Clinical Research Directory

Combining Mental Health and Parenting Interventions to Improve Child Wellbeing Among Refugee Families in Tanzania

The goal of this clinical trial is to learn whether improving caregivers' mental health and parenting practices can enhance child wellbeing among Congolese refugee families living in the Nyarugusu Refugee Camp, Tanzania. The WEMA trial ("Wellbeing through combined Evidence-based tools for Mental health and Attuned parenting") is a three-arm, family-level cluster-randomized, controlled superiority trial involving 324 families (approximately 648 children aged 7-10 years and their two primary caregivers). Participants and intervention facilitators will know which program a family receives, but outcome assessors (enumerators) will not know group assignment. The main questions it aims to answer are: * Does Self-Help Plus (SH+), a World Health Organization (WHO) group stress-management program, improve children's emotional and behavioral functioning at 12 months post-intervention, compared with usual care? * Does adding Interaction Competencies with Children for Parents (ICC-P), a participatory parenting program, after SH+ further improve children's emotional and behavioral functioning at 12 months post-intervention, compared with SH+ alone? Researchers will compare (1) Usual Care, (2) SH+, and (3) SH+ followed by ICC-P to see whether SH+ improves outcomes versus usual care, and whether SH+ followed by ICC-P provides additional benefits beyond SH+ alone. Participants will: * Be assigned by chance by family clusters to one of three groups: Usual Care, SH+, or SH+ followed by ICC-P. * Receive either (a) information about available psychosocial and mental health services (Usual Care), (b) SH+ (five group sessions delivered by trained non-specialists), or (c) SH+ followed by ICC-P (a four-day participatory parenting training to strengthen positive parenting and reduce harsh discipline). * Complete study assessments at baseline, 3 months, and 12 months post-intervention. The primary outcome is children's emotional and behavioral functioning, measured using the Pediatric Symptom Checklist-17 (PSC-17) at 12 months post-intervention. Secondary outcomes include children's wellbeing and quality of life, as well as caregivers' mental health, well-being, and parenting practices. Additional exploratory outcomes will also be assessed, including measures collected from caregivers and behavioral tasks with children. The trial is implemented by Uppsala University in collaboration with the Dar es Salaam University College of Education (DUCE) and partners, with funding from the Swedish Research Council (grant no. 2022-02476).

A Multi-level Mother-daughter Physical Activity Intervention for Pre- Adolescent Latinas

The goal of this Cluster Randomized Control Trial (RCT) is to learn if the mother-daughter intervention titled "Conmigo" can increase Latina preadolescents' physical activity (PA). The main objectives of the study are: * To test the effectiveness of Conmigo on daughters' Moderate-to-Vigorous level PA (MVPA) over time * To evaluate individual (e.g. mothers' MVPA) and family level (e.g. mother-daughter communication) mechanisms of change and their bidirectional effects Researchers will compare the 10-week physical activity promotion intervention to a 10-week parallel intervention with emphasis on another health behavior (dietary intake) to see if there are differences in MVPA levels. We will enroll 216 Latina mother-daughter pairs at 18 elementary schools; each school will randomly receive the PA intervention or the control group program. Mothers and daughters will attend 10 weekly sessions (2 hours each) at their elementary school, led by YMCA staff. Informed by social cognitive theory and family systems theory, the PA intervention sessions target family-level correlates of physical activity such as PA promotion parenting strategies (monitoring, role-modeling, etc.) and mother-daughter communication. Participants in the intervention group engage in weekly PA during sessions, discuss different topics each week, and set goals and receive PA homework during the week. The investigators hypothesize that daughters participating in Conmigo will have higher minutes of device-assessed MVPA at M2 (post program), M3 (6 months post program), and M4 (12-months post program) compared to girls in the control condition.

Mothers and CareGivers Investing in Children Study 2.0

The study will use a longitudinal, randomized control trial design to determine intervention impact on parent and child behaviors, and infant health. The two intervention groups include: 1) MAGIC-FEED+; and 2) MAGIC-SAFE. This trial is an efficacy trial of the MAGIC-FEED and MAGIC-SAFE program that has been successfully implemented with families as part of the MAGIC 1.0 program trial (IRB#: 2015040017). * The primary aim is to investigate each intervention's impact on infant BMIZ at 13 months. * The investigators will also assess the effect of MAGIC-FEED on caregiver nutrition knowledge and feeding practices, responsive feeding, infant diet, and child self-regulatory abilities and assess how these factors impact child self-regulation of eating and adiposity. * Finally, the investigators will determine if the interventions demonstrate the factors necessary to be a successful intervention as determined by the RE-AIM and PRISM frameworks.

Increasing Kindergarten Social-Emotional Skills for Positive Long-Term Mental Health

The goal of this clinical trial is to learn if the Social-emotional Skills for Thriving and Relating at School (SSTRS) Program can help children entering kindergarten and their families. The main questions it aims to answer are: 1) Do children who participate in SSTRS have better social-emotional skills and mental health? and 2) Do parents who participate in SSTRS have more positive parenting skills and involvement in their children's learning? Researchers will compare the SSTRS Program to the regular kindergarten curriculum without SSTRS to see if being in SSTRS helps children to have better mental health and parents to have better parenting skills. Kindergarteners will have daily SSTRS lessons in their kindergarten classes for 8 weeks. Their parents will watch videos and attend group meetings with other parents and answer questions about their own and their children's behaviors and mental health

Parenting for Lifelong Health Program in Kuwait

Parenting interventions play a crucial role in promoting positive parent-child interactions, which are fundamental to fostering child well-being. Over the years, substantial progress has been made in understanding the importance of these interactions, particularly in the context of early childhood development. Positive parent-child interactions lay the groundwork for various aspects of child development, including socioemotional skills, academic performance, and mental health. Evidence-based parenting programs have demonstrated strong effectiveness in promoting positive parenting and preventing child maltreatment. The Parenting for Lifelong Health (PLH) program has yielded positive outcomes in many countries. This project aims to culturally adapt the PLH program and conduct a randomized controlled trial (RCT) to assess its feasibility and effectiveness in Kuwait.

Putting Children First - Parent Training for Parents in High Conflict

Intervention efficacy will be evaluated via a randomized controlled trial in Indiana over 17 weeks with 250 dyads (i.e., divorcing/divorced/separated parents). Dyads will be randomized to business as usual (BAU) or BAU+PCF. Compared to BAU, BAU+PCF will (a) increase parental self-efficacy, (b) decrease parental stress, (c) increase parental knowledge, (d) increase parental motivation to engage with the intervention, (f) increase the quality of parent-child relationships, and (g) improve parent-reported child stress and prosocial behaviors. Parents with higher levels of conflict will be more responsive to parallel parenting, and increased parallel parenting among HIC dyads will lead to reductions in child adjustment problems.