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Cradling Our Future Through Family Strengthening Study

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ClinicalTrials.gov Identifier: NCT00373750
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : January 12, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Allison Barlow, Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date  ICMJE September 7, 2006
First Posted Date  ICMJE September 8, 2006
Last Update Posted Date January 12, 2015
Study Start Date  ICMJE June 2006
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2015)
Increase in parental competence at nine intervals over 39 month study period [ Time Frame: birth-3 year postpartum ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
  • Increase in parental competence at nine intervals over 39 month study period
  • Increase in maternal outcomes at nine intervals over 39 month study period
  • Improved childhood outcomes at nine intervals over 39 month study period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2015)
  • Differences in social and emotional competence, and internalizing, externalizing and regulatory problems for children between ages 12-36 months [ Time Frame: birth-3 year postpartum ]
  • Moderators and mediators of intervention response for mothers and children. [ Time Frame: birth-3 year postpartum ]
  • Increase in maternal outcomes at nine intervals over 39 month study period [ Time Frame: birth-3 year postpartum ]
  • Improved childhood outcomes at nine intervals over 39 month study period [ Time Frame: birth-3 year postpartum ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
  • Differences in social and emotional competence, and internalizing, externalizing and regulatory problems for children between ages 12-36 months
  • Moderators and mediators of intervention response for mothers and children.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cradling Our Future Through Family Strengthening Study
Official Title  ICMJE In-home Prevention of SA Risks for Native Teen Families
Brief Summary The purpose of this study is to determine whether an in-home, paraprofessional-delivered family strengthening curriculum entitled Family Spirit is effective at increasing parental competence, improving maternal outcomes and improving childhood outcomes in a sample of at-risk teen mothers living in four Native American reservation communities. The effectiveness of the Family Spirit curriculum will be determined by comparing outcomes of mothers who receive the intervention plus assisted transportation to prenatal and well baby visits (called Optimal Standardized Care) to mothers who receive only Optimal Standardized Care. Outcomes will be assessed at multiple intervals over the course of a 39-month study period.
Detailed Description

American Indians (AIs) in reservation communities have the poorest health, education and socioeconomic status of any racial or ethnic group in the U.S., placing AI youth at increased risk for drug abuse (alcohol, marijuana, tobacco, etc.) and adverse health and behavior outcomes. This study focuses on one of the most vulnerable groups of reservation-based AIs-AI teen mothers and their children.

Over the past two decades a number of research-based health promotion and drug abuse prevention programs for youth have been found to be effective. Of these, parenting interventions have been found to be more effective than other types of interventions. Home visiting programs for young, high-risk mothers have been designed to impact a wide range of outcomes--parenting, child and maternal health and behavior outcomes. More than 40 studies have been published since 1982 supporting the short and long-term efficacy of home visiting programs delivered during pregnancy and early childhood for low-income families. Positive outcomes have been demonstrated for improved parenting and the home environment; increased social support for mothers and children from extended family members and improved maternal health and behavior outcomes; increased birth spacing; improved children's health and behavior outcomes; prevention of child abuse and neglect; and reduced drug use.

AI teen mothers and their offspring are arguably the most vulnerable and underserved population at risk for drug abuse and adverse health and behavior outcomes in the U.S. Given their high-risk status, pregnant AI teens are likely to benefit from a parenting-focused, home visiting intervention. Cultural support for developing individual strengths through a family-based model and the noted cultural relevance of employing AI paraprofessionals are expected to enhance participants' outcomes. As nearly half of AI women begin child-bearing in adolescence, improvement in outcomes of teen mothers and their offspring could substantially impact the public health and welfare of AI communities.

Both nurses and paraprofessionals have been utilized in effective home visiting programs. However, the shortage of indigenous nurses in reservation communities renders an AI nurse-delivered, home visiting intervention unfeasible for the participating communities at this time. Further, young AI women's discomfort with health care delivered by non-Indians and the potential for cultural barriers with non-Indian home visitors provides an additional rationale for AI paraprofessionals as home visitors.

Successful home visiting programs maintain a standard for frequency and dosage of visits, employ strategies for participant retention, provide intensive training, frequent direct supervision and intensive quality assurance measures. For this study, we will maintain the highest standards for dosage, retention strategies, home visitor training and supervision, and quality assurance. The core content of the curriculum is based on American Academy of Pediatrics' comprehensive guidelines for preparing mothers to care for infants and young children, with cultural adaptations derived through guidance from our Native Advisory Board and an iterative process of community input.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Substance Abuse
  • Post-partum Depression
  • Depression
Intervention  ICMJE Procedure: Family Spirit Intervention
The Family Spirit Intervention was developed over a decade through community-based participatory research.The intervention content included 43 structured lessons and followed a culturally congruent format.
Study Arms  ICMJE
  • Experimental: Family Spirit Intervention
    The Family Spirit Intervention included 43 structured lessons and followed a culturally congruent format. Positive parenting lessons were focused on reducing behaviors (i.e., poor monitoring; coercive interactions;harsh, unresponsive, or rejecting parenting; and abuse/ neglect) associated with early childhood behavior problems, including externalizing, internalizing, and dysregulation problems.
    Intervention: Procedure: Family Spirit Intervention
  • No Intervention: Optimized Standard Care Control Group
    Optimized standard care consisted of transportation to recommended prenatal and well-baby clinic visits, pamphlets about child care and community resources, and referrals to local services. It also addressed access barriers to health care for young mothers and children, and it overcame concerns that home-visiting programs have operated in parallel, not in partnership, with pediatric care. Family health liaisons conducted the optimized standard care and were not trained in the Family Spirit intervention, to avoid contamination of the control condition.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2015)
322
Original Enrollment  ICMJE
 (submitted: September 7, 2006)
320
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant AI females aged 12 to 19 years old at time of conception.
  • Gestational age of 28 weeks or less (in order to complete intervention prior to delivery).
  • Parent/guardian consent for youth under 18 years old.
  • Reside within 1-hour transportation range (50 miles) of the local Indian Health Service medical facility.

Exclusion Criteria:

  • Current participation in other mental or behavior health research project.
  • Factors that preclude full participation, identified at baseline and after caseness review, including: unstable and severe medical, psychiatric or drug use problem; acute suicidal or homicidal ideation requiring immediate intervention; recent, severe stressful life event such as physical or sexual abuse, or victim of a violent crime that requires specific and high intensity intervention or out of home placement; or chronic pattern of unstable caretakers or living situation.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00373750
Other Study ID Numbers  ICMJE 1R01DA019042-01A1( U.S. NIH Grant/Contract )
1R01DA019042-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allison Barlow, Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: John Walkup, MD Johns Hopkins University
Study Director: Allison Barlow, MA, MPH Johns Hopkins Center for American Indian Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP