Cradling Our Future Through Family Strengthening Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Allison Barlow, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00373750
First received: September 7, 2006
Last updated: January 9, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Substance Abuse
Post-partum Depression
Depression
Procedure: Family Spirit Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: In-home Prevention of SA Risks for Native Teen Families

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

Primary Outcome Measures:
  • Increase in parental competence at nine intervals over 39 month study period [ Time Frame: birth-3 year postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Moderators and mediators of intervention response for mothers and children. [ Time Frame: birth-3 year postpartum ] [ Designated as safety issue: No ]
  • Increase in maternal outcomes at nine intervals over 39 month study period [ Time Frame: birth-3 year postpartum ] [ Designated as safety issue: No ]
  • Improved childhood outcomes at nine intervals over 39 month study period [ Time Frame: birth-3 year postpartum ] [ Designated as safety issue: No ]

Enrollment: 322
Study Start Date: June 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00373750

Locations
United States, Arizona
Johns Hopkins Center for American Indian Health
Fort Defiance, Arizona, United States, 86540
Johns Hopkins Center for American Indian Health
San Carlos, Arizona, United States, 85550
Johns Hopkins Center for American Indian Health
Tuba City, Arizona, United States, 86045
Johns Hopkins Center for American Indian Health
Whiteriver, Arizona, United States, 85941
United States, Maryland
Johns Hopkins Center for American Indian Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: John Walkup, MD Johns Hopkins University
Study Director: Allison Barlow, MA, MPH Johns Hopkins Center for American Indian Health
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allison Barlow, Assistant Scientist, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00373750     History of Changes
Other Study ID Numbers: 1 R01 DA019042-01A1, 1R01DA019042-01A1
Study First Received: September 7, 2006
Last Updated: January 9, 2015
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Native American health
Teen pregnancy
Family strengthening
Substance abuse prevention
Injury prevention

Additional relevant MeSH terms:
Depression
Depression, Postpartum
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pregnancy Complications
Puerperal Disorders

ClinicalTrials.gov processed this record on July 01, 2015