Sex BehaviorNCT04863729
Evaluation of Asdzáán Be'eená Teen Pregnancy and Substance Use Prevention Program for Native American Youth and Their Caregiver
A study testing Asdzaan Be'eena Program in people with Sex Behavior, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sex Behavior
- What is being tested?
- Asdzaan Be'eena Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2021to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 17Show fewer
- 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
- Not cognitively or visually impaired (able to complete assessments)
- Review and sign a study assent and have a parent/guardian sign parental permission
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for American Indian Health - Chinle
Chinle, Arizona, 86503
Center for American Indian Health - Tuba City
Tuba City, Arizona, 86045
About this study
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.
Read the detailed description
American Indian/Alaska Native(AI/AN) communities contend with high rates of poverty and unemployment, as well as historical trauma and adverse events resulting in poor health outcomes and health disparities across their life course. AI youth adolescents are particularly impacted by these health disparities. They are more likely to be sexually active, have their first sexual intercourse at a young age and have higher rates of teen pregnancy and repeat teen pregnancy than other racial/ethnic groups. In 2016, the birth rate for AI/AN teen girls (age 15-19) was 35 per 1,000, well above the national birth rate of 20.3 per 1,000.
Teen pregnancy may lead to lower educational attainment and is associated with a lower annual income for the mother. Nationally, only about 63% of teen mothers obtain a high school diploma and just 2% earn a college degree. Furthermore, studies have found that decades after becoming a parent, teen mothers have lower annual incomes than women who wait to become mothers. The consequences of teen pregnancy continue generations later. Babies born as result of a teen pregnancy are more likely to be premature and of low birth weight, raising their risk for other health problems including blindness, deafness, chronic respiratory problems, mental illness and mental retardation. Children of teen parents are more likely to live in poverty, drop out of high school and themselves become teen parents. The poverty rate for children born to teenage mothers who never married and who did not graduate from high school is 78% (compared to 9% of children born to women over age 20 who are currently married and did graduate from high school).
Compounding teen pregnancy, AI/ANs have the highest substance use and related morbidity and mortality of any U.S. racial group and are more likely to initiate drug and alcohol use before the age of 13. In AI communities, girls and boys have distinct patterns and processes for underage substance use that leads to early initiation of sex and sexual risk-taking. Among AIs, girls are more likely than boys to use substances during adolescence due to poor self-esteem or self-identity. Girls are also more likely than boys to be offered substances in private settings by female relatives. Additionally, poor attachment to parents is a stronger risk factor for substance use among girls than boys. Thus, gender-specific approaches are needed for optimal prevention of adolescent substance use in AI communities.
An intervention that works with AI females together with their female caregivers and incorporates AI cultural strengths and traditions, while also helping girls grow their ethnic identity and self-esteem may prove efficacious in preventing teen pregnancy, reducing early initiation of substance use and progression to misuse, and improving the health and well being of AI girls and families. The Navajo Nation and Johns Hopkins (JHU) have a long-standing history of addressing AI health disparities through culturally tailored and community-engaged programming and are poised to conduct the RCT described herein.
Investigators will evaluate the intervention: "Asdzaan Be'eena: Female Pathways" (AB). The program consists of 11 weekly sessions conducted with girls ages 10-14 and their female caregivers. Five 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. Transportation to the group sessions will be provided upon request. The program will be conducted over 2.5-3 months with one session occurring every week for 11 weeks. The total program duration is 660-990 minutes. The control condition was selected by community members and allows for minimal contamination and/or overlap between the AB curriculum and control group
- Conditions
- Sex Behavior
- Being tested
- Asdzaan Be'eena Program
- Keywords
- Primary prevention, Teen pregnancy prevention, Substance use prevention, Parent-child intervention
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asdzaan Be'eena ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 6- and 12-months post implementation
Secondary outcomes (13)
Change in caregiver parenting self-efficacy
Investigators will measure change in caregiver parenting self-efficacy from baseline and 6- and 12- months post program completion via a 10-item parenting self-efficacy questionnaire (5-point Likert scale [0-Never; 4-Always]). A higher score indicates a better outcome.
Measured: Baseline, 6- and 12-months post implementation
Change in caregiver parenting agency
Investigators will measure change in caregiver parenting agency from baseline and 6- and 12- months post program completion via a 10-item parenting self-agency questionnaire (5-point Likert scale [0-Never; 4-Always]). A higher score indicates a better outcome.
Measured: Baseline and 6- and 12-months post implementation
Change in mean score on healthy relationship skills
Investigators will measure change in healthy relationship skills between individuals randomized to the AB program vs. those randomized to the control condition. This outcome measures will be assessed from baseline to 6- and 12-months post program completion via the Five Domains of Interpersonal Competence in Peer Relationships, a 7-item questionnaire (0-I'm not good at this; 4-I'm really good at this). A higher score indicates a better outcome.
Measured: Baseline, 6- and 12-months post implementation
Change in in youth future aspirations
Investigators will measure change in youth future aspirations between individuals randomized to the AB program vs. those randomized to the control condition. This outcome measure will be assessed from baseline to 6- and 12-months post-program completion via the Youth Assets Survey (4-point Likert Scale [0-not at all important; 4-somewhat important]). A higher score indicates a better outcome.
Measured: Baseline, 6- and 12-months post implementation
Change in youth cultural connectedness
Change in youth cultural connectedness at 6- and 12-month follow-up between individuals randomized to the AB program vs. those randomized to the control condition. Youth will be assessed on a 7-item scale (4-point Likert Scale [1-strongly disagree; 4-strongly agree]). A higher score indicates a better outcome Time Frame: Baseline, 6- and 12 months post implementation
Measured: Baseline, 6- and 12-months post implementation
Change in caregiver cultural connectedness
Change in caregiver cultural connectedness at 6- and 12-month follow-up between individuals randomized to the AB program vs. those randomized to the control condition. Caregivers will be assessed on an 8-item scale (4-point Likert Scale [1-strongly disagree; 4-strongly agree]). A higher score indicates a better outcome
Measured: Baseline and 6- and 12-months post implementation
Change in youth sexual initiation
Study investigators will compare youth sexual initiation between youth randomized to the AB program vs. those randomized to the control condition. This outcome will be assessed via one question (0-No; 1-Yes). The outcome measure will be reported as a proportion. A higher proportion indicates more youth have had sex.
Measured: Baseline, 6- and 12-months post implementation
Change in proportion on youth substance use initiation
Investigators will measure change in proportion of youth who report they have ever used alcohol, marijuana or other illegal drugs between youth randomized to the AB program vs. those randomized to the control condition. This outcome measure will be assessed from baseline to 6- and 12-months post program completion via one question (0-No; 1- Yes). This is completed by the child. A higher proportion indicates more youth have ever used a substance.
Measured: Baseline, 6- and 12-months post implementation
Change in sexual activity, past 3 months
Change in youth sexual activity, past 3 months at 6 and 12-month follow-up will be compared between individuals randomized to the AB program vs. those randomized to the control condition. This outcome measure will be reported as a proportion. A higher proportion indicates a negative outcome.
Measured: Baseline and 6- and 12-months post implementation
Change in youth reported substance use, past 3 months
Change in youth substance use, past 3 months at 6 and 12-month follow-up, will be compared between individuals randomized to the AB program vs. those randomized to the control condition. This outcome measure will be reported as a proportion. A higher proportion indicates a negative outcome.
Measured: Baseline and 6- and 12-months post implementation
Change in family environment and functioning
Change in family environment and functioning will be compared between youth/caregivers randomized to the AB program vs. those randomized to the control condition. This outcome measure will be assessed using the Family Environment Scale (true=1/false=0). The scale ranges from 0 - 27. A higher score indicates a better outcome.
Measured: Baseline and 6- and 12-months post implementation
Change in parental attitudes and expectations related to substance use and sexual intercourse
Investigators will measure change in parental attitudes and expectations related to substance use and sexual intercourse between those randomized to the AB program vs. those randomized to the control condition. This outcome measure will be assessed from baseline to 6- and 12-months post program completion via a 6-item assessment (5-point Likert scale [0-strongly disagree; 4-strongly agree]) completed by caregivers. A higher score indicates a better outcome.
Measured: Baseline and 6- and 12-months post implementation
Change in proportion of caregivers reporting substance use in the past 3 months
Change in caregiver substance use in the past 3 months at 6- and 12-month follow-up will be compared between individuals randomized to the AB program vs. those randomized to the control condition.
Measured: Baseline and 6- and 12-months post implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start20 May 2021
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sex BehaviorStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families
- Responsible party
- Sponsor
- Investigators
- Lauren Tingey, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthJennifer Richards, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863729
- Sponsor's protocol ID
- IRB00014736
- Status last verified
- Oct 2025
- First submitted
- 13 Apr 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34154552
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Asdzáán Be'eená Teen Pregnancy and Substance Use Prevention Program for Native American Youth and Their Caregiver
- ClinicalTrials.gov ID
- NCT04863729
- Acronym / sponsor ID
- IRB00014736
- Conditions
- Sex Behavior
- Keywords
- Primary prevention, Teen pregnancy prevention, Substance use prevention, Parent-child intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families
- Study start
- 20 May 2021 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
American Indian/Alaska Native(AI/AN) communities contend with high rates of poverty and unemployment, as well as historical trauma and adverse events resulting in poor health outcomes and health disparities across their life course. AI youth adolescents are particularly impacted by these health disparities. They are more likely to be sexually active, have their first sexual intercourse at a young age and have higher rates of teen pregnancy and repeat teen pregnancy than other racial/ethnic groups. In 2016, the birth rate for AI/AN teen girls (age 15-19) was 35 per 1,000, well above the national birth rate of 20.3 per 1,000.
Teen pregnancy may lead to lower educational attainment and is associated with a lower annual income for the mother. Nationally, only about 63% of teen mothers obtain a high school diploma and just 2% earn a college degree. Furthermore, studies have found that decades after becoming a parent, teen mothers have lower annual incomes than women who wait to become mothers. The consequences of teen pregnancy continue generations later. Babies born as result of a teen pregnancy are more likely to be premature and of low birth weight, raising their risk for other health problems including blindness, deafness, chronic respiratory problems, mental illness and mental retardation. Children of teen parents are more likely to live in poverty, drop out of high school and themselves become teen parents. The poverty rate for children born to teenage mothers who never married and who did not graduate from high school is 78% (compared to 9% of children born to women over age 20 who are currently married and did graduate from high school).
Compounding teen pregnancy, AI/ANs have the highest substance use and related morbidity and mortality of any U.S. racial group and are more likely to initiate drug and alcohol use before the age of 13. In AI communities, girls and boys have distinct patterns and processes for underage substance use that leads to early initiation of sex and sexual risk-taking. Among AIs, girls are more likely than boys to use substances during adolescence due to poor self-esteem or self-identity. Girls are also more likely than boys to be offered substances in private settings by female relatives. Additionally, poor attachment to parents is a stronger risk factor for substance use among girls than boys. Thus, gender-specific approaches are needed for optimal prevention of adolescent substance use in AI communities.
An intervention that works with AI females together with their female caregivers and incorporates AI cultural strengths and traditions, while also helping girls grow their ethnic identity and self-esteem may prove efficacious in preventing teen pregnancy, reducing early initiation of substance use and progression to misuse, and improving the health and well being of AI girls and families. The Navajo Nation and Johns Hopkins (JHU) have a long-standing history of addressing AI health disparities through culturally tailored and community-engaged programming and are poised to conduct the RCT described herein.
Investigators will evaluate the intervention: "Asdzaan Be'eena: Female Pathways" (AB). The program consists of 11 weekly sessions conducted with girls ages 10-14 and their female caregivers. Five 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. Transportation to the group sessions will be provided upon request. The program will be conducted over 2.5-3 months with one session occurring every week for 11 weeks. The total program duration is 660-990 minutes. The control condition was selected by community members and allows for minimal contamination and/or overlap between the AB curriculum and control group
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Asdzaan Be'eena ProgramThe 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). |
| 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 |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asdzaan Be'eena ProgramThe 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. | Behavioural | Intervention |
Primary outcome
Change in youth reported parent-youth communication scale
Time frame: Baseline, 6- and 12-months post implementation
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.
Change in parent reported parent-youth communication scale
Time frame: Baseline, 6- and 12-months post implementation
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.
Change in youth reported monitoring
Time frame: Baseline, 6- and 12-months post implementation
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.
Change in parent reported monitoring
Time frame: Baseline, 6- and 12-months post implementation
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.
Change in youth reported parental responsiveness
Time frame: Baseline, 6- and 12-months post implementation
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.
Change in parent reported parental responsiveness
Time frame: Baseline, 6- and 12-months post implementation
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.
Change in proportion of youth who state they plan to delay having sexual intercourse until they graduate from high school
Time frame: Baseline, 6- and 12-months post implementation
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.
Change in proportion of youth who state they plan to engage in sexual intercourse while they are a teenager
Time frame: Baseline, 6- and 12-months post implementation
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.
Change in mean score on externalizing and internalizing behaviors
Time frame: Baseline, 6- and 12-months post implementation
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).
13 secondary outcomes
Change in caregiver parenting self-efficacy
Time frame: Baseline, 6- and 12-months post implementation
Change in caregiver parenting agency
Time frame: Baseline and 6- and 12-months post implementation
Change in mean score on healthy relationship skills
Time frame: Baseline, 6- and 12-months post implementation
Change in in youth future aspirations
Time frame: Baseline, 6- and 12-months post implementation
Change in youth cultural connectedness
Time frame: Baseline, 6- and 12-months post implementation
Change in caregiver cultural connectedness
Time frame: Baseline and 6- and 12-months post implementation
Change in youth sexual initiation
Time frame: Baseline, 6- and 12-months post implementation
Change in proportion on youth substance use initiation
Time frame: Baseline, 6- and 12-months post implementation
Change in sexual activity, past 3 months
Time frame: Baseline and 6- and 12-months post implementation
Change in youth reported substance use, past 3 months
Time frame: Baseline and 6- and 12-months post implementation
Change in family environment and functioning
Time frame: Baseline and 6- and 12-months post implementation
Change in parental attitudes and expectations related to substance use and sexual intercourse
Time frame: Baseline and 6- and 12-months post implementation
Change in proportion of caregivers reporting substance use in the past 3 months
Time frame: Baseline and 6- and 12-months post implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 34154552Chambers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Tingey, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
Jennifer Richards, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asdzaan Be'eena Program in people with Sex Behavior, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in youth reported parent-youth communication scale (time frame: Baseline, 6- and 12-months post implementation). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.