An interventional study of Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS) and Control condition - 3 Monthly Group Activities in the Community in Substance Use and Sexual Behavior, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in United States. Open to female participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention
Among 19 studies in Substance-Related Disorders by Johns Hopkins Bloomberg School of Public Health — 6 open to participants now, 6 under way, none of them phase 3. Substance-Related Disorders · Johns Hopkins Bloomberg School of Public Health.
Among the 19 studies in Substance-Related Disorders by Johns Hopkins Bloomberg School of Public Health, this one is the 11th largest by enrollment, is one of 2 that started in 2019, is one of 18 with no phase, and was the 12th registered.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's enrollment of 183 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →6 of the 19 studies in Substance-Related Disorders by Johns Hopkins Bloomberg School of Public Health are open now, in 1 country. Each count lists the studies.
Of the 266 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 118 (44%) stop at 75 or younger; 56 take children under 18; 89 take healthy volunteers.
This study: 8 Years and older · female · no healthy volunteers.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2019.
Median enrollment 188 across the 19 interventional studies. Of the 13 that completed or were terminated, 2 (15%) have results posted.
Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
2 of the studies in Substance-Related Disorders by Johns Hopkins Bloomberg School of Public Health that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05743699Johns Hopkins Bloomberg School of Public HealthAdaptation and Evaluation of Bright Horizons | 2027-01-31 |
| NCT06559774Johns Hopkins Bloomberg School of Public HealthThe Hastiin Bidziil (Strong Man) Intervention | 2027-06 |
Among the 19 studies in Substance-Related Disorders by Johns Hopkins Bloomberg School of Public Health, from their registry updates:
The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female children and the children's 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.
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 girl's female caregivers. Five of the 11 sessions will be taught to small groups of girls and the girl's mothers, and 6 of the sessions will be taught to individual girl/female 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 program's 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 program's impact on key outcomes immediately after program implementation, 6-month and 12-month post program implementation.
Inclusion Criteria for Caregivers:
Inclusion Criteria for Child Participants:
Exclusion Criteria:
Participants in the TODOS Intervention Group will receive the intervention "Nowhi Isdza bit Nadagoldi": Telling Our Daughters Our Story. They will receive 11 intervention sessions of 60-90 minutes over 11 weeks.
Behavioral: Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS)
Children and their female caregivers randomized to the control group will receive 3 group sessions delivered monthly for three months. The first group session will occur at a community center and will consist of a meal and ice breaker activities. The second group session will consist of going to a movie at the local movie theatre. The third group session will consist of going bowling at the local bowling alley.
Behavioral: Control condition - 3 Monthly Group Activities in the Community
The TODOS program consists of 11 weekly sessions conducted with girls ages 8-11 and their female caregivers. Five of the 11 sessions will be taught to small groups, and 6 of the Each of the sessions (group and individual) will be 60-90 minutes in duration and delivered by a trained Family Health Coach (FHC). Group sessions will take place at a local community center in a private room.
The control condition consists of 3 group sessions delivered monthly for three months. The first group session will occur at a community center and will consist of a meal and ice breaker activities. The second group session will consist of going to a movie at the local movie theatre The third group session will consist of going bowling at the local bowling alley.
Change in child cultural knowledge score on knowledge assessment
Using a questionnaire developed by the study team, investigators will measure change in knowledge from baseline to immediately following the intervention and 6 months and 12 months after program completion via a knowledge assessment completed by the child. This is a 4- question assessment that is on a 5-point Likert scale (score: 0-20) A higher score indicates higher (greater) knowledge.
Time frame: Baseline, 11 weeks, 6 months, 12 months
Change in average score on risky behaviors assessment
Using a questionnaire developed by the study team, the investigators will assess the impact of the TODOS program on child attitudes related to risky behaviors via a 6-item assessment on a 5-point Likert scale (score: 0-30). Investigators will measure change in knowledge from baseline to immediately following the intervention and 6 months and 12 months after program completion via a knowledge assessment completed by the child. A higher score indicates better attitudes (less endorsement of) risk behaviors.
Time frame: Baseline, 11 weeks, 6 months, 12 months
Change in child reproductive health knowledge via a reproductive health knowledge questionnaire
Using a questionnaire developed by the study team, investigators will measure change in knowledge from baseline to immediately following the intervention and 6 months and 12 months after program completion via a 3-question knowledge assessment completed by the child (score 0-100). A higher score indicates more knowledge.
Time frame: Baseline, 11 weeks, 6 months, 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2019 to primary completion in Mar 2022, 35 months.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 35 months is close to that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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