Trials / Completed
CompletedNCT01910701
Extension Study of the Family Spirit Program
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Johns Hopkins Bloomberg School of Public Health · Academic / Other
- Sex
- Female
- Age
- 12 Years – 20 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2018-11-30
- Completion
- 2018-11-30
- First posted
- 2013-07-30
- Last updated
- 2019-03-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01910701. Inclusion in this directory is not an endorsement.