HHS Criteria for Evidence-Based Models

Understanding the HHS Criteria

HomVEE relies on a set of criteria specified by the U.S. Department of Health and Human Services for evidence of effectiveness, the “HHS criteria”. These criteria require that favorable findings for a home-visiting model be replicated in one or more of HomVEE’s eight outcome domains. A home-visiting model must meet these criteria to earn a HomVEE evidence based designation.

HomVEE recognizes that other systematic reviews may use different criteria to evaluate evidence of effectiveness. Thus, an evidence-based model in the context of HomVEE might or might not meet requirements for evidence of effectiveness according to other systematic reviews.

To meet HHS’ criteria for an “evidence-based early childhood home visiting service delivery model,” models must meet at least one of the following criteria:

At least one high- or moderate-rated impact study of the model finds favorable (statistically significant) impacts in two or more of the eight outcome domains.
At least two high- or moderate-rated impact studies of the model (using non-overlapping analytic study samples) find one or more favorable (statistically significant) impacts in the same domain.

In both cases, the impacts must either (1) be found in the full sample or (2) if found for subgroups but not for the full sample, be replicated in the same domain in two or more studies using non-overlapping analytic study samples. Additionally, following the statute, if the model meets the above criteria based on findings from randomized controlled trial(s) only, then two additional requirements apply. First, one or more favorable (statistically significant) impacts must be sustained for at least one year after program enrollment. Second, one or more favorable (statistically significant) impacts must be reported in a peer-reviewed journal.

These criteria are consistent with the MIECHV statutory requirements: 42 U.S.C. 711(d)(3)(A)(i)(I)

HomVEE assesses whether or not a model meets the criteria for an evidence-based model by considering the following:

Is there well-designed research?
All findings used to meet the criteria must receive high or moderate ratings.
Is the impact replicated?
Favorable findings must be in at least two different outcome domains, or in the same domain in at least two non-overlapping study samples.
Are favorable impacts found on the full sample?
If found for subgroups of the full sample instead, the favorable findings must be replicated in the same outcome domain in at least two nonoverlapping study samples.

IF favorable findings to satisfy the criteria are from an RCT, two additional criteria must be met:

Is the impact sustained?
At least one favorable finding must be measured at least 12 months after participant enrollment.
Is the research peer-reviewed?
At least one favorable finding must be reported in a peer-reviewed journal.

HHS criteria decision tree — Figure 1: How HomVEE determines whether a home-visiting model is evidence-based

For more information, see the HomVEE Handbook of Procedures and Evidence Standards.

Frequently Asked Questions

What are evidence-based models?

HomVEE uses the term “evidence-based model” to refer specifically to a model that meets HHS criteria developed based on statutory requirements in the authorizing legislation for the MIECHV Program. HomVEE recognizes that other systematic reviews may use different criteria to evaluate evidence of effectiveness. Thus, an evidence-based model in the context of HomVEE might or might not meet requirements for evidence of effectiveness according to other systematic reviews. The HHS criteria for an evidence-based early childhood home visiting service delivery model are designed to ensure confidence in model impacts through replicated findings from well-designed research.

How does HomVEE apply HHS criteria for evidence-based early childhood service delivery models?

All research, including research that includes virtual service delivery, is subject to the same standards and procedures. HomVEE groups together all research on a model to apply the HHS criteria unless the model developer indicates that particular manuscripts are research on an adaptation of their model.

HomVEE assesses whether each model meets the HHS criteria for an “evidence-based early childhood service delivery model.” To operationalize the HHS criteria related to studies, and because study findings may be reported across several manuscripts, HomVEE rates manuscripts based on the highest-rated finding reported in that manuscript. Any high- or moderate-rated finding from a study about a model is considered as part of the evidence base for that model. Notably, for models with research solely from either randomized controlled trial (RCT) or single-case design (SCD) studies, additional criteria apply (see the HHS criteria). For example, the additional criteria for RCTs to be from peer-reviewed journal articles and to have sustained findings align with MIECHV Program statutory requirements. The HHS criteria for an evidence-based model have no additional requirements for regression discontinuity design (RDD) or non-experimental comparison group design (NED) studies.

A model may be evidence based on the strength of subgroup findings alone only if the research about it satisfies all of the subgroup criteria.

Is a model required to have evidence from an RCT in order to be evidence-based according to HHS criteria?

No. A model may be evidence-based, according to HHS criteria, on the strength of either RCT research or quasi-experimental design (QED) research (including non-experimental comparison group, single-case, and regression discontinuity designs). The research must be of high or moderate quality based on HomVEE’s published standards. Additional HHS criteria apply when the research uses an RCT design. For details, please see the HHS criteria for evidence-based early childhood home visiting service delivery models.

Where can I find a list of models that meet the HHS criteria for evidence-based models?

Users can find a filtered list of models that meet the HHS criteria on the Model Search page by clearing the "MIECHV Eligible" filter. The information is also available in the summary brief, available on the HomVEE Summary page. Notably, a HomVEE designation as an evidence-based model does not guarantee that a model is eligible to be implemented with MIECHV funding.

Does HomVEE consider the magnitude of impacts?

The HHS criteria do not consider the magnitude of impacts in determining whether a model has evidence of effectiveness.

Even though magnitude is not considered in the HHS criteria, HomVEE reports standardized effects (or, effect sizes) for findings rated high and moderate when they are available in the manuscripts or the HomVEE team had enough information to calculate them. Effect sizes can be found in the "Effects shown in research" section of each model effectiveness research report. The reports can be accessed through the Model Search Page.