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. Author manuscript; available in PMC: 2025 Mar 11.
Published in final edited form as: Prev Sci. 2022 Aug 23;24(1):39–49. doi: 10.1007/s11121-022-01415-y

Promoting First Relationships® for Primary Caregivers and Toddlers in a Native Community: a Randomized Controlled Trial

Cathryn Booth-LaForce 1, Monica L Oxford 1, Rae O’Leary 2, Dedra S Buchwald 3
PMCID: PMC11896639  NIHMSID: NIHMS2057096  PMID: 35997845

Abstract

This study tested the effectiveness of Promoting First Relationships® (PFR), a preventive intervention program aimed at fostering positive caregiver-child relationships in Native families living on a rural reservation. Participants were 162 primary caregivers (96% Native; 93% female) and their Native toddlers (10–31 months old; 50% female). Families were randomized to a PFR group (n = 81) or Resource and Referral (RR) control group (n = 81), after baseline data collection (Time 1) to assess the quality of caregiver-child interaction, caregiver knowledge about children’s social-emotional needs, caregiver depressive symptoms, and child externalizing behavior. After delivery of the PFR intervention or the RR service, follow-up assessments were repeated immediately post-intervention (Time 2) and 3 months later (Time 3). After controlling for baseline assessments, multivariate analyses of covariance revealed that caregivers in the PFR group had significantly higher scores on knowledge about children’s social-emotional needs at Time 2 (p < .01, η2 = .06) and Time 3 (p < .05, η2 = .04) and less severe depressive symptoms at Times 2 and 3 (both p < .05, η2 = .04). At Time 3, the quality of caregiver-child interaction was better in the PFR group (p < .01, η2 = .06), an effect that was moderated by severity of depressive symptoms (p = .05, η2 = .06), with PFR having the greatest impact at low levels of initial symptoms (p = .02). Results support the positive impact of PFR in a Native community and suggest conditions under which the intervention may be most effective.

Keywords: American Indians, Native, Indigenous, Home visiting, Promoting First Relationships, Caregiver-child interaction, Randomized controlled trial, Parenting

Children (wakanyeja or “little sacred ones” in Lakota) are highly valued and play a central role in many Native1 cultures (BigFoot & Funderburk, 2011; BigFoot & Schmidt, 2010). However, many Native children are at elevated risk of experiencing poverty, household exposure to substance use, parental mental health disorders, domestic violence, maltreatment, and the effects of historical and other traumas—all factors which increase their risk of developing mental and physical health issues and substance use problems in adolescence and adulthood (Brockie et al., 2013; Sarche & Spicer, 2008; Warne & Lajimodiere, 2015; Whitesell et al., 2009).

Although many Native parents provide an environment for their children that optimizes growth and development, others may have parenting difficulties due to their own historic and current challenges. Historically, the US government’s forced removal of Native people from their traditional lands, removal of children from families to residential boarding schools, cultural erasure, and genocidal policies resulted in mass psychological and physical harm to Native people that continues to be expressed through intergenerational transmission of trauma (Gameon & Skewes, 2020; Walls & Whitbeck, 2012). In this context, the negative impact on some Native caregivers may interfere with optimal parenting.

Data suggest that Native children exhibit more behavior problems and less social competence when their families are living in poverty and their parents are stressed or experience mental health challenges (Frankel et al., 2014; Sarche et al., 2009). Also, Native parents’ own adverse childhood experiences (including maltreatment, exposure to domestic violence, and parental substance abuse) are associated with diminished social-emotional functioning in their children, due to parental mental distress. This effect is attenuated under conditions of high parental emotional availability, which buffers this pathway (Wurster et al., 2020). Moreover, despite the historical context and present-day symptoms of trauma, Native families demonstrate inherent strengths and resilience to overcome generations of adversity (Oré et al., 2016). Taken together, these observations highlight the potential positive influence of parental emotional availability on Native children’s early childhood development and the importance of interventions that help caregivers become more sensitive and responsive to their children’s social and emotional needs.

Early preventive interventions focusing on enhancing parenting sensitivity and early childhood attachment security have demonstrated positive effects, as summarized in a meta-analysis of 51 randomized controlled trials (Bakermans-Kranenburg et al., 2003). However, very few of these trials have included Native caregivers and children (Lyon et al., 2015; Macvean et al., 2017), who merit culturally appropriate prevention efforts offered in their own Tribal communities. In this study, we evaluated the effectiveness of one such program—Promoting First Relationships® (PFR; Kelly et al., 2008).

Promoting First Relationships®

PFR is a theory-driven, relationship-based preventive intervention strategy for primary caregivers and their young children aged birth to 5 years. It uses a strengths-based approach, which supports and builds on the resilience of Tribal communities. The intervention is delivered in a relatively brief home-visiting program comprising 10 sessions. The goal is to increase caregivers’ awareness of their children’s social and emotional needs, including their need for a sense of safety and security, and to understand their own needs as caregivers. PFR promotes trusting and secure caregiver-child relationships and healthy child development. PFR providers interact with caregivers in ways that do not contribute to their shame, guilt, or defensiveness; that build on their parenting strengths; and that improve their reflective capacity. The PFR provider fosters a trusting relationship with the caregiver that enhances the caregiver’s feelings of safety and security, which forms a foundation to support positive changes in parenting and the caregiver-child relationship (Crittenden, 2016; Graybeal, 2007; Larrieu & Zeanah, 2004).

Randomized controlled trials (RCT) have shown consistent positive effects of PFR on measures assessing the quality of caregiver-child interaction and caregivers’ knowledge of children’s social and emotional needs. These results were observed in children in foster care (Spieker et al., 2012), in families under investigation by child protective services due to report of maltreatment (Oxford et al., 2016a, b), and in low-income new mothers receiving mental-health treatment beginning in pregnancy (Oxford et al., 2021). In addition, positive effects on children’s behavior and physiological responses have been reported (Hash et al., 2019; Hastings et al., 2019; Nelson & Spieker, 2013; Oxford et al., 2013, 2021; Pasalich et al., 2016; Spieker et al., 2012). Notably, PFR was tested in another reservation-based Native community using a randomized waitlist design with a small sample (N = 34). In that study, as in all other RCTs of PFR, the intervention group showed significant gains in the quality of caregiver-child interaction and in caregivers’ knowledge of children’s social and emotional needs (Booth-LaForce et al., 2020).

Current Study

Using an RCT design, we tested the effectiveness of PFR in improving the quality of interaction between toddlers and their primary caregivers as our primary outcome measure. We also examined the impact of PFR on secondary outcomes: caregivers’ knowledge about the social-emotional needs of infants and toddlers, caregiver depressive symptoms, and child externalizing behaviors. Caregivers were randomized to receive the PFR intervention or a Resource and Referral (RR) service.

The trial was conducted with Native participants living on a rural reservation in the Northern Plains area of the USA and was administered in collaboration with a Native-owned research organization. Local Tribal members were trained to implement all aspects of the study. Specifically, two Native PFR providers delivered the intervention, a Native RR coordinator connected the control group families with resources, and a Native Research Visitor collected assessment data from both groups at baseline and two follow-up points.

We evaluated the effectiveness of the PFR intervention by comparing the PFR and RR groups on immediate post-intervention outcomes (Time 2) and 3 months later (Time 3), controlling for baseline (Time 1) values. We hypothesized that at both post-intervention time points, (1) caregivers and children in the PFR group would have significantly higher-quality interaction, (2) caregivers in the PFR group would have greater knowledge and more appropriate expectations of their children’s social and emotional needs, and (3) their children would exhibit fewer externalizing behavior problems.

We also evaluated the impact of PFR on caregivers’ depressive symptoms, given evidence that PFR reduced maternal depression among low-income new mothers (Oxford et al., 2021). Social support and other protective factors have been shown to mitigate depressive symptoms in Native populations (McKinley et al., 2021); therefore, we reasoned that PFR might provide a level of support that would be reflected in reduced symptoms.

Additionally, we evaluated the role of caregiver depressive symptoms in moderating intervention effects, given prior reports about sources of variability in the impact of early intervention programs (Breitborde et al., 2010). For example, caregivers with more depressive symptoms (Duggan et al., 2009) or fewer psychological resources (including greater depression; DuMont et al., 2006) have been shown to gain fewer benefits from home visiting interventions. In contrast, in a large study of Early Head Start programs, the impact of intervention was greater among caregivers with more depressive symptoms at baseline (Mathematica Policy Research, Inc., 2002). Therefore, we hypothesized that caregivers’ depressive symptoms at baseline would moderate the impact of PFR, but could not predict the direction of the effect.

Method

Participants

The participants were 162 primary caregivers living on or near the reservation with their toddlers aged 10–31 months (M = 20.10, SD = 7.41). As in any reservation-based Native community, the local Native study staff were acquainted with, or related to some of the research participants. However, none of these were close relationships. Table 1 presents the demographic characteristics of the total sample and each study group. Half of the children were female, and all were reported to be American Indian or Alaska Native (AI/AN). Almost all of the caregivers also self-reported as AI/AN (96%); 62% were married or partnered; 45% had a high school education or below. The majority of the primary caregivers were biological mothers of the study children (75%). Other primary caregivers were a female relative (16%), the biological father (6%), a male relative (< 1%), other female (2%), or other male (< 1%). At baseline, there were no statistically significant (p < 0.05) differences between the PFR and RR groups on any demographic variables.

Table 1.

Demographic Characteristics at Baseline for Whole Sample and by Study Group

Total (N = 162) PFR (n = 81) RR (n = 81)
Characteristic M (SD) or n (%) M (SD) or n (%) M (SD) or n (%)
Child age, mean months (SD) 20.10 (7.41) 19.90 (7.34) 20.30 (7.51)
Child gender, female 81 (50.0%) 40 (49.4%) 41 (50.6%)
Caregiver gender, female 150 (92.6%) 76 (93.8%) 74 (91.4%)
Caregiver race
 AI/ANa 155 (95.7%) 78 (96.3%) 77 (95.1%)
 White 7 (4.3%) 3 (3.7%) 4 (4.9%)
Caregiver relationship to child
 Birth parent 133 (82.1%) 65 (80.2%) 68 (84.0%)
 Relative 25 (15.4%) 13 (16.0%) 12 (14.8%)
 Other 4 (2.5%) 3 (3.7%) 1 (1.2%)
Caregiver married or partnered 100 (61.7%) 48 (59.3%) 52 (64.2%)
Caregiver education
 Less than high school 43 (26.5%) 20 (24.7%) 23 (28.4%)
 High school 30 (18.5%) 16 (19.8%) 14 (17.3%)
 Some college or more 61 (37.7%) 30 (37.0%) 31 (38.3%)
 Assoc., bachelor’s degree or higher 28 (17.3%) 15 (18.5%) 13 (16.0%)
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a

American Indian or Alaska Native

The study was conducted from 2017 to 2019. We present the study flow of participant recruitment, random assignment, and completion in Fig. 1. We recruited potential participants at community events, from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), and used flyers/brochures, word of mouth, and Facebook. Community programs (including the Birth-to-Three program, health care providers, Head Start, Department of Social Services, and childcare providers) also recommended the study to their patients or clients. Interested individuals were contacted by a Native Research Visitor, who provided detailed information on the study, determined eligibility, and then scheduled a home visit to obtain informed consent and collect baseline data.

Fig. 1.

Fig. 1

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CONSORT Flowchart of Participants

To be eligible for the study, families were required to have at least one parent or guardian who (1) was at least 18 years old and lived on or near the reservation; (2) spoke English; (3) was the primary caregiver for a child aged 10–31 months reported to be Native by their caregiver; (4) had telephone access; (5) was not living in a treatment facility or shelter, nor hospitalized or imprisoned; and (6) was willing to have study staff come to their home. If multiple children in the target age range lived in the household, the caregiver was asked to select the child with whom to participate. Caregivers received $50 for each data collection visit they completed, for a maximum of $150. They did not receive payment for intervention visits.

Intervention and Control Conditions

Promoting First Relationships Intervention

The PFR program is delivered in 10 weekly home visits (although it takes 14 weeks on average to complete; Oxford et al., 2016a, b). Sessions are conducted by a trained provider who follows a manualized curriculum and uses five specific consultation strategies. These strategies—Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Discussion with Handouts—are designed to create trust and rapport between the PFR provider and the caregiver and are used to engage with the caregiver around the social and emotional needs of the child. Each session has a unique theme and includes check-in, reflection on the previous week’s content, a discussion topic for the current week, video recording or observation, and handouts (14 total illustrations and charts). Each session has specific goals and deliverables, with a checklist to ensure complete, successful administration.

An essential component of the program is that a portion of each visit is set aside for either recording an interaction between caregiver and child (Weeks 1, 3, 5, 7, 9), or observing and reflecting on a video of such an interaction (Weeks 2, 4, 6, 8, 10), for a total of five opportunities for video reflection. During the time that the PFR provider and caregiver view the videos together, the caregiver is invited to reflect on the child’s behaviors, feelings, and needs, as well as his or her own behaviors, feelings, and needs. PFR providers do not tell caregivers how to parent; rather, they encourage the caregiver to reflect on their own and their child’s underlying needs and behaviors. In this way, PFR is personalized to support the existing strengths of the caregiver-child relationship.

We delivered a version of PFR in this study that was adapted for Native families (see Oxford et al., 2020). Modifications included changing the study name and logo to align with the Tribe’s culture and language; lengthening the home visit to include more time for conversation and checking in, which is consistent with cultural norms; providing a small gift to the child at each data-collection visit, in accordance with cultural practices; adding a handout on caregiver-child transitions and separations; and changing part of a session from asking caregivers about “any memory of a first emotion” to “a time when they felt cared for by an adult,” due to the amount of childhood trauma the original exercise elicited and the desire to focus on a less traumatizing experience. None of these adaptations changed the basic format, structure, or principles of the PFR intervention.

Training, Certification, and Fidelity.

We trained two Tribal members living on the reservation to become PFR providers, using an established PFR distance-learning model (see http://www.pfrprogram.org/training/) that included expanded background content (see Oxford et al., 2020). After training and certification, each PFR provider submitted one video recording per family of an intervention session, for all families in the PFR group. The master trainer evaluated each provider’s quality and completeness of intervention delivery on a 5-point scale, with 1 = “not at all like PFR” to 5 = “adhering excellently to PFR” (see Oxford et al., 2018).

Acceptability and Satisfaction.

For those who completed the PFR intervention (n = 41), a staff member unknown to participants called and requested an evaluation of their experience with PFR. Items on satisfaction were scored on a 4-point scale (4 = “strongly agree,” 3 = “agree,” 2 = “disagree,” 1 = “strongly disagree”).

Resource and Referral Service

The RR service consisted of three phone contacts between a local Native staff member and each primary caregiver in the control group. In an initial call of 20–60-min duration, participants answered questions about health care, financial needs, and personal or family struggles. Next, RR participants were sent information on more than 75 local services and recommendations tailored to their needs. Two 10-min follow-up calls took place 2 weeks and then 3 months after the initial call.

Procedures

The Research Visitor, a local Tribal member, was trained in person on research visit protocols prior to data collection, and fidelity was monitored throughout the data collection phase. 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. After baseline data collection, an algorithm was used to randomize participants, blocking on male or female caregiver, in equal numbers to the PFR and RR groups. Each research visit lasted about 90 min (30 min to administer questionnaires, 20 min for video recording of caregiver-child interaction, and 40 min to conduct interviews). The Research Visitor read aloud the survey instruments, which were written at a 7th-grade level. The Research Visitor also video recorded caregiver-child interactions during a teaching task. From a list ordered according to developmental level (e.g., taking the lid off a small container, stacking blocks), caregivers were asked to select the first activity their child could not perform and to try to teach their child how to perform it.

Measures

Caregiver‑Child Interaction: Primary Outcome

Video recordings of caregiver-child interaction during the teaching task were assessed using the Nursing Child Assessment Teaching Scale (NCATS; Oxford & Findlay, 2013). The NCATS was an appropriate measure to use because (1) it has excellent psychometric properties and an extensive literature on its predictive validity in relation to social-emotional and cognitive outcomes in children (Oxford & Findlay, 2013); (2) it is sensitive to PFR (Booth-LaForce et al., 2020; Oxford et al., 2016a, b; Spieker et al., 2012) and other intervention effects (Bakermans-Kranenburg et al., 2003); and (3) it has been used successfully with Native families (Booth-LaForce et al., 2020; Letourneau et al., 2005; Seideman et al. 1992).

A certified NCATS coder viewed the video recordings and scored them for the quality of caregiver-child interaction based on 73 yes/no items. The items evaluated the caregiver’s sensitivity, stimulation of the child, and emotional responsiveness, as well as the child’s clarity of cues and responsiveness to the caregiver. The coder was blind to treatment group and time of assessment (baseline versus follow-up) and was given the videos to review in a randomized order. “Yes” scores were summed to calculate the NCATS total score, which was the primary outcome measure in this study.

Caregiver Measures: Secondary Outcomes

Raising a Baby questionnaire (Kelly & Korfmacher, 2008) was used to assess the degree to which caregivers’ expectations of their children were developmentally appropriate, as well as assessing caregiver knowledge of the social-emotional needs of infants and toddlers. Caregivers rated 16 items on a 4-point scale (from “strongly agree” to “strongly disagree”), with higher scores indicating a higher level of caregiver knowledge. Internal consistency (Cronbach’s α) was α = .70 at Time 1, α = .80 at Time 2, and α = .72 at Time 3.

The 20-item Center for Epidemiological Studies-Depression scale (CES-D; Radloff, 1977) was used to assess caregiver depressive symptoms. Caregivers rated how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = “rarely or none of the time,” 1 = “some or little of the time,” 2 = “moderately or much of the time,” 3 = “most or almost all the time”). Internal consistency (Cronbach’s α) was α = .83 at Time 1, α = .86 at Time 2, and α = .89 at Time 3.

Child Behavior: Secondary Outcome

The 125-item Infant–Toddler Social Emotional Assessment (ITSEA) (Briggs-Gowan & Carter, 1998), a comprehensive caregiver-report measure, was used to assess the children’s social-emotional competencies and behavior problems. Caregivers rated each item on a 3-point scale (0 = “not true/rarely,” 1 = “somewhat true/sometimes,” 2 = “very true/often”). The mean summary score for the Externalizing domain (Cronbach’s α = .80 at Time 1, α = .82 at Time 2, and α = .80 at Time 3) was used in the present analysis, due to its relevance to PFR goals.

Results

Implementation, Dosage, and Attrition

Both PFR providers passed every fidelity test, with a mean global rating of 4.88 (SD = 0.33) out of 5 points. All caregivers in the PFR group agreed or strongly agreed that they were satisfied with the PFR program (M = 3.90, SD = 0.30), and all agreed or strongly agreed that they would recommend PFR to other caregivers (M = 3.90, SD = 0.30). For additional details on PFR implementation, see Booth-LaForce et al. (in press).

In the PFR group, 41 (51%) of the participants completed all 10 visits, 37 (45%) withdrew from the study before starting PFR or receiving only one visit, and 3 (4%) dropped out of the study after 3 or more visits. None of the PFR participants who completed the 10 visits was lost to follow-up. In the RR group, 71 (88%) completed all of the calls, and 10 (12%) withdrew from the study before or during RR. Three RR participants who completed the service were lost to follow-up (see Fig. 1).

Intervention Effects

Table 2 presents descriptive statistics by study group for all study variables at baseline (Time 1) and post-intervention at Times 2 and 3. We performed a series of repeated-measures multivariate analyses of covariance (MANCOVA) using the SPSS (Version 27) General Linear Model program to assess the Group main effect and the CES-D (baseline score) × Group interaction on each outcome measure post-intervention (Time 2 and Time 3), adjusting for the baseline (Time 1) score on the given measure and the CES-D. Cutoff scores to interpret effect sizes were η2 = .01 for small, .06 for medium, and .14 for large effects (Cohen, 1988). The analyses yielded significant overall post-intervention Group effects and trends, with small-to-medium effect sizes for the NCATS Total, Wilks’ lambda = .934; F(2, 98) = 3.46, p = .035, η2 = .07; Raising a Baby, Wilks’ lambda = .928, F(2, 101) = 3.90, p = .023, η2 = .07; and the CES-D, Wilks’ lambda = .951; F(2, 103) = 2.64, p = .076, η2 = .05. Results were not significant for ITSEA Externalizing, Wilks’ lambda = .986; F(2, 101) = 0.72, p = .491, η2 = .01.

Table 2.

Measures for PFR and RR Groups at Baseline (Time 1), Immediately Post-intervention (Time 2), and 3 Months Later (Time 3)

Time 1
 Time 2
 Time 3
PFR
 RR
 PFR
 RR
 PFR
 RR
n = 81
 n = 81
 n = 41
 n = 68
 n = 41
 n = 68
Measure M (SD) M (SD) M (SD) M (SD) M (SD) M (SD)
NCATS Total 48.46 (5.28) 47.23 (6.24) 49.60 (4.58) 48.06 (5.98) 49.18 (7.20) 48.10 (5.76)
Raising a Baby 49.21 (4.92) 48.31 (4.11) 54.05 (5.02) 48.63 (4.90) 51.28 (4.47) 48.35 (4.90)
CES-D 12.67 (8.90) 10.63 (7.06) 10.10 (6.74) 12.28 (9.24) 9.89 (8.39) 12.35 (9.83)
ITSEA Externalizing 0.88 (0.30) 0.78 (0.30) 0.83 (0.28) 0.84 (0.33) 0.78 (0.29) 0.77 (0.28)
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PFR Promoting First Relationships, RR resource and referral, NCATS Nursing Child Assessment Teaching Scale, ITSEA Infant–Toddler Social Emotional Assessment, CES-D Center for Epidemiologic Studies Depression scale

The MANCOVAs also tested intervention effects for Time 2 and Time 3 separately (see Table 3). Compared with the RR group, at Time 2 the PFR group had significantly higher scores on Raising a Baby, F(1,102) = 6.72, p = .01, η2 = .06, and lower scores on the CES-D, F(1,104) = 3.92, p = .05, η2 = .04. The groups did not differ on the NCATS Total at Time 2, F(1,99) = 1.17, p = .28, η2 = .01.

Table 3.

Adjusted Means, Standard Errors, and One-Way Analyses of Variance Results by Group at Time 2 and Time 3

Measure PFR
 RR
 F η 2
M SE M SE
Time 2
NCATS Total 49.39 0.91 48.12 0.68 1.17 .01
Raising a Baby 53.42 0.64 48.88 0.48 6.72** .06
CES-D 9.65 1.19 12.61 0.90 3.92* .04
ITSEA Externalizing 0.77 0.04 0.87 0.03 1.30 .01
Time 3
NCATS Total 49.50 0.94 48.22 0.70 6.88** .06
Raising a Baby 50.64 0.54 48.75 0.41 4.44* .04
CES-D 9.33 1.26 12.68 0.95 4.52* .04
ITSEA Externalizing 0.73 0.04 0.80 0.03 0.84 .01
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NCATS Nursing Child Assessment Teaching Scale, ITSEA Infant–Toddler Social Emotional Assessment, CES-D Center for Epidemiologic Studies Depression scale

*

p ≤ .05;

**

p ≤ .01;

***

p < .001

At Time 3, the PFR group had significantly higher scores than the RR group on the NCATS Total F(1,99) = 6.88, p = .01, η2 = .06, and on Raising a Baby, F(1,102) = 4.44, p = .04, η2 = .04, and significantly lower scores on the CES-D, F(1,104) = 4.52, p = .04, η2 = .04.

CES‑D × Group Interaction

The MANCOVAs also yielded a significant CES-D × Group interaction only for the NCATS Total, Wilks’ lambda = .941; F (2, 98) = 3.08, p = .05, η2 = .06. Separate tests for Time 2 and Time 3 revealed that the interaction term was not significant at Time 2, F(1,99) = 0.31, p = .58, but it was significant at Time 3, F(1,99) = 6.18, p = .02. To evaluate and interpret this Time 3 moderation effect, we used the Hayes (2017) PROCESS macro (Version 3) for SPSS. To determine region of significance, we tested the conditional effects of Group at different levels of depressive symptoms, using the Johnson-Neyman technique (Johnson & Fay, 1950). This test revealed that the impact of PFR on the NCATS Total was significant only for low CES-D scores from 0 to 7.5 (p = .009 to .05).

Discussion

The results of this RCT add to the growing evidence of the effectiveness of the PFR program, which has been tested in child welfare samples (Oxford et al., 2016a, b; Spieker et al., 2012), in a perinatal mental health setting (Oxford et al., 2021), and in one other Native community (Booth-LaForce et al., 2020). Our results are consistent with all four prior RCTs in which PFR significantly improved the quality of caregiver-child interaction, as well as caregivers’ knowledge about children’s social-emotional needs. This body of evidence suggests that PFR improves critical aspects of parenting that provide building blocks for children to develop secure attachment relationships with their caregivers (Bakermans-Kranenburg et al., 2003; De Wolff & van IJzendoorn, 1997).

Of particular importance is that this RCT focused on Native children and their primary caregivers. Very few preventive intervention programs have been evaluated in Native communities, and even fewer have focused on the quality of the caregiver-child relationship. Within the scientific community, consensus exists that evidence-based programs supporting safe, stable, nurturing relationships are essential for promoting child well-being (Centers for Disease Control & Prevention, 2019; Merrick et al., 2020). By focusing on positive and nurturing caregiver-child interactions, PFR is in alignment with this view. The present results add to this literature and inform successful strategies for promoting child well-being in Native communities. Additionally, these results support our initial findings in a smaller waitlist-control study of PFR in a different Native community, in which significant effects of PFR were found on the same measures as in the present study (Booth-LaForce et al., 2020). PFR also aligns with the existing strengths and resilience of this Native community as well as their beliefs about children as highly valued, the importance of trusting kin relationships, and the inclusion of primary caregivers from the child’s extended family, or Thiyóšpaye in the Lakota language.

The effect sizes we obtained in this study could be characterized primarily as medium in magnitude, in accordance with the results of earlier PFR studies. Spieker et al. (2012), Oxford et al. (2016a, b), and Oxford et al. (2021) found similar small-to-medium effect sizes on the NCATS and on Raising a Baby. Moreover, a meta-analysis of 51 RCTs of other brief attachment-based interventions revealed a comparable medium effect size (Bakermans-Kranenburg et al., 2003). The only other study of PFR in a Native community yielded larger effect sizes (Booth-LaForce et al., 2020), but the source of this difference is not clear.

In comparing the immediate (Time 2) and subsequent (Time 3) effects of PFR, the results were mixed. The effect sizes were the same at both time points for the CES-D and ITSEA Externalizing. For Raising a Baby, the effect size decreased slightly but was in the moderate range at both time points (η2 = .06 at Time 2 and η2 = .04 at Time 3), and the analyses yielded significant group differences for both. In contrast, the effect size for the NCATS was small at Time 2 (η2 = .01) and increased to moderate at Time 3 (η2 = .06). As well, the groups did not differ significantly on the NCATS score at Time 2, but the positive effect of PFR increased over time and was significant at Time 3.

We speculate that changes in parenting generally take practice and reinforcement, and that the caregivers continued to make gains in their sensitive and responsive caregiving over time. However, this pattern was not evident in two of the other PFR RCTs, in which significant group differences on the NCATS were found immediately post-intervention and sustained during follow-up (Oxford et al., 2021, 2016a, b). In the third PFR RCT (Spieker et al., 2012), the significant intervention effects were not retained by the 6-month follow-up. Although the effect size remained positive (Cohen’s d = 0.29), the sample size had decreased such that the effect did not reach statistical significance. Finally, PFR has shown positive long-term outcomes, reducing child welfare placements by 2.5 times 1 year post-intervention (Oxford et al., 2016a, b) and enhancing placement stability 2 years post-intervention (Spieker et al., 2014). These varying patterns may reflect differences in sample characteristics and environments that serve to support or diminish immediate post-intervention gains.

The PFR intervention did not impact children’s behavior problems, as evaluated by caregivers. However, PFR did have a positive effect on the children in that their behavior contributed to the improved post-intervention quality of caregiver-child interactions we observed on the NCATS. Prior PFR studies have shown significant positive effects of PFR on caregiver reports of child externalizing behavior problems (Oxford et al., 2021; Pasalich et al., 2016), child competence (Spieker et al., 2012), and child sleep problems (Hash et al., 2019; Oxford et al., 2013) as well as significant positive effects on observational and physiological measures. For example, Oxford et al. (2016a, b) found that an observational measure detected PFR-related improvement in children’s affective communication. In the same sample, children in the intervention group were more emotionally regulated during a series of difficult tasks, as measured by respiratory sinus arrhythmia (Hastings et al., 2019). Nelson and Spieker (2013) also found an improvement in children’s stress-response physiology in the PFR group in their study. Together, these results lead us to conclude that the effects of PFR on children may be more fine-grained than caregiver-reported assessment of child behavior could detect in this sample.

We found that the PFR intervention also significantly reduced caregivers’ depressive symptoms. We speculate that the development of a positive, strengths-based relationship between the PFR provider and the caregiver, as well as the opportunity for the caregiver to learn effective ways of dealing with their child’s needs and behaviors, may have led to the observed decrease in depressive symptoms. Even though caregivers’ depressive symptoms decreased significantly at both Time 2 and Time 3 in the PFR group, the intervention had the largest positive impact on caregiver-child interaction at Time 3 in the context of relatively low scores on initial depressive symptoms. This result aligns with findings from other home visiting trials that report more positive impacts of intervention programs at low levels of depressive symptoms (Duggan et al., 2009; DuMont et al., 2006), but not with other results that show interventions to be more impactful when depression symptom scores are high (Mathematica Policy Research, Inc., 2002). These mixed results highlight the importance of carefully examining the conditions under which intervention programs are likely to be the most successful.

Limitations

One limitation is that our study was conducted in a single reservation community, so our findings may not generalize to Native families who live on other reservations or in urban, or other non-reservation communities. Another is the limited sample size and the large number of participants who withdrew from the PFR program during the course of the study. Based on the information we received about reasons for withdrawal, we speculate that a significant factor was that participants were compensated only at the three assessment visits but were not paid for the ten PFR visits. Within this community, ongoing payment for participation in research is a common practice as a sign of appreciation and respect, as well as much-needed compensation for lost work time, transportation costs, childcare costs, etc. As in all of our prior PFR studies, we considered the provision of the PFR program to be a substantial benefit that would obviate the need for other compensation but that is not the norm in this Tribal community. In fact, 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. We note that those who completed the program did perceive it to be very beneficial.

Conclusions

Despite these limitations, our results—which align with other studies to confirm the effectiveness of the PFR preventive intervention—make an appreciable contribution to the small literature base on the effects of such programs in Native communities. The participants’ positive perceptions of the PFR program add to the value of our findings, and hold promise for broader implementation efforts as well as ongoing plans to continue and sustain PFR in this community. As well, our training of community members to implement the study was an important aspect of the program that increased its acceptability and potential sustainability.

Acknowledgements

We acknowledge, in alphabetical order, the contributions of Tara Ducheneaux, Corrine Huber, Odile Madesclaire, Katie Nelson, Marcia O’Leary, Ellie OneFeather, Jamie Pesicka, Anthippy Petras, and Jennifer Rees. We are grateful to our Tribal partner for collaborating with us on this research and allowing us to work with their community, and to the families who participated in the project.

Funding

Funding for this research was provided by the National Institute of Nursing Research, NIH, R01 NR014153 (Principal Investigators: C. Booth-LaForce, M. Oxford, D. Buchwald).

Footnotes

Declarations

Ethics Approval All research reported herein received Tribal approval, Indian Health Service Institutional Review Board approval, and university Institutional Review Board approval. All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Consent to Participate Informed consent was obtained from all individual participants included in the study upon which this manuscript is based.

1

We use “Native” rather than American Indian, Native American, or Indigenous because of the Tribe’s preference.

Conflict of Interest The second author is the Director of the University of Washington Parent–Child Relationship Programs at the Barnard Center, which provides materials and training for Promoting First Relationships® on a fee basis.

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