Piloting a Precision Approach to Home Visiting

NCT03975530 | Completed

• 1 other identifier: 9315
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting; Mother-Child Relations; Child Development

Keywords

Home visiting interventions; American Indian; Community based participatory research; Pregnancy

Outcome Measures

Primary Outcomes (5)

• Acceptability of the home-visiting program from the perspective of mothers enrolled

  We will use the acceptability subscale from the Applied Mental Health Research group's Implementation Measure: Haroz, E. E., Bolton, P., Nguyen, A. J., Lee, C., Bogdanov, S., Bass, J., ... \& Murray, L. (2019). Measuring implementation in global mental health: validation of a pragmatic implementation science measure in eastern Ukraine using an experimental vignette design. BMC health services research, 19(1), 262. The acceptability subscale has 17 items and is scored as an average across items with a range of 0 being lowest acceptability to 3 being highest acceptability.

  Baseline, 2-months postpartum, 6-months postpartum, 12-months postpartum

• Retention in the home-visiting programs

  We will compare the proportion of mothers who enroll and are still enrolled at the measurement timepoint across the study arms.

  2-months postpartum, 6-months postpartum, 12-months postpartum

• Participant satisfaction

  We will use an adapted version of the satisfaction scale used in the final Family Spirit trial: Barlow A, Mullany B, Neault N, et al. Paraprofessional Delivered, Home-Visiting Intervention for American Indian Teen Mothers and Children: Three-Year Outcomes from a Randomized Controlled Trial. American Journal of Psychiatry. 2015; 172(2):154-162. doi: 10.1176/appi.ajp.2014.14030332. For the purposes of this study, we will focus on the seven items that aimed to measure satisfaction with the skills and competencies Family Spirit aims to instill in parents (e.g., "I learned helpful skills" or "Because of what I've learned in the program, I feel that my child is healthier"). The satisfaction items are scored 0 "Strongly Disagree" to 5 "Strongly Agree," and higher total scores correlate with higher levels of satisfaction.

  6-months postpartum, 12-months postpartum

• Adherence

  We will compare the percent of prescribed visits completed at 6- and 12-months across study arms.

  Study enrollment through study completion, an average of 1 year

• Home visitor-participant relationship

  We will use the shortened version of the Working Alliance Inventory (WAI). It has 12 items, and the participant and home visitor each complete their own version of the measure. Possible scores for each item on the WAI ranged from 1 "Never" to 7 "Always" and are summed for a total score. A higher score on the WAI indicates a stronger therapeutic alliance.

  2-months postpartum, 6-months postpartum, 12-months postpartum

Study Arms (2)

Precision Family Spirit

EXPERIMENTAL

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. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive a customized version of Family Spirit that is unique to your circumstances. The two sites randomized to provide the Precision approach will receive additional training on how to provide it. At 6 months postpartum, and upon completion of the intervention, participants in the treatment group will be asked to participate in brief semi-structured phone interviews.

Behavioral: Precision Family Spirit

Standard Family Spirit

ACTIVE COMPARATOR

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. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive Family Spirit lessons based on a standard program schedule.

Behavioral: Standard Family Spirit

Interventions

Precision Family Spirit BEHAVIORAL

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. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive a customized version of Family Spirit that is unique to your circumstances. The two sites randomized to provide the Precision approach will receive additional training on how to provide it.

Precision Family Spirit

Standard Family Spirit BEHAVIORAL

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. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit.Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive Family Spirit lessons based on a standard program schedule.

Standard Family Spirit

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Study participants will be pregnant or recent postpartum females aged 14 or older at time of conception of index pregnancy who are already enrolled in Family Spirit.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Inter-Tribal Council of Michigan, Inc.: collaborator

Study Sites (1)

Inter-Tribal Council of Michigan (ITC of MI)

Sault Ste. Marie, Michigan, 49783, United States

Location

Related Publications (2)

• Ingalls A, Rebman P, Martin L, Kushman E, Leonard A, Cisler A, Gschwind I, Brayak A, Amsler AM, Haroz EE. Towards precision home visiting: results at six months postpartum from a randomized pilot implementation trial to assess the feasibility of a precision approach to Family Spirit. BMC Pregnancy Childbirth. 2022 Sep 23;22(1):725. doi: 10.1186/s12884-022-05057-4.

  PMID: 36151535 DERIVED

• Ingalls A, Barlow A, Kushman E, Leonard A, Martin L, Team PFSS, West AL, Neault N, Haroz EE. Precision Family Spirit: a pilot randomized implementation trial of a precision home visiting approach with families in Michigan-trial rationale and study protocol. Pilot Feasibility Stud. 2021 Jan 6;7(1):8. doi: 10.1186/s40814-020-00753-4.

  PMID: 33407939 DERIVED

Study Officials

• Emily Haroz, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 5, 2019
• Study Start: June 24, 2019
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: January 6, 2022

Record last verified: 2022-01

Locations

US (1)