Manuscript Detail

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 Unpublished manuscript submitted to HomVEE.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	225 infants	Unadjusted mean = 2.23	Unadjusted mean = 2.71	Mean difference = -0.48	Study reported = -0.22	Not statistically significant, p = 0.11	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. Unadjusted mean.
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	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. Adjusted to control for preferred language and baseline measure.
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	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. 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	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. Unadjusted mean.
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	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. 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	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. 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	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. 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	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. Adjusted to control for preferred language.

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	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. 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	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. 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	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	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	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	Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. Unadjusted mean.
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	Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. 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	Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. Unadjusted mean.
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	Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. Unadjusted mean.
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	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	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	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	225 mothers	Unadjusted mean = 36.73	Unadjusted mean = 35.32	Mean difference = 1.41	Study reported = 0.32	Statistically significant, p = 0.02	Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. 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	Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. Unadjusted mean.
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	Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. Unadjusted mean.
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	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	243 mothers	Unadjusted mean = 51.84	Unadjusted mean = 48.67	Mean difference = 3.17	Study reported = 0.64	Statistically significant, p = 0.00	Submitted by nwu on Fri, 04/12/2019 - 18:31 Statistical significance is based on HomVEE calculations. Unadjusted mean.

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.

Findings that rate moderate or high

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.