Family Spirit Study

Substance Abuse Clinical Trial

Official title:

Family Strengthening in Native Communities Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356551
• Other study ID #: 1 UDI SPO9588
• Status: Completed
• Phase: N/A
• First received: July 25, 2006
• Last updated: July 29, 2016
• Start date: May 2002
• Est. completion date: September 2005

Study information

• Verified date: July 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 24 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• Family Spirit curriculum

Locations

Country	Name	City	State
United States	Johns Hopkins Center for American Indian Health	Baltimore	Maryland
United States	Johns Hopkins Center for American Indian Health	Fort Defiance	Arizona
United States	Johns Hopkins Center for American Indian Health	Gallup	New Mexico
United States	Johns Hopkins Center for American Indian Health	Tuba City	Arizona
United States	Johns Hopkins Center for American Indian Health	Whiteriver	Arizona

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins University	Annie E. Casey Foundation, Charles Stewart Mott Foundation, Educational Foundation of America, Ford Foundation, Substance Abuse and Mental Health Services Administration (SAMHSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in parent knowledge, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
Primary	Increase in parent skills, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
Primary	Decrease in parental high-risk behaviors, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
Primary	Increase in parental-child involvement, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum