Extension Study of the Family Spirit Program

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Parenting

Treatments: Behavioral: Family Spirit

Study type: Interventional

Funder types: Other

Identifiers

NCT01910701

ADHS12-014900

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: Female

Ages: 12 to 20 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

Family Spirit Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Family Spirit