Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Contraception, Contraception, Psychiatric, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 11 - Any |
| Updated: | 1/6/2019 |
| Start Date: | May 2016 |
| End Date: | February 2022 |
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.
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.
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.
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.
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
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