Female Pathways Program for Substance Use Prevention in Native American Youth

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

820 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called 'Asdzaan Be'eena: Female Pathways' (AB) for AI girls aged 10-14 and their caregivers. The program aims to prevent early substance use and teen pregnancy by enhancing self-esteem and cultural identity through regular sessions. It addresses specific health issues faced by AI communities.

Will I have to stop taking my current medications?

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

Is the Female Pathways Program for Substance Use Prevention in Native American Youth safe?

The Asdzáán Be'eená program, also known as the Female Pathways Program, was tested with Navajo families and showed positive effects on self-esteem, family communication, and cultural engagement without any reported safety concerns. ^{1 2 3 4 5}

How is the Asdzaan Be'eena Program treatment unique for substance use prevention in Native American youth?

The Asdzaan Be'eena Program is unique because it is an intergenerational, culturally grounded program specifically designed for Navajo girls and their female caregivers, focusing on strengthening cultural connections and improving protective factors like self-esteem and parent-child relationships to prevent substance use and teen pregnancy. ^{1 2 3 6 7}

What data supports the effectiveness of the Asdzaan Be'eena treatment for substance use prevention in Native American youth?

The Asdzáán Be'eená program showed promising results in improving self-esteem, parent-child relationships, and cultural engagement among Navajo girls and their caregivers, which are important factors in preventing substance use. Additionally, similar programs that incorporate cultural elements have been effective in reducing substance use among Native American youth. ^{1 2 3 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. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

American Indian substance use: the hazards for substance use initiation and progression for adolescents aged 14 to 20 years. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Cultural Protection from Polysubstance Use Among Native American Adolescents and Young Adults. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Impacts of the respecting the circle of life teen pregnancy prevention program on risk and protective factors for early substance use among native American youth. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Integrating Motivational Interviewing and Traditional Practices to Address Alcohol and Drug Use Among Urban American Indian/Alaska Native Youth. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A preliminary needs assessment of American Indians who inject drugs in northeastern Montana. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

The development and pandemic-related adaptation of a resilience program for native middle-school youth: A case study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Is culturally based prevention effective? Results from a 3-year tribal substance use prevention program. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Substance Use Prevention for Urban American Indian Youth: A Efficacy Trial of the Culturally Adapted Living in 2 Worlds Program. [2022]