Clinical trial NCT06276595: Telling Our Daughters Our Story
Official title: Telling Our Daughters Our Story: Pre-Conception Health Program for American Indian Girls as They Transition to Adulthood
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use
Sexual Behavior
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: White Mountain Apache Tribe
name: Native American Research Center for Health
First posted: 2024-02-26
Enrollment: 183
Sex: FEMALE
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Change in child cultural knowledge score on knowledge assessment
timeFrame: Baseline, 11 weeks, 6 months, 12 months
measure: Change in average score on risky behaviors assessment
timeFrame: Baseline, 11 weeks, 6 months, 12 months
measure: Change in child reproductive health knowledge via a reproductive health knowledge questionnaire
timeFrame: Baseline, 11 weeks, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: White Mountain Apache Center for Indigenous Health
state: Arizona
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Mary Barlow, PhD
role: PRINCIPAL_INVESTIGATOR
References: