Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
183 participants
INTERVENTIONAL
2019-03-30
2024-07-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
8 Years
FEMALE
No
Sponsors
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White Mountain Apache Tribe
UNKNOWN
Native American Research Center for Health
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Mary Barlow, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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White Mountain Apache Center for Indigenous Health
Whiteriver, Arizona, United States
Countries
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Other Identifiers
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IRB00009466
Identifier Type: -
Identifier Source: org_study_id
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