Please select the arm or intervention descriptions that belong 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: Arm Label: Precision Family Spirit; Type: EXPERIMENTAL; Interventions: Behavioral: Precision Family Spirit | Arm Label: Standard Family Spirit; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Family Spirit | Intervention Type: BEHAVIORAL; Name: Precision Family Spirit; Assigned to Arm(s): Precision Family Spirit | Intervention Type: BEHAVIORAL; Name: Standard Family Spirit; Assigned to Arm(s): Standard Family Spirit
B: Arm Label: COHS administered fluoride varnish and oral health education; Type: EXPERIMENTAL; Interventions: Device: Fluoride varnish, Behavioral: Oral health education | Arm Label: Usual care; Type: ACTIVE_COMPARATOR; Interventions: Other: Dental services delivered by the Indian Health Service. | Intervention Type: DEVICE; Name: Fluoride varnish; Assigned to Arm(s): COHS administered fluoride varnish and oral health education | Intervention Type: BEHAVIORAL; Name: Oral health education; Assigned to Arm(s): COHS administered fluoride varnish and oral health education | Intervention Type: OTHER; Name: Dental services delivered by the Indian Health Service.; Assigned to Arm(s): Usual care
C: Intervention Type: BEHAVIORAL; Name: Family Spirit curriculum; Assigned to Arm(s): N/A
D: Arm Label: Motivational interviewing and enhanced community services; Type: EXPERIMENTAL; Interventions: Behavioral: Motivational interviewing, Behavioral: Enhanced community services | Arm Label: Enhanced community services; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced community services | Intervention Type: BEHAVIORAL; Name: Motivational interviewing; Assigned to Arm(s): Motivational interviewing and enhanced community services | Intervention Type: BEHAVIORAL; Name: Enhanced community services; Assigned to Arm(s): Enhanced community services, Motivational interviewing and enhanced community services

Answer: A