Skip to main content

Table 2 List of hybrid trial objectives and evaluation measures

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

Pilot trial objectives Instrument Timepoint
Baseline 2 months postpartum 6 months postpartum 12 months postpartum
Baseline characteristics
N/A Maternal demographics X    
Primary objectives
Acceptability Program acceptability    X X
Qualitative interview**    X X
Satisfaction Participant satisfaction    X X
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
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
  1. *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
  2. **Qualitative interviews will only be conducted with intervention participants at midpoint and endpoint