Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents

Study Overview
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Brief Summary
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The objective of this research study is to evaluate a culturally tailored sexual and reproductive health intervention among American Indian (AI) youth. Specifically, the investigators aim to evaluate the impact of Respecting the Circle of Life: Mind, Body and Spirit on knowledge, attitude and behavioral outcomes associated with risk for unprotected sex, sexually transmitted infection (STI) and unintended pregnancy through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the RCL intervention effectively reduces risky sexual behavior among AI adolescents (11-19 years old), with long term goals of reducing teen pregnancy and incidence/prevalence of STIs. The evaluation will focus on well-established intermediate outcomes/risky sexual behaviors that predict long-term impact on teen pregnancy and STI incidence.

Detailed Description
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The investigators have the following research questions: Confirmatory Research Question 1: Assess the effectiveness of the RCL intervention, compared to the control condition, on improving knowledge related to reproductive health, pregnancy, contraception and STIs. Outcome Measure 1: Knowledge Score (0-100%): Mean score on a 44-question reproductive and sexual health knowledge survey. Confirmatory Research Question 2: Assess the effectiveness of the RCL intervention, compared to the control condition, on delaying initiation of sexual activity. Outcome Measure 2: Proportion of participants who report they have ever had sex. Confirmatory Research Question 3: Assess effectiveness of the RCL intervention, compared to the control condition, on improving condom use self-efficacy. Outcome Measure 3: Condom Use Self-Efficacy Scale (range 1-5): Mean score on a 6-question Likert scale (1-5). Confirmatory Research Question 4: Assess the effectiveness of the RCL intervention, compared to the control condition, on increasing intention to use a condom at next sex. Outcome Measure 4: Proportion of participants who report they intend to use a condom at next sex. Sub-Group Analysis Question 1: Assess the effectiveness of the RCL intervention, compared to the control condition, on increasing reported condom use at last sex among sexually active participants. Sub-Group Analysis Outcome Measure 1: Proportion sexually active participants who report using a condom at last sex. Sub-Group Analysis Question 2: Assess the effectiveness of the RCL intervention, compared to the control condition, on reducing the number of sexual partners reported by sexually active participants in the past three months. Sub-Group Analysis Outcome Measure 2: Mean number of sexual partners reported in the past three months by sexually active participants. Sub-Group Analysis Question 3: Assess the effectiveness of the RCL intervention, compared to the control condition, on reducing the number of times sexually active participants reported having sex without a condom in the past three months. Sub-Group Analysis Outcome Measure 3: 1) Proportion of sexually active participants who had sex without a condom in the past three months. 2) Mean number of times reported having sex without a condom in past three months by sexually active participants. Sub-Group Analysis Question 4: Assess the effectiveness of the RCL intervention, compared to the control condition, on increasing contraceptive use among sexually active participants in the past three months. Sub-Group Analysis Outcome Measure 4: 1) Proportion sexually active participants who had sex without birth control in past three months. 2) Mean number of times reported having sex without birth control in past three months by sexually active participants. The impact evaluation will also examine two exploratory research questions: Exploratory Research Question 1: Examine whether the RCL intervention, compared to the control condition, improves parental engagement (communication and monitoring) among teen participants, and whether improved parental engagement is associated with decreased risky sexual behavior among those who are sexually active (as measured by confirmatory research question outcomes). Exploratory Research Question 2: a) Explore differences in risky sexual behaviors between adolescent participants who do and do not report substance use, and whether the RCL intervention, compared to the control condition, impacts adolescent substance use. b) Examine whether the RCL intervention, compared to the control condition, reduces reported substance use immediately prior to and/or during sex among sexually active participants.

Official Title
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Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents

Conditions
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Sex, Unprotected Sex, Contraception, Alcohol Use, Drug Use, Pregnancy

Intervention / Treatment
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* Behavioral: Respecting the Circle of Life (RCL)
* Other: Control Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Indian ethnicity Membership in the White Mountain Apache community. (Although the investigators anticipate the vast majority of participants will be White Mountain Apache tribal members, study participation is open to all American Indian individuals who live on the Fort Apache Indian Reservation or on/near the border). Participants ages 11+ must have parent/legal guardian consent Adult participants must sign written informed consent Exclusion Criteria: Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.) Unwilling to be randomized

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RCL Intervention<br>Respecting the Circle of Life (RCL) includes peer-group & youth-parent components. The peer-group component has 8 educational lessons, each lasting 90-120 minutes, delivered to self-selected same-sex peer groups of 8-10 AI teens. RCL lessons are delivered once/day during an 8-day summer basketball camp. The youth-parent component is one educational lesson lasting 90-120 minutes delivered within 3 months after camp to a teen and parent together at home. Total RCL duration is 810-1,080 minutes over 3 months. All 8 days of the camp are study days, in which RCL youth will receive one lesson each day. The investigators will evaluate RCL's impact on key sexual and reproductive health risk factors at 3-, 9-, 12-, 24-, and 36-month post-intervention follow-up time points. | Behavioral: Respecting the Circle of Life (RCL)<br>* Intervention activities will consist of the delivery of RCL: an holistic sexual, reproductive health and teen pregnancy prevention curriculum. RCL was adapted in 2011 from an evidence-based intervention (EBI) for the prevention of HIV/AIDS called Focus on Youth (FOY) + Informed Parents and Children Together (ImPACT).<br>|
| Other: Control<br>The control program includes peer-group & youth-parent components. The peer-group component has 8 educational lessons, each lasting 90-120 minutes, delivered to self-selected same-sex peer groups of 8-10 AI teens. Control lessons are delivered once/day during an 8-day summer basketball camp. The youth-parent component is one educational lesson lasting 90-120 minutes delivered within 3 months after camp to a teen and parent together at home. Total control duration is 810-1,080 minutes over 3 months. All 8 days of the camp are study days, in which control youth will receive one lesson each day. The investigators will evaluate the control program's impact on key sexual and reproductive health risk factors at 3-, 9-, 12-, 24-, and 36-month post-intervention follow-up time points. | Other: Control Program<br>* Control activities will consist of the delivery of educational lessons on nutrition, fitness, outdoor recreation, safety, environmental protection and nature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condom use self efficacy as measured by the Condom Use Self-Efficacy Scale (range 1-5): Mean score on a 6-question Likert scale (1-5) | Mean difference in ability to correctly and consistently use condoms, between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention. | 3-month, 9-month, 12-month, 24-month, 36-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of sexual activity as measured by the proportion of participants who report ever having sex | Delayed initiation of sexual activity between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention. | 3-month, 9-month, 12-month, 24-month, 36-month | 
| Knowledge of sexual and reproductive health as measured by the mean score on a 44-question reproductive and sexual health knowledge survey | Change in knowledge score (range 0-100%) related to sexual and reproductive health, pregnancy and contraception between intervention and control groups at between baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention. | 3-month, 9-month, 12-month, 24-month, 36-month | 
| Condom use intention as measured by the proportion of participants who report they intend to use a condom at next sex | Change in intention to use a condom at next sex, between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention | 3-month, 9-month, 12-month, 24-month, 36-month |