Extension Study of the Family Spirit Program

The aim of the proposed research is to implement and evaluate a follow-up study of the impact of the Family Spirit family strengthening program among a high-risk sample of Apache mothers and their children. The Family Spirit intervention is a 52-session home-visiting curriculum administered by American Indian paraprofessionals to young mothers from 28 weeks gestation through the child's first 3 years of life. In a series of pilot studies and a recently completed randomized controlled trial, the Family Spirit intervention has been found to positively impact several maternal, parenting and child outcomes up through three years postpartum. In the proposed study, the investigators will implement the Family Spirit intervention to young mothers (12-20 years at conception), with revisions to several assessment measures and to the curriculum such that the substance abuse prevention curriculum modules will be taught earlier than in the original study.

Study Overview

• Status: Completed
• Conditions: Parenting
• Intervention / Treatment: Behavioral: Family Spirit

Detailed Description

This is a single group pre-post study designed to evaluate the impact of a home visiting intervention in improving parenting self-efficacy and a number of other maternal and child health and behavioral outcomes among a sample of young mothers, including maternal substance use. The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase. All sessions are designed to be taught at the participant's home, but they may also occur at another location chosen by the participant (e.g. study office, vehicle). Outcome data will be collected at Baseline and at 2 months, 6 months, 12 months, 24 months and 36 months postpartum.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Center for American Indian Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant American Indian female less than or equal to 32 weeks gestation.
• Reside within 60 miles of Whiteriver Indian Health Service unit.
• Age 12-20 years of age at time of conception

Exclusion Criteria:

• Completed previous randomized controlled trial of Family Spirit
• ≤11 years old or ≥21 years old at time of conception of index pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Spirit Intervention; The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase and designed to positively impact a number of maternal and child behavioral and health outcomes.	Behavioral: Family Spirit; The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase and designed to positively impact a number of maternal and child behavioral and health outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increase in score on parenting self-efficacy scale	24 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved prenatal and infant medical care practices	Includes: prenatal care utilization, prenatal use of alcohol/drugs, preconception care, inter-birth intervals, screening for maternal depressive symptoms, breastfeeding, well-child visit utilization, maternal and child health insurance status	24 months postpartum
Reduction in emergency department visits due to childhood injuries	Includes: visits for children to emergency department for all causes and due to injury, home safety	24 months postpartum
Improved school readiness scores	Includes: parent support for children's learning and development, parent knowledge of child development, parenting behaviors, parent-child relationship, parent stress, child's communication and literacy, child's cognitive skills, child's approach to learning, child's social behavior, and child's physical health and development	24 months postpartum
Improved score on family economic self-sufficiency scale		24 months postpartum
Increased referrals for community resources		24 months postpartum

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Investigators: Principal Investigator: Allison Barlow, MPH, MA, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: American Indian; Community based participatory research; Home visiting interventions
• Other Study ID Numbers: ADHS12-014900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO