Female Pathways Program for Substance Use Prevention in Native American Youth

No longer recruiting at 1 trial location

Overseen By Lauren Tingey, PhD

Age: < 18

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a culturally grounded program called Asdzaan Be'eena, designed for Native American girls and their female caregivers. The research focuses on reducing risk factors associated with early substance use and sexual activity. Participants will either join a control group receiving small incentives or a group participating in 11 weekly sessions covering topics like Navajo history and family values. Girls aged 10-14 who self-identify as Navajo and live near Chinle or Tuba City, Arizona, along with their female caregivers, may be a good fit for this study.

As an unphased trial, this study offers a unique opportunity to contribute to culturally relevant research that could benefit the community.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Asdzaan Be'eena Program is safe for Native American youth?

Research has shown that the Asdzaan Be'eena Program is promising in preventing early substance use and teen pregnancy among Native American youth. The program emphasizes cultural values and strengthens the bond between girls and their caregivers. Several studies have tested it.

These studies examined the program's integration into the community and participants' perceptions of its usefulness. Results suggest that participants feel comfortable with the program. No serious safety issues have been reported, indicating its safety.

The trial phase is "Not Applicable," meaning there are no standard safety phases like in drug trials. However, early evaluations have shown no negative effects, supporting its safety for community use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Asdzaan Be'eena Program is unique because it combines both group and individual sessions specifically tailored for Native American girls and their female caregivers. Unlike standard substance use prevention programs that might not consider cultural nuances, this program integrates cultural elements like Navajo history and family values, making it more relatable and impactful for participants. Researchers are excited about this program because it targets both community and family dynamics, which are crucial for effective prevention in this demographic. This culturally tailored approach has the potential to address the root causes of substance use more effectively than general prevention programs.

What evidence suggests that the Asdzaan Be'eena Program is effective for substance use prevention in Native American youth?

Research shows that the Asdzaan Be'eena Program (AB), which participants in this trial may receive, may help reduce early substance use and early sexual activity among Native American youth. Studies have found that programs like AB, which incorporate community values and history, can be more effective. For example, another program for Native American youth successfully reduced substance use by focusing on cultural teachings and community involvement. Early results suggest that AB's combination of group and individual sessions on cultural topics could lead to positive outcomes. By boosting protective factors and reducing risky behaviors, AB aims to address these important issues effectively. ^{2 6 7 8 9}

Who Is on the Research Team?

Lauren Tingey, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Jennifer Richards, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for Navajo female adolescents and their caregivers living within 50 miles of Chinle or Tuba City, Arizona. Participants must speak English, be willing to complete assessments and be randomized. Caregivers should have a girl aged 10-14 years old to enroll with them in the study.

Inclusion Criteria

You agree to complete all required evaluations.

You can understand and communicate in English.

I can see well and think clearly enough to complete tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The Asdzaan Be'eena: Female Pathways program consists of 11 weekly sessions conducted with girls ages 10-14 and their female caregivers. Sessions include both group and individual dyad formats.

11 weeks

11 visits (in-person)

Follow-up

Participants are monitored for changes in various outcomes such as parental responsiveness, youth aspirations, and substance use initiation at 6 and 12 months post-program completion.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Asdzaan Be'eena Program

Trial Overview The 'Asdzaan Be'eena' program (Female Pathways) is being tested for its effectiveness in reducing early substance use and sexual activity among Native American youth. This research involves a randomized controlled trial to see if it can lower teen pregnancy and substance abuse risks.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The program consists of 11 weekly sessions conducted with girls ages 10-14 and their female caregivers. 5 of the 11 sessions will be taught to groups of 9-13 girls and their female caregivers, and 6 of the sessions will be taught to individual girl/female caregiver dyads. The choice to use a mix of group- and individual sessions is based on findings from the formative phase indicating certain topics should be taught in groups (e.g. Navajo history and reproductive health 101), and certain topics be taught in individual dyads (e.g. family values and the clan system).

Group II: Control Active Control 1 Intervention

Girls and their female caregivers randomized to the control group will receive 4 retention incentives that are mailed to them monthly. These incentives will each be \<$10 per dyad, examples include: water bottles, lanyards, pencil cases and tote bags. The control condition was selected by community members and allows for minimal contamination and/or overlap between the AB curriculum and control group

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Children's Bureau - Administration for Children and Families

Collaborator

Trials

23

Recruited

40,900+

Published Research Related to This Trial

The Asdzáán Be'eená program, designed for Navajo girls aged 8 to 11 and their caregivers, showed promising results in increasing self-esteem, self-efficacy, and cultural knowledge, as well as improving parent-child relationships and communication after 3 months.

Caregivers also reported enhanced family engagement in Navajo culture and better child functioning, indicating that the program may effectively reduce risk factors for substance use and teen pregnancy in Native communities, although further rigorous studies are needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Impact of Asdzáán Be'eená: An Intergenerational, Strength-Based, and Culturally Grounded Program to Improve the Health of Navajo Families. Chambers, RA., Patel, H., Richards, J., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04863729

Evaluation of Asdzáán Be'eená Teen Pregnancy and ... FDAAA 801 Violations. A FDAAA 801 Violation is shown on a study record when the U.S. Food and Drug Administration (FDA) has issued a Notice of Noncompliance ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8218410/

Rigorous evaluation of a substance use and teen pregnancy ... It follows that Native adolescents have higher rate of substance use and abuse. Compared to all U.S. adolescents, in 2018, Native adolescents ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27943031/

Substance Use Prevention for Urban American Indian Youth This article describes a small efficacy trial of the Living in 2 Worlds (L2W) substance use prevention curriculum, a culturally adapted version of keepin' it ...

4. coloradosph.cuanschutz.edu coloradosph.cuanschutz.edu/docs/librariesprovider205/journal_files/vol31/31_1_2024_50_hunter.pdf?sfvrsn=64afd8bb_1

AIANMHR, Vol. 31, Issue No. 1, 2024 - Hunter et al. According to the National Institute of Drug Abuse survey from 2009-2012, lifetime prevalence for disordered use of alcohol is 39%, marijuana is ...

5. ojp.gov ojp.gov/ncjrs/virtual-library/abstracts/preventing-substance-use-among-native-american-youth-three-year

Preventing Substance Use Among Native American Youth This study developed and tested skills- and community-based approaches to prevent substance abuse among Native American youth. Abstract. After completing ...

6. trialx.com trialx.com/clinical-trials/listings/253916/evaluation-of-asdzaan-beeena-teen-pregnancy-and-substance-use-prevention-program-for-native-american-youth-and-their-caregiver/

Evaluation of Asdzáán Be'eená Teen Pregnancy and ... The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female adolescents and their female caregivers.

7. cps.ca cps.ca/uploads/imich/March_25_D1_Jaime_Begay2-OK.pdf

Evaluation of Asdzáán Be'eena' Teen Pregnancy and ... What is the Asdzaan Be'eena'. (Female Pathways) Program? A program for Native girls ages 10-. 14 and their female caregiver(s) that is grounded in the strengths.

8. researchgate.net researchgate.net/publication/352542377_Feasibility_Acceptability_and_Preliminary_Impact_of_Asdzaan_Be'eena_An_Intergenerational_Strength-Based_and_Culturally_Grounded_Program_to_Improve_the_Health_of_Navajo_Families

Feasibility, Acceptability, and Preliminary Impact of ... The overarching goal of the program is to reduce substance use and teen pregnancy by improving caregiver-youth relationships, promoting pride in ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10890292/

Preventing substance use among Native American youth This study developed and tested skills- and community-based approaches to prevent substance abuse among Native American youth.