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Oxford, M. L., Hash, J. B., Lohr, M. J., Bleil, M., Unützer, J., & Spieker, S. J. (2020). Randomized trial of Promoting First Relationships® for new mothers who received community mental health services in pregnancy. Unpublished manuscript submitted to HomVEE.

Manuscript screening details
Screening decision Screening conclusion HomVEE procedures and standards version
Passes screens Eligible for review Version 2
Study design details
Rating Design Attrition Baseline equivalence Compromised randomization Confounding factors Valid, reliable measure(s)
High Randomized controlled trial Low

Not assessed for randomized controlled trials with low attrition

No

No

Yes, details reported below for findings on valid, reliable outcomes

Notes:

Baseline assessments were completed when infants were between 6 and 12 weeks old. Follow-up measures were completed when infants were 6 and 12 months old. Findings for "Infant difficultness" when infants were 6-months old received a low evidence rating because the outcome did not satisfy HomVEE's reliability requirements. All other reviewed findings received a high evidence rating. The authors' analyses controlled for intervention condition, mother's preferred language, and baseline measures of outcomes. Baseline measures were available for all measures except those using the Infant Toddler Social Emotional Assessment (ITSEA), which were not feasible to assess at baseline. Information that demonstrated the reliability of the outcome measures and baseline equivalence of the intervention and comparison groups was based on correspondence with the authors.

Study characteristics
Study participants Study participants were pregnant women and mothers of children younger than 3 months old recruited from two community mental health programs in King County, Washington. Mothers were eligible to participate in the study if they received mental health services during pregnancy at one of the community programs, spoke English or Spanish, had access to a telephone, and were planning to stay in the area for the duration of the follow-up period. Mother-child dyads were randomly assigned to the intervention group or a comparison group. A total of 252 mother-child dyads were included in the study: 127 in the Promoting First Relationships intervention group and 125 in the comparison group. Over half (58 percent) of the participating children were Caucasian, 15 percent were Black, 23 percent were multiracial, and 4 percent were another race. Most children in the study (53 percent) were Hispanic or Latino. Annual household income was $10,000 or less for 29 percent of dyads; $10,001 to $20,000 for 21 percent; $20,001 to $30,000 for 19 percent; $30,001 to $40,000 for 13 percent; and $40,001 or more for 11 percent. The remaining households did not report income.
Setting The study took place in Seattle and King County, Washington.
Intervention services Promoting First Relationships – Home Visiting Intervention Model consisted of 10 weekly sessions with a mental health professional. The home visit content was informed by attachment theory and aimed to increase parenting sensitivity. All sessions took place in the families' homes. The home visitor videotaped caregiver-child interactions during five of the weekly sessions and watched the videos with the caregiver on alternating weeks. After they watched the videos, the home visitor gave reflective video feedback through a guided discussion on the caregiver's strengths.
Comparison conditions Families assigned to the comparison group were not eligible to receive services through Promoting First Relationships. Families received a packet of information including handouts on child development and parenting and a list of local resources.
Subgroups examined This field lists subgroups examined in the manuscript (even if they were not replicated in other samples and not reported on the summary page for this model’s report).

There were no subgroups reported in the manuscript.

Funding sources Not reported.
Author affiliation The authors are affiliated with the Barnard Center at the University of Washington, which sponsors Promoting First Relationships. Monica Oxford, one of the authors of the study, is the executive director of Promoting First Relationships.
Peer reviewed No
Study Registration:

Clinicaltrials.gov Identifier: NCT02724774. SocialScienceRegistry.org Identifier: None found. Registry of Efficacy and Effectiveness Studies Identifier: None found. Study registration was assessed by HomVEE for Clinicaltrials.gov beginning with the 2014 review, and for other registries beginning with the 2021 review.

Findings that rate moderate or high

Child development and school readiness
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
High

Difficultness

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

252 infants Adjusted mean = 2.23 Adjusted mean = 2.71 Difference = -0.49 Study reported = -0.16

Not statistically significant, p= 0.09

Adjusted to control for preferred language and baseline measure.

High

Difficultness

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

225 infants Unadjusted mean = 2.23 Unadjusted mean = 2.71 Mean difference = -0.48 Study reported = -0.22

Not statistically significant, p = 0.11

Unadjusted mean.

High

Dysregulation

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

252 infants Adjusted mean = 54.82 Adjusted mean = 55.33 Difference = -0.56 Study reported = -0.04

Not statistically significant, p= 0.75

Adjusted to control for preferred language.

High

Dysregulation

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

243 infants Unadjusted mean = 54.82 Unadjusted mean = 55.33 Mean difference = -0.51 Study reported = -0.04

Not statistically significant, p = 0.77

Unadjusted mean.

High

Externalizing behavior

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

252 infants Adjusted mean = 59.24 Adjusted mean = 62.54 Difference = -3.27 Study reported = -0.28

Statistically significant, p= 0.03

Adjusted to control for preferred language.

High

Externalizing behavior

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

243 infants Unadjusted mean = 59.24 Unadjusted mean = 62.54 Mean difference = -3.30 Study reported = -0.28

Statistically significant, p = 0.03

Unadjusted mean.

High

Internalizing behavior

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

252 infants Adjusted mean = 53.64 Adjusted mean = 54.93 Difference = -1.22 Study reported = -0.11

Not statistically significant, p= 0.39

Adjusted to control for preferred language.

High

Internalizing behavior

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

243 infants Unadjusted mean = 53.64 Unadjusted mean = 54.93 Mean difference = -1.29 Study reported = -0.12

Not statistically significant, p = 0.37

Unadjusted mean.

Maternal health
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
High

Maternal GAD-7 anxiety severity score

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

6 months of age

252 mothers Unadjusted mean = 5.28 Unadjusted mean = 6.45 Difference = -1.17 Study reported = -0.19

Not statistically significant, p= 0.05

Unadjusted mean.

High

Maternal PHQ-9 depression severity score

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

252 mothers Unadjusted mean = 5.31 Unadjusted mean = 6.29 Difference = -0.98 Study reported = -0.18

Not statistically significant, p= 0.09

Unadjusted mean.

Positive parenting practices
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
High

Dyadic synchronicity

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

225 mother/child dyads Unadjusted mean = 6.45 Unadjusted mean = 5.98 Mean difference = 0.47 Study reported = 0.21

Not statistically significant, p = 0.12

Unadjusted mean.

High

Dyadic synchronicity

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

6 months of age

252 mother/child dyads Adjusted mean = 5.43 Adjusted mean = 5.31 Difference = 0.01 Study reported = 0.00

Not statistically significant, p= 0.98

Adjusted to control for preferred language and baseline measure.

High

Dyadic synchronicity

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

252 mother/child dyads Adjusted mean = 6.45 Adjusted mean = 5.98 Difference = 0.43 Study reported = 0.19

Not statistically significant, p= 0.15

Adjusted to control for preferred language and baseline measure.

High

Dyadic synchronicity

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

6 months of age

239 mother/child dyads Unadjusted mean = 5.43 Unadjusted mean = 5.31 Mean difference = 0.12 Study reported = 0.05

Not statistically significant, p = 0.68

Unadjusted mean.

High

Maternal confidence

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

243 mothers Unadjusted mean = 4.40 Unadjusted mean = 4.36 Mean difference = 0.04 Study reported = 0.11

Not statistically significant, p = 0.38

Unadjusted mean.

High

Maternal confidence

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

6 months of age

252 mothers Adjusted mean = 4.44 Adjusted mean = 4.36 Difference = 0.05 Study reported = 0.12

Not statistically significant, p= 0.10

Adjusted to control for preferred language and baseline measure.

High

Maternal confidence

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

252 mothers Adjusted mean = 4.40 Adjusted mean = 4.36 Difference = 0.02 Study reported = 0.05

Not statistically significant, p= 0.52

Adjusted to control for preferred language and baseline measure.

High

Maternal confidence

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

6 months of age

244 mothers Unadjusted mean = 4.44 Unadjusted mean = 4.36 Mean difference = 0.08 Study reported = 0.23

Not statistically significant, p = 0.07

Unadjusted mean.

High

Parenting sensitivity

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

6 months of age

238 mothers Unadjusted mean = 33.86 Unadjusted mean = 32.38 Mean difference = 1.48 Study reported = 0.30

Statistically significant, p = 0.02

Unadjusted mean.

High

Parenting sensitivity

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

6 months of age

252 mothers Adjusted mean = 33.86 Adjusted mean = 32.38 Difference = 1.24 Study reported = 0.25

Statistically significant, p= 0.05

Adjusted to control for preferred language and baseline measure.

High

Parenting sensitivity

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

252 mothers Adjusted mean = 36.73 Adjusted mean = 35.32 Difference = 1.28 Study reported = 0.26

Statistically significant, p= 0.03

Adjusted to control for preferred language and baseline measure.

High

Parenting sensitivity

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

225 mothers Unadjusted mean = 36.73 Unadjusted mean = 35.32 Mean difference = 1.41 Study reported = 0.32

Statistically significant, p = 0.02

Unadjusted mean.

High

Understanding of toddlers

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

243 mothers Unadjusted mean = 51.84 Unadjusted mean = 48.67 Mean difference = 3.17 Study reported = 0.64

Statistically significant, p = 0.00

Unadjusted mean.

High

Understanding of toddlers

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

6 months of age

252 mothers Adjusted mean = 52.07 Adjusted mean = 50.17 Difference = 1.06 Study reported = 0.21

Statistically significant, p= 0.03

Adjusted to control for preferred language and baseline measure.

High

Understanding of toddlers

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

12 months of age

252 mothers Adjusted mean = 51.84 Adjusted mean = 48.67 Difference = 2.32 Study reported = 0.45

Statistically significant, p <0.001

Adjusted to control for preferred language and baseline measure.

High

Understanding of toddlers

FavorableUnfavorable or ambiguousNo Effect

PFR vs. comparison, Washington 2015-2020, full sample

6 months of age

244 mothers Unadjusted mean = 52.07 Unadjusted mean = 50.17 Mean difference = 1.90 Study reported = 0.38

Statistically significant, p = 0.00

Unadjusted mean.