Precision Family Spirit: a pilot randomized implementation trial of a precision home visiting approach with families in Michigan—trial rationale and study protocol

Table 2 List of hybrid trial objectives and evaluation measures

Pilot trial objectives	Instrument	Timepoint
Pilot trial objectives	Instrument	Baseline	2 months postpartum	6 months postpartum	12 months postpartum
Baseline characteristics
N/A	Maternal demographics	X
Primary objectives
Acceptability	Program acceptability			X	X
Acceptability	Qualitative interview**			X	X
Satisfaction	Participant satisfaction			X	X
Satisfaction	Qualitative interview**			X	X
Home visitor-participant relationship	Working alliance inventory: 1. Client WAI 2. Home visitor WAI		X	X	X
Retention	Participant tracking information collected throughout the duration of the pilot study
Adherence
Secondary objectives
Maternal substance use	Alcohol, Smoking and Substance Involvement Screening Test	X	X	X	X
Maternal depression	Edinburgh Postnatal Depression Scale	X	X	X	X
Parenting feeding practices	Child Feeding Assessment		X	X	X
Maternal parental knowledge	Parent Knowledge Assessment	X	X	X	X
Child development	Ages and Stages: Social Emotional - 2*		X	X	X
Child development	Ages and Stages Questionnaire, 3rd Edition*		X	X	X
Quality of life	EURO-QOL	X	X	X	X
Maternal self-efficacy	Parenting Locus of Control			X	X
Maternal stress	Perceived Stress Scale 4	X	X	X	X
Substance abuse/domestic violence risk	Institute for Health and Recovery Integrated Screening Tool	X	X	X	X
Client priority outcomes	Top problems	X	X	X	X

*These measures will not be administered as part of the Care4 data collection platform, as they are licensed by ITC of MI external to the Care4 platform
**Qualitative interviews will only be conducted with intervention participants at midpoint and endpoint

ISSN: 2055-5784