Please select the eligibility criteria that correspond to the clinical trial below.
Title: Piloting a Precision Approach to Home Visiting
Brief Summary: The proposed study will be a randomized pilot study. Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either standard Family Spirit or precision Family Spirit to their clients. Sites in both groups will use an electronic platform to support implementation. The investigators will select four sites and randomize two of them to standard Family Spirit and two to precision Family Spirit. Sites will be matched based on annual volume of clients served and geographic similarity (i.e. urban vs. rural). All participating sites will be trained in the electronic implementation support platform. The two sites randomized to provide the precision approach will receive additional training on how to provide it.

In each site, all new clients who are prenatal or up to 2-months postpartum will be offered participation in the study. The study will then follow them until 12 months postpartum and measure outcomes during this time (see measurement table below). Qualitative interviews with precision participants will be done at 6 and 12 months postpartum. Focus group discussions with home visitors will also be completed during regular study team meetings. Analysis of study instruments (basic psychometrics based on baseline and end line data) and preliminary differences between the sites on Aim 3 and 4 outcomes will be done in December 2019 assuming the investigators have achieved their estimated sample size with enough retention for 6-months post enrollment. Dissemination of results will be done upon completion of the analysis.


Options:
A: Inclusion Criteria:

* Prenatal or postpartum females who have a baby no older than 2 months old
* At least 14 years of age at time of conception
* Receiving Family Spirit services through ITC of MI

Exclusion Criteria:

* \< 13 years old at time of conception of index pregnancy
* Index child is older than 2 months of age
* Inability to participate in full intervention or evaluation
B: Inclusion Criteria:

* Children ages 3-5 enrolled in Head Start Centers on a Southwest Indian Reservation and having a primary caregiver (preferably mother, or the child's legal guardian as documented by the HSC)
* American Indian, as defined by the tribe, or
* Children of other racial/ethnic groups who are in the Head Start classes on the Reservation
* Parent/caregiver able to read, understand, and sign the study consent form, and
* Willing and able to follow the study procedures and instructions

Exclusion Criteria:

* Allergy to any of the components of the fluoride varnish
* Ulcerative gingivitis
* Stomatitis
* Other conditions resulting in disrupted or irritated oral mucosa
* Any other conditions or findings that, in the opinion of the investigators, would interfere with or preclude participation in the study.
C: Inclusion Criteria:

* Native American pregnant teens or young women ages 12-22 years old at the time of conception.
* Women ages 20-22 years at the time of conception must be pregnant for the first time.
* Partners of pregnant teens must be between the ages of 12-24.
* Pregnant \<28 weeks gestation and able to meet the requirements for completing the program in a timely way.
* An enrolled tribal member.
* Reside in the Reservation Service Unit Catchment Area and within 60 mile of the Indian Health Service Unit Headquarters.

Exclusion Criteria:

* Severe mental illness - schizophrenia, bipolar disorder, incapacitating depression, or Substance abuse/dependence in need of intensive and specific treatment
* Active legal problems - subjects will not be enrolled if they are incarcerated or if program participation has been made a condition of parole
* Ongoing social service involvement for abuse and neglect
D: Inclusion Criteria:

* Be American Indian, as defined by the tribe
* Be mothers or caregivers of newborn children
* At least 15-44 years of age (Minors who are 15-17 years of age must get consent from a parent or legal guardian according to Tribal, State, and IHS rules and regulations)
* Able to read, understand, and sign a consent form/assent form,
* Be willing and able to follow study procedures and instructions.

Exclusion Criteria:

* No exclusion criteria. Although expected to be rare, if the father is a sole caregiver, he and his child will be eligible for the study.

Answer: A