Telling Our Daughters Our Story

NCT06276595 | Completed

• 1 other identifier: IRB00009466
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Substance Use; Sexual Behavior

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

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.

Behavioral: Control condition - 3 Monthly Group Activities in the Community

Interventions

Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS) BEHAVIORAL

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.

TODOS Intervention

Control condition - 3 Monthly Group Activities in the Community BEHAVIORAL

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.

Control condition - 3 Monthly Group Activities in the Community

Eligibility Criteria

• Age: 8 Years+
• Gender Eligibility Details: This is a program for female caregivers of female children.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• White Mountain Apache Tribe: collaborator
• Native American Research Center for Health: collaborator

Study Sites (1)

White Mountain Apache Center for Indigenous Health

Whiteriver, Arizona, 85941, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Sexual Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Mary Barlow, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 26, 2024
• Study Start: March 30, 2019
• Primary Completion: March 22, 2022
• Study Completion: July 30, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)