Contraceptive Awareness and Reproductive Education

NCT ID: NCT01627574

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2018-06-30

Brief Summary

The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served at-risk youth population.

Detailed Description

This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for at-risk youth for both those who do and do not want a pregnancy. Those interested in becoming pregnant will be counseled in the risks associated with teen pregnancy and what it means to have a healthy pregnancy and raise a child. The investigators will utilize Title X programs in Rhode Island to provide reproductive health services in the community. The investigators will recruit 250 at risk youth from RI Juvenile Probation Department (JPD), RI group homes and alternative schools, Job Corps of Rhode Island, and Community Mental Health Centers and randomize them to two interventions: two sessions of personalized MI or two sessions of Awareness for Sexual Health (ASH), both delivered individually by trained counselors. MI is based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. ASH provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.

Conditions

Pregnancy; Sexually Transmitted Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Motivational Intervention

There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up.

Group Type: EXPERIMENTAL

Motivational Intervention

Intervention Type: BEHAVIORAL

There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.

Didactic Educational Intervention

There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up.

Group Type: ACTIVE_COMPARATOR

Didactic Educational Intervention

Intervention Type: BEHAVIORAL

There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up.

Interventions

Motivational Intervention

There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.

Intervention Type: BEHAVIORAL

Didactic Educational Intervention

There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up.

Intervention Type: BEHAVIORAL

Other Intervention Names

Motivational Interviewing (MI); Awareness of Sexual Health (ASH)

Eligibility Criteria

Inclusion Criteria

• 1) Age 14-21;
• 2) Currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months;
• 3) Willing to comply with protocol, follow-up assessments, and provide at least one locator; and
• 4) Fluent in English.

Exclusion Criteria

• 1) Inability to give informed consent secondary to organic brain dysfunction, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that preclude participation in assessment or counseling);
• 2) Girls who are not sexually active; or
• 3) Currently pregnant.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: collaborator

University of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Lynda Stein, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynda Stein, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rhode Island

Locations

Juvenile Probation

Cranston, Rhode Island, United States

Exeter Job Corps

Exeter, Rhode Island, United States

Family Services of Rhode Island (i.e. group homes)

Providence, Rhode Island, United States

MET Schools (i.e., network of alternative schools throughout Providence and Newport)

Providence, Rhode Island, United States

Community Care Alliance (i.e., Community Mental Health Center)

Woonsocket, Rhode Island, United States

Countries

United States

References

Delaney DJ, Stein LAR, Bassett SS, Clarke JG. Motivational interviewing for family planning and reducing risky sexual behavior among incarcerated men nearing release: A randomized controlled pilot study. Psychol Serv. 2023 Aug;20(3):538-552. doi: 10.1037/ser0000552. Epub 2021 Nov 4.

Reference Type: DERIVED

PMID: 34735198 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HD065942

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HD065942

Identifier Type: -

Identifier Source: org_study_id