Black or African American
18%
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 Unpublished manuscript submitted to HomVEE.
Study Registration: ClinicalTrials.gov
Study design characteristics contributing to rating
| Design | Attrition | Baseline equivalence | Confounding factors? | Valid, reliable measures? |
|---|---|---|---|---|
| Randomized controlled trial | Low |
Not assessed for randomized controlled trials with low attrition |
No |
Yes, details reported below for findings on valid, reliable outcomes |
Notes from the review of this manuscript
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.
Child Development and School Readiness
| Outcome Measure | Timing of Follow-Up | Rating | Direction of Effect | Effect Size (Absolute Value) | Stastical Significance | Sample Size | Sample Description |
|---|---|---|---|---|---|---|---|
| Difficultness | 12 months of age | High | 0.22 | Not statistically significant, p = 0.11 | 225 infants | PFR vs. comparison, Washington 2015-2020, full sample | |
| Difficultness | 12 months of age | High | 0.16 | Not statistically significant, p= 0.09 | 252 infants | PFR vs. comparison, Washington 2015-2020, full sample | |
| Dysregulation | 12 months of age | High | 0.04 | Not statistically significant, p = 0.77 | 243 infants | PFR vs. comparison, Washington 2015-2020, full sample | |
| Dysregulation | 12 months of age | High | 0.04 | Not statistically significant, p= 0.75 | 252 infants | PFR vs. comparison, Washington 2015-2020, full sample | |
| Externalizing behavior | 12 months of age | High | 0.28 | Statistically significant, p = 0.03 | 243 infants | PFR vs. comparison, Washington 2015-2020, full sample | |
| Externalizing behavior | 12 months of age | High | 0.28 | Statistically significant, p= 0.03 | 252 infants | PFR vs. comparison, Washington 2015-2020, full sample | |
| Internalizing behavior | 12 months of age | High | 0.12 | Not statistically significant, p = 0.37 | 243 infants | PFR vs. comparison, Washington 2015-2020, full sample | |
| Internalizing behavior | 12 months of age | High | 0.11 | Not statistically significant, p= 0.39 | 252 infants | PFR vs. comparison, Washington 2015-2020, full sample |
Maternal Health
| Outcome Measure | Timing of Follow-Up | Rating | Direction of Effect | Effect Size (Absolute Value) | Stastical Significance | Sample Size | Sample Description |
|---|---|---|---|---|---|---|---|
| Maternal GAD-7 anxiety severity score | 6 months of age | High | 0.19 | Not statistically significant, p= 0.05 | 252 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Maternal PHQ-9 depression severity score | 12 months of age | High | 0.18 | Not statistically significant, p= 0.09 | 252 mothers | PFR vs. comparison, Washington 2015-2020, full sample |
Positive Parenting Practices
| Outcome Measure | Timing of Follow-Up | Rating | Direction of Effect | Effect Size (Absolute Value) | Stastical Significance | Sample Size | Sample Description |
|---|---|---|---|---|---|---|---|
| Dyadic synchronicity | 6 months of age | High | 0.05 | Not statistically significant, p = 0.68 | 239 mother/child dyads | PFR vs. comparison, Washington 2015-2020, full sample | |
| Dyadic synchronicity | 12 months of age | High | 0.21 | Not statistically significant, p = 0.12 | 225 mother/child dyads | PFR vs. comparison, Washington 2015-2020, full sample | |
| Dyadic synchronicity | 6 months of age | High | 0.00 | Not statistically significant, p= 0.98 | 252 mother/child dyads | PFR vs. comparison, Washington 2015-2020, full sample | |
| Dyadic synchronicity | 12 months of age | High | 0.19 | Not statistically significant, p= 0.15 | 252 mother/child dyads | PFR vs. comparison, Washington 2015-2020, full sample | |
| Maternal confidence | 6 months of age | High | 0.23 | Not statistically significant, p = 0.07 | 244 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Maternal confidence | 12 months of age | High | 0.11 | Not statistically significant, p = 0.38 | 243 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Maternal confidence | 6 months of age | High | 0.12 | Not statistically significant, p= 0.10 | 252 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Maternal confidence | 12 months of age | High | 0.05 | Not statistically significant, p= 0.52 | 252 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Parenting sensitivity | 6 months of age | High | 0.30 | Statistically significant, p = 0.02 | 238 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Parenting sensitivity | 12 months of age | High | 0.32 | Statistically significant, p = 0.02 | 225 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Parenting sensitivity | 6 months of age | High | 0.25 | Statistically significant, p= 0.05 | 252 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Parenting sensitivity | 12 months of age | High | 0.26 | Statistically significant, p= 0.03 | 252 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Understanding of toddlers | 6 months of age | High | 0.38 | Statistically significant, p = 0.00 | 244 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Understanding of toddlers | 12 months of age | High | 0.64 | Statistically significant, p = 0.00 | 243 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Understanding of toddlers | 6 months of age | High | 0.21 | Statistically significant, p= 0.03 | 252 mothers | PFR vs. comparison, Washington 2015-2020, full sample | |
| Understanding of toddlers | 12 months of age | High | 0.45 | Statistically significant, p <0.001 | 252 mothers | PFR vs. comparison, Washington 2015-2020, full sample |
This study included participants from the following locations:
- Washington
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 condition
Note: Navigate to the model page for more information about the home visiting model. See the source manuscript for more information about how the model was implemented in this study.
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
There were no subgroups reported in the manuscript.
Funding Sources
Not reported.