Extension Study of the Family Spirit Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01910701
First received: July 17, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

The aim of the proposed research is to implement and evaluate a follow-up study of the impact of the Family Spirit family strengthening program among a high-risk sample of Apache mothers and their children. The Family Spirit intervention is a 52-session home-visiting curriculum administered by American Indian paraprofessionals to young mothers from 28 weeks gestation through the child's first 3 years of life. In a series of pilot studies and a recently completed randomized controlled trial, the Family Spirit intervention has been found to positively impact several maternal, parenting and child outcomes up through three years postpartum. In the proposed study, the investigators will implement the Family Spirit intervention to young mothers (12-20 years at conception), with revisions to several assessment measures and to the curriculum such that the substance abuse prevention curriculum modules will be taught earlier than in the original study.


Condition Intervention
Home Visiting
Behavioral: Family Spirit

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Increase in score on parenting self-efficacy scale [ Time Frame: 24 months postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved prenatal and infant medical care practices [ Time Frame: 24 months postpartum ] [ Designated as safety issue: No ]
    Includes: prenatal care utilization, prenatal use of alcohol/drugs, preconception care, inter-birth intervals, screening for maternal depressive symptoms, breastfeeding, well-child visit utilization, maternal and child health insurance status

  • Reduction in emergency department visits due to childhood injuries [ Time Frame: 24 months postpartum ] [ Designated as safety issue: No ]
    Includes: visits for children to emergency department for all causes and due to injury, home safety

  • Improved school readiness scores [ Time Frame: 24 months postpartum ] [ Designated as safety issue: No ]
    Includes: parent support for children's learning and development, parent knowledge of child development, parenting behaviors, parent-child relationship, parent stress, child's communication and literacy, child's cognitive skills, child's approach to learning, child's social behavior, and child's physical health and development

  • Improved score on family economic self-sufficiency scale [ Time Frame: 24 months postpartum ] [ Designated as safety issue: No ]
  • Increased referrals for community resources [ Time Frame: 24 months postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Spirit Intervention Behavioral: Family Spirit
The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase and designed to positively impact a number of maternal and child behavioral and health outcomes.

Detailed Description:

This is a single group pre-post study designed to evaluate the impact of a home visiting intervention in improving parenting self-efficacy and a number of other maternal and child health and behavioral outcomes among a sample of young mothers, including maternal substance use. The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase. All sessions are designed to be taught at the participant's home, but they may also occur at another location chosen by the participant (e.g. study office, vehicle). Outcome data will be collected at Baseline and at 2 months, 6 months, 12 months, 24 months and 36 months postpartum.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant American Indian female less than or equal to 32 weeks gestation.
  • Reside within 60 miles of Whiteriver Indian Health Service unit.
  • Age 12-20 years of age at time of conception

Exclusion Criteria:

  • Completed previous randomized controlled trial of Family Spirit
  • ≤11 years old or ≥21 years old at time of conception of index pregnancy.
  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: NCT01910701

Contacts
Contact: Allison Barlow, MPH, MA 410-955-6931 abarlow@jhsph.edu

Locations
United States, Maryland
Johns Hopkins Center for American Indian Health Recruiting
Baltimore, Maryland, United States, 21205
Contact: Allison Barlow, MPH, MA    410-955-6931    abarlow@jhsph.edu   
Principal Investigator: Allison Barlow, MPH, MA         
Sub-Investigator: Britta Mullany, PhD         
Sub-Investigator: Nicole Neault, MPH         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Allison Barlow, MPH, MA Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01910701     History of Changes
Other Study ID Numbers: ADHS12-014900
Study First Received: July 17, 2013
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Parenting
Home visiting interventions
American Indian
Community based participatory research

ClinicalTrials.gov processed this record on July 28, 2014