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 Unpublished manuscript submitted to HomVEE.
Screening decision | Screening conclusion | HomVEE procedures and standards version |
---|---|---|
Passes screens | Eligible for review | Version 2 |
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 |
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 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. |
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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 |
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
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 |
Negative effect is favorable to the intervention. 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 |
Negative effect is favorable to the intervention. Statistical significance is based on HomVEE calculations. Unadjusted mean. |
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 |
Negative effect is favorable to the intervention. Statistical significance is based on HomVEE calculations. 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 |
Negative effect is favorable to the intervention. 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 |
252 infants | Adjusted mean = 59.24 | Adjusted mean = 62.54 | Difference = -3.27 | Study reported = -0.28 | Statistically significant, p= 0.03 |
Negative effect is favorable to the intervention. 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 |
Negative effect is favorable to the intervention. 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 |
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 |
Negative effect is favorable to the intervention. Statistical significance is based on HomVEE calculations. Unadjusted mean. |
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 |
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 |
Negative effect is favorable to the intervention. Unadjusted mean. |
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 |
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 |
Statistical significance is based on HomVEE calculations. Unadjusted mean. |
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 |
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 | 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 |
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 |
Statistical significance is based on HomVEE calculations. Unadjusted mean. |
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 |
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 |
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 |
243 mothers | Unadjusted mean = 51.84 | Unadjusted mean = 48.67 | Mean difference = 3.17 | Study reported = 0.64 | Statistically significant, p = 0.00 |
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 |
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. |