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Family Spirit Study

Primary Purpose

Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Spirit curriculum
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse focused on measuring Teen pregnancy, Family strengthening, Substance abuse prevention, Depression prevention, Parent involvement

Eligibility Criteria

12 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Center for American Indian Health
  • Johns Hopkins Center for American Indian Health
  • Johns Hopkins Center for American Indian Health
  • Johns Hopkins Center for American Indian Health
  • Johns Hopkins Center for American Indian Health

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
July 25, 2006
Last Updated
July 29, 2016
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
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1. Study Identification

Unique Protocol Identification Number
NCT00356551
Brief Title
Family Spirit Study
Official Title
Family Strengthening in Native Communities Project
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Teen pregnancy, Family strengthening, Substance abuse prevention, Depression prevention, Parent involvement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Family Spirit curriculum
Primary Outcome Measure Information:
Title
Increase in parent knowledge, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
Title
Increase in parent skills, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
Title
Decrease in parental high-risk behaviors, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
Title
Increase in parental-child involvement, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Walkup, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allison Barlow, MA, MPH
Organizational Affiliation
Johns Hopkins Center for American Indian Health
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins Center for American Indian Health
City
Fort Defiance
State/Province
Arizona
ZIP/Postal Code
86540
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
Tuba City
State/Province
Arizona
ZIP/Postal Code
86045
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
Whiteriver
State/Province
Arizona
ZIP/Postal Code
85941
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
Gallup
State/Province
New Mexico
ZIP/Postal Code
87001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19454915
Citation
Walkup JT, Barlow A, Mullany BC, Pan W, Goklish N, Hasting R, Cowboy B, Fields P, Baker EV, Speakman K, Ginsburg G, Reid R. Randomized controlled trial of a paraprofessional-delivered in-home intervention for young reservation-based American Indian mothers. J Am Acad Child Adolesc Psychiatry. 2009 Jun;48(6):591-601. doi: 10.1097/CHI.0b013e3181a0ab86.
Results Reference
derived

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Family Spirit Study

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