Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276595
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-16
Brief Title:
Telling Our Daughters Our Story
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Telling Our Daughters Our Story Pre-Conception Health Program for American Indian Girls as They Transition to Adulthood
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
TODOS
Brief Summary:
The objective of this research study is to evaluate a culturally grounded program among American Indian AI female children and the childrens female caregivers This project will evaluate the impact of Nowhi Isdza bit Nadagoldi Telling Our Daughters Our Story henceforth referred to as TODOS on associated risk and protective factors for early substance use and sexual debut through a randomized controlled trial on the White Mountain Apache WMA reservation The investigators will examine whether the TODOS program effectively reduces risk factors and improves protective factors associated with early substance use and sexual debut with long term goals of reducing teen pregnancy and teen substance use
Detailed Description:
The investigators will employ a randomized controlled trial RCT design to assess the preliminary impact of the TODOS program on many factors including improving cultural knowledge family engagement in Apache culture mother daughter communication self-esteem self-efficacy social support attitudes about risky behaviors and knowledge of reproductive health and substance use Participants will be caregivers of girls ages 8-11 years
The TODOS program consists of 11 weekly sessions conducted with girls ages 8-11 and the girls female caregivers Five of the 11 sessions will be taught to small groups of girls and the girls mothers and 6 of the sessions will be taught to individual girlfemale caregivers dyads The choice to use a mix of group- and home-based sessions is based on findings from the formative phase about preference that certain topics be taught in groups and certain topics be taught in individual dyads Each of the sessions group and individual will be 60-90 minutes in duration and delivered by a trained Family Health Coach FHC
The investigators will enroll up to 94 dyads into four cohorts each consisting of 18-26 dyads Dyads will receive either the TODOS program or a control condition The control condition will consist of 3 group sessions delivered monthly for three months The investigators will evaluate the TODOS programs feasibility through process data including attendance forms and session summary feedback forms completed by the FHCs The investigators will assess program acceptability immediately after program completion through implementation assessments completed by caregiver and children participants The investigators will assess the programs impact on key outcomes immediately after program implementation 6-month and 12-month post program implementation
The TODOS program consists of 11 weekly sessions conducted with girls ages 8-11 and the girls female caregivers Five of the 11 sessions will be taught to small groups of girls and the girls mothers and 6 of the sessions will be taught to individual girlfemale caregivers dyads The choice to use a mix of group- and home-based sessions is based on findings from the formative phase about preference that certain topics be taught in groups and certain topics be taught in individual dyads Each of the sessions group and individual will be 60-90 minutes in duration and delivered by a trained Family Health Coach FHC
The investigators will enroll up to 94 dyads into four cohorts each consisting of 18-26 dyads Dyads will receive either the TODOS program or a control condition The control condition will consist of 3 group sessions delivered monthly for three months The investigators will evaluate the TODOS programs feasibility through process data including attendance forms and session summary feedback forms completed by the FHCs The investigators will assess program acceptability immediately after program completion through implementation assessments completed by caregiver and children participants The investigators will assess the programs impact on key outcomes immediately after program implementation 6-month and 12-month post program implementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None