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Cradling Our Future Through Family Strengthening Study

Primary Purpose

Substance Abuse, Post-partum Depression, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Spirit Intervention
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse focused on measuring Native American health, Teen pregnancy, Family strengthening, Substance abuse prevention, Injury prevention

Eligibility Criteria

12 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins Center for American Indian Health
  • Johns Hopkins Center for American Indian Health
  • Johns Hopkins Center for American Indian Health
  • Johns Hopkins Center for American Indian Health
  • Johns Hopkins Center for American Indian Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Family Spirit Intervention

Optimized Standard Care Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Increase in parental competence at nine intervals over 39 month study period

Secondary Outcome Measures

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.
Increase in maternal outcomes at nine intervals over 39 month study period
Improved childhood outcomes at nine intervals over 39 month study period

Full Information

First Posted
September 7, 2006
Last Updated
January 9, 2015
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00373750
Brief Title
Cradling Our Future Through Family Strengthening Study
Official Title
In-home Prevention of SA Risks for Native Teen Families
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Post-partum Depression, Depression
Keywords
Native American health, Teen pregnancy, Family strengthening, Substance abuse prevention, Injury prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Spirit Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Optimized Standard Care Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Family Spirit Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase in parental competence at nine intervals over 39 month study period
Time Frame
birth-3 year postpartum
Secondary Outcome Measure Information:
Title
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
Title
Moderators and mediators of intervention response for mothers and children.
Time Frame
birth-3 year postpartum
Title
Increase in maternal outcomes at nine intervals over 39 month study period
Time Frame
birth-3 year postpartum
Title
Improved childhood outcomes at nine intervals over 39 month study period
Time Frame
birth-3 year postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Walkup, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allison Barlow, MA, MPH
Organizational Affiliation
Johns Hopkins Center for American Indian Health
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins Center for American Indian Health
City
Fort Defiance
State/Province
Arizona
ZIP/Postal Code
86540
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
San Carlos
State/Province
Arizona
ZIP/Postal Code
85550
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
Tuba City
State/Province
Arizona
ZIP/Postal Code
86045
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
Whiteriver
State/Province
Arizona
ZIP/Postal Code
85941
Country
United States
Facility Name
Johns Hopkins Center for American Indian Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17088511
Citation
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. doi: 10.1001/archpedi.160.11.1101.
Results Reference
background
PubMed Identifier
31432381
Citation
Haroz EE, Ingalls A, Kee C, Goklish N, Neault N, Begay M, Barlow A. Informing Precision Home Visiting: Identifying Meaningful Subgroups of Families Who Benefit Most from Family Spirit. Prev Sci. 2019 Nov;20(8):1244-1254. doi: 10.1007/s11121-019-01039-9.
Results Reference
derived
PubMed Identifier
25321149
Citation
Barlow A, Mullany B, Neault N, Goklish N, Billy T, Hastings R, Lorenzo S, Kee C, Lake K, Redmond C, Carter A, Walkup JT. Paraprofessional-delivered home-visiting intervention for American Indian teen mothers and children: 3-year outcomes from a randomized controlled trial. Am J Psychiatry. 2015 Feb 1;172(2):154-62. doi: 10.1176/appi.ajp.2014.14030332. Epub 2014 Oct 31.
Results Reference
derived
PubMed Identifier
23409290
Citation
Barlow A, Mullany B, Neault N, Compton S, Carter A, Hastings R, Billy T, Coho-Mescal V, Lorenzo S, Walkup JT. Effect of a paraprofessional home-visiting intervention on American Indian teen mothers' and infants' behavioral risks: a randomized controlled trial. Am J Psychiatry. 2013 Jan;170(1):83-93. doi: 10.1176/appi.ajp.2012.12010121.
Results Reference
derived
Links:
URL
http://www.trialscentral.org/cradlingourfuture-condtrid-24923.htm
Description
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