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

NCT04863729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2025-10-02

No results posted yet for this study

Summary

The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female adolescents and their female caregivers. Specifically, investigators aim to evaluate the impact of "Asdzaan Be'eena'" or Female Pathways in English (henceforth referred to as AB) on risk and protective factors for early substance use and sexual debut through a randomized controlled trial (RCT) in partnership with the Navajo Nation. The program was developed and pilot tested through an extensive formative phase conducted by our tribal-academic partnership (IRB protocols: #00006569 and #00009117). Investigators will examine the efficacy of the AB program for reducing risk factors and improving protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use.

Conditions

  • Sex Behavior

Interventions

BEHAVIORAL

Asdzaan Be'eena Program

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). Each of the sessions (group and individual) will be 60-90 minutes in duration and delivered by a trained Family Health Coach (FHC). Group sessions will take place at a local community center in a private room. Individual dyad sessions will take place in the girls'/female caregivers' home or another private place of their choosing, such as our local Johns Hopkins offices.

Sponsors & Collaborators

  • Children's Bureau - Administration for Children and Families

    collaborator OTHER
  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Lauren Tingey, PhD · Johns Hopkins Bloomberg School of Public Health

  • Jennifer Richards, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2025-09-29
Completion
2025-09-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04863729 on ClinicalTrials.gov