Telling Our Daughters Our Story (TODOS)

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.

Study Overview

• Status: Completed
• Conditions: Substance Use; Sexual Behavior
• Intervention / Treatment: Behavioral: Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS); Behavioral: Control condition - 3 Monthly Group Activities in the Community

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 Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Whiteriver, Arizona, United States, 85941
      • White Mountain Apache Center for Indigenous Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for Caregivers:

• 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
• Speaks and reads English

Inclusion Criteria for Child Participants:

• 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)

Exclusion Criteria:

• Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, cognitive impairment, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TODOS Intervention; 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); 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.
Other: Control condition - 3 Monthly Group Activities in the Community; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, 11 weeks, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: White Mountain Apache Tribe; Native American Research Center for Health
• Investigators: Principal Investigator: Mary Barlow, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2019
• Primary Completion (Actual): March 22, 2022
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: IRB00009466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No