Dataset Information

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

ABSTRACT:

Background

Home visiting is a well-supported strategy for addressing maternal and child health disparities. However, evidence-based models generally share implementation challenges at scale, including engagement and retention of families. Precision home visiting may address this issue. This paper describes the first known pilot randomized implementation trial of a precision home visiting approach vs. standard implementation. Primary aims are to: 1) explore the acceptability and feasibility of a precision approach to home visiting and 2) examine the difference between Standard Family Spirit and Precision Family Spirit on participants' program satisfaction, client-home visitor relationship, goal alliance, and the impact of these factors on participant engagement and retention. Secondary aims are to explore potential differences on maternal behavioral and mental health outcomes and child development outcomes to inform sample size estimations for a fully powered study.

Methods

This is a pilot Hybrid Type 3 implementation trial. Four Michigan communities primarily serving the Native American families and already using Family Spirit were randomized by site to receive Standard Family Spirit or Precision Family Spirit. Participants include N = 60 mothers at least 14?years of age (pregnant or with a newborn < 2?months of age) currently enrolled in Family Spirit. Precision Family Spirit participants receive core lessons plus additional lessons based on needs identified at baseline and that emerge during the trial. Control mothers receive the standard sequence of Family Spirit lessons. Data is collected at baseline (< 2?months postpartum), and 2, 6, and 12?months postpartum. All Precision Family Spirit participants are invited to complete qualitative interviews at study midpoint and endpoint. All home visitors are invited to participate in focus groups between study midpoint and endpoint. Exploratory data analysis will assess feasibility, acceptability, client-home visitor relationship, retention, adherence, and potential differences in intervention outcomes.

Discussion

This trial will provide new information about the acceptability and feasibility of precision home visiting and pilot data on program satisfaction, client-home visitor relationship, goal alliance, retention, and targeted maternal-child intervention outcomes. Findings will inform the design of a fully powered randomized implementation trial of precision vs. standard home visiting.

Trial registration

ClinicalTrials.gov # NCT03975530 ; Registered on June 5, 2019.

SUBMITTER: Ingalls A

PROVIDER: S-EPMC7786970 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

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

Ingalls Allison A Barlow Allison A Kushman Elizabeth E Leonard Amanda A Martin Lisa L Team Precision Family Spirit Study PFSS West Allison L AL Neault Nicole N Haroz Emily E EE

Pilot and feasibility studies 20210106 1

<h4>Background</h4>Home visiting is a well-supported strategy for addressing maternal and child health disparities. However, evidence-based models generally share implementation challenges at scale, including engagement and retention of families. Precision home visiting may address this issue. This paper describes the first known pilot randomized implementation trial of a precision home visiting approach vs. standard implementation. Primary aims are to: 1) explore the acceptability and feasibili ...[more]

PMID: 33407939

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Project description:BackgroundShared implementation challenges at scale in early childhood home visiting have led researchers to explore precision home visiting as a promising service delivery mechanism to better address families' unique needs and build greater program efficiencies. This randomized controlled pilot study aimed to assess the acceptability of a precision approach to one home visiting model, Family Spirit® and explore potential differences between Precision Family Spirit (PFS) and Standard Family Spirit (Standard FS) on participant-home visitor relationship and maternal outcomes.MethodsParticipants (N = 60) were at least 14 years old, pregnant or within 2 months postpartum, and enrolled in Family Spirit. Four sites in Michigan were randomized 1:1 to deliver PFS (up to 17 core lessons plus up to 13 additional lessons as needed) or Standard FS (home visiting services as usual). Primary (program acceptability, participant satisfaction, home visitor-participant relationship quality, retention, adherence) and secondary (knowledge, quality of life, difficulty with parenting problems, substance use, depression, stress) outcomes at 6 months postpartum are presented. PFS participants also self-reported on quality of life, difficulty with parenting problems, stress, substance use, and concerns with sexual and reproductive health and self and child's nutrition status at each home visit. This informed which lessons they should receive.ResultsMothers in both groups reported positive program acceptability, satisfaction, and home visitor-participant relationships at 6 months postpartum. However, open-ended feedback from Standard FS participants indicates that some lesson content may not be applicable to all participants. At 6 months, retention was 82.3% for PFS and 66.7% for Standard FS, and adherence was 30.1% for PFS and 20.6% for Standard FS.ConclusionsPreliminary findings indicate that precision home visiting may be acceptable and feasible. A definitive trial is needed to build on this pilot data, assess outcomes for mothers and children participating in a precision approach to home visiting as compared to standard home visiting, and ready this approach for scale.Trial registrationClinicalTrials.gov NCT03975530 (first posted on 05/06/2019).

Project description:ImportanceAntisocial behavior and adult criminality often have origins in childhood and are best addressed early in the child's life using evidence-based parenting programs. However, families with additional risk factors do not always make sufficient changes while attending such programs; these families may benefit from additional support.ObjectiveTo evaluate the efficacy of adding a 10-session, structured home parent support (HPS) intervention to enhance outcomes for high-risk families attending the Incredible Years Parent (IYP) program.Design, setting, and participantsA randomized clinical superiority trial of 126 parents of children aged 3 to 7 years with conduct problems compared the IYP program plus HPS with treatment as usual of the IYP program alone. Child behavior measures were collected before and after treatment and at the 6-month follow-up. Recruitment from 19 IYP groups began February 13, 2013, and follow-up data collection was completed June 4, 2015. All data were analyzed using an intention-to-treat design with last observation carried forward. Statistical analysis took place from May 20, 2015, to March 31, 2016.InterventionParents were randomly assigned to receive IYP program plus HPS or IYP alone.Main outcomes and measuresThe primary outcome measure was the posttreatment change in Eyberg Child Behavior Inventory Total Problem Scale (ECBI-P) score. Secondary outcomes included maintenance of change on the ECBI-P score, ECBI Intensity Scale score, and Social Competence Scale score at the 6-month follow-up; percentage of child behavior scores in the clinical range after treatment; retention; and attendance.ResultsA total of 126 parents (112 women and 14 men; mean [SD] age, 34.7 [8.4] years) were included; 63 parents were randomly assigned to each intervention group. Analysis of variance using intention to treat showed no significant difference between groups after treatment (P = .62). At follow-up, there was a medium effect (d = 0.63) showing a significant benefit from IYP plus HPS of 3.6 (95% CI, 0.8-6.5) on the ECBI-P score (F1,124 = 6.3; P = .01). Families receiving the IYP plus HPS intervention had significantly fewer children with child behavior scores in the clinical range after treatment (9 of 51 [17.6%]) compared with families receiving the IYP program alone (18 of 45 [40.0%]), and this status was maintained at follow-up. The HPS intervention had better retention than the IYP program (dropout, 7 [5.6%] vs 16 [12.7%]) as well as better attendance.Conclusions and relevanceIn this trial, the IYP plus HPS intervention significantly improved outcomes for the most vulnerable families at 6 months. This study demonstrated that the HPS intervention is an effective addition to the IYP program to improve engagement and implementation of IYP program strategies and enhance child behavior outcomes for the most vulnerable families.Trial registrationhttp://anzctr.org.au Identifier: ACTRN12612000878875.

Project description:Implementation fidelity is a key issue in home-visiting programs as it determines a program's effectiveness in accomplishing its original goals. This paper seeks to evaluate fidelity in a 27-month program addressing maternal and child health which took place in France between 2006 and 2011.To evaluate implementation fidelity, home visit case notes were analyzed using thematic qualitative and computer-assisted linguistic analyses.During the prenatal period, home visitors focused on the social components of the program. Visitors discussed the physical changes in pregnancy, and psychological and social environment issues. Discussing immigration, unstable employment and financial related issues, family relationships and dynamics and maternity services, while not expected, were found in case notes. Conversely, health during pregnancy, early child development and postpartum mood changes were not identified as topics within the prenatal case notes. During the postnatal period, most components of the intervention were addressed: home visitors observed the mother's adaptation to the baby; routine themes such as psychological needs and medical-social networks were evaluated; information on the importance of social support and on adapting the home environment was given; home visitors counseled on parental authority, and addressed mothers' self-esteem issues; finally, they helped to find child care, when necessary. Some themes were not addressed or partially addressed: health education, child development, home environment, mother's education plans and personal routine, partner support and play with the child. Other themes were not expected, but found in the case notes: social issues, mother-family relationship, relation with services, couple issues, quality of maternal behavior and child's language development.In this program, home visitors experienced difficulties addressing some of the objectives because they gave precedence to the families' urgent needs. This research stresses the importance of training home visitors to adapt the intervention to the social, psychological and health needs of families.

Project description:BACKGROUND: Antisocial behaviour and adult criminality often have their origins in childhood and are best addressed early in the child's life using evidence-based treatments such as the 'Incredible Years Parent Programme'. However, families with additional risk factors who are at highest risk for poor outcomes do not always make sufficient change while attending such programmes. Additional support to address barriers and improve implementation of positive parenting strategies while these families attend the Incredible Years Programme may improve overall outcomes.The study aims to evaluate the efficacy of adding a structured home visiting intervention (Home Parent Support) to improve outcomes in families most at risk of poor treatment response from the Incredible Years intervention. This study will inform the design of a larger prospective randomised controlled trial. METHODS/DESIGN: A pilot single-blind, parallel, superiority, randomised controlled trial. Randomisation will be undertaken using a computer-generated sequence in a 1:1 ratio to the two treatments arranged in permuted blocks with stratification by age, sex, and ethnicity. One hundred and twenty six participants enrolled in the Incredible Years Parent Programme who meet the high-risk criteria will be randomly allocated to receive either Incredible Years Parent Programme and Home Parent Support, or the Incredible Years Parent Programme alone. The Home Parent Support is a 10-session structured home visiting intervention provided by a trained therapist, alongside the usual Incredible Years Parent Programme, to enhance the adoption of key parenting skills. The primary outcome is the change in child behaviour from baseline to post-intervention in parent reported Eyberg Child Behavior Inventory Problem Scale. DISCUSSION: This is the first formal evaluation of adding Home Parent Support alongside Incredible Years Parent Programme for families with risk factors who typically have poorer treatment outcomes. We anticipate that the intervention will help vulnerable families stay engaged, strengthen the adoption of effective parenting strategies, and improve outcomes for both the children and families. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000878875.

Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

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