Factors Predicting Ineffective Contraception Use

NCT03500978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2020-06-26

No results posted yet for this study

Summary

Unintended pregnancy (UP), defined as a mistimed or unwanted pregnancy, is a significant and prevalent public health problem, particularly among low-income women. Over half of all pregnancies are reportedly unintended and UP has been linked to adverse health outcomes in mothers and their children. Correct and consistent use of effective contraception is the primary method to prevent UP. Research has shown that low self-esteem and elevated depressive symptoms increase women's risk for ineffective contraception use and, by extension, for UP. This project examines the feasibility and possible efficacy of reducing ineffective contraception using an intervention that addresses depressive symptoms and self concept among young, low-income, predominantly minority women at risk for UP. Traditional cognitive behavioral therapy (CBT) is effective in reducing depressive symptoms and improving self concept; but limited utilization, poor response, and low adherence to CBT is common among low-income and minority women. A more acceptable method for delivering CBT is needed for the target population. This project will use peer-specialists to deliver a CBT-based intervention to women at risk for UP. Because peer specialists are drawn from the same community as the target population and share some similar life experiences, the intervention may be more acceptable and effective than one offered by trained professionals.

This project will examine the effectiveness of a 9 week (8-session) peer-specialist led CBT-based intervention compared to an observational control condition to reduce depressive symptoms, improve self-esteem, and improve consistent contraceptive use to prevent UP. The weekly intervention sessions are delivered by telephone by a trained peer specialist. The study will evaluate the effectiveness of the intervention to improve consistent contraceptive use (primary outcome) and decrease depressive symptoms and increase self-esteem (secondary outcomes).

Conditions

  • Contraception Behavior

Interventions

BEHAVIORAL

Peer CBT Intervention

Peer specialist delivery of cognitive behavioral therapy intervention over the phone.

Sponsors & Collaborators

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

    collaborator NIH
  • Temple University

    lead OTHER

Principal Investigators

  • Stephen Lepore, PHD · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03500978 on ClinicalTrials.gov