Clinical Research Directory

Evaluation of a Trauma-Informed Partner Violence Intervention Program

The goal of this study is to conduct a randomized controlled trial (RCT) comparing outcomes between two programs to reduce intimate partner violence (IPV)- the Strength at Home (SAH) program and a standard, state-approved IPV intervention program, Treatment as Usual (TAU). Primary outcomes will include self- and partner-reported physical and psychological IPV. Secondary outcomes will include self-reported PTSD symptoms, alexithymia, alcohol use problems, and treatment satisfaction, assessed across five time points.

Peer Counselling to Reduce Psychological Distress and Exposure to Violence Among Sexual and Gender Minorities

Lesbian, Gay, Bisexual, Transgender, Intersex, Queer, Asexual, and other sexually or gender diverse (LGBTIQA+) communities in many countries face high levels of mental health problems compared to the general population. This is often due to discrimination, being excluded, abuse, and unfair treatment. In many low- and middle-income countries, including Nepal, the mental health needs of LGBTIQA+ people are not met, and the violence they experience is often ignored because they are seen as breaking gender norms. The low number of trained mental health specialists in a country like Nepal imply that any short-term effort to alleviate the mental health problems among LGBTIQA+ must rely on other type of support workers such as peers. There is growing evidence that help from community members-such as counselling given by non-professionals-can improve mental well-being. Considering that discrimination of LGBTIQA+ is common also within the health services, this study will look at whether peer counselling-support provided by trained LGBTIQA+ community members-can work well in Nepal. We have improved a counselling program called 'Problem Management Plus' (PM+), developed by the World Health Organization, by adding new parts that focus on reducing the risk of some of the contributing causes of mental distress, namely violence, marginalisation and loneliness. The added components include safety planning, counselling that builds confidence and strength, and goal setting strategies to help study participants use the skills they learn and reach the desired impact. In addition, peer-led monthly group meetings will be conducted to enhance social cohesion, strengthen interpersonal networks, and reduce feeling of loneliness. The study uses a community based participatory research approach, meaning LGBTIQA+ people are invited to give inputs throughout the study from study design to being involved as peer advocates to deliver the counselling. The trial will recruit at least 960 LGBTIQA+ individuals aged 18 to 55 years living in seven districts of Nepal. Study participants will be randomly allocated to one of three arms: one arm receiving individual augmented PM+ counselling with six weekly sessions; one arm receiving the individual augmented PM+ counselling followed by 11 monthly group sessions; and one control arm. There will be a one year follow-up to examine whether the peer support helps improve mental health and reduce exposure to violence among LGBTIQA+ people. The study findings will help guide programmes to improve the mental health of LGBTIQA+ in other low- and middle-income countries where they also experience discrimination, exclusion, and violence.

Camouflaged WeChat-based Intervention for Abused Women

Intimate partner violence (IPV) is a major public health issue and human rights threat worldwide, especially for Chinese immigrant women victims in Hong Kong. Interventions that address negative physical and emotional outcomes from IPV could therefore play a crucial role in enhancing empowerment, social support, and healthy lifestyle among these women. The overall objective of this pilot mixed methods study is to determine the feasibility and acceptability of a camouflaged WeChat mini-program-based WOMEN Health intervention for women victims of IPV. This study will evaluate the feasibility and acceptability of a camouflaged WeChat mini-program-based WOMEN Health intervention for women victims of IPV.

Improving Outcomes in Social Services Through Routine Outcome Monitoring and Systematic Client Feedback

In this project the investigators want to test whether a new method FIT (Feedback informed treatment) can improve the interventions people receive through social services. The FIT method involves regularly providing information about how the client think things are going and what the client thinks about the help and care they receive.

Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwano Intervention

This study will develop and pilot test a couples-based intervention to help adolescent girls and young women living with HIV (WLHIV (15-24 years) living in Uganda access HIV care and improve the outcomes of their HIV treatment by targeting male partner alcohol use to reduce IPV risk.

Clinical Trial to Reduce Perinatal Intimate Partner Violence

This is a two-armed, fully powered hybrid type 1 trial to test the effectiveness of a doula intervention compared with an active control in reducing intimate partner violence (IPV) among perinatal IPV survivors

Occupational Therapy for Adults Who Have Experienced Intimate Partner Violence (IPV)

The purpose of this graduate student research study is to understand the effectiveness of an occupational therapy program in a domestic violence shelter. It is expected that participation will last about 6 weeks. Subjects will complete pretests involving lifestyle assessments and a coping scale and then participate in 8 occupational therapy sessions during the 4 weeks of program implementation. The occupational therapy sessions will last approximately 90 minutes. After the program is completed, subjects will complete the posttests. Procedures and Activities. You will be asked to: Complete a series of questionnaires about your health, well-being, and daily activities. Participate in 8 OT sessions that may include activities such as journaling, positive self-talk, coping skills methods, and grounding exercises. Complete the posttests.

Self-Dehumanization and Hesitation to Report Domestic Violence

The patients included in the study will be adult women who are victims of domestic violence, consulting for this reason. The duration of participation of each patient will be one hour. After obtaining the patient's non-opposition to her participation in the study, socio-demographic and history of violence suffered will be collected during an interview with the doctor/nurse. After that, the hetero-questionnaire MADRS (Montgomery-Asberg Depression Rating Scale) will be administered to the patient. This first part will last 30 minutes. The second part of the study, carried out immediately after the interview, will be carried out on computer in the form of 4 self-questionnaires (Childhood Trauma Questionnaire, Deshumanization Measure within Romantic Relationships scale, self-esteem scale, violentometer) and an implicit association test (IAT). This second part will last 30 minutes. Then, the participation of the patient in the study is over.

'Effectively Intervening in Traumatized Parents and Young Children After Structural Domestic Violence: A Multiple Baseline Analysis'

The goal of this study is to evaluate the effectiveness of an individualized treatment trajectory in which the order of trauma therapy for the parent (Eye movement desensitization and reprocessing (EMDR) therapy), trauma therapy for the child (EMDR therapy) and attachment-based therapy (Dutch short-term intervention for atypical parenting behavior (NIKA)) is tailored towards the complex needs of victimized parents and their young children (4-6 y/o) after domestic violence. The treatment trajectory is based on a guidance document that supports therapists to determine the optimal order of interventions based on a standardized set of factors. The primary goals of this study are: 1. To examine how post-traumatic stress disorder (PTSD)-symptoms of parent and child and parental sensitive and disruptive parenting behavior develop and interact over time, while they follow the individualized treatment trajectory. 2. To test whether the start of the treatment trajectory (e.g. the phase in which parents can receive NIKA and EMDR therapy and their child can receive EMDR therapy) leads to a decrease in disruptive parenting behavior towards the child, an increase in sensitive parenting behavior towards the child, and a decrease in PTSD symptoms of the parent in comparison to the baseline phase. 3. To test whether the start of the treatment trajectory (e.g. the phase in which children can receive EMDR therapy and their parent can receive NIKA and EMDR therapy) leads to a decrease in PTSD symptoms of the child in comparison to the baseline phase.

Musical Group Intervention for Children in Shelters

The aim of the study is to augment knowledge on interventions for children who live, or have lived, in shelters after exposure to domestic violence. Research questions concern the feasibility of a music group intervention for children. The experiences of children, caregivers, and professionals will be investigated. Additionally, outcomes concerning emotional reactivity, capacity for emotional regulation, quality of life, and psychological health will be evaluated.

Adaptation and Pilot Testing of Web and Mobile Interface for the ATTACH™ Intervention

COVID-19 has placed unprecedented strains on parents impacted by toxic stressors (depression, addiction, family violence, and poverty) and reluctant to see mental health-service providers in home/clinic due to fears of infection. Due to the pandemic, PI Letourneau ceased/delayed recruitment in ATTACH™, a CIHR-funded randomized controlled trials (RCT) of in-person (home or clinic) program designed to improve children's mental, emotional and behavioral (MEB) health and development via parent-child relationship intervention. Recognizing the heightened need for already vulnerable families to obtain safe parenting support to manage depressive symptoms/other stressors. The team's primary knowledge user (D. McNeil, Scientific Director, Maternal Newborn Child and Youth Strategic Clinical Network, Alberta Health Services) advocated for online delivery of the ATTACH™ parent training program. In response, an interdisciplinary team from nursing and software engineering rapidly pivoted to an online delivery format. Critical barriers to using existing commercial technologies emerged, making it essential to develop and implement tailored, user-informed virtual care delivery platforms and tools safe, secure, user-friendly for families already stressed. Innovative user interface design and integrated knowledge transfer approaches will be used to: (a) adapt ATTACH™ for virtual delivery; (b) develop virtual platforms (web-based applications) and tools (mobile apps) for flexible delivery of mental health supports for parents and training for professional facilitators; (c) integrate virtual mental health services into the primary care system promoting program uptake; and (d) design/test streamlined and intuitive virtual systems for nimble spread/scaleup. The project catalyzes and enriches the PIs' research program by crossing disciplines (nursing \& engineering) in cutting edge research that is responsive to trends in both mental health intervention and web-interface design. The aim is to adapt, develop, design and pilot test virtual (web-based) intervention program to improve children's mental, emotional and behavioral (MEB) health and development. This will be done by building on successful CIHR funded in-person (home or clinic) programs and pivoting to user-engaged program development, adaptation and pilot testing for virtual delivery in the face of COVID19.

Manual of Emotional Regulation and Interpersonal Abilities in Children and Adolescents Group Therapy

Purpose: Domestic violence (DV) is a mental health problem that affects children and adolescents. Widespread evidence suggests that witnessing DV has physical and mental health consequences. 19% of children and adolescents cared for in Children, and Youth Mental Health Centers in Catalonia declare having witnessed DV between their parents. However, there are low specialized therapeutic tools to intervene effectively. In this line, the research team of the current project adapted and manualized a group treatment designed to treat children and adolescents between 8 and 16 years old witnesses of DV on an outpatient basis called: 'Manual of Emotional Regulation and Interpersonal Abilities group Therapy - MERITA'. The treatment main aim is to improve the emotional regulation and interpersonal skills of children and adolescents who have witnessed DV. We carried out a pilot study of MERITA (Lacasa et al., 2016) where we obtained promising results. Now, we want to carry out this study to improve methodological limitations by increasing the sample size. We have added a waiting list for assigning patients in different arms (MERITA intervention vs. treatment as usual as control group), as well as we improved the assessment (pre, post, and follow-ups) using several scales with good psychometric properties. Aims: The aim of this trial is twofold: firstly, to assess the effectiveness of Emotional Regulation and Interpersonal Abilities group Therapy (MERITA) in children and adolescents who are witnesses of DV and treated at the Infant and dolescent mental health center (TAU); and secondly, to analyze the differences (MERITA vs only TAU) on traumatic, depressive and anxious symptomatology, emotional dysregulation, interpersonal difficulties, externalizing and internalizing symptoms, somatic complaints, prosocial behavior, attachment, and family functioning. Specifically, MERITA will be compared to TAU alone (post and 3-month follow-up). Methods Design: Trail with two arms: 1. MERITA + TAU (intervention group) 2. TAU (control group) Sample: The necessary sample size to detect statistically significant differences between the groups has been calculated using the G\*Power: with a minimum effect size (0.50), a significance level of 5% and a power of 80%. A minimum of 36 participants would be required.