Collaborative Perinatal Mental Health and Parenting Support in Primary Care
Phase: NA
Conditions: Parenting, Mother-child Relations
Sponsor: University of Washington

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Cover Page 
Study Protocol 
 
Official title of the study: Collaborative Perinatal Mental Health and Parenting Support in 
Primary Care 
 
NCT Number: 02724774 
 
Date of document: 10/20/2021 (created for ClinicalTrials.gov) 
 
 

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Research Plan and Methodology 
Study Design 
 
This study was a randomized control trial. The effects of the intervention were tests using 
a two-arm randomixed controlled trial, comparing PFR (Arm 1) to Resource and Referral (Arm 
2). Assessments were completed at T1 (before randomization), immediately after the 
intervention (T2), and a 6-month follow-up. 
Participants 
The Moms and Babies Program/Programa para Mamás y Bebés (MBP) research 
procedures were reviewed and approved by the University of Washington Institutional Review 
Board. Between November 2015 and June 2019, 252 mothers with their infants living in King 
County, Washington were enrolled in the study. The flow of participant recruitment, assignment, 
and completion of assessments is shown in Figure 1. Information on demographic and other 
baseline characteristics, including mental health concerns (PHQ-9 depression and GAD-7 
anxiety, Spitzer et al., 1999; PCL-C-SF post-traumatic stress disorder, Lang & Stein, 2005) is 
shown by condition in Table 1. 
Eligibility and recruitment. Participants were eligible if they had received mental health 
treatment during pregnancy at one of the participating health centers, were conversant in English 
or Spanish, had an infant under three months of age, had access to a telephone, were planning to 
remain in the study area until the child’s first birthday, and had not already received PFR. All 
aspects of the study, including the intervention and research visits, were offered in English and 
Spanish.  
Study recruitment was conducted in collaboration with the Mental Health Integration 
Program (MHIP) and Maternity Support Services (MSS) of Public Health Seattle and King 
County, Washington. MHIP is based on a public health approach that uses a collaborative care 
model to treat behavioral health problems like depression, anxiety, and trauma symptoms 
through primary care clinics in low-resourced settings Public Health in Seattle/King County 
(PHSKC) targets pregnant and parenting women for collaborative care through the MHIP Moms 
program. Five community health clinics offering MHIP agreed to assist in study recruitment. In 
addition to MHIP Moms, PHSKC offers MSS, provided by public health social workers, nurses, 
and nutritionists who deliver case management plus referral to community mental health services 
from pregnancy through two months postpartum. Mothers were recruited for the study through 
both mechanisms. 
Eligible mothers were identified via the Mental Health Integrated Tracking System 
(MHITS), the data base for MHIP managed by PHSKC in King County, or the PHSKC MSS 
database. Each MHIP participating community health center ‘owns’ the list of its patients and 
agreed for the county public health department to generate a monthly list of eligible pregnant 
women receiving mental health services at each clinic. The monthly list contained the names of 
their own eligible patients who were pregnant or had an infant less than three months of age. 
MHIP care managers and MSS social workers talked with women on the list by phone or at a 
clinic visit, briefly outlining the study. If the mother spoke, English or Spanish and interested in 
learning more about the study, the care manager or social worker connected her to the study 
recruitment coordinator either immediately or through a follow-up phone call. The recruitment 
coordinator conducted additional screening and answered any questions the mother had. If the 
mother was eligible and interested, the study research visitor scheduled and conducted the first 
research visit when the baby was between 6 and 12 weeks old. Written informed consent was 
obtained at the first research visit. 

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The project director initiated the randomization after the first research visit was 
completed. Randomization into the PFR intervention or control condition was computer 
generated, blocked on language group. Sample attrition was very low. Follow-up research visits 
were conducted when infants were 6 and 12 months old. At both follow-up timepoints, over 94% 
of families in both conditions completed the assessments. Overall, 95.2% completed all three 
research visits, 2.0% completed only the first visit, 1.6% completed the first and second visits, 
and 1.2% completed the first and third visits. Comparing the 240 cases with complete data with 
the 12 cases that missed one or both follow-up timepoints, attrition did not differ significantly by 
condition, nor did tests of condition-by-baseline characteristics reveal any evidence of 
differential attrition by condition with respect to language, race/ethnicity, age of mother, baseline 
mental health measures, or any of the primary outcome measures. At baseline, mothers with 
incomplete data were more likely to be separated, divorced or widowed, had lower incomes, and 
had more children.  
Promoting First Relationship® (PFR) Intervention 
The manualized PFR intervention was delivered by seven female master’s-prepared 
mental health professionals. Six were employees of a community agency, and one was employed 
by the University of Washington. Four primary providers, who were all employed by a 
community agency, worked with 93% of the study families, and three fill-in providers 
administered the intervention to the remaining 7%. Three of the providers were fluent in Spanish, 
and all were fluent in English.  The providers completed PFR training and were certified before 
meeting with study families. Throughout the study, fidelity was monitored by a PFR master 
trainer. The providers were required to submit videotapes of themselves working with the 
families during the sixth session for each family on their caseload, which the master trainer 
reviewed to rate the quality of delivery. If a provider did not meet fidelity (i.e., received a rating 
of less than 4 on a 5-point scale), she received additional one-on-one mentoring from the master 
trainer until her fidelity to PFR was reestablished. Of 98 fidelity videotapes that were coded, 6% 
did not meet fidelity. Providers were not assigned additional families to work with until they 
reestablished fidelity. The PFR training model includes weekly reflective practice group 
sessions, facilitated by a PFR consultant, to support providers in their work with vulnerable 
families. 
The majority of the 127 mothers randomized to PFR received a full dose of the 
intervention: 82% received 9-10 weekly sessions, 9% had 5-8 sessions, 8% had 1-4 sessions, and 
2% did not start the intervention. The sessions typically ranged from 60 to 75 minutes and took 
place in the families’ homes. The providers delivered activities and instructional content as 
prescribed in the PFR manual; however, the pace of delivery of these components was tailored to 
individual mothers, and some sessions were adapted for very young infants. A key component of 
PFR is videotaped caregiver-child interaction, completed during five sessions and serving as the 
focus of reflective video feedback during alternating weeks. The tapes were viewed together by 
the mother and intervention provider, who guided discussion focusing on parenting strengths and 
interpretation of her baby’s cues.   
Control Condition 
The 125 mothers randomized to the control condition were mailed a resource packet 
containing a listing of a variety of local resources, child development handouts, and parenting 
handouts. Packets were provided in the mother’s desired language. The materials did not overlap 
with the content of PFR. To help minimize attrition, mothers in the control condition also 

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received two check-in phone calls before the second research visit to see if their contact 
information had changed and to answer any questions about the study.  
Measures and Procedures 
Infants and their mothers were assessed in three 90-minute in-home research visits: at 
baseline (infant age 6-12 weeks), and when the babies were 6 months and 12 months old. The 
intervention was completed between the baseline and 6-month research visits. Assessments were 
conducted by three bilingual study research visitors who had bachelor’s or master’s degrees, who 
were blinded to intervention assignment, and whose offices were not near the intervention staff. 
One primary research visitor completed 96% of the research visits. The time from baseline to the 
6-month research visit averaged 4.4 months, and the time from the 6-month to 12-month research 
visit averaged 6.0 months. Time between visits did not differ by intervention group. The research 
visits included standardized interview questions and videotaped mother-infant interactions. The 
consent form and all study measures were read to the participants to ensure understanding and 
minimize missing data. All measures have been used with mothers from different cultural 
backgrounds, including Latina mothers, in other studies. Research visits were conducted by 
telephone if the family moved outside of the study area after the first research visit (15 research 
visits), and also for the final five families completing the 12-month research visit due to stay-at-
home requirements caused by the COVID-19 pandemic. Research visits were conducted in-
person and in-home for 98% of the assessments. Study participants received $50 in cash or gift 
card after each research visit to compensate for their time.  
Primary Caregiver Outcomes  
Parenting sensitivity was an observational measure collected at each research visit using 
the Nursing Child Assessment Teaching Scale (NCATS; Barnard, 1994). Mothers were 
presented with a list of activities and instructed to select the first activity that their infant could 
not yet do (e.g., hold onto a rattle, transfer an object from one hand to another, play pat-a-cake), 
to attempt to teach their infant. A standard set of manipulatives were provided for the activities. 
Teaching interactions were videotaped. Videotapes were scored by a blinded coder on 50 
caregiver items measuring sensitivity to cues, response to distress, and fostering of social, 
emotional, cognitive growth, and continency between caregiver and child. Items were scored yes 
(1) or no (0) and summed for a total sensitivity score. A single bilingual and bicultural coder, 
blind to intervention condition, was trained to reliability by a certified NCATS instructor and 
passed biannual reliability checks with a minimum of 85% inter-rater agreement with a master 
trainer. 
The Infant CARE-Index (ICI, Crittenden,1979-2010) assesses parent-infant interaction 
during play and was included at each research visit. The mother was asked to play with her child 
as she usually would, and the interaction was filmed for 3-5 minutes. If mothers wanted to use 
toys, they were offered toys that they could use, or they could choose their own toys. The videos 
were scored by 16 coders certified to code the ICI for research purposes. To be certified, coders 
rated videos from a collection of videos gathered in multiple countries and that represented the 
full range of potential scores on the ICI constructs. Coders had to meet a standard for inter-rater 
reliability of r = .80 on the measure of dyadic synchrony and an average of r = .70 across all 
scales. Prior to coding the full sample in this study, coders coded 20 MBP study tapes, coder 
agreement was somewhat lower in this selection of videos (r = .74, range = .66 to .87). The 
coders’ work was overseen by the author of the coding scheme (Crittenden). To address the 
study’s primary hypotheses regarding caregiver outcomes, the rating for dyadic synchrony in 
play was used in the current study. Dyadic synchrony is any mutual pattern of behavior that 

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enables the infant to explore the activity with interest and spontaneity and without inhibiting or 
exaggerating negative affect. Dyadic synchrony scores of 11-14 are sensitive, with mutual 
delight or a smooth, pleasing interaction. Scores between 7 and 10 are adequate, with satisfactory 
play but noticeable periods of desynchrony. Scores between 5 and 6 reflect clear, unresolved 
problems and limited playfulness, but no evidence of hostility or unresponsiveness. Scores 
between 0 and 4 reflect high risk, with a clear lack of empathy, insufficient or unsuccessful 
attempt to respond to the infant, or total failure to perceive or attempt to soothe the infant, and no 
play. As a further check of reliability, approximately 20% of the videos were randomly selected 
to be coded by a reliability coder. Inter-rater correlations for dyadic synchrony between the two 
coders averaged r = .67. 
Understanding of infant and toddler behavior was measured by the Raising a Baby Scale 
(RAB; Kelly, Korfmacher, & Buehlman, 2008). The RAB is a measure of caregiver knowledge 
of infant and toddler social-emotional needs and developmentally appropriate expectations. At 
each research visit, mothers rated the 16 RAB items on a 4-point scale (strongly agree to 
strongly disagree; αs ranged from .68 to .71 across the three time points). The scale was 
summed, and higher scores indicate greater parental knowledge. 
Maternal confidence, the perceptions mothers have of their ability to care for and 
understand their infants, was measured at each research visit using the Maternal Confidence 
Questionnaire (MCQ; Zahr, 1991). Mothers rated 14 items on a 5-point scale (never to always; 
αs ranged from .66 to .76 across the three time points). Maternal confidence is reflected by the 
mean of the scale, with higher scores indicating greater confidence.  
Secondary Infant Outcomes  
The Infant CARE-Index (described above) also yields scores for the infant’s contribution 
to the interaction. We included infant difficultness. Scores could range from 0 to 14. Higher 
scores reflect more infant difficult behaviors, such as crying and fussing, turning away, negative 
facial expressions, avoidance of eye contact, high arousal, and lack of engagement in a 
developmentally satisfying shared activity. Inter-rater correlations for difficultness on the 20% of 
videos selected for coding by an additional coder averaged r = .49. 
At the final research visit, when infants were 12 months old, infant externalizing 
behavior, internalizing behavior, and dysregulation were measured with mother’s report on the 
Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006). The 
ITSEA was not included at the baseline or 6-month research visits because it is not valid for 
children younger than 12 months. The ITSEA has been standardized and normed on a nationally 
representative sample that was stratified to match the 2002 United States Census. Mothers rated 
their infant on an extensive list of behaviors from 0 (not true/rarely) to 2 (very true/often). T-
scores were calculated for externalizing, internalizing, and dysregulation domains. In the study 
sample, alpha reliabilities for the domains were α = .81 for externalizing, α = .68 for 
internalizing, and α =.80 for dysregulation.