Factors Predicting Ineffective Contraception Use

NCT03500978 | Completed DMC

• 2 other identifiers: HD0919271R21HD091927
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Consistent contraception use at 14-week follow-up

  Categorical (yes/no). Self report of using birth control consistently in prior month with a male sexual partner.

  14-week follow-up

Secondary Outcomes (2)

• Change in mean level of depressive symptoms from baseline to 14-week follow-up

  at 14-week follow-up

• Change in mean level of self esteem from baseline to 14-week follow-up

  at 14-week follow-up

Other Outcomes (6)

• Change in mean level of anxiety symptoms from baseline to 14-week follow-up

  14-week follow-up

• Change in mean level of somatic symptoms from baseline to 14-week follow-up

  14-week follow-up

• Change in mean level of perceived social support (belonging) from baseline to 10-week follow-up

  10-week follow-up

Study Arms (2)

Peer CBT Intervention

EXPERIMENTAL

Women allocated to the peer-specialist delivered CBT intervention group will be mailed an intervention workbook (CBT exercises) and have their first telephone-based intervention session scheduled. The CBT intervention group will receive 8 telephone-based CBT intervention sessions (over 9 weeks) delivered by peer specialists. Each session will last up to 30 minutes.

Behavioral: Peer CBT Intervention

Control

NO INTERVENTION

Women allocated to the observation-only control group will not receive any intervention.

Interventions

Peer CBT Intervention BEHAVIORAL

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

Peer CBT Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female, aged 18-45, sexually active with a man in past 3 months, report inconsistent or no contraception use in the past 3 months, English speaking, own a smartphone, report subclinical to mild depressive symptoms in past two weeks (score 5 to 14 on PHQ-9)

You may not qualify if:

• pregnant, using Long Acting Reversible Contraceptives, sterilized, planning to get pregnant in the next 6 months, report acute suicide risk (assessed via the PHQ Follow-up Suicide Risk Assessment form or self-repot a suicide attempt in the past 6 months)

Sponsors & Collaborators

• Temple University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Temple University School of Medicine OB/GYN

Philadelphia, Pennsylvania, 19122, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Stephen Lepore, PHD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization occurs after the baseline assessment, so the assessor is blinded to study condition. Follow-up assessments of outcome are completed by study personnel who are blinded to intervention (i.e., they had no part in the intervention and no access to the randomization schedule). An electronic research management system (RedCAP) is used to deliver the random assignments to the interventionist digitally after baseline is completed. None of the data collection or intervention staff have access to the database underlying the random assignment in RedCAP. The randomization schedule was established by the biostatistician, who has no role in the data collection or intervention delivery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two group (behavioral intervention vs. no treatment) randomized trial with a pre-intervention and 10- and 14-week post-intervention assessment phases.

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 18, 2018
• Study Start: March 19, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)