Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579781
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Evaluation of Parent Toolkit 20 Morehouse Family Health Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rigorous Evaluation of Morehouse School of Medicines Parent Toolkit 20 Intervention Morehouse Family Health Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Child Trends will conduct a randomized control trial evaluation of Parent Toolkit 20 an innovative intervention for parents and caregivers of middle and high school students Child Trends will collaborate with Morehouse School of Medicine Tressa Tucker Associates LLC and Good Deeds Ministry to implement and evaluate the program with 1000 parent-teen pairs across Georgia The program includes three components that will be delivered across a three-week period 1 an online self-paced Parent Guide with information tips tools and resources on adolescent health including sexual health 2 four videos modeling parent-teen communication around sex and contraception and 3 two group-based sessions for parent participants to discuss program content and improve communication skills The program aims to increase parent knowledge and parent-teen communication about adolescent health sexual health and relationships to help youth adopt health-promoting behaviors such as delaying sexual initiation and increasing contraceptive use
Detailed Description:
Child Trends in partnership with the Morehouse School of Medicine MSM will implement Parent Toolkit 20 The Georgia Campaign for Adolescent Power Potential developed the Parent Toolkit intervention and Morehouse School of Medicines MSM Health Promotion Research Center tested and adapted it through an OPA Innovation Network grant
Child Trends plans to conduct an individual randomized controlled trial RCT to evaluate the effectiveness of Parent Toolkit 20 in delaying sexual initiation and increasing contraceptive use among youth who engage in sexual activity Youth outcomes are expected to improve as a result of the expansion of parental knowledge and improvement of parent-teen communication about adolescent health sexual health and relationships Associated outcomes will be measured through two surveys one of which will be distributed immediately after the intervention ends while the other will be administered nine months after the end of the intervention
The intended population is African American youth ages 12-15 living in rural and micropolitan areas in central north and southeast Georgia and their parents or caregivers A caregiver in this context is defined as someone who lives with the child at least 50 percent of the time and who is one of the main people responsible for the child The parents or caregivers will be the program participants since they are the intended recipients of all intervention-related resources such as the toolkit videos and group-based virtual sessions By contrast the youth enrolled in the study will not directly engage in the programming
As a part of this study treatment group parentcaregiver participants will be asked to
Review a self-paced parent guide and four videos modeling parent-teen communication on Canvas
Attend two 1-hour group sessions with other parents
Complete baseline and post-intervention surveys
Participate in an optional focus group discussion
Control group parentcaregiver participants will be asked to
Review a self-paced parent guide on Canvas
Complete baseline and post-intervention surveys
Participate in an optional focus group discussion
Treatment and control group youth participants will be asked to
Complete baseline post-intervention and nine-month follow-up surveys
Participate in an optional focus group discussion
Child Trends plans to conduct an individual randomized controlled trial RCT to evaluate the effectiveness of Parent Toolkit 20 in delaying sexual initiation and increasing contraceptive use among youth who engage in sexual activity Youth outcomes are expected to improve as a result of the expansion of parental knowledge and improvement of parent-teen communication about adolescent health sexual health and relationships Associated outcomes will be measured through two surveys one of which will be distributed immediately after the intervention ends while the other will be administered nine months after the end of the intervention
The intended population is African American youth ages 12-15 living in rural and micropolitan areas in central north and southeast Georgia and their parents or caregivers A caregiver in this context is defined as someone who lives with the child at least 50 percent of the time and who is one of the main people responsible for the child The parents or caregivers will be the program participants since they are the intended recipients of all intervention-related resources such as the toolkit videos and group-based virtual sessions By contrast the youth enrolled in the study will not directly engage in the programming
As a part of this study treatment group parentcaregiver participants will be asked to
Review a self-paced parent guide and four videos modeling parent-teen communication on Canvas
Attend two 1-hour group sessions with other parents
Complete baseline and post-intervention surveys
Participate in an optional focus group discussion
Control group parentcaregiver participants will be asked to
Review a self-paced parent guide on Canvas
Complete baseline and post-intervention surveys
Participate in an optional focus group discussion
Treatment and control group youth participants will be asked to
Complete baseline post-intervention and nine-month follow-up surveys
Participate in an optional focus group discussion
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