop and test an outpatient intervention for preadolescents (ages 7-12) with self-injurious thoughts and behaviors (SITBs). The main questions it aims to answer are: 1. Does the newer intervention lead to better engagement of families in treatment compared to treatment as usual (TAU)? 2. Is the new intervention feasible, acceptable, and appropriate? 3. Does the new intervention lead to more improvements in SITBs, mental health symptoms, and treatment targets compared to TAU? Preadolescent participants with SITBs and their families will be randomized to either the new intervention or TAU, which will consist of the typical interventions the study therapist would use for preadolescents with SITBs. Participants will: 1. Complete an initial baseline assessment to determine eligibility and assess SITBs, mental health symptoms, executive functioning, and emotion regulation 2. Participate in a \~weekly, outpatient intervention lasting around 3-4 months 3. Complete additional assessments at mid-treatment, post-treatment, and 3-month follow-up 4. Participate in an interview sharing their perceptions of the intervention

Skills Video Intervention for Chinese/Chinese Americans

This is a study that aims to test a coping skills intervention delivered via brief animated videos for Chinese and Chinese American college students.

Intervention on Socio-emotional Development and Well-being Through ICTs in Early Adulthood

emoWELL is a serious game, that is, a video game designed to inform and train in skills and competencies in a more dynamic way. emoWELL focuses on understanding and developing healthy emotional regulation strategies to improve well-being.

ACT-Based Group Therapy and Mobile Application Intervention for Emotional Eating

This study aims to evaluate the effects of an Acceptance and Commitment Therapy (ACT)-based group therapy program, combined with an ACT-based mobile app, on emotional eating, emotion regulation, and psychological flexibility in overweight individuals. Emotional eating is a condition in which individuals frequently use eating behavior as a coping mechanism for negative emotions. Participants will be randomly assigned to intervention groups receiving ACT-based group therapy, ACT-based group therapy combined with an ACT-based mobile app, or a control group. The intervention will last six weeks and will include structured group sessions as well as mobile-based exercises, reminders, and coping strategies. Outcome measures will include emotional eating, emotion regulation, and psychological flexibility. Assessments will be conducted at baseline, post-intervention, and during the follow-up phase. The findings of this study are expected to contribute to the development of accessible and effective interventions for emotional eating.

GUTLINK4KIDS Intervention

This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.

Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)

Having a family member or loved one in the ICU can be a very stressful experience. The investigators have created a tablet-based tool (FAMCOPE-ICU) that is designed to help people in this position cope with this experience.

The Social Regulation of Threat-related Vigilance and Arousal

This study will examine the effects of social support on threat vigilance and arousal using eye tracking. We will also test the moderating effects of trauma and discrimination history.

PACE Study: School-Based Mindfulness and Compassion Interventions for Children

This study aims to evaluate the effects of three school-based interventions focused on mindfulness, compassion, and social-emotional learning on children's psychological well-being and higher-order cognitive functions. The interventions are delivered in the classroom through structured experiential activities. Children are assessed before and after the interventions using standardized tests and questionnaires measuring attention, executive functions, emotional regulation, mindfulness, self-compassion, and social-emotional skills.

DOD Regulating Together Intervention

Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.