|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Johns Hopkins University |
|---|---|
| Collaborators: |
Substance Abuse and Mental Health Services Administration (SAMHSA) Annie E. Casey Foundation Ford Foundation Charles Stewart Mott Foundation Educational Foundation of America |
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00356551 |
Purpose
The goals of this study are to evaluate the effects of an in-home parenting education program, called Family Spirit, on parenting knowledge and skills and decreasing alcohol and substance use compared to a breast-feeding education. In addition, we will assess aspects of mother/child interaction.
| Condition | Intervention |
|---|---|
|
Substance Abuse |
Behavioral: Family Spirit curriculum |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Family Strengthening in Native Communities Project |
| Estimated Enrollment: | 320 |
| Study Start Date: | May 2002 |
| Estimated Study Completion Date: | September 2005 |
To evaluate the study, we employed a randomized controlled design using a blocked randomization procedure. In this procedure, single woman and women with a participating father were randomized in equal numbers to the Family Spirit or the breast-feeding education program.
Both treatment and comparison groups were assessed at multiple times. The number of times depended on when the participant was recruited into the program. Women recruited into the program between the study’s start (May 2002) and January 31, 2004 were assessed at four times: 1) The Pre-test occurs after informed consent (occurring at least 16 weeks before the birth of the infant), 2) The Mid-Test at 6-8 weeks after the delivery of the infant, 3) The Post-Test at 6 months post-partum (which is the end of the intervention period), and 4) The 6-month Follow Up Test occurs at 1 year post-partum. Women recruited into the program between Februrary 1, 2004 and March 31, 2004 (the date recruitment ended) were assessed at three times: 1) The Pre-test occurs after informed consent (occurring at least 16 weeks before the birth of the infant), 2) The Mid-Test at 6-8 weeks after the delivery of the infant, and 3) The Post-Test at 6 months post-partum (the end of the intervention period).
FHEs also conducted two instruments specific to child development: the HOME and the ITSEA. The Home Observation for Measurement of the Environment (HOME) was administered at the Post-Test and Follow-Up points (just the post-point for women recruited into the study between February 1, 2004 and March 31, 2004). This measure was an observatory measure completed by FHEs and provided a systematic measurement of the family environment. The Infant-Toddler Social and Emotional Assessment (ITSEA) was a self-report form completed by parents at their Follow-Up visit (not completed for women recruited into the study between February 1 and March 31, 2004). This measure assessed social-emotional problems and competencies in 12- to 36-month olds. FHEs also administered a Client Satisfaction Scale to mothers in the FSP group who completed their participation in the program. This Scale assessed their satisfaction with the various curricular sections and their FHE.
Eligibility| Ages Eligible for Study: | 12 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Johns Hopkins Center for American Indian Health | |
| Fort Defiance, Arizona, United States, 86540 | |
| 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 | |
| United States, New Mexico | |
| Johns Hopkins Center for American Indian Health | |
| Gallup, New Mexico, United States, 87001 | |
| Principal Investigator: | John Walkup, MD | Johns Hopkins University |
| Study Director: | Allison Barlow, MA, MPH | Johns Hopkins Center for American Indian Health |
More Information
| ClinicalTrials.gov Identifier: | NCT00356551 History of Changes |
| Other Study ID Numbers: | 1 UDI SPO9588 |
| Study First Received: | July 25, 2006 |
| Last Updated: | July 25, 2006 |
| Health Authority: | United States: Institutional Review Board |
|
Teen pregnancy Family strengthening Substance abuse prevention Depression prevention Parent involvement |
|
Substance-Related Disorders Mental Disorders |