Family Spirit Study

July 29, 2016 updated by: Johns Hopkins University

Family Strengthening in Native Communities Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 February 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).

Family Health Educator (FHE)s 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 (Family Support Person) FSP group who completed their participation in the program. This Scale assessed their satisfaction with the various curricular sections and their FHE.

Study Type

Interventional

Enrollment

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • 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
        • Johns Hopkins Center for American Indian Health
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Center for American Indian Health
    • New Mexico
      • Gallup, New Mexico, United States, 87001
        • Johns Hopkins Center for American Indian Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 UDI SPO9588

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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