Clinical trial NCT01627574: Contraceptive Awareness and Reproductive Education
Official title: Contraceptive Awareness and Reproductive Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Sexually Transmitted Infections
Keywords: Pregnancy
STI prevention
adolescents
probation
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Brown University
First posted: 2012-06-26
Enrollment: 272
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.
timeFrame: 9 month follow-up
measure: Number of Participants With a Positive STI Test After A Baseline Negative Test.
timeFrame: 9 month follow-up
measure: Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.
timeFrame: 9 month follow up
Secondary outcomes:
measure: Number of Participants With a Positive Pregnancy Test After Baseline Assessment
timeFrame: 9 month follow up
measure: Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.
timeFrame: 9 month follow up
measure: Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex.
timeFrame: 9 month follow-up
Other outcomes:
Locations:
city: Cranston
country: United States
facility: Juvenile Probation
state: Rhode Island
city: Exeter
country: United States
facility: Exeter Job Corps
state: Rhode Island
city: Providence
country: United States
facility: Family Services of Rhode Island (i.e. group homes)
state: Rhode Island
city: Providence
country: United States
facility: MET Schools (i.e., network of alternative schools throughout Providence and Newport)
state: Rhode Island
city: Woonsocket
country: United States
facility: Community Care Alliance (i.e., Community Mental Health Center)
state: Rhode Island
Study officials:
affiliation: University of Rhode Island
name: Lynda Stein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.