Randomized Control Trials

Promoting First Relationships and Bright Start

Promoting First Relationships

See Promoting First Relationships RESEARCH SUMMARY for research findings and results across all completed studies.

Families Connected

The Families Connected Study is an R01 funded by the National Institutes of Child Health and Human Development and is designed to assess if the home visiting program, Promoting First Relationships, is as effective when delivered by Telehealth. We will recruit 357 participants with infants aged 6 – 12 months of age and whose family has a recent investigation in Child Protective Services. Families will be randomized to receive either PFR by home visiting, PFR by Telehealth, or a resource service. The study began recruitment in October 2023. This research is actively recruiting participants, to read about the eligibility criteria click here (Stamped Recruitment document link) and to see the flow of our research click here ((Flow Chart link). This research is actively recruiting participants, to read about the eligibility criteria click here and to see the flow of our research click here . NIH Clinical Trial # NCT04382677

Principal Investigator, Dr. Monica Oxford, and Co-investigator, Dr. Jonika Hash

Families Together Program

This R01 study, funded by National Institute of Child Health and Human Development, is a randomized clinical trial designed to assess the effectiveness of Promoting First Relationships® among children aged 1 to 5 years in child welfare who have recently been reunited with their birth parent after a foster care separation. Promoting First Relationships was adapted and evaluated for service with preschool-aged children. We are partnering with Washington State to implement this community-based clinical trial of effectiveness. Sample recruitment is complete, and we are continuing to collect outcome data. Recruitment for this study ended in the summer of 2023, we continue to collect outcome data until mid-2024. Sample recruitment is complete, and we are continuing to collect outcome data. Recruitment for this study ended in the summer of 2023, we continue to collect outcome data until mid-2024. NIH Clinical Trial # NCT06109766

Principal Investigator, Dr. Monica Oxford, and Co-investigator,Dr. Susan Spieker

Moms & Babies Program
(Programa de Mamás y Bebés)

This RO1 study, funded by the National Institute of Child Health and Human Development, is a randomized clinical trial designed to evaluate the effectiveness of adding a research-based 10-week home visiting parenting program to Evidence-Based depression treatment, to counter the pernicious effects of mothers’ depression on parenting quality and infant development. Participants will be English and Spanish-speaking low-income mothers who began publicly funded depression treatment in pregnancy at their primary care community health centers and their infants 2-4 months of age. 

Principal Investigator, Dr. Susan Spieker, and Co-investigator, Dr. Monica Oxford      

Supporting Parents Program

This R01 study, funded by the National Institute of Child Health and Human Development, is a randomized clinical trial designed to test the effectiveness of Promoting First Relationships® for 247 birth parents of infants and toddlers identified by Child Protective Services. Results showed the intervention improved observed caregiver sensitivity and knowledge of children’s developmental needs; PFR also improved child’s stress physiology during difficult tasks. Children whose parents received PFR were 2.5 times less likely to be placed in foster care. Published Results

Principal Investigator, Dr. Monica Oxford, and Co-investigator, Dr. Susan Spieker 

Fostering Families Program

This R01 study, funded by the National Institute of Mental Health, is a randomized clinical trial designed to test the effectiveness of Promoting First Relationships® for 210 birth, kin and foster caregivers of infants and toddlers in child welfare who recently transitioned into their care. Results showed the intervention improved observed caregiver sensitivity and knowledge of children’s developmental needs. Children improved in social competency and children showed more normalized stimulated cortisol patterns. Children with kin and foster families were more  likely to achieve permanency if their caregivers received PFR. Published Results 

 Principal Investigator, Dr. Susan Spieker, and Co-investigator, Dr. Monica Oxford. 

A Primary Prevention Trial to Strengthen Child Attachment in a Native Community

This study, funded by the National Institute on Minority Health and Health Disparities, with MPI’s Oxford, Booth-LaForce & Buchwald, is a randomized clinical trial that has partners with two tribes in the Midwest to adapt and implement infant mental health services using Promoting First Relationships® in a community-based partnership. We will train local providers to implement services using a distance learning program. Once trained community providers will implement a clinical trial using a wait-list control design.

Multiple Principal Investigators, Dr. Cathryn Booth-LaForce, Dr. Monica Oxford, and Dr. Dedra Bushwald  

Promoting First Relationships®: Primary Prevention in Two Native Communities

An R01, within a P20, NIMHD Exploratory Centers of Excellence grant in collaboration with UW School of Medicine and Washington State University. MPIs—John Roll & Dedra Buchwald: Behavioral Health Collaborative for Rural American Indian Communities. Using a waitlist design, the aim of this study is to adapt and evaluate the adaption of Promoting First Relationships ® within a tribal community.

Principal Investigators, Dr. Cathryn Booth-LaForce, and Co-investigator, Dr. Monica Oxford

Examining Biomarkers of Emotional Regulation in a Sample of Maltreated Toddler 

This study, funded by the Royalty Research Fund, University of Washington, was designed to provide an opportunity to augment an ongoing, longitudinal, clinical trial of a 10-week home visiting intervention with maltreated infants and toddlers. In the parent study, families are receiving one of two interventions in a clinical trial of Promoting First Relationships (PFR; Kelly et al., 2003). We collected collect additional physiological indicators of emotional regulation of infants and toddlers in this sample, specifically respiratory sinus arrhythmia (RSA) during a home visit. Results indicated that children whose parents received PFR demonstrated significantly better emotional regulation than those children in the control group (see Hastings et al., 2018 in SPP Publication List).

Principal Investigator, Dr. Monica Oxford, R01HD061362-02

A Dyadic Approach to Perinatal Depression Treatment in Primary Care

This project will test a user centered design adaptation of an evidence-based parenting intervention Promoting First Relationships (PFR). We will test this adaptation within a comprehensive perinatal depression treatment model in a collaborative care setting. We will focus on important mediators of worsened postpartum depression (decreased parenting self-efficacy and impaired mother-infant interaction), and test if PFR improves both maternal and child outcomes.

Principal Investigator, Dr. Amritha Bhat, and Co-investigator, Monica Oxford, NIH R34

Bright Start

Bright Start: Teaching Parenting Skills to At-Risk Mothers

This study is a collaboration with Seattle Children’s to test the hypothesis that a series of pragmatic, actionable, evidence-based and cost-effective caregiver behaviors can enhance early child-parent attachment as well as the cognitive and emotional development of children 3 years old and younger. The intervention consists of parent education and the provision of specific tools and recommendations for appropriate developmental stimulation after the first three years.

Principal investigator, Dr. Dimitri Christakis and Co-investigator, Dr. Susan Spieker