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Extension Study of the Family Spirit Program

Not Applicable
Completed
Conditions
Parenting
Interventions
Behavioral: Family Spirit
Registration Number
NCT01910701
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
92
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Family Spirit InterventionFamily SpiritThe 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.
Primary Outcome Measures
NameTimeMethod
Increase in score on parenting self-efficacy scale24 months postpartum
Secondary Outcome Measures
NameTimeMethod
Improved prenatal and infant medical care practices24 months postpartum

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

Reduction in emergency department visits due to childhood injuries24 months postpartum

Includes: visits for children to emergency department for all causes and due to injury, home safety

Improved school readiness scores24 months postpartum

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

Improved score on family economic self-sufficiency scale24 months postpartum
Increased referrals for community resources24 months postpartum

Trial Locations

Locations (1)

Johns Hopkins Center for American Indian Health

🇺🇸

Baltimore, Maryland, United States

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