Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136279
Status:
COMPLETED
Last Update Posted:
2009-02-03
First Post:
2005-08-25
Brief Title:
Linking Lives Building Quality Parent Components for School-Based Health Programs in Middle Schools
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
RCT of Tobacco Use Prevention and Sexual Risk Reduction Interventions for Parents of African American and Latino Youth in Middle School
Status:
COMPLETED
Status Verified Date:
2009-01
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 develop and evaluate the effectiveness of a parent-based intervention that can be implemented in conjunction with existing school-based programs designed to prevent or reduce sexual risk behavior or to prevent or reduce tobacco use in young adolescents The parent programs are expected to have effects on adolescent behavior over and above the effects of the school-based programs
Detailed Description:
Although parent-based programs have shown promise in reducing adolescent risk behavior few have been rigorously evaluated and shown to be effective Recruitment and retention of parents into lengthy workshops has been a problem and few programs have been developed specifically for inner-city minority populations who are at greatest risk for a number of adverse health outcomes Linking Lives was designed to address these issues
Parent Intervention The primary feature of the parent component is a written manual distributed in modules to mothers that teaches them how to communicate effectively with their children about sex or tobacco risk behaviors and how to improve their relationships with their children This is accompanied by two face-to-face intervention sessions for mothers during which they are given the intervention materials and an opportunity to participate in role playing activities with other parents and by regular contact by trained parent volunteers to determine if the parent has implemented the manual contents Mothers and their adolescents attend Linking Lives events together at the school in the evenings and on weekends during which time adolescents attend their own intervention sessions at the same time mothers are attending theirs mothers in the control condition participate in sessions on helping their children choose a high school
Sample Nine middle schools in the Bronx New York and two schools in the Harlem neighborhood of New York are participating in the study The schools are located in communities that are financially disadvantaged Approximately 70 of the students in the schools are Latino and 30 are African American A total of 4750 adolescents and their mothers will participate in the study 1900 for tobacco and 2850 for sexual risk reduction Students are randomly sampled and their parent is contacted regarding family participation in the study
Evaluation Based on input from elicitation studies focus groups with adolescents and mothers a pre-intervention survey of 668 mother-adolescent pairs a psychometric study for both English- and Spanish-language instruments feedback from community and school leaders and a scientific panel of experts the instruments manuals and intervention protocol have been developed All measures and intervention materials have been developed in English and in Spanish The evaluation includes a baseline 3-month post-test and a 15-month delayed post-test assessment of adolescents and mothers For tobacco within schools students will be randomly assigned to an experimental group school-based curriculum plus parent component or a control group school-based curriculum only For sexual risk reduction students will be randomly assigned to the combined experimental condition school-based curriculum plus parent component a parent-only experimental condition parent component is distributed to mothers but no school component is delivered or a control group school-based curriculum only
Parent Intervention The primary feature of the parent component is a written manual distributed in modules to mothers that teaches them how to communicate effectively with their children about sex or tobacco risk behaviors and how to improve their relationships with their children This is accompanied by two face-to-face intervention sessions for mothers during which they are given the intervention materials and an opportunity to participate in role playing activities with other parents and by regular contact by trained parent volunteers to determine if the parent has implemented the manual contents Mothers and their adolescents attend Linking Lives events together at the school in the evenings and on weekends during which time adolescents attend their own intervention sessions at the same time mothers are attending theirs mothers in the control condition participate in sessions on helping their children choose a high school
Sample Nine middle schools in the Bronx New York and two schools in the Harlem neighborhood of New York are participating in the study The schools are located in communities that are financially disadvantaged Approximately 70 of the students in the schools are Latino and 30 are African American A total of 4750 adolescents and their mothers will participate in the study 1900 for tobacco and 2850 for sexual risk reduction Students are randomly sampled and their parent is contacted regarding family participation in the study
Evaluation Based on input from elicitation studies focus groups with adolescents and mothers a pre-intervention survey of 668 mother-adolescent pairs a psychometric study for both English- and Spanish-language instruments feedback from community and school leaders and a scientific panel of experts the instruments manuals and intervention protocol have been developed All measures and intervention materials have been developed in English and in Spanish The evaluation includes a baseline 3-month post-test and a 15-month delayed post-test assessment of adolescents and mothers For tobacco within schools students will be randomly assigned to an experimental group school-based curriculum plus parent component or a control group school-based curriculum only For sexual risk reduction students will be randomly assigned to the combined experimental condition school-based curriculum plus parent component a parent-only experimental condition parent component is distributed to mothers but no school component is delivered or a control group school-based curriculum only
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 |
|---|---|---|---|
| U87CCU220155-05 | None | None | None |