Brief Summary

The goals of this study are to evaluate the effects of an in-home parenting education program, called Family Spirit, on parenting knowledge and skills and decreasing alcohol and substance use compared to a breast-feeding education. In addition, we will assess aspects of mother/child interaction.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

320

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2002

Longer than P75 for not_applicable

Geographic Reach

1 country

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.3 years study duration

Study Start

First participant enrolled

May 1, 2002

Completed

3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed

Last Updated

August 1, 2016

Status Verified

July 1, 2016

First QC Date

July 25, 2006

Last Update Submit

July 29, 2016

Conditions

Substance Abuse

Keywords

Teen pregnancyFamily strengtheningSubstance abuse preventionDepression preventionParent involvement

Outcome Measures

Primary Outcomes (4)

Increase in parent knowledge, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
Increase in parent skills, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
Decrease in parental high-risk behaviors, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
Increase in parental-child involvement, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum

Interventions

Family Spirit curriculumBEHAVIORAL

Eligibility Criteria

Age12 Years - 24 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Native American pregnant teens or young women ages 12-22 years old at the time of conception.
Women ages 20-22 years at the time of conception must be pregnant for the first time.
Partners of pregnant teens must be between the ages of 12-24.
Pregnant \<28 weeks gestation and able to meet the requirements for completing the program in a timely way.
An enrolled tribal member.
Reside in the Reservation Service Unit Catchment Area and within 60 mile of the Indian Health Service Unit Headquarters.

You may not qualify if:

Severe mental illness - schizophrenia, bipolar disorder, incapacitating depression, or Substance abuse/dependence in need of intensive and specific treatment
Active legal problems - subjects will not be enrolled if they are incarcerated or if program participation has been made a condition of parole
Ongoing social service involvement for abuse and neglect

Contact the study team to confirm eligibility.