CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 322 enrolled
Drug / intervention
Family Spirit Interventionprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00373750
NCT00373750N/ACompleted

In-home Prevention of SA Risks for Native Teen Families

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Sep 8, 2006·Updated Jan 12, 2015

In Brief

A clinical study evaluating Family Spirit Intervention for Substance Abuse and 2 related conditions. Completed, enrolled 322 participants across 5 sites.

Detailed Summary

The purpose of this study is to determine whether an in-home, paraprofessional-delivered family strengthening curriculum entitled Family Spirit is effective at increasing parental competence, improving maternal outcomes and improving childhood outcomes in a sample of at-risk teen mothers living in four Native American reservation communities. The effectiveness of the Family Spirit curriculum will be determined by comparing outcomes of mothers who receive the intervention plus assisted transportation to prenatal and well baby visits (called Optimal Standardized Care) to mothers who receive only Optimal Standardized Care. Outcomes will be assessed at multiple intervals over the course of a 39-month study period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2006
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.8 years ago

Interventions

Family Spirit Interventionprocedure

The Family Spirit Intervention was developed over a decade through community-based participatory research.The intervention content included 43 structured lessons and followed a culturally congruent format.