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Clinical Trials/NCT01910701
NCT01910701
Completed
N/A

Extension Study of the Family Spirit Program

Johns Hopkins Bloomberg School of Public Health1 site in 1 country92 target enrollmentJanuary 2013
ConditionsParenting

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parenting
Sponsor
Johns Hopkins Bloomberg School of Public Health
Enrollment
92
Locations
1
Primary Endpoint
Increase in score on parenting self-efficacy scale
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
November 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Increase in score on parenting self-efficacy scale

Time Frame: 24 months postpartum

Secondary Outcomes

  • Improved prenatal and infant medical care practices(24 months postpartum)
  • Reduction in emergency department visits due to childhood injuries(24 months postpartum)
  • Improved school readiness scores(24 months postpartum)
  • Improved score on family economic self-sufficiency scale(24 months postpartum)
  • Increased referrals for community resources(24 months postpartum)

Study Sites (1)

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