Family Spirit Study
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

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.
    

Intervention name(s): Family Spirit curriculum
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Teen pregnancy; Family strengthening; Substance abuse prevention; Depression prevention; Parent involvement