Cradling Our Future Through Family Strengthening Study

Depression Clinical Trial

Official title:

In-home Prevention of SA Risks for Native Teen Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373750
• Other study ID #: 1R01DA019042-01A1
• Secondary ID: 1R01DA019042-01A
• Status: Completed
• Phase: N/A
• First received: September 7, 2006
• Last updated: January 9, 2015
• Start date: June 2006
• Est. completion date: December 2010

Study information

• Verified date: January 2015
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 19 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post-partum Depression
• Substance Abuse

Intervention

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.

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	San Carlos	Arizona
United States	Johns Hopkins Center for American Indian Health	Tuba City	Arizona
United States	Johns Hopkins Center for American Indian Health	Whiteriver	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Barlow A, Varipatis-Baker E, Speakman K, Ginsburg G, Friberg I, Goklish N, Cowboy B, Fields P, Hastings R, Pan W, Reid R, Santosham M, Walkup J. Home-visiting intervention to improve child care among American Indian adolescent mothers: a randomized trial. Arch Pediatr Adolesc Med. 2006 Nov;160(11):1101-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in parental competence at nine intervals over 39 month study period		birth-3 year postpartum	No
Secondary	Differences in social and emotional competence, and internalizing, externalizing and regulatory problems for children between ages 12-36 months		birth-3 year postpartum	No
Secondary	Moderators and mediators of intervention response for mothers and children.		birth-3 year postpartum	No
Secondary	Increase in maternal outcomes at nine intervals over 39 month study period		birth-3 year postpartum	No
Secondary	Improved childhood outcomes at nine intervals over 39 month study period		birth-3 year postpartum	No

External Links

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