Clinical trial NCT01910701: Extension Study of the Family Spirit Program
Official title: Extension Study of the Family Spirit Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Keywords: Home visiting interventions
American Indian
Community based participatory research
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 92
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Increase in score on parenting self-efficacy scale
timeFrame: 24 months postpartum
Secondary outcomes:
measure: Improved prenatal and infant medical care practices
timeFrame: 24 months postpartum
measure: Reduction in emergency department visits due to childhood injuries
timeFrame: 24 months postpartum
measure: Improved school readiness scores
timeFrame: 24 months postpartum
measure: Improved score on family economic self-sufficiency scale
timeFrame: 24 months postpartum
measure: Increased referrals for community resources
timeFrame: 24 months postpartum
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Allison Barlow, MPH, MA
role: PRINCIPAL_INVESTIGATOR
References: