Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373750
Status:
COMPLETED
Last Update Posted:
2015-01-12
First Post:
2006-09-07
Brief Title:
Cradling Our Future Through Family Strengthening Study
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
In-home Prevention of SA Risks for Native Teen Families
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 childrens 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 US 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 womens 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
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 childrens 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 US 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 womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DA019042-01A1 | NIH | None | httpsreporternihgovquickSearch1R01DA019042-01A1 |