What is the mechanism of action of this treatment?

The Asdzaan Be'eena' program uses culturally tailored education and support to modify risk and protective factors related to early substance use and sexual debut. Common treatments for sexual activity that align with this approach include sex education, attitude restructuring, and behavioral interventions. These treatments work by providing knowledge, reshaping attitudes towards sexual health, and promoting healthy behaviors. This matters for patients because it empowers them with the information and skills needed to make informed decisions, reduce risky behaviors, and enhance protective factors, ultimately leading to improved sexual health outcomes.

What side effects are associated with this type of intervention?

Common treatments for sexual activity issues, such as those involving pharmacological and psychosocial interventions, can have various side effects. Pharmacological treatments like antiviral suppression therapies for genital herpes may cause mild to moderate side effects such as headaches, nausea, and fatigue. Psychosocial interventions, including self-hypnosis and psychological support, generally have fewer physical side effects but may involve emotional discomfort as individuals confront and work through personal issues. In culturally tailored education and support programs like Asdzaan Be'eena', the focus is on modifying risk and protective factors, which typically have minimal physical side effects but require active participation and engagement, which can be emotionally challenging.

What prior FDA approvals exist?

The FDA has not specifically approved culturally tailored educational and support programs like Asdzaan Be'eena' for the treatment of sexual activity. However, there are various behavioral and educational interventions that are widely recognized and utilized to address sexual health and modify risk factors. These interventions often include comprehensive sex education, counseling, and support services aimed at reducing risky behaviors and promoting healthy sexual practices. While these programs may not require FDA approval, they are supported by public health organizations and have been shown to be effective in various populations.

What other types of research exist?

Promising alternatives to Asdzaan Be'eena' for sexual health education and support include the 'EBAN café' intervention, which provides couples with a menu of safer sex behaviors and emphasizes sexual communication and cultural relevance. Additionally, comprehensive sexual health programs that incorporate cognitive-behavioral strategies and culturally tailored content, similar to those used in HIV-serodiscordant African American couples, may also be effective.

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Behavioral Intervention

Female Pathways Program for Substance Use Prevention in Native American Youth

N/A

Waitlist Available

Led By Lauren Tingey, PhD

Research Sponsored by Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not cognitively or visually impaired (able to complete assessments)

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6- and 12-months post implementation

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention is an educational program rather than a medical treatment, there are no direct physical side effects expected from participating in the Asdzaan Be'eena program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6- and 12-months post implementation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6- and 12-months post implementation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6- and 12-months post implementation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mean score on externalizing and internalizing behaviors

Change in parent reported monitoring

Change in parent reported parent-youth communication scale

+6 more

Secondary study objectives

Change in caregiver cultural connectedness

Change in caregiver parenting agency

Change in caregiver parenting self-efficacy

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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: ControlActive Control1 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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Asdzaan Be'eena' program uses culturally tailored education and support to modify risk and protective factors related to early substance use and sexual debut. Common treatments for sexual activity that align with this approach include sex education, attitude restructuring, and behavioral interventions. These treatments work by providing knowledge, reshaping attitudes towards sexual health, and promoting healthy behaviors. This matters for patients because it empowers them with the information and skills needed to make informed decisions, reduce risky behaviors, and enhance protective factors, ultimately leading to improved sexual health outcomes.

Treatment for premature ejaculation through male-only groups.Group vs. couple treatment of sexual dysfunctions.The stepwise development of an interactive web-based sex education programme for subfertile couples: the Pleasure & Pregnancy programme.