Clinical Research Directory

Thrive Initiative Parent-Education Programming Study

The purpose of this study is to evaluate the effectiveness of the Thrive Initiative's parent-education program delivery methods by comparing hybrid (i.e., a combination of online and group components) program delivery to online-only program delivery. The Thrive Initiative consists of four, universal parent-education programs that correpsond to specific child developmental periods. These programs inlcude: Take Root for parents/caregivers of 0-3-year-old children; Sprout for parents/caregivers of 3-5-year-old children; Grow for parents/caregivres of 5-10-year-old children; and Branch Out for parents/caregivers of 10-18-year-old children. The effectiveness of delivery method will be examined for each program. Eligible participants for this study will be United States Air Force service members or dependents who are caregivers of a child 0-18 years old. The study will involve randomization to condition meaning that participants will be assigned to the online-only or hybrid program delivery condition by chance.

Randomized Control Trial of the Co-Parenting for Resilience Program

Because parental divorce has been linked to a significant increase in mental health diagnoses among children, it is important to develop effective interventions that reduce the negative impact of divorce on children. This study assesses the efficacy of the Co-Parenting for Resilience (CPR) resilience program by randomly assigning divorcing individuals to three different forms of the intervention to test whether one or both of versions of CPR are better than reading a self-help book, and whether an in-person version of CPR is more effective than an online version. The three conditions or versions are: 1) an in-person version of CPR taught by a trained non-clinician, 2) an asynchronous fully online version of CPR, and 3) a group that simply reads a self-help book and responds to a knowledge check to ensure the material was read.

Self-Help Plus to Enhance Early Development: A Cluster-Randomized Controlled Trial of Maternal Mental Health, Child Cognitive Abilities, and Socio-Behavioral Skills Among Refugee Mothers and Their Preschool-Aged Children in Rhino Camp, Uganda

This study evaluates whether the group-based mental health program Self-Help Plus (SH+) can improve the mental health, wellbeing, and functioning of refugee mothers and their preschool-aged children living in Rhino Refugee Settlement (Rhino Camp), Uganda. SH+ is a stress management course developed by the World Health Organization for people affected by adversity. A previous study in this setting found that SH+ improved mental health outcomes among South Sudanese refugee women (Tol et al., 2020). However, it remains unclear whether these effects are sustained over time and whether improvements in maternal mental health also lead to positive outcomes for children. This study asks two main research questions: * Does SH+ lead to lasting improvements in maternal mental health one year after the intervention? * Does SH+ administered to mothers improve children's wellbeing? The trial's main focus is on two outcomes assessed 12 months post-intervention: the primary outcome is maternal psychological distress (Kessler-6; K6), and the key secondary outcome is children's psychosocial wellbeing (Kiddy-KINDLR; parent report). To answer these questions, this study will employ a cluster-randomized controlled trial with two arms. Villages are randomized to receive either SH+ plus Enhanced Usual Care (EUC) or EUC only (active control). Outcomes are assessed at baseline, 3 months post-intervention, and 12 months post-intervention (the primary endpoint). In addition to the primary outcome and key secondary outcome, the study includes a broader set of secondary outcomes capturing maternal mental health and functioning, parenting, and child wellbeing. The study also collects prespecified exploratory outcomes, including socio-behavioral skills of mothers and children measured using incentivized economic games, as well as child cognitive development. The study uses caregiver reports, direct child assessments, and incentivized tasks to measure outcomes. By integrating mental health, developmental, and behavioral measures, this study examines whether SH+ produces lasting mental health benefits and whether improvements in maternal mental health translate into positive outcomes for preschool-aged children in an adverse humanitarian setting.

Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults. The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

Evaluation of the Parenting in the Moment Online Program for Forcibly Displaced Families

This Randomized Controlled Trial will test the effectiveness of the Parenting in the Moment (PIM) online parenting program for parents with experiences of forced displacement. The primary objective of this study is to conduct a summative (impact) evaluation of the PIM online parenting program as an in-home parent, skill-based program for parents of school-aged children, using a randomized controlled trial research design with community partnerships that inform the research throughout. The longer-term objectives are to build the evidence-base for in-home parent skill-based programs with strong empirical support (i.e., eligible for listing on the Families First Clearinghouse) and increase access to parenting programs for forcibly displaced families thereby improving child safety and wellbeing and strengthening their public health support. 720 families will be recruited with forced migration backgrounds and within 10 years of arrival in the USA; 360 families will be assigned to the PIMonline program and 360 to a family resource list only, wait-list control group. Families will be recruited using stratified random sampling within the four PIM language groups: English, Spanish, Arabic, French. Within each language, half the families will be assigned to the PIMonline intervention program and the other half will be assigned to receiving a Family Resource List with access to the PIMonline program once the study ends. One parent and one child per eligible family may participate. Data collection with participating families will take place at baseline (T1), 4-months after baseline (T2) and finally, 16 months after baseline (T3). Data collection includes caregiver online surveys, caregiver and child Zoom recorded Family Interaction Task conversations and interviewer administered child surveys for children aged 8-12 at each time point. Standardized, reliable and valid measures in the four languages will be used to assess change in outcomes through the surveys. Longitudinal growth curve analysis will be used to test PIM intervention effects. Our extensive dissemination plan involves nationwide community partners in child welfare and services to forcibly displaced families.