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

NCT02904629 | Completed

• 1 other identifier: 6670
• Study Type: interventional
• Target: 1,072
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sex; Unprotected Sex; Contraception; Alcohol Use; Drug Use; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Initiation of sexual activity as measured by the proportion of participants who report ever having sex

  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

  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

  3-month, 9-month, 12-month, 24-month, 36-month

Other Outcomes (7)

• Condom use at last sex as measured by the proportion of sexually active participants who report using a condom at last sex

  3-month, 9-month, 12-month, 24-month, 36-month

• Number of sexual partners as measured by the mean number of sexual partners reported in the past 3 months

  3-month, 9-month, 12-month, 24-month, 36-month

• Sexual activity without using a condom as measured by the proportion of participants who had sex without a condom in the past 3 months and the mean number of times reported having sex without a condom in the past 3 months

  3-month, 9-month, 12-month, 24-month, 36-month

Study Arms (2)

RCL Intervention

EXPERIMENTAL

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)

Control

OTHER

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

Interventions

Respecting the Circle of Life (RCL) BEHAVIORAL

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)."

RCL Intervention

Control Program OTHER

Control activities will consist of the delivery of educational lessons on nutrition, fitness, outdoor recreation, safety, environmental protection and nature.

Control

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
• Unwilling to be randomized

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Johns Hopkins Center for American Indian Health

Whiteriver, Arizona, 85941, United States

Location

Related Publications (2)

• Tingey L, Chambers R, Patel H, Littlepage S, Lee S, Lee A, Susan D, Melgar L, Slimp A, Rosenstock S. Prevention of Sexually Transmitted Diseases and Pregnancy Prevention Among Native American Youths: A Randomized Controlled Trial, 2016-2018. Am J Public Health. 2021 Oct;111(10):1874-1884. doi: 10.2105/AJPH.2021.306447. Epub 2021 Sep 16.

  PMID: 34529503 DERIVED

• Tingey L, Chambers R, Goklish N, Larzelere F, Lee A, Suttle R, Rosenstock S, Lake K, Barlow A. Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):89. doi: 10.1186/s13063-017-1842-6.

  PMID: 28241775 DERIVED

MeSH Terms

Conditions

Coitus; Unsafe Sex; Alcohol Drinking

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Drinking Behavior

Study Officials

• Allison Barlow, PhD

  Center for American Indian Health

  STUDY DIRECTOR

• Lauren Tingey, PhD

  Center for American Indian 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: August 30, 2016
• First Posted: September 19, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)