Clinical trial NCT04863729: Evaluation of Asdzáán Be'eená Teen Pregnancy and Substance Use Prevention Program for Native American Youth and Their Caregiver
Official title: Evaluation of Asdzáán Be'eená Teen Pregnancy and Substance Use Prevention Program for Native American Youth and Their Caregiver
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sex Behavior
Keywords: Primary prevention
Teen pregnancy prevention
Substance use prevention
Parent-child intervention
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Children's Bureau - Administration for Children and Families
First posted: 2021-04-28
Enrollment: 820
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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:

-

Primary outcomes:
measure: Change in youth reported parent-youth communication scale
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in parent reported parent-youth communication scale
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in youth reported monitoring
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in parent reported monitoring
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in youth reported parental responsiveness
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in parent reported parental responsiveness
timeFrame: Baseline, 6- and 12-months post implementation
measure: 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
measure: Change in proportion of youth who state they plan to engage in sexual intercourse while they are a teenager
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in mean score on externalizing and internalizing behaviors
timeFrame: Baseline, 6- and 12-months post implementation
Secondary outcomes:
measure: Change in caregiver parenting self-efficacy
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in caregiver parenting agency
timeFrame: Baseline and 6- and 12-months post implementation
measure: Change in mean score on healthy relationship skills
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in in youth future aspirations
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in youth cultural connectedness
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in caregiver cultural connectedness
timeFrame: Baseline and 6- and 12-months post implementation
measure: Change in youth sexual initiation
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in proportion on youth substance use initiation
timeFrame: Baseline, 6- and 12-months post implementation
measure: Change in sexual activity, past 3 months
timeFrame: Baseline and 6- and 12-months post implementation
measure: Change in youth reported substance use, past 3 months
timeFrame: Baseline and 6- and 12-months post implementation
measure: Change in family environment and functioning
timeFrame: Baseline and 6- and 12-months post implementation
measure: Change in parental attitudes and expectations related to substance use and sexual intercourse
timeFrame: Baseline and 6- and 12-months post implementation
measure: Change in proportion of caregivers reporting substance use in the past 3 months
timeFrame: Baseline and 6- and 12-months post implementation
Other outcomes:
Locations:
city: Chinle
country: United States
facility: Center for American Indian Health - Chinle
state: Arizona
city: Tuba City
country: United States
facility: Center for American Indian Health - Tuba City
state: Arizona
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lauren Tingey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Jennifer Richards, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.