CompletedNot Applicable

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

United States408 participantsStarted 2021-05-20

Plain-language 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.

Who can participate

Age range10 Years – 14 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (Caregivers): * Female \> 18 years of age * Self-identify as Navajo * Be a caregiver of a girl 10-14 years old who is available to enroll in the study * Living within 50 miles of the Chinle, Arizona or Tuba City, Arizona Johns Hopkins program offices * Willing to complete all assessments * Willing to be randomized * Speaks and reads English * Not cognitively or visually impaired (able to complete assessments) * Review and sign informed consent Inclusion Criteria (Youth) * Female, 10-14 years old * Have a caregiver enrolled in the study * Living within 50 miles of the Chinle, Arizona or Tuba City, Arizona Johns Hopkins program offices * Willing to be randomized * Willing to complete all assessments * Speaks and reads English * Not cognitively or visually impaired (able to complete assessments) * Review and sign a study assent and have a parent/guardian sign parental permission Exclusion Criteria: \-

What they're measuring

Change in youth reported parent-youth communication scale

Timeframe: Baseline, 6- and 12-months post implementation

Change in parent reported parent-youth communication scale

Timeframe: Baseline, 6- and 12-months post implementation

Change in youth reported monitoring

Timeframe: Baseline, 6- and 12-months post implementation

Change in parent reported monitoring

Timeframe: Baseline, 6- and 12-months post implementation

Change in youth reported parental responsiveness

Timeframe: Baseline, 6- and 12-months post implementation

Change in parent reported parental responsiveness

Timeframe: Baseline, 6- and 12-months post implementation

Change in proportion of youth who state they plan to delay having sexual intercourse until they graduate from high school

Timeframe: Baseline, 6- and 12-months post implementation

Trial details

NCT IDNCT04863729

SponsorJohns Hopkins Bloomberg School of Public Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-29

View on ClinicalTrials.gov More Sex Behavior trials

Plain-language summary

Who can participate

Age range10 Years – 14 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in youth reported parent-youth communication scale

Timeframe: Baseline, 6- and 12-months post implementation

Change in parent reported parent-youth communication scale

Timeframe: Baseline, 6- and 12-months post implementation

Change in youth reported monitoring

Timeframe: Baseline, 6- and 12-months post implementation

Change in parent reported monitoring

Timeframe: Baseline, 6- and 12-months post implementation

Change in youth reported parental responsiveness

Timeframe: Baseline, 6- and 12-months post implementation

Change in parent reported parental responsiveness

Timeframe: Baseline, 6- and 12-months post implementation

Change in proportion of youth who state they plan to delay having sexual intercourse until they graduate from high school

Timeframe: Baseline, 6- and 12-months post implementation