NIH funded

NIH-Funded Randomized Trials

Several Randomized Clinical Trial (RCT) studies have been conducted using the Promoting First Relationships program across a broad range of populations:

  • Two RCT’s have been conducted with PFR in child welfare populations. The first is Fostering Families Project (FFP: N = 210). The second is Supporting Parents Program (SPP: N = 247).
  • One RCT with siblings of children diagnosed on the Autism Spectrum in the Sib Study (SIBS).
  • Two RCT studies in rural tribal communities are in progress.
  • One RCT with mothers (Spanish and English speaking) who have been treated for depression during pregnancy (the focus will be to serve infants birth to three months of age) is in progress.


  • Parenting: Both child welfare studies showed an increase in observed parental sensitivity, parental knowledge of child developmental needs [1, 2].

Figure 1. Post-Test Parenting Results of FFP Observed (green) and Self-Reported Parenting (blue)


  • Child behavior: FFP significantly improved child social competency; for other behavioral outcomes the effect sizes in both programs were in the right direction. SPP showed a reduction of atypical affective communication in toddlers, suggesting better parent-child interaction [1, 2]. In FFP at 6 month follow up we had a trend on reducing sleep problems; in a subsample of reunified birth families [1], PFR showed a reduction in sleep problems mediated by a reduction of separation distress [3].  In the SIB study, those children in PFR showed significant improvement in social attention and learning and were less likely to exhibit attention seeking behavior and separation distress during the parent child interactions; mothers showed less depression [4].
  • Child Welfare Outcomes: FFP was conducted within the foster care system, serving foster parents, kin, and reunified birth families. For kin and foster care parents, children were more likely to experience permanency if they received PFR [5]. We also demonstrated much stronger effect sizes for reunified birth families[6]. In SPP, we enrolled 247 families who had an open CPS investigation. Children whose parents received PFR were much less likely to be placed in foster care, see Figure 2 [2].

Figure 2. Cumulative Percent of Foster Care Placement in SPP (solid line PFR; dotted line Resource and Referral). *Significant p<.05

figure 2

  • Stress Physiology:  In a small pilot study (n= 50) in FFP we found that PFR normalized a stimulated cortisol response [7]. In a small pilot study (n= 60)  in SPP we found PFR improved child stress regulation, measured by Respiratory Sinus Arrhythmia, during difficult tasks [8].

Download a PDF of this research summary here.  For more information about the specific studies, please click on the links below:

Reference List:

  1. Spieker, S.J., et al. (2012). Promoting First Relationships: Randomized trial of a relationship-based intervention for toddlers in child welfare. Child Maltreatment, 17(4) 271-286.
  2. Oxford, M.L., Spieker, S.J. and Fleming, C.B. (2015). Preliminary results from the Supporting Parents Program: An evaluation of Promoting First Relationships ® in a sample of toddlers in CPS.  Society of Research in Child Development.
  3. Oxford, M. L., Fleming, C. B., Nelson, E. M., Kelly, J. F., & Spieker, S. J. (2013). Randomized trial of Promoting First Relationships: Effects on maltreated toddlers’ separation distress and sleep regulation after reunification.Children and youth services review35(12), 1988-1992.
  4. Jones, E.J.H., Burner, K., Venema, K., Earl, R., Lowy, R. Kelly, J. , Dawson, G., & Webb, S.J. Early intervention improves social processing in infants at high familial risk for ASD. International Meeting for Autism Research (IMFAR), May 16, 2015, ,Salt Lake City, Utah, USA.
  5. Spieker, S.J., Oxford, M. L. and Fleming, C.B. (2014). Permanency outcomes for toddlers in child welfare two years after a randomized trial of a parenting intervention. Children and Youth Services Review, 44, 201-206.
  6. Oxford, M.L., et al. (2016). Promoting birth parents’ relationships with their toddlers upon reunification: Results from Promoting First Relationships® home visiting program. Children and Youth Services Review, 61, 109-116.
  7. Nelson, E.M. and Spieker, S.J. (2013). Intervention effects on morning and stimulated cortisol responses among toddlers in foster care. Infant Mental Health Journal, 34(3), 211-221.
  8. Oxford, M.L. (2016). Toddlers in Child Protective Services: Positive post-intervention effects on Respiratory Sinus Arrhythmia as an indicator of emotional responding. University of Washington: Seattle, WA.