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

NCT04863729 | Completed

• 1 other identifier: IRB00014736
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Primary prevention; Teen pregnancy prevention; Substance use prevention; Parent-child intervention

Outcome Measures

Primary Outcomes (9)

• Change in youth reported parent-youth communication scale

  Investigators will measure change in youth reported parent-youth communication from baseline and 6- and 12- months post program completion via 9-item communication assessment (5-point Likert scale \[0-Never; 4- Everyday). A higher score indicates a better outcome.

  Baseline, 6- and 12-months post implementation

• Change in parent reported parent-youth communication scale

  Investigators will measure change in parent reported parent-youth communication from baseline and 6- and 12- months post program completion via an 8-item communication assessment (5-point Likert scale \[0-Never; 4- Everyday). A higher score indicates a better outcome.

  Baseline, 6- and 12-months post implementation

• Change in youth reported monitoring

  Investigators will measure change in youth reported monitoring from baseline and 6- and 12- months post program completion via a 5-item parental monitoring assessment (5-point Likert scale \[0-Never; 4- Everyday). A higher score indicates a better outcome.

  Baseline, 6- and 12-months post implementation

• Change in parent reported monitoring

  Investigators will measure change in parent reported monitoring from baseline and 6- and 12- months post program completion via a 9-item parental monitoring assessment (5-point Likert scale \[0-Never; 4- Everyday). A higher score indicates a better outcome.

  Baseline, 6- and 12-months post implementation

• Change in youth reported parental responsiveness

  Investigators will measure change in youth reported parental responsiveness from baseline and 6- and 12- months post program completion via a 5-item authoritative parenting index (4-point Likert scale \[0-Not at all like her; 3- Just Like her). A higher score indicates a better outcome.

  Baseline, 6- and 12-months post implementation

• Change in parent reported parental responsiveness

  Investigators will measure change in parent reported parental responsiveness from baseline and 6- and 12- months post program completion via a 5-item authoritative parenting index (4-point Likert scale \[0-Not at all like her; 3- Just Like her). A higher score indicates a better outcome.

  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

  Change in proportion of youth who report they intend to delay sexual intercourse until they graduate from high school between individuals randomized to the AB program vs. those randomized to the control condition. Proportions will be measured from baseline to 6- and 12-months post program completion via one question. This is completed by the child (0-No; 1-Yes). A higher proportion indicates more youth intend to abstain from sex.

  Baseline, 6- and 12-months post implementation

• Change in proportion of youth who state they plan to engage in sexual intercourse while they are a teenager

  Investigators will measure change in proportion of youth who report they intend to have sexual intercourse when they are a teenager between individuals randomized to the AB program vs. those randomized to the control condition. Proportions will be measured from baseline to 6- and 12-months post program completion via one question. This is completed by the child (0-No; 1- Yes). A higher proportion indicates more youth intend to have sex when they are a teenager. A higher proportion indicates a worse outcome.

  Baseline, 6- and 12-months post implementation

• Change in mean score on externalizing and internalizing behaviors

  Investigators will measure change in internalizing and externalizing behaviors between individuals randomized to the AB program vs. those randomized to the control condition. Change in internalizing/externalizing behaviors will be measured via the Achenbach System of Empirically Based Assessment (ASEBA) completed by the caregiver (reporting on child behaviors) (3-point Likert Scale \[0-not true; 2-very true\]). A higher score across these variables indicates a worse outcome (i.e. higher (more) internalizing and externalizing behaviors).

  Baseline, 6- and 12-months post implementation

Secondary Outcomes (13)

• Change in caregiver parenting self-efficacy

  Baseline, 6- and 12-months post implementation

• Change in caregiver parenting agency

  Baseline and 6- and 12-months post implementation

• Change in mean score on healthy relationship skills

  Baseline, 6- and 12-months post implementation

• Change in in youth future aspirations

  Baseline, 6- and 12-months post implementation

• Change in youth cultural connectedness

  Baseline, 6- and 12-months post implementation

Study Arms (2)

Intervention

EXPERIMENTAL

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).

Behavioral: Asdzaan Be'eena Program

Control

NO 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

Interventions

Asdzaan Be'eena Program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Children's Bureau - Administration for Children and Families: collaborator

Study Sites (2)

Center for American Indian Health - Chinle

Chinle, Arizona, 86503, United States

Location

Center for American Indian Health - Tuba City

Tuba City, Arizona, 86045, United States

Location

Related Publications (1)

• Chambers RA, Begay J, Patel H, Richards J, Nelson D, Rosenstock S, Huskon R, Mitchell K, Begay T, Tingey L. 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. 2021 Jun 21;21(1):1179. doi: 10.1186/s12889-021-11131-x.

  PMID: 34154552 DERIVED

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lauren Tingey, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Jennifer Richards, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 28, 2021
• Study Start: May 20, 2021
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

US (2)