NIH funded

NIH-Funded Randomized Trials

Because infants and toddlers in child welfare are vulnerable to social, emotional, and regulatory problems and can thus be difficult to nurture, tested effective programs for caregivers of these children that increase caregiver sensitivity and improve child outcomes are needed. We (Susan Spieker, PI; Jean Kelly, Monica Oxford, Maureen Marcenko, Co-PIs, 2006-2012) conducted a community based, randomized control trial of Promoting First Relationships to improve parenting and toddler outcomes for toddlers in state dependency. Toddlers (10 – 24 months; n = 210) with a recent placement disruption involving a move to a new birth, kin, or foster caregiver, were randomized to 10-week PFR or a comparison condition. Community providers were trained to use PFR in the intervention. Results supported that the brief, 10-week PFR program could improve caregiver sensitivity, knowledge of appropriate developmental practices, perceptions of child competence, and observations of child emotional regulation. Modest effect sizes persisted to the six-month follow-up.

In early 2006, Promoting First Relationships began a 5-year project funded by the National Institute of Mental Health (Susan Spieker, PI; Jean Kelly, Monica Oxford, Maureen Marcenko, Co-PIs) to acquire crucially needed evidence to support interventions promoting infants’ mental health in foster care. This project was also designed to build community capacity to deliver infant mental health interventions and services to foster families. This research project was a longitudinal, randomized controlled trial, and involved over 200 foster families in Western Washington. The project staff collaborated with community partners to conduct the research and assist in modifying the existing interventions for implementation with infants in foster care and their caregivers.


We conducted a randomized control trial in child welfare and hypothesized that PFR would result in improvements in caregiver sensitivity and child attachment and engagement, relative to a comparison condition in which families received case management, resources and referrals. Toddlers (10 – 24 months; N = 210) with a recent child welfare placement disruption were randomized to 10-week PFR or a comparison condition. Participation was offered to the child’s current foster, kin, or birth parent. If children were moved during the course of the intervention, it was offered to their next foster, kin, or birth parent. Community providers delivered PFR or the comparison intervention.

The group that received the PFR intervention showed significant improvements on observational ratings of caregiver sensitivity, caregiver reports of child competence, and caregiver understanding of the child’s social-emotional needs. At six-month follow-up 61% of original sample dyads were still intact. Most differences on child outcomes still favored the PFR condition, and a measure of child sleep problems was statistically significant. Although in the smaller sample, significant effects were not sustained, the direction of differences consistently favored the PFR group (Spieker, Oxford, Kelly, Nelson, Fleming, under review).

Two other sets of analyses currently in process with this same sample show very encouraging results of PFR on physiological regulation in children and toddlers in the foster care system. A sub study (n=50) examined cortisol levels following a mild stressor and found that almost all of the children who showed indications of mobilizing a regulated stress response had received the PFR treatment (Spieker and Nelson, under review). Another sub study found that recently reunified birth parents who received PFR reported fewer child sleep problems six months following the intervention (Oxford, Nelson, Fleming, Kelly and Spieker, under review).

In 2007, Promoting First Relationships began another 5-year randomized trial funded by National Institute of Child Health and Development to study the effects of early detection and intervention for infants at risk for autism. Results are currently being analyzed.

In 2010, Promoting First Relationships began a third, 5-year NIH funded randomized trial to study the effects of PFR intervention with families involved in the Child Protective System (Monica Oxford, PI; Susan Spieker, Jean Kelly, Co-PIs).