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Behavioral Intervention

Female Pathways Program for Substance Use Prevention in Native American Youth

Q: What are the expected outcomes of this experiment?

The objectives of this trial are to evaluate the impact of parental responsiveness, sexual activity in the past three months, caregiver parenting self-efficacy and cultural connectedness over a baseline period as well as 6 and 12 Months post implementation. The results will be reported according to proportions for negative outcomes, with higher numbers indicating more severe cases; Likert scales from 0 to 4 for positive outcomes, where 4 is better; and four-point Likert Scales from 1 to 4 for youth culture connectivity assessments - again with four being superior.

Q: Are there any vacancies available to individuals who wish to participate in this trial?

This clinical trial is presently recruiting patients, as relayed on the website for clinicaltrials.gov. This research project was initially posted to the site on May 20th 2021 and had its most recent update take place September 27th 2022.

Q: What criteria must be met to qualify for participation in this trial?

The research team are seeking 820 indigenous Navajo females who meet the following criteria: aged over 18, a caregiver of an eligible female between 10 and 14 years old, willing to comply with <a href="https://www.withpower.com/clinical-trials/all">all</a> assessments, ready for randomisation and not limited by cognitive or vision impairments.

Q: Is this medical experiment open to those over the age of seventy?

This trial is geared towards children aged 10 to 14, and there are a total of 80 studies for individuals below the age of 18 as well as 255 for adults over 65.

Q: What is the participant pool for this clinical examination?

Correct. According to the clinicaltrials.gov records, this research endeavor which was initially posted on May 20th 2021 is currently recruiting participants. The total number of individuals needed for enrollment stands at 820 and will be sourced from two locations.

N/A

Recruiting

Led By Jennifer Richards, 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

Study Summary

This trial will test a culturally grounded program called "Asdzaan Be'eena'" or Female Pathways in English (AB) to see if it can reduce risk and improve protective factors for early substance use and sexual debut among American Indian female adolescents and their female caregivers.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in caregiver cultural connectedness

Change in caregiver parenting agency

Change in caregiver parenting self-efficacy

+10 more

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

Find a Location

Who is running the clinical trial?

Children's Bureau - Administration for Children and FamiliesOTHER

22 Previous Clinical Trials

39,609 Total Patients Enrolled

Johns Hopkins Bloomberg School of Public HealthLead Sponsor

410 Previous Clinical Trials

2,106,110 Total Patients Enrolled

1 Trials studying Sexual Activity

65 Patients Enrolled for Sexual Activity

Jennifer Richards, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health

Media Library

Asdzaan Be'eena Program (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04863729 — N/A

Sexual Activity Research Study Groups: Control, Intervention

Sexual Activity Clinical Trial 2023: Asdzaan Be'eena Program Highlights & Side Effects. Trial Name: NCT04863729 — N/A

Asdzaan Be'eena Program (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04863729 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the expected outcomes of this experiment?

"The objectives of this trial are to evaluate the impact of parental responsiveness, sexual activity in the past three months, caregiver parenting self-efficacy and cultural connectedness over a baseline period as well as 6 and 12 Months post implementation. The results will be reported according to proportions for negative outcomes, with higher numbers indicating more severe cases; Likert scales from 0 to 4 for positive outcomes, where 4 is better; and four-point Likert Scales from 1 to 4 for youth culture connectivity assessments - again with four being superior."

Answered by AI

Are there any vacancies available to individuals who wish to participate in this trial?

"This clinical trial is presently recruiting patients, as relayed on the website for clinicaltrials.gov. This research project was initially posted to the site on May 20th 2021 and had its most recent update take place September 27th 2022."

Answered by AI

What criteria must be met to qualify for participation in this trial?

"The research team are seeking 820 indigenous Navajo females who meet the following criteria: aged over 18, a caregiver of an eligible female between 10 and 14 years old, willing to comply with all assessments, ready for randomisation and not limited by cognitive or vision impairments."

Answered by AI

Is this medical experiment open to those over the age of seventy?

"This trial is geared towards children aged 10 to 14, and there are a total of 80 studies for individuals below the age of 18 as well as 255 for adults over 65."

Answered by AI

What is the participant pool for this clinical examination?

"Correct. According to the clinicaltrials.gov records, this research endeavor which was initially posted on May 20th 2021 is currently recruiting participants. The total number of individuals needed for enrollment stands at 820 and will be sourced from two locations."

Answered by AI

Recent research and studies

BMC Public HealthJournal

Rigorous Evaluation of a Substance Use and Teen Pregnancy Prevention Program for American Indian Girls and Their Female Caregivers: A Study Protocol for a Randomized Controlled Trial

Chambers, Rachel A., Jaime Begay, Hima Patel, Jennifer Richards, Danielle Nelson, Summer Rosenstock, Ronni Huskon, Kristin Mitchell, Tiffani Begay, and Lauren Tingey. 2021. “Rigorous Evaluation of a Substance Use and Teen Pregnancy Prevention Program for American Indian Girls and Their Female Caregivers: A Study Protocol for a Randomized Controlled Trial”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-021-11131-x.

clinicaltrials.govStudy

Evaluation of Asdzáán Be'eená Teen Pregnancy and Substance Use Prevention Program for Native American Youth and Their Caregiver

2021. "Evaluation of Asdzáán Be'eená Teen Pregnancy and Substance Use Prevention Program for Native American Youth and Their Caregiver". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04863729.

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