Substance UseTODOSNCT06276595
Telling Our Daughters Our Story
A study testing Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS) in people with Substance Use and Sexual Behavior, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 years and older, women only
- Conditions the study is for
- Substance Use, Sexual Behavior
- What is being tested?
- Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2019to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female > 18 years of age
- Self-identify as Apache
- Be a caregiver of a girl 8-11 years old who is available to enroll in the study
- Living within 50 miles of the Whiteriver or Fort Apache, Arizona Johns Hopkins program offices
- Willing to complete all implementation and follow-up assessments
- Willing to be randomized
Show all 14Show fewer
- Speaks and reads English
- Female, 8-11 years old
- Have a caregiver enrolled in the study
- Living within 50 miles of the Whiteriver or Fort Apache, Arizona Johns Hopkins program offices
- Willing to be randomized
- Willing to complete all implementation and follow-up assessments
- Speaks and reads English
- Not cognitively or visually impaired (able to complete questionnaires)
Who cannot join
- Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, cognitive impairment, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
White Mountain Apache Center for Indigenous Health
Whiteriver, Arizona, 85941
About this study
Official title: Telling Our Daughters Our Story: Pre-Conception Health Program for American Indian Girls as They Transition to Adulthood
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.
Read the 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 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.
- Conditions
- Substance Use, Sexual Behavior
- Being tested
- Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS), Control condition - 3 Monthly Group Activities in the Community
- Medical subject headings
- Substance-Related Disorders, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS)Behavioural
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.
Control condition - 3 Monthly Group Activities in the CommunityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TODOS Intervention | Experimental | 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. Receives: Behavioral: Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS) |
| Control condition - 3 Monthly Group Activities in the Community | Other | 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. Receives: Behavioral: Control condition - 3 Monthly Group Activities in the Community |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 11 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start30 Mar 2019
- Primary completion22 Mar 2022
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- White Mountain Apache Tribe, Native American Research Center for Health
- Responsible party
- Sponsor
- Investigators
- Mary Barlow, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276595
- Sponsor's protocol ID
- IRB00009466
- Acronym
- TODOS
- Status last verified
- Jul 2025
- First submitted
- 16 Feb 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telling Our Daughters Our Story: Pre-Conception Health Program for American Indian Girls as They Transition to Adulthood
- ClinicalTrials.gov ID
- NCT06276595
- Acronym / sponsor ID
- TODOS / IRB00009466
- Conditions
- Substance Use, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- White Mountain Apache Tribe, Native American Research Center for Health
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TODOS Intervention | Experimental | Behavioral: Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS)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. |
| Control condition - 3 Monthly Group Activities in the Community | Other | Behavioral: Control condition - 3 Monthly Group Activities in the CommunityChildren 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Female > 18 years of age
- Self-identify as Apache
- Be a caregiver of a girl 8-11 years old who is available to enroll in the study
- Living within 50 miles of the Whiteriver or Fort Apache, Arizona Johns Hopkins program offices
- Willing to complete all implementation and follow-up assessments
Key exclusion criteria (1 listed)
- Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, cognitive impairment, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS)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. | Behavioural | TODOS Intervention |
| Control condition - 3 Monthly Group Activities in the CommunityThe 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. | Behavioural | Control condition - 3 Monthly Group Activities in the Community |
Primary outcome
Change in child cultural knowledge score on knowledge assessment
Time frame: Baseline, 11 weeks, 6 months, 12 months
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.
Change in average score on risky behaviors assessment
Time frame: Baseline, 11 weeks, 6 months, 12 months
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.
Change in child reproductive health knowledge via a reproductive health knowledge questionnaire
Time frame: Baseline, 11 weeks, 6 months, 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Barlow, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS) in people with Substance Use and Sexual Behavior, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child cultural knowledge score on knowledge assessment (time frame: Baseline, 11 weeks, 6 months, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.