Family Spirit Study

This study has been completed.
Sponsor:
Collaborators:
Substance Abuse and Mental Health Services Administration (SAMHSA)
Annie E. Casey Foundation
Ford Foundation
Charles Stewart Mott Foundation
Educational Foundation of America
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00356551
First received: July 25, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Substance Abuse
Behavioral: Family Spirit curriculum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Family Strengthening in Native Communities Project

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 320
Study Start Date: May 2002
Estimated Study Completion Date: September 2005
Detailed Description:

To evaluate the study, we employed a randomized controlled design using a blocked randomization procedure. In this procedure, single woman and women with a participating father were randomized in equal numbers to the Family Spirit or the breast-feeding education program.

Both treatment and comparison groups were assessed at multiple times. The number of times depended on when the participant was recruited into the program. Women recruited into the program between the study’s start (May 2002) and January 31, 2004 were assessed at four times: 1) The Pre-test occurs after informed consent (occurring at least 16 weeks before the birth of the infant), 2) The Mid-Test at 6-8 weeks after the delivery of the infant, 3) The Post-Test at 6 months post-partum (which is the end of the intervention period), and 4) The 6-month Follow Up Test occurs at 1 year post-partum. Women recruited into the program between Februrary 1, 2004 and March 31, 2004 (the date recruitment ended) were assessed at three times: 1) The Pre-test occurs after informed consent (occurring at least 16 weeks before the birth of the infant), 2) The Mid-Test at 6-8 weeks after the delivery of the infant, and 3) The Post-Test at 6 months post-partum (the end of the intervention period).

FHEs also conducted two instruments specific to child development: the HOME and the ITSEA. The Home Observation for Measurement of the Environment (HOME) was administered at the Post-Test and Follow-Up points (just the post-point for women recruited into the study between February 1, 2004 and March 31, 2004). This measure was an observatory measure completed by FHEs and provided a systematic measurement of the family environment. The Infant-Toddler Social and Emotional Assessment (ITSEA) was a self-report form completed by parents at their Follow-Up visit (not completed for women recruited into the study between February 1 and March 31, 2004). This measure assessed social-emotional problems and competencies in 12- to 36-month olds. FHEs also administered a Client Satisfaction Scale to mothers in the FSP group who completed their participation in the program. This Scale assessed their satisfaction with the various curricular sections and their FHE.

  Eligibility

Ages Eligible for Study:   12 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356551

Locations
United States, Arizona
Johns Hopkins Center for American Indian Health
Fort Defiance, Arizona, United States, 86540
Johns Hopkins Center for American Indian Health
Tuba City, Arizona, United States, 86045
Johns Hopkins Center for American Indian Health
Whiteriver, Arizona, United States, 85941
United States, Maryland
Johns Hopkins Center for American Indian Health
Baltimore, Maryland, United States, 21205
United States, New Mexico
Johns Hopkins Center for American Indian Health
Gallup, New Mexico, United States, 87001
Sponsors and Collaborators
Johns Hopkins University
Substance Abuse and Mental Health Services Administration (SAMHSA)
Annie E. Casey Foundation
Ford Foundation
Charles Stewart Mott Foundation
Educational Foundation of America
Investigators
Principal Investigator: John Walkup, MD Johns Hopkins University
Study Director: Allison Barlow, MA, MPH Johns Hopkins Center for American Indian Health
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00356551     History of Changes
Other Study ID Numbers: 1 UDI SPO9588
Study First Received: July 25, 2006
Last Updated: July 25, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Teen pregnancy
Family strengthening
Substance abuse prevention
Depression prevention
Parent involvement

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014