Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461487
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2007-04-16
Brief Title:
A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Reducing Teen Sexual Behavior A Clinic-Based Approach
Status:
COMPLETED
Status Verified Date:
2013-07
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:
This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk Latino and African-American adolescents
Detailed Description:
In the United States racial and ethnic minorities suffer disproportionately from preventable diseases and conditions Many of these problems result from health-related behaviors that are established during childhood and adolescence Latino and African-American adolescents are at considerable risk for the negative health consequences of early risky sexual activity This study will focus on inner-city Latino and African-American adolescents in grades 6 7 and 8 The primary aim will be to develop an intervention that parents can use to address the issue of sexual risk behavior with their children
The intervention will take place in a primary health care clinic when mothers accompany their children for annual physical exams Mothers will meet with a social worker for approximately 25 minutes while their children are being examined by the physician During this time mothers will receive information about the problem of premature adolescent sexual activity support in preventing or reducing their childrens sexual risk behavior instruction about how to talk with their children about sexual risk behavior and targeted homework activities All parents will also receive three follow-up phone calls to increase the probability that the homework tasks will be completed
Participants in this study will also be assigned to one of the following three groups an experimental group an active control group or a passive control group Participants in all groups will complete three questionnaires over the course of the study to assess outcomes Participants in the experimental and active control groups will partake in an additional meeting with a clinic social worker Parents in the experimental group will meet with the social worker to discuss effective parent-adolescent communication strategies They will also receive take-home materials to help them communicate with and parent their adolescents to reduce sexual risk behavior Parents in the active control group will meet with the social worker to discuss adolescent nutrition and receive informational brochures
Three booster sessions will take place via telephone for parents in the experimental and active control groups The first booster call will occur approximately 1 month after study entry the second will occur 5 months after the intervention ends and the third will occur 9 months post intervention No such booster calls will be provided to parents in the passive control condition
The intervention will take place in a primary health care clinic when mothers accompany their children for annual physical exams Mothers will meet with a social worker for approximately 25 minutes while their children are being examined by the physician During this time mothers will receive information about the problem of premature adolescent sexual activity support in preventing or reducing their childrens sexual risk behavior instruction about how to talk with their children about sexual risk behavior and targeted homework activities All parents will also receive three follow-up phone calls to increase the probability that the homework tasks will be completed
Participants in this study will also be assigned to one of the following three groups an experimental group an active control group or a passive control group Participants in all groups will complete three questionnaires over the course of the study to assess outcomes Participants in the experimental and active control groups will partake in an additional meeting with a clinic social worker Parents in the experimental group will meet with the social worker to discuss effective parent-adolescent communication strategies They will also receive take-home materials to help them communicate with and parent their adolescents to reduce sexual risk behavior Parents in the active control group will meet with the social worker to discuss adolescent nutrition and receive informational brochures
Three booster sessions will take place via telephone for parents in the experimental and active control groups The first booster call will occur approximately 1 month after study entry the second will occur 5 months after the intervention ends and the third will occur 9 months post intervention No such booster calls will be provided to parents in the passive control condition
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 |
|---|---|---|---|
| DAHBR 9A-ASAP | US NIH GrantContract | None | httpsreporternihgovquickSearchR34MH078719 |
| R34MH078719 | NIH | None | None |