Spieker, S. J., Oxford, M. L., Kelly, J. F., Nelson, E. M., & Fleming, C. B. (2012). Promoting First Relationships: Randomized trial of a relationship-based intervention for toddlers in child welfare. Child Maltreatment, 17(4), 271–286. https://doi.org/10.1177/1077559512458176

Type of Study: Randomized controlled trial
Number of Participants: 210 children

Population:

• Age — 10-24 months
• Race/Ethnicity — 55% White, 20% Mixed, 15% African American, 10% Hispanic, 7% Native American, and 4% Other
• Gender — 56% Male
• Status — Participants were children in foster care.

Location/Institution: Seattle, Washington

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to present analyses on the Promoting First Relationships (PFR) program in regard to improving parenting and toddler outcomes for toddlers in state dependency. Participants were randomly assigned to 10-weeks of PFR or the Early Education Support (EES) comparison condition. Measures utilized include the Nursing Child Assessment Teaching Scale (NCATS), the Indicator of Parent Child Interaction, This is My Baby, Raising a Baby, the Parenting Stress Index (PSI), the Toddler Attachment Sort – 45 (TAS45), the Attachment Q Sort, the Brief Toddler Social and Emotional Assessment (BITSEA), Child Behavior Checklist for Ages 1 ½–5 (CBCL), Bayley-III Screening Test, and the Bayley Behavior Rating Scales. Results indicate that caregivers’ sensitivity improved more in the PFR participants than in the comparison subjects, although the differences were no longer significant at the 6-month follow-up. Subjects in the PFR condition also reported more understanding of toddlers and child competence than the comparison subjects, although, again, these differences were no longer significant at the 6-month follow-up. There were no significant differences between intervention and comparison children on security at either postintervention or 6-month follow-up. Limitations include an internal validity threat due to changes in child placement, which eliminated subjects from the sample at follow-up and reduced the study’s power.

Length of controlled postintervention follow-up: 6 months.

Nelson, E. M., & 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. https://doi.org/10.1002/imhj.21382

Type of Study: Randomized controlled trial
Number of Participants: 48

Population:

• Age — 10–25 months
• Race/Ethnicity — 69% White, 17% Black, 13% American Indian, and 2% Hawaiian Native
• Gender — Not specified
• Status — Participants were children in foster care.

Location/Institution: Seattle, Washington

Summary: (To include basic study design, measures, results, and notable limitations)
The study used a subset of the same sample as Spieker et al. (2012). The purpose of the study was to test whether toddlers with caregivers in the Promoting First Relationships (PFR) program would show postintervention change in stimulated salivary cortisol patterns during a research home visit involving a separation-reunion procedure when compared to a condition including child development and resource advice, but no attachment strategies. Participants were randomly assigned to PFR or to a control condition. Measures utilized include 4 saliva samples during a 1.5-hour research visit and samples the next morning. Results indicate that 92% of children demonstrated atypically low morning cortisol. Results also indicated that at post-intervention, flat, decreasing, and increasing patterns were also exhibited. Significantly more children in the PFR condition showed an increasing pattern. Limitations include lack of a non-maltreated or child welfare services involved comparison group, possible sample collection time variation, lack of follow-up, and small sample size.

Length of controlled postintervention follow-up: None.

Oxford, M. L., Marcenko, M., Fleming, C. B., Lohr, M. J., & Spieker, S. J. (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. https://doi.org/10.1016/j.childyouth.2015.12.004

Type of Study: Randomized controlled trial
Number of Participants: 43

Population:

• Age — Children: 10–25 months; Parents: Not specified
• Race/Ethnicity — Children: 69% White, 17% Black, 13% American Indian, and 2% Hawaiian Native; Parents: Not specified
• Gender — Children: 20 Male; Parents: 6 Male
• Status — Participants were parents of children in foster care.

Location/Institution: Seattle, Washington

Summary: (To include basic study design, measures, results, and notable limitations)
The study used a subset of the same sample as Spieker et al. (2012). The purpose of the study was to report on the findings from a randomized control trial of Promoting First Relationships (PFR) for a subsample of reunified birth parents that were part of the larger trial. Participants were randomly assigned to PFR or to a control condition. Measures utilized include the Nursing Child Assessment Teaching Scale (NCATS), the Indicator of Parent Child Interaction, This is My Baby, Raising a Baby, the Parenting Stress Index (PSI), the Toddler Attachment Sort – 45 (TAS45), the Attachment Q Sort, the Brief Toddler Social and Emotional Assessment (BITSEA), Child Behavior Checklist for Ages 1 ½–5 (CBCL), Bayley-III Screening Test, and the Bayley Behavior Rating Scales. Results indicate that although the sample size was small and most of the estimates of intervention effects were not statistically significant, the effect sizes and the pattern of results suggest that the intervention may have improved both observed parenting sensitivity and observed child behaviors as well as decreased parent report of child behavior problems. Limitations include small sample size, and participants in this study may differ from the general population of reunified birth families.

Length of controlled postintervention follow-up: 6 months.

Oxford, M. L., Spieker, S. J., Lohr, M. J., & Fleming, C. B. (2016). Promoting First Relationships®: Randomized trial of a 10-week home visiting program with families referred to child protective services. Child Maltreatment, 21(4), 267–277. https://doi.org/10.1177/1077559516668274

Type of Study: Randomized controlled trial
Number of Participants: 247 families

Population:

• Age — Children: R&R: Mean=16.77 months, PFR: Mean=15.97 months; Adults: R&R: Mean=27.04 years, PFR: Mean=26.41 years
• Race/Ethnicity — Child: R&R/PFR: 59%/65% White, 35%/27% Other, 29%/34% Hispanic, 4%/4% African Am., 2%/0% AI/AN, 0.8%/3% Asian; Parent: R&R/PFR: 77%/77% White, 19%/20% Hisp., 11%/10% Oth., 6%/5% Afr. Am., 3%/5% Asian, 2%/3% AI/AN
• Gender — Children: R&R: 58% Male, PFR: 50% Male; Parents: R&R: 91% Female, PFR: 90% Female
• Status — Participants were toddlers and their caregivers involved with child welfare services (CWS).

Location/Institution: Washington State

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to examine Promoting First Relationships (PFR) effect on enhancing parent sensitivity and preventing child removals for families in the child welfare system. Participants were randomly assigned to PFR or a control treatment group (brief resource and referral [R&R]). Measures utilized include the Raising a Baby scale (RAB), the Nursing Child Assessment Teaching Scale (NCATS), the Brief Infant Toddler Social and Emotional Assessment (BITSEA), the Bayley Behavior Rating Scales (BRS), the Attachment Q-Sort (AQS), the Parenting Stress Index (PSI-3), and the Parenting Stress Index-Short Form (PSI-SF). Results indicate that across postintervention time points, parents in the PFR condition scored higher than families in the control group in parent understanding of toddlers’ social emotional needs and observed parental sensitivity. Children in the PFR condition scored lower than children in the comparison condition on an observational measure of atypical affective communication and were less likely than children in the comparison group to be placed into foster care through one-year postintervention. No significant differences were found on measures of parenting stress or child social-emotional competence, behavior problems, or secure base behavior. Limitations include lack of generalizability due to ethnicity of participants, and reliance on self-reported measures.

Length of controlled postintervention follow-up: 1 year (for CWS records only)

Jones, E. J., Dawson, G., Kelly, J., Estes, A., & Webb, S. J. (2017). Parent‐delivered early intervention in infants at risk for ASD: Effects on electrophysiological and habituation measures of social attention. Autism Research, 10(5), 961–972. https://doi.org/10.1002/aur.1754

Type of Study: Randomized controlled trial
Number of Participants: 33

Population:

• Age — 9–11 months
• Race/Ethnicity — 87% White
• Gender — 36% Female
• Status — Participants were parent–toddler dyads.

Location/Institution: Not specified

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to determine the efficacy of Promoting First Relationships (PFR) for parents with infants at high familial risk for autism spectrum disorder (ASD) with treatment between 9 and 11 months. Participants were randomly assigned to either PFR or on-going assessment without intervention. Measures utilized include the Mullen Scales of Early Learning. Results indicate that compared to infants who only received assessment and monitoring, infants who received PFR showed improvements in neurocognitive metrics of social attention, as reflected in a greater reduction in habituation times to face versus object stimuli between 6 and 12 months, maintained at 18 months; a greater increase in frontal EEG theta power between 6 and 12 months; and a more comparable P400 response to faces and objects at 12 months. The high-risk infants who received the intervention showed a pattern of responses that appeared closer to the normative responses of two groups of age-matched low-risk control participants. Limitations include small sample size, participant attrition, and length of follow-up. 

Length of controlled postintervention follow-up: 6 months.

Pasalich, D. S., Fleming, C. B., Spieker, S. J., Lohr, M. J., & Oxford, M. L. (2019). Does parents’ own history of child abuse moderate the effectiveness of the Promoting First Relationships® intervention in child welfare? Child Maltreatment, 24(1), 56–65. https://doi.org/10.1177/1077559518809217

Type of Study: Randomized controlled trial
Number of Participants: 247 families

Population:

• Age — Children: 10-24 months; Adults: Not specified
• Race/Ethnicity — Children: 32% Hispanic and 31% Biracial; Adults: 77% White, 19% Hispanic, and 10% Mixed Race
• Gender — Not specified
• Status — Participants were toddlers and their caregivers involved with child welfare services.

Location/Institution: Washington State

Summary: (To include basic study design, measures, results, and notable limitations)
The study used the sample as Oxford et al. (2016). The purpose of the study was to examine whether parents’ own history of child abuse moderated the indirect effects of the Promoting First Relationships® (PFR) intervention on toddlers’ secure base behavior via parental sensitivity. Participants were randomly assigned to PFR or a control intervention. Measures utilized include the Childhood Trauma Questionnaire–Short Form, the Nursing Child Assessment Teaching Scale, and the Toddler Attachment Sort-45. Results indicate that the PFR group demonstrated greater parental sensitivity at postintervention than the control group, which in turn led to higher levels of toddler secure base behavior at 6-month follow-up. Findings also indicated that these intervention effects were only evident for parents who experienced physical abuse in their childhood. Parents’ history of sexual or emotional abuse did not significantly moderate outcomes. Limitations include the measure of toddler attachment used, reliance on parents’ retrospective reports of their abuse experiences in childhood, a lack of information on parents’ child neglect experiences, and concerns about generalizability beyond the majority White sample.

Length of controlled postintervention follow-up: 6 months.

Booth-LaForce, C., Oxford, M. L., Barbosa-Leiker, C., Burduli, E., & Buchwald, D. S. (2020). Randomized controlled trial of the Promoting First Relationships® preventive intervention for primary caregivers and toddlers in an American Indian community. Prevention Science, 21(1), 98–108. https://doi.org/10.1007/s11121-019-01053-x

Type of Study: Randomized controlled trial
Number of Participants: 34 child-caregiver dyads

Population:

• Age — Children: Immediate: Mean=18.53 months, Waitlist: Mean=17.29 months; Caregivers: Not specified
• Race/Ethnicity — Children: Immediate: 100% American Indian/Alaska Native, Waitlist: 100% American Indian/Alaska Native; Caregivers: Immediate: 59% American Indian/Alaska Native, 29% White, and 12% Mixed; Waitlist: 88% American Indian/Alaska Native and 12% Mixed
• Gender — Children: Immediate: 65% Female, Waitlist: 41% Female; Caregivers: Not specified
• Status — Participants were American Indian/Alaska Native children living on or near the reservation, and their primary caregivers.

Location/Institution: Rural reservation in the Northwest region (as defined by the Indian Health Service) of the USA.

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to test the efficacy of the Promoting First Relationships® (PFR) program in American Indian families living on a rural reservation. Participants were randomly assigned to PFR or waitlist group. Measures utilized include the Nursing Child Assessment Teaching Scale, the Raising a Baby scale, the short-form Parenting Stress Index and the Infant-Toddler Social Emotional Assessment (ITSEA). Results indicate that the PFR group, compared with waitlist, had significantly higher scores on the quality and contingent responsiveness of caregiver-child interactions, as well as on caregiver knowledge of toddlers’ social and emotional needs and level of developmentally appropriate expectations. Caregiver stress and caregivers’ reports of child behavior did not differ significantly. Limitations include small sample size, lack of post-intervention follow-up, high attrition rate, and whether the findings would generalize to American Indian families or others not living on a rural reservation.

Length of controlled postintervention follow-up: None.

Oxford, M. L., Hash, J. B., Lohr, M. J., Bleil, M. E., Fleming, C. B., Unützer, J., & Spieker, S. J. (2021). Randomized trial of promoting first relationships for new mothers who received community mental health services in pregnancy. Developmental Psychology, 57(8), 1228–1241. https://doi.org/10.1037/dev0001219

Type of Study: Randomized controlled trial
Number of Participants: 252 mothers and their infants

Population:

• Age — Children: PFR: Mean=1.8 months, Control: Mean=1.9 months; Mothers: PFR: Mean=28.8 years, Control: Mean=27.4 years
• Race/Ethnicity — Children: PFR/Control: 62%/54% Caucasian, 54%/53% Hispanic, 20%/26% Multiracial, 16%/14% African American and 2%/6% Other; Mothers: PFR/Control: 66%/65% Caucasian, 49%/46% Hispanic, 17%/18% African American, 13% Multiracial, 5%/9% Other, and NR/8% Multira
• Gender — Children: PFR: 56% Male and 44% Female, Control: 51% Female and 49% Male; Mothers: 100% Female
• Status — Participants were mothers who had begun treatment for a mental health diagnosis (depression, anxiety, and/or posttraumatic stress disorder/PTSD) at a community or public health center in pregnancy.

Location/Institution: King County, Washington

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to test the effectiveness of Promoting First Relationships® (PFR) in underserved communities. Participants were randomly assigned to the PFR program or receipt of a resource packet. Measures utilized include the Nursing Child Assessment Teaching Scale (NCATS), the Infant CARE-Index (ICI), the Raising a Baby Scale (RAB), the Maternal Confidence Questionnaire (MCQ), and the Infant Toddler Social Emotional Assessment (ITSEA). Results indicate that compared to mothers in the control condition, mothers in the PFR condition had significantly higher observed sensitivity scores at both follow-up time points, improved understanding of infant-toddler social emotional needs at both time points, and reported less infant externalizing behavior at age 12 months. Limitations include poor inter-rater agreement of the ICI coders and a smaller Spanish speaking sample than intended.

Length of controlled postintervention follow-up: Varied.

Booth-LaForce, C., Oxford, M. L., O’Leary, R., & Buchwald, D. S. (2023). Promoting First Relationships® for primary caregivers and toddlers in a Native community: A randomized controlled trial. Prevention Science, 24(1) 39–49. https://doi.org/10.1007/s11121-022-01415-y

Type of Study: Randomized controlled trial
Number of Participants: 162 mothers and their toddlers

Population:

• Age — Children: 10–31 months (Mean=20.10 months); Mothers: Not specified
• Race/Ethnicity — Children: 100% American Indian or Alaska Native; Mothers: 96% American Indian or Alaska Native, and 4% White
• Gender — Children: 50% Female; Mothers: 93% Female
• Status — Participants were Native families living on a rural reservation.

Location/Institution: A rural reservation in the Northern Plains area of the USA

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to test the effectiveness of Promoting First Relationships® (PFR) aimed at fostering positive caregiver-child relationships in Native families living on a rural reservation. Participants were randomized to a PFR group or Resource and Referral (RR) control group. Measures utilized include the Nursing Child Assessment Teaching Scale (NCATS), the Raising a Baby Scale (RAB), and the Center for Epidemiological Studies Depression scale (CES-D). The Research Visitor, who was blinded to study group assignment, conducted one home visit before randomization to collect baseline data (Time 1), a second visit (Time 2) following the completion of PFR or RR (at approximately 3 months after Time 1) to collect data to test the immediate effects of PFR compared with the RR service, and a third visit (Time 3) approximately 3 months later to test the subsequent effects. Results indicate that caregivers in the PFR group had significantly higher scores on knowledge about children’s social-emotional needs at Time 2 and Time 3 and less severe depressive symptoms at Times 2 and 3. At Time 3, the quality of caregiver-child interaction was better in the PFR group an effect that was moderated by severity of depressive symptoms with PFR having the greatest impact at low levels of initial symptoms. Limitations include findings may not generalize to Native families who live on other reservations or in urban, or other non-reservation communities; sample size; the large number of participants who withdrew from the PFR program during the course of the study, and most participants who withdrew did not get an opportunity to experience the benefits of PFR because they left the study immediately after baseline assessment and randomization or after one PFR visit, in part because of the lack of compensation.

Length of controlled postintervention follow-up: 3 and 6 months.

The following studies were not included in rating PFR on the Scientific Rating Scale...

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 Review, 35(12), 1988–1992. https://doi.org/10.1016/j.childyouth.2013.09.021

The study used a subset of the same sample as Spieker et al. (2012). The purpose of the study was to investigate the impact of Promoting First Relationships® (PFR) on sleep problems among toddlers in child welfare recently reunified with their birth parent. Measures utilized include parental report of sleep problems and research visitor observation of separation distress using the Toddler Attachment Sort-45, the Child Behavior Checklist (CBCL), and the Brief Infant Toddler Social and Emotional Assessment (BITSEA). Results indicate that toddlers in the PFR condition showed a significant decrease in their separation distress scores, and toddlers exhibiting less separation distress had fewer sleep problems. Limitations include small sample size, participant attrition, and lack of generalizability beyond birth parents to other caregivers, due to their exclusion from these analyses. Note: This study was not used for rating Promoting First Relationships (PFR) in Infant and Toddler Mental Health (Birth-3) and Parenting Training Programs that Address Problem Behaviors in Children and Adolescents since subgroup analyses cannot be used for rating of a program designed for a broader target population

Spieker, S. J., Oxford, M. L., & 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. https://doi.org/10.1016/j.childyouth.2014.06.017

The study used the sample as Spieker et al. (2012). The purpose of the study was to report on child welfare outcomes of a community-based trial of Promoting First Relationships (PFR), specifically on the stability of children’s placements and their permanency status two years after enrollment into the study. Participants were randomly assigned to PFR or a control treatment group. Measures utilized include a state child welfare administrative database. Results indicate that there was no difference by intervention group on stability or permanency, but there was a significant interaction between caregiver type (birth parent vs. foster/kin) and intervention group. More foster/kin caregivers who received the PFR intervention provided stable, uninterrupted care and eventually adopted or became the legal guardians of the toddlers in their care, compared to foster/kin caregivers randomized to the comparison condition. Limitations include small sample size, permanency had not been achieved for many of the children by the end of the follow-up period, and significant results were only seen in a subset of the population. Note: This study was not used for rating Promoting First Relationships (PFR) in Infant and Toddler Mental Health (Birth-3) and Parenting Training Programs that Address Problem Behaviors in Children and Adolescents since subgroup analyses cannot be used for rating of a program designed for a broader target population.

Pasalich, D. S., Fleming, C. B., Oxford, M. L., Zheng, Y., & Spieker, S. J. (2016). Can parenting intervention prevent cascading effects from placement instability to insecure attachment to externalizing problems in maltreated toddlers?. Child Maltreatment, 21(3), 175–185. https://doi.org/10.1177/1077559516656398

The study used a subset of the same sample as Spieker et al. (2012). The purpose of the study was to conduct secondary data analysis of a randomized controlled trial to examine whether Promoting First Relationships (PFR) reduced risk for a maladaptive cascade from placement instability to less secure attachment to elevated externalizing problems. Participants were randomized to PFR or a control treatment group. Measures utilized include the Brief Infant Toddler Social and Emotional Assessment (BITSEA), the Toddler Attachment Sort-45 (TAS45), and the Child Behavior Checklist (CBCL). Results indicate that PFR weakened the association between multiple placement changes (baseline) and less security (postintervention) and that the indirect effect of placement instability on greater externalizing problems (6-month follow-up) via less security was evident only in toddlers in the comparison condition. Limitations include small sample size at 6-month follow-up and utilization of subset of original population. Note: This study was not used for rating Promoting First Relationships (PFR) in Infant and Toddler Mental Health (Birth-3) and Parenting Training Programs that Address Problem Behaviors in Children and Adolescents since subgroup analyses cannot be used for rating of a program designed for a broader target population.